Diagnostics & Mitigation

There are several types of SARS-CoV-2 and COVID-19 related In vitro diagnostics

Diagnostic Tests – Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
Serology/Antibody Tests – Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody tests cannot be used to diagnose a current infection.
Tests for Management of COVID-19 Patients – Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.

To date, the FDA has currently authorized 166 tests under Emergency Use Authorizations (EUAs); these include 138 molecular tests, 26 antibody tests, and 2 antigen tests. A select few are highlighted below.

Product: BD Veritor System for Rapid Detection of SARS-CoV-2 (Rapid Antigen Testing)

Date of approval: July 06, 2020 (FDA EUA)

Time: 15 min

Brief Description: Rapid Point-of-Care Antigen Test

Details: FDA granted EUA for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor Plus System. The launch of this new assay that delivers results in 15 minutes on an easy-to-use, highly portable instrument is critical for improving access to COVID-19 diagnostics because it enables real-time results and decision making while the patient is still onsite. BD will begin shipping the new test and expects to ramp-up manufacturing capacity to 2 million tests per week by the end of September.

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Product: CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay

Date of approval: July 02, 2020

Time: Unknown

Brief Description: RT-PCR based multiplex assay

Details: The CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is a real-time reverse-transcriptase polymerase chain reaction (RT-PCR) test that detects and differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in upper or lower respiratory specimens. The assay provides a sensitive, nucleic-acid-based diagnostic tool for evaluation of specimens from patients in the acute phase of infection.

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Product: SARS-CoV-2 RT-PCR Test

Date of approval: July 01, 2020

Time: Unknown

Brief Description: RT-PCR based SARS-CoV-2 RNA detection kit

Details: CENTOGENE’S SARS-CoV-2 RT-PCR test is a real-time test based on the reverse transcription polymerase chain reaction (RT-PCR) for the qualitative detection of SARS-CoV-2, the underlying virus causing COVID-19. It is intended to be used with samples of the upper respiratory tract (oropharyngeal swabs) collected from individuals suspected by their healthcare provider to have COVID-19, belonging to a risk cohort, or having been in contact with a confirmed COVID-19 patient. The test is intended for use by qualified laboratory personnel to be performed in CENTOGENE’s CLIA certified high-complexity laboratories in Germany.

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Product: Sofia 2 SARS Antigen FIA

Date of approval: May 8, 2020

Time: 15 min

Brief Description: Lateral flow (strip) test for COVID-19 nucleocapsid protein

Details: Sofia 2 SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia 2 Instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARSCoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleocapsid protein antigen is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleocapsid protein antigen, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management.

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Product: COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit

Date of approval: June 30, 2020 (EUA)

Time: Unknown

Brief Description: RT-qPCR PNA KIT

Details: The COVID-19 RT-qPCR PNA KIT is developed with reusable fluorescence hybridization probe real-time PCR technique using Peptide Nucleic Acid (PNA), sort of artificial nucleic acid which has more higher binding ability to its complement sequence DNA than which of DNA one, to in vitro reverse transcription of SARS-CoV-2 (also known as SARS-2019-nCoV) RNA followed with cDNA amplification and detection.</span><br><span class=”fsize13″><br>The kit targets three specific genomic regions of SARS-CoV-2, those are RNA dependent RNA Polymerase (RdRP) gene , Nucleocapsid (N).

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Product: SCoV-2 Detect IgM ELISA & SCoV-2 Detect IgG ELISA

Date of approval: June 30, 2020 (EUA) for IgM & June 10, 2020 (EUA) for IgG

Time: Unknown

Brief Description: ELISA that specifically detects IgM antibodies and IgG antibodies to SARS-CoV-2

Details:

The SCoV-2 Detect IgM ELISA is an in vitro diagnostic test for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The SCoV-2 Detect IgM ELISA should be used to diagnose acute SARS-CoV-2 infection.
The SCoV-2 Detect IgG ELISA kit is an in vitro diagnostic test for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum. The test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The SCoV-2 Detect IgG ELISA should not be used to diagnose acute SARS-CoV-2 infection.

Source Link: IgM assay, IgG assay

Product: Access SARS-CoV-2 IgG

Date of approval: June 26, 2020 (EUA and CE)

Time: Unknown

Brief Description: Antibodies to SARS-CoV-2 in serum

Details: Qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes, and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

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Product: Illumina COVIDSeq Test

Date of approval: June 9, 2020

Time: 12 h

Brief Description: SARS-CoV-2 RT-PCR test

Details: The Illumina COVIDSeq Test is the first NGS test approved for use under the U.S. Food and Drug Administration’s Emergency Use Authorization (EUA). This amplicon-based NGS test includes 2019-nCoV primer and probe sets designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and mid-turbinate nasal swabs from patients with signs and symptoms of infection who are suspected of COVID-19.

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Product: Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)

Date of approval: June 8, 2020 (EUA)

Time: Unknown

Brief Description: Total Antibody, CLIA

Details: The COV2T assay detects both IgM and longer-lasting IgG antibodies with high sensitivity of recent and prior infection. This allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.

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Product: Lyra Direct SARS-CoV-2 Assay

Date of approval: May 19, 2020

Time: Unknown

Brief Description: RT-PCR based SARS-CoV-2 RNA detection kit

Details: Lyra Direct SARS-CoV-2 Assay is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleic acid is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

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Product: LineaCOVID-19 Assay Kit

Date of approval: May 13, 2020 (FDA EUA)

Time: Unknown

Brief Description: RT-PCR based qualitative detection of SARS-CoV-2 RNA

Details: Applied DNA Sciences’ Linea COVID-19 SARS-CoV-2 assay kit is a real-time polymerase chain reaction (RT-PCR) test for the qualitative detection of SAR S-CoV-2 RNA in upper respiratory specimens. The Linea COVID-19 SARS-CoV-2 Assay Kit provides a high-throughput solution to help laboratories address the urgent need for patient testing during the Coronavirus pandemic.

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Product: Alinity m SARS-CoV-2 assay

Date of approval: May 11, 2020 (FDA EUA)

Time: Unknown

Brief Description: Real-time RT-PCR assay to be run on run on the Alinity m system

Details: The Alinity m SARS-CoV-2 assay is a real-time reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal swabs, self-collected at a health care location or collected by a healthcare worker, nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare worker or bronchoalveolar lavage fluid (BAL) from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the CLIA, to perform moderate or high complexity tests.

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Product: Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay

Date of approval: May 7, 2020

Time: Unknown

Brief Description: RT-PCR kit

Details: Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in in oropharyngeal (throat) swab, nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, and bronchoalveolar lavage (BAL) fluid from individuals suspected of COVID-19 by their healthcare provider.

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Product: Quick SARS-CoV-2rRT-PCR Kit

Date of approval: May 7, 2020

Time: Unknown

Brief Description: RT-PCR COVID-19 detection kit

Details: Quick SARS-CoV-2rRT-PCR Kit is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, nasopharyngeal, mid-turbinate or oropharyngeal swabs), and lower respiratory specimens (such as sputum, tracheal aspirates, and bronchoalveolar lavage) from patients suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleic acid is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses

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Product: OPTI SARS-CoV-2 RT PCR Test

Date of approval: May 6, 2020

Time: Unknown

Brief Description: Real-time RT-PCR COVID-19 detection kit

Details: OPTI SARS-CoV-2 RT PCR Test is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasal, nasopharyngeal, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from patients suspected of COVID-19 by their health care provider. The SARSCoV-2 nucleic acid is generally detectable in upper and lower respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.

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Product: Sherlock CRISPR SARS-CoV-2 Kit

Date of approval: May 6, 2020

Time: Unknown

Brief Description: The assay is comprised of two steps. Step one is RT-LAMP where targeted SARS-CoV-2 genomic RNA is reverse transcribed to DNA then amplified by a strand-displacing DNA polymerase. Step two transcribes the amplified DNA to activate collateral cleavage activity of a CRISPR complex programmed to the target RNA sequence.

Details: Based on the SHERLOCK method, which stands for Specific High-sensitivity Enzymatic Reporter unLOCKing, the kit works by programming a CRISPR molecule to detect the presence of a specific genetic signature – in this case, the genetic signature for SARS-CoV-2 – in a nasal swab, nasopharyngeal swab, oropharyngeal swab or bronchoalveolar lavage (BAL) specimen. When the signature is found, the CRISPR enzyme is activated and releases a detectable signal. In addition to SHERLOCK, the company is also developing its INSPECTR platform to create an instrument-free, handheld test – similar to that of an at-home pregnancy test – that utilizes Sherlock Biosciences’ Synthetic Biology platform to provide rapid detection of a genetic match of the SARS-CoV-2 virus.

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Product: SARS-COV-2 R-GENE

Date of approval: May 6, 2020 (EUA)

Time: Unknown

Brief Description: SARS-CoV-2 RT-PCR test

Details: Qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes and bronchoalveolar lavage (BAL) fluid from individuals suspected of COVID-19 by their healthcare provider.

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Product: FTD SARS-CoV-2

Date of approval: May 5, 2020

Time: Unknown

Brief Description: Real-time RT-PCR for detection of COVID-19 nucleic acids

Details: FTD SARS-CoV-2 is a qualitative test for the detection of nucleic acid from SARS-CoV-2 upper respiratory specimens (such as nasal, nasopharyngeal, oropharyngeal swabs, and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage from individuals who are suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleic acid is generally detectable in upper respiratory specimens and bronchoalveolar lavage during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

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Product: Anti-SARS-CoV-2 ELISA (IgG)

Date of approval: May 4, 2020 (EUA, CE)

Time: Unknown

Brief Description: Anti-SARS-CoV-2 ELISA (IgG)

Details: ELISA test Qualitative detection of IgG antibodies against SARS-CoV-2 in human serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

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Product: EURORealTime SARS-CoV-2

Date of approval: June 8, 2020 (EUA, CE)

Time: Unknown

Brief Description: SARS-CoV-2 RT-PCR test

Details: Qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, nasopharyngeal, midturbinate and oropharyngeal swabs) and bronchioalveolar lavage (BAL) from individuals suspected of COVID-19 by their healthcare provider.

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Product: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Date of approval: May 4, 2020

Time: Unknown

Brief Description: Real time RT-PCR using approved real-time PCR instrument

Details: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate swabs, nasal washes, and nasal aspirates from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleic acid is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

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Product: Elecsys Anti-SARS-CoV-2

Date of approval: May 2, 2020

Time: Unknown

Brief Description: Immunoassay to detect anti-COVID-19 antibodies

Details: Elecsys Anti-SARS-CoV-2 is a qualitative test for the detection of antibodies against SARS-CoV-2 in human serum or plasma (Heparin or EDTA). The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection

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Product: Bio-Rad SARS-CoV-2 ddPCR Test & Platelia SARS-CoV-2 Total Ab assay

Date of approval: May 1, 2020 (EUA)

Time: Unknown

Brief Description: Quantitative Droplet Digital PCR & Qualitative detection of anti COVID-19 antibodies, based on immunoassay

Details:

Bio-Rad SARS-CoV-2 ddPCR Test: Qualitative detection of nucleic acid from SARS-CoV-2 innasopharyngeal, anterior nasal and mid-turbinate nasal swabspecimens as well as nasopharyngeal wash/aspirate and nasalaspirate specimens collected from individuals suspected of COVID-19 by their healthcare provider. Emergency use of thistest is limited to authorized laboratories.

Platelia SARS-CoV-2 Total Ab assay: Qualitative detection of total antibodies (including IgM/IgA/IgG) to SARS-CoV-2 in human serum and plasma (EDTA). Intendedfor use as an aid in identifying individuals with an adaptiveimmune response to SARS-CoV-2, indicating recent or priorinfection. Emergency use of this test is limited to authorizedlaboratories.

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Product: BioFire Respiratory Panel 2.1

Date of approval: May 1, 2020

Time: Unknown

Brief Description: Multiplex RT PCR for identification of several viruses including COVID-19

Details: BioFire Respiratory Panel 2.1 is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and differentiation of nucleic acids from multiple respiratory viral and bacterial organisms, including nucleic acid from the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 by their healthcare provider.

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Product: New York SARS-CoV Microsphere Immunoassay for Antibody Detection

Date of approval: April 30, 2020 (EUA)

Time: Unknown

Brief Description: Microsphere Immunoassay for Antibody Detection (IgG, IgM, IgA).

Details: Qualitative detection of total antibody (IgG, IgM, and IgA) to SARS-CoV-2 in human serum. Intended for use as an aid in identifying individuals who may have high levels of SARS-CoV-2-reactive antibodies in their blood that reflect an adaptive immune response to SARS-CoV-2 indicating recent or prior infection. Emergency use of this test is limited to Wadsworth Center, New York State Department of Health, which is certified under the CLIA to perform high complexity tests.

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Product: SARS-CoV-2 IgG assay

Date of approval: April 26, 2020 (EUA & CE Mark)

Time: Unknown

Brief Description: Detection of SARS-CoV-2 antibody

Details: The SARS-CoV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (ACD, CPD, CPDA-1, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium citrate, sodium heparin). The SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The SARSCoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform moderate or high complexity test.

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Product: LIAISON SARS-CoV-2 S1/S2 IgG

Date of approval: April 24, 2020

Time: Unknown

Brief Description: Qualitative detection of anti COVID-19 antibodies in human serum an plasma

Details: is a qualitative test for the detection of IgG antibodies against SARS-CoV-2 in serum and plasma (sodium heparin, lithium heparin, and potassium EDTA). The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARSCoV-2, indicating recent or prior infection

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Product: Anti-SARS-CoV-2 IgG Reagent Pack

Date of approval: April 24, 2020

Time: Unknown

Brief Description: Qualitative immunoassay for presence of anti COVID-19 antibodies in human serum

Details: Anti-SARS-CoV-2 IgG Reagent Pack is a qualitative test for the detection of IgG antibodies against SARS-CoV-2 in human serum. The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

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Product: Anti-SARS-CoV-2 Rapid Test

Date of approval: April 24, 2020

Time: Unknown

Brief Description: Immunoassay for qualitative detection of IgG and IgM anti-COVID-19 antibodies

Details: This test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin/ EDTA/ sodium citrate) or serum. The Anti-SARS-CoV-2 Rapid Test is intended for use as an aid in identifying patients with an adaptive immune response to COVID-19, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

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Product: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV

Date of approval: April 24, 2020 (EUA)

Brief Description: Taqman RT-PCR for ORF1ab gene

Time: 4 h for 192 samples

Details: On April 24, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) amendment for BGI’s Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2. The amendment expands the previously issued EUA label to further include the use of automated sample preparation system, additional viral RNA extraction kit and PCR systems for testing a broader range of clinical samples. Specifically, viral RNA extraction can be processed by the kits manufactured by MGI (a subsidiary of BGI Group) or Qiagen. In addition, the highly sensitive SARS-CoV-2 detection test can return results within 4 hours for 192 samples collected from throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) using the MGI automated sample preparation system.

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Product: STANDARD M nCoV Real-Time Detection kit

Date of approval: April 23, 2020

Time: Unknown

Brief Description: Multiplex real-time RT-PCR-based detection system

Details: STANDARD M nCoV Real-Time Detection kit is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens, and sputum from individuals who are suspected of COVID-19 by their healthcare provider. The SARS-CoV2 nucleic acid is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

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Product: RealStar SARS-CoV-2 RT-PCR Kit

Date of approval: April 23, 2020

Time: Unknown

Brief Description: Multiplex real-time RT-PCR-based detection system

Details: RealStar SARS-CoV-2 RT-PCR Kit is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes and nasal aspirates from individuals who are suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleic acid is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

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Product: Allplex 2019-nCoV Assay

Date of approval: April 21, 2020

Time: 1 h 50 min

Brief Description: Multiplex real-time RT-PCR-based detection system

Details: Allplex test kit is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in human nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate and sputum specimens from individuals who are suspected of COVID-19 by their health care provider. Detection and identification of target genes (E gene, RdRP gene, N gene) specific for COVID-19 in a single tube.

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Product: GeneFinder COVID-19 Plus RealAmp Kit

Date of approval: April 18, 2020 (FDA EUA, CE)

Brief Description: One step RT-PCR Kit

Time: 120 min

Details: GeneFinder COVID-19 Plus RealAmp Kit is the One-Step Reverse Transcription Real-Time PCR Kit designed to detect Novel Corona virus (COVID-19) qualitatively through Reverse Transcription reaction and Real-Time Polymerase Chain Reaction. It provides in about 120 minutes, detection for COIVD-19 in a single tube.

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Product: SARS-CoV-2 Fluorescent PCR Kit

Date of approval: April 15, 2020

Time: 2 hours

Details: This product is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (e.g., oropharyngeal swabs, nasopharyngeal swabs, nasal swabs, and midturbinate swabs) from individuals suspected of COVID-19 by their healthcare providers. The SARS-CoV-2 nucleic acid is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.

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Product: COVID-19 ELISA IgG Antibody Test

Date of approval: April 15, 2020

Time: NA

Details: The COVID-19 ELISA IgG Antibody Test consists of two serial direct Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative detection of human IgG antibodies in serum and plasma specimens collected from individuals suspected of prior infection with the virus that causes COVID-19 by their healthcare provider. An initial ELISA is performed against recombinant Receptor Binding Domain of SARS-CoV-2 in serum and plasma, followed for positive specimen by a confirmatory ELISA against full length SARS-CoV-2 Spike protein in serum and plasma. The COVID-19 ELISA IgG Antibody Test detects IgG antibodies as indicative of an immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection, or for the detection of IgG seroconversion in patients following known recent SARS-CoV-2 infection. The test is an aid in the diagnosis of patients with suspected of prior COVID-19 in conjunction with clinical presentation and the results of other laboratory tests. Results from the COVID-19 ELISA IgG Antibody Test should not be used as the sole basis for diagnosis and should not be used for the diagnosis of patients with acute COVID-19 infection. Testing is limited to the Mount Sinai Laboratory (MSL), Center for Clinical Laboratories), Department of Pathology, Molecular,and Cell-Based Medicine, New York, NY-10029, that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

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Product: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack

Date of approval: April 14, 2020

Time: 48 min

Details: The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator is for the qualitative measurement of total antibody (including IgG and IgM) to SARS-CoV-2 in human serum and plasma (K2 EDTA) samples from patients suspected of COVID-19 by a healthcare provider, using VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test should not be used as the sole basis for diagnosis. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high complexity tests .

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Product: iAMP COVID-19 Detection Kit

Date of approval: April 10, 2020

Time: 1.5 hours sample to result

Details: This is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in in nasal, nasopharyngeal (NP), and oropharyngeal (OP) swabs from patients suspected of COVID-19 by their health care provider. The SARS-CoV-2 nucleic acid is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

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Product: COVID-19 antibody test

Date of approval: Stanford is testing its health care worker and local people. No FDA approval yet.

Time: 2-3 days

Details: The Stanford Clinical Virology Laboratory was one of the first academic medical labs in the country to develop and administer a diagnostic test for the COVID-19 virus. Since starting to use the test in early March, more than 12,000 have been conducted on samples collected from people with symptoms of COVID-19 or with a known exposure to someone with the disease. Of these, about 9% have tested positive. The laboratory currently performs as many as 2,000 tests per day from samples collected at several Bay Area locations.

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Product: 2019-nCoV IgG/IgM Antibody Detection Kit (Colloidal Gold)

Date of approval: April 6, 2020 (CE)

Brief Description: IgG/IgM Antibody Detection Kit

Time: 10 min.

Details: Simultaneous detection of SARS-CoV-2 specific IgM and IgG antibodies: The 2019-nCov IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG & IgM antibody of Coronavirus in human venous whole blood, serum or plasma.

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Product: Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

Date of approval: April 3, 2020 (EUA)

Brief Description: Single step real-time RT-PCR

Time: 63-90 min., depending on PCR equipment.

Details: The Logix Smart Coronavirus Disease 2019 (COVID-19) Test kit is an in vitro diagnostic test that uses our patented CoPrimer technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus (COVID-19). The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in lower respiratory tract fluids (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs) from patients who meet the clinical criteria. The test is available to laboratories certified under the CLIA.

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Product: ARIES SARS-CoV-2 Assay

Date of approval: April 3, 2020

Time: Minimal hands-on time and an automated workflow delivers results in about 2 hours.

Details: This product is a qualitative test for the detection of SARS-CoV-2 nucleic acids in nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleic acid is detectable in nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.

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Product: qSARS-CoV-2 IgG/IgM Rapid Test

Date of approval: April 1, 2020 (FDA EUA)

Brief Description: Lateral flow immunoassay for IgM and IgG antibodies

Time: 15 to 20 min.

Details: The Cellex qSARS-CoV-2 IgG/IgM Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, citrate) or venipuncture whole blood specimens from patients suspected of COVID-19 infection by a healthcare provider.

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Product: QIAstat-Dx Respiratory SARS-CoV-2 Panel

Date of approval: March 30, 2020

Time: less than one minute for sample preparation and delivers results in about one hour.

Details: A multiplexed nucleic acid real-time PCR test intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

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Product: ID NOW COVID-19 assay

Date of approval: March 27, 2020 (FDA EUA)

Brief description: Rapid test targeting COVID-19 RdRp gene (PoC)

Time: Positive results may be detected in as little as 5 minutes and negative results in 13 minutes

Details: ID NOW COVID-19 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology intended for the qualitative detection of nucleic acid from the SARS-CoV-2 viral RNA in direct nasal, nasopharyngeal or throat swabs and nasal, nasopharyngeal or throat swabs eluted in viral transport media from individuals who are suspected of COVID-19 by their healthcare provider.

Source Link

Product: cobas SARS-CoV-2 Test.

Date of approval: March 12, 2020

Time: 96 results in about 3.5 hours and a total of 384 results for the cobas® 6800 System and 1056 results for the cobas® 8800 System in 8 hours

Supply: 1.5 million per month

Gene targets: specific target unique to COVID-19 and a conserved region of the E-gene

Details: The cobas SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2. The test is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the CDC SARS-CoV-2 clinical criteria. The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control.

Source Link

Product: RealTime SARS-C0V-2 assay

Date of approval: March 18, 2020 (EUA)

Details: The Abbott RealTime SARS-C0V-2 assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories, using real-time (RT) polymerase chain reaction (PCR) technology for the qualitative detection of nucleic acids from the SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection from individuals meeting CDC clinical and/or epidemiological testing criteria.

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Product: TaqPath COVID-19 Combo Kit.

Date of approval: March 13, 2020 (FDA EUA).

Brief Description: Multiplex real-time PCR detection of RNA from the SARS-CoV-2

Time: 94 patient specimens in under 3 hours.

Details: The TaqPath COVID-19 Combo Kit consists of both the TaqPath RT-PCR COVID-19 Kit and the TaqPath COVID-19 Control Kit. The kit can be used by clinical and public health laboratories to quickly evaluate up to 94 patient specimens in under 3 hours. The kit is approved for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) from patients at risk of exposure to the SARS-CoV-2 virus or with signs and symptoms of COVID-19. Testing is limited to laboratories certified under the CLIA.

Source Link

Product: NxTAG CoV Extended Panel Assay

Date of approval: March 27, 2020

Time: 96 samples in approximately 4 hours.

Supply: 300,000 NxTAG tests per month, with the majority of that capacity focused on SARS-CoV-2.

Target gene: ORF1ab, E gene, and N gene

Detail: NxTAG® CoV Extended Panel Assay for use on Luminex® MAGPIX® instrument is a RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider.

Source Link

Product: Accula SARS-Cov-2 Test

Brief Description: Rapid point-of-care PCR test

Date of approval: March 23, 2020 (FDA EUA)

Time: 30 min.

Details: Mesa Biotech has developed a qualitative, visually read test utilizing polymerase chain reaction (PCR) technology to detect SARS-CoV-2, the virus responsible for COVID-19. Using throat and nasal swabs, results are available in 30 minutes, based on the principles of Mesa’s commercially available Accula Influenza and RSV tests.

Source Link

Product: Xpert Xpress SARS-CoV-2 test

Brief Description: Rapid, near-patient RT-PCR test

Date of approval: March 20, 2020 (EUA)

Time: 30 min.

Details: Cepheid has developed an automated molecular test for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19. The test leverages the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted. The test can provide rapid detection of the current pandemic coronavirus SARS-CoV-2 in as soon as 30 minutes for positive results with less than a minute of hands on time to prepare the sample.

Source Link

The Race for COVID-19 Vaccines

As per the draft landscape of COVID-19 candidate vaccines released by the WHO (July 7, 2020), there are 21 candidate vaccines in clinical evaluation and 139 candidate vaccines in preclinical evaluation [Link]. Researchers are evaluating different strategies, some tested and some novel, to induce the immune system to produce effective antibodies and get a safe and effective vaccine ready by next year.

The vaccine testing process, right from the preclinical trials to the Phase I safety trials, the expanded Phase II (hundreds enrolled) as well as Phase III efficacy trials (thousands enrolled) are required to determine if the vaccine protects against the pathogen. The approval process follows once a vaccine successfully clears these checks. In a pandemic situation like the current crisis, the phases II and III can be combined to save time to reach the ultimate safety and efficacy goals.

Vaccine development is a time-consuming (often many years) and expensive process. Developing a vaccine quickly requires a new paradigm, with many steps executed in parallel. It involves high risk financially as well, including an early manufacturing scale-up plan and set-up expected even before actual results are seen.

Vaccine Development Process

With deciphering of the SARS-CoV-2 genome in January, the race to vaccine accelerated at unprecedented pace. As of July 7, 2020, there are 15 vaccines in Phase II and III combined with one vaccine (CanSino Biologics) being approved for military use in China. Overall, the vaccines development can be visualized as below based on their current stage of development.

Current status

Currently, there are at least eight approaches explored for the development of a vaccine. These include Virus vaccines (weakened or inactivated form), Viral-vector vaccines (replicating or non-replicating), nucleic acid forms (RNA, DNA), Protein-based vaccines (Subunit or Virus-like Particles) as well as testing whether existing vaccines (e. g. poliovirus or tuberculosis) could elicit a response to the pathogen.

Methods

Select vaccines that have reached clinical trials, as well as promising candidates in preclinical trials are highlighted below.

Candidate: Non-Replicating Viral Vector AZD1222 (ChAdOx1)

Sponsors/Developers: The University of Oxford, The Jenner Institute | AstraZeneca; BARDA; UK Ministry of Health

Location: UK, Brazil

Trial Identifier: NCT04400838 – A Phase 2/3 Study to Determine the Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 (COV002)

Description: Developed at the University of Oxford’s Jenner Institute, and working with the Oxford Vaccine Group, ChAdOx1 nCoV-19 uses a viral vector based on a weakened version of the common cold (adenovirus) containing the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack COVID-19 if it later infects the body. The recombinant adenovirus vector (ChAdOx1) was chosen to generate a strong immune response from a single dose and it is not replicating, so cannot cause an ongoing infection in the vaccinated individual. Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated, although they can cause temporary side effects such as a temperature, flu-like symptoms, headache or sore arm.

Status: July 02, 2020 – Sarah Gilbert, professor of vaccinology at the university, said 8,000 volunteers had been enrolled for the Phase III of its trial into the vaccine, AZD1222, which was licensed to AstraZeneca. Gilbert said she hoped that her Oxford vaccine would make progress earlier, but was not more specific as she said the timeline for when the vaccine might be ready depends on the results of the tria (Link).

Publications:

  • BioRxiv preprint: A single dose of ChAdOx1 MERS provides broad protective immunity against a variety of MERS-CoV strains – A prime-boost regimen of ChAdOx1 MERS boosted antibody titers, and viral replication was completely absent from the respiratory tract tissue of these rhesus macaques.
  • BioRxiv preprint and Publication: ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques – A single vaccination with ChAdOx1 nCoV-19 induced a humoral and cellular immune response in rhesus macaques – a significantly reduced viral load in bronchoalveolar lavage fluid and respiratory tract tissue of vaccinated animals challenged with SARS-CoV-2 compared with control animals, and no pneumonia was observed in vaccinated rhesus macaques. There was no evidence of immune-enhanced disease following viral challenge in vaccinated animals was observed.

Candidate: Non-replicating viral vector (Adenovirus type 5 vector) vaccine

Sponsors/Developers: CanSino Biologics | Beijing Institute of Biotechnology (Beijing); Jiangsu Province CDC, Hubei Provincial CDC, Zhongnan Hospital, Canadian Center for Vaccinology

Location: China, Canada

Trial identifier: LIMITED APPROVAL (Military use only). NCT04313127 (Phase 1), NCT04398147 (phase 2, Canada), NCT04341389 (Phase 2, China)

Description: Recombinant adenovirus type 5 (Ad5) vector expressing the SARS-CoV-2 S protein: The vaccine is a replication defective Ad5 vectored vaccine expressing the spike glycoprotein of SARS-CoV-2. An optimised full-length spike gene based on Wuhan-Hu-1 (GenBank accession number YP_009724390) was cloned with the tissue plasminogen activator signal peptide gene into an E1 and E3 deleted Ad5 vector and constructed the Ad5 vectored COVID-19 vaccine using the Admax system from Microbix Biosystem (Toronto, ON, Canada). The Ad5 vectored COVID-19 vaccine was manufactured as a liquid formulation containing 5 × 1010 viral particles per 0·5 mL in a vial.

Status: On Monday, June 29, the company developing a vaccine called Ad5-nCoV, CanSino, announced it had been authorized for use in the military by the country’s Central Military Commission.

Publications:

Candidate: Lipid nanoparticle (LNP) encapsulated mRNA (mRNA-1273)

Sponsors/Developers: Moderna, Inc. | National Institute of Allergy and Infectious Diseases (NIAID); Funding from the Biomedical Advanced Research and Development Authority (BARDA); Kaiser Permanente Washington Health Research Institute

Location: U.S.

Trial identifier: NCT04405076 (Phase 2)

Description: mRNA-1273 is an mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the NIAID. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.

Status: The company is eyeing Phase III trials in July and hopes to have vaccine doses ready by early 2021. Moderna completed enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273) on July 7, 2020.

Publications:

  • BioRxiv preprint (11 June): mRNA-1273 induces both potent neutralizing antibody and CD8 T cell responses and protects against SARS-CoV-2 infection in lungs and noses of mice without evidence of immunopathology.
  • July 10, 2020: Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19: Remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials. Traditionally marginalized racial/ethnic groups treated with Remdesivir had similar clinical outcomes as overall patient population. Compassionate use program, which demonstrated that 83 percent of pediatric patients (n=77) and 92 percent of pregnant and postpartum women (n=86) with a broad spectrum of disease severity recovered by Day 28.

Candidate: Inactivated virus (CoronaVac)

Sponsors/Developers: Sinovac Biotech Ltd.; Funding by Advantech Capital and Vivo Capital

Location: Brazil; China

Trial identifier: NCT04456595 (Phase III)

Description: To develop preclinical in vitro neutralization and challenge models for a candidate SARS-CoV-2 vaccine, SARS-CoV-2 strains were isolated from BALF samples of 11 hospitalized patients. The 11 samples contained SARS-CoV-2 strains that are widely scattered on the phylogenic tree constructed from all available sequences, representing, to some extent, circulating SARS-CoV-2 populations. Strain CN2 was chosen for purified inactivated SARS-CoV-2 virus vaccine development (PiCoVacc) and another 10 strains (termed as CN1, CN3-CN5 and OS1-OS6) as preclinical challenge strains. Of note, the CN1 and OS1 strains are closely related to 2019-nCoV-BetaCoV /Wuhan/WIV04/2019 and EPI_ISL_412973, respectively, which have been reported to cause severe clinical symptoms, including respiratory failure, requiring mechanical ventilation.

Status: Sinovac (Beijing, China), in collaboration with Butantan (Sao Paulo, Brazile), receives approval from the Brazilian National Regulatory Agency, Anvisa, for a Phase III trial of its COVID-19 vaccine candidate, as on July 6, 2020.

Publications:

Candidate: Protein subunit; NVX-CoV2373; Full-length recombinant SARS COV-2 glycoprotein nanoparticle vaccine adjuvanted with Matrix M

Sponsors/Developers: Novavax, Inc.

Location: Australia

Trial identifier: NCT04368988 (Phase III)

Description: NVX-CoV2373 is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology. Novavax’ proprietary Matrix-M adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies. NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, antibodies that block the binding of the spike protein to the receptor and wild-type virus neutralizing antibodies. High levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were observed after a single immunization. In addition, the already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.

Status: On July 6, Novavax announced a U.S. government award of $1.6 billion to support clinical trials and manufacturing. If the trials succeed, Novavax expects to deliver 100 million doses for use in the United States by the first quarter of 2021. Plants in Europe and Asia would be able to satisfy more of the world’s demand. The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020.

Candidate: Four BNT162 Vaccines – BNT162 a1, b1, b2, and c2

Sponsors/Developers: BioNTech RNA Pharmaceuticals GmbH | Fosun Pharma | Pfizer

Location: Germany, U. S.

Trial identifier: NCT04368728 (Phase I/II); NCT04368728 (Phase I/II)

Description: BNT162b1 is a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.

Status: Pfizer’s press release (July 01, 2020) says they will pick a lead candidate from the 4 to go into a phase 2b/3 global trial with 30,000 people, possibly starting by the end of July if they get the green light from regulatory agencies. They also say they expect journal publication of the results in the preprint soon. July 10, 2020: BioNTech SE and Pfizer Inc’s COVID-19 vaccine candidate is expected to be ready to seek regulatory approval by the end of 2020, the Wall Street Journal reported, citing the German biotech firm’s chief executive officer.

Publications:

Recent Progress:

  • Rapid isolation and profiling of a diverse panel of human monoclonal antibodies targeting the SARS-CoV-2 spike protein [Link] (07/10/20)
  • Potent neutralizing antibodies against SARS-CoV-2 identified by high-throughput single-cell sequencing of convalescent patients’ B cells [Link] (07/09/20)
  • U.S. phase 3 trial of Kevzara (Sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation fails to meet its primary and key secondary endpoints [Link] (07/02/20)
  • TOCIVID-19 prospective phase 2 trial (n=301) results show reduced 30-day lethality for Tocilizumab [Link] (07/02/20)
  • Early treatment with Tocilizumab and Methylprednisolone shows better failure-free and overall survival in cases of severe COVID-19 [Link] (06/27/20)
  • Tocilizumab, intravenously or subcutaneously administered, reduced risk of invasive mechanical ventilation or death in an Italian study [Link] (06/24/20)
  • Siltuximab, via IL-6 signaling inactivation, shows reduced 30-day mortality rate than best supportive care [Link] (06/20/20)
  • All patients treated with GM-CSF blocking antibody Mavrilimumab (n=13) show clinical improvement compared with standard care (65%) [Link] (06/16/20)
  • Tocilizumab is associated with reduced lethality rate at 30 but not at 14-days, without significant toxicity in a multicenter single-arm phase 2 trial [Link] (06/05/20)
  • A retrospective study of 171 patients shows Tocilizumab in the early stages of the inflammatory flare reduces ICU admissions and mechanical ventilation use [Link] (06/05/20)
  • An alpaca nanobody neutralizes SARS-CoV-2 by blocking receptor interaction (Karolinska Institutet study) [Link] (06/02/20)

Country: UK

Product type: Nucala/Meplazumab, interleukin-5 antagonist monoclonal antibody

Stage: FDA-approved since 2015, approved to treat Asthma, Eosinophilic Granulomatosis with Polyangiitis

Publish date: March 21, 2020

Cure effect: Compared to control group, meplazumab treatment significantly improved the discharged (p=0.006) and case severity (p=0.021) in critical and severe patients.

Source Link

Country: France/US

Type of antibody: Kevzara (sarilumab), interleukin-6 receptor antagonist

Stage of clinical: Phase II/III (FDA-approved since 2017, approved to treat rheumatoid arthritis)

Anticipated timing: March 2020

Description: IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 while Sarilumab (Kevzara) can inhibit the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor.

Status: The first patient outside of the US has been treated with Kevzara (sarilumab) in the second phase of the clinical programme for patients hospitalized with severe COVID-19. Trials have now started in Italy, Spain, Germany, France, Canada, Russia and the US. (March 30)

Source Link

Country: US

Type of antibody: Actemra (tocilizumab), interleukin-6 receptor antagonist

Stage of clinical: Phase 3(FDA-approved since 2010, approved to treat various type of arthritis, including rheumatoid arthritis, and cytokine release syndrome)

Anticipated timing: April 2020

Source Link

Other related trials: China (3), Italy (1)

Cure effect: On March 5, Chinese researchers reported a retrospective that 19 out of 21 severe patients have been discharged on average 13.5 days after the treatment with tocilizumab and the rest are recovering well. While on March 21, Italian researchers found possible correlation of interleukin-6 receptor inhibitors with osteonecrosis of the jaws, reminding the potential risk of using tocilizumab for treatment.

Read more: Reference 1, Reference 2

Product type: Avastin (bevacizumab), vascular endothelial growth factor inhibitor

Stage: FDA-approved since 2004, approved to treat certain types of cancer

Status: An interventional clinical trial is underway at the Qilu Hospital of Shandong University in Jinan, China. The trial aims to assess the safety of bevacizumab and its effectiveness in treating severe and severe new crown pneumonia and dyspnea (shortness of breath) and diffuse pulmonary lesions in patients with COVID-19. The trial aims to enroll over 100 participants and its estimated completion date is May 31, 2020. A second trial of bevacizumab is a Phase II/III trial, also being conducted by Qilu Hospital of Shandong University. This is an open-label, single-group trial that will include 20 participants with severe COVID-19 and pneumonia, with an estimated completion date of May 2020. (March 23, 2020)

Product type: Sylvant (siltuximab), interleukin-6 targeted monoclonal

Stage: Clinical (FDA-approved since 2004, approved to treat multicentric Castleman disease who are HIV-negative and human herpesvirus-8 negative)

Status: Initial data is expected in late March 2020.

Source Link

Product type: Soliris (eculizumaab), complement inhibitor

Stage:Expanded Access(FDA-approved since 2007)

Detail:COVID-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient’s own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.

Source Link

Product type: Ilaris (canakinumab), interleukin-1beta blocker

Stage: Clinical (FDA approved since 2009)

Source Link

Product type: leronlimab (PRO 140), a CCR5 antagonist

Stage: Clinical

Status: Phase 2

Source Link

Product type: Antibodies from recovered COVID-19 patients

Stage: Pre-clinical

Status: Vir Biotechnology announces that it has identified multiple human monoclonal antibody (mAb) development candidates that neutralize SARS-CoV-2, the virus responsible for COVID-19. The firm expects human trials to begin within 3-5 months. (March 25)

Source Link

Recent Progress:

  • High Favipiravir dose alleviates disease in Syrian hamster model but shows significant toxicity effects [Link] (07/07/20)
  • HCQ and lopinavir/ritonavir treatment arms for COVID-19 to be discontinued in Solidarity trial by WHO based on poor interim results [Link] (07/04/20)
  • Combinations of nitazoxanide with three other compounds (remdesivir, amodiaquine and umifenovir) exhibit significant synergy based on in silico approaches [Link] (07/01/20)
  • A retrospective study of hospitalized patients in Thailand shows 67.7% day-7 clinical improvement rate following Favipiravir treatment with a low loading dose as poor prognostic factor for early clinical response [Link] (07/01/20)
  • Berzosertib, an ATR kinase inhibitor in the DDR pathway, seen as a potential repurposed candidate following screening of small molecule library of 430 protein kinase inhibitors [Link] (06/27/20)
  • Screening of a repurposing library reveals Cyclosporine as a potent antiviral against SARS-CoV-2 in lung epithelial cells [Link](06/19/20)
  • Boceprevir, GC-376, calpain inhibitors II and XII inhibit SARS-CoV-2 replication in cell culture [Link] (06/14/20)
  • Retrospective cohort study shows prolonged viral shedding was significantly associated with delayed initiation of Arbidol (7 days after symptom onset) [Link] (06/09/20)
  • Remdesivir shows improvements in SARS-CoV-2 infected Rhesus macaque; no respiratory disease, reduced virus viral loads and damage to the lungs [Link] (06/09/20)
  • Sofosbuvir, an FDA-approved antiviral drug, shows promise in infected iPSC-derived human brain organoids [Link] (05/31/20)
  • Remdesivir Most ‘Beneficial’ In Covid-19 Patients Who Need Extra Oxygen [Link] (05/24/20)
  • Triple anti-viral drug shows COVID-19 promise in Hong Kong study [Link] (5/10/20)
  • Inhibition of the replication of SARS-CoV-2 in human cells by the FDA approved drug chlorpromazine [Link] (5/7/20)
  • FDA issues emergency-use authorization for remdesivir to treat hospitalized patients with severe Covid-19 [Link] (5/2/20)
  • Preliminary data show that tocilizumab improved the clinical outcome immediately in severe and critical COVID-19 patients [Link] (4/30/20)
  • Gilead says critical study of Covid-19 drug shows patients are responding to treatment [Link] (4/29/20)
  • Gilead Virus Drug May Reduce Sperm Count in Mice: Chinese Study [Link] (4/26/20)
  • New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients (some experts see the result as inconclusive) [Link] (4/23/20)
  • Enisamium inhibits the influenza A virus and SARS-CoV-2 RNA polymerases [Link] (4/22/20)
  • New study shows no benefit of hydroxychloroquine to treat COVID-19 [Link] (4/21/20)
  • Remdesivir prevents COVID-19 progression in monkeys [Link] (4/19/20)
  • Early peek on Remdesivir clinical trial data shows promising results [Link] (4/16/20)
  • A couple new compounds (Auranofin, Baicalin, Baicalein and Doxycycline) have been identified to inhibit coronavirus replication in vitro [Link][Link][Link](4/15/20)
  • No evidence of clinical efficacy of hydroxychloroquine in patients hospitalized for COVID-19 infection with oxygen requirement [Link] (4/14/20)
  • Hopeful results of Remdesivir for Patients with Severe Covid-19 [Link] (4/11/20)
  • Viriom Initiates Phase 2 Clinical Study of Elsulfavirine for Treatment of COVID-19 [Link] (4/8/20)
  • Algernon regulatory submission for Ifenprodil human trial in South Korea [Link] (4/7/20)
  • A new study shows that among those patients who received lopinavir-ritonavir, the time to clinical improvement was significantly shorter than in patients receiving standard of care alone [Link] (4/6/20)
  • EIDD-2801, a new compound inhibits multiple coronaviruses in mice [Link] (4/6/20)

Details: The broad-spectrum antiviral agent Remdesivir (GS-5734; Gilead Sciences, Inc) is a nucleotide analog prodrug. The US FDA issued EUA of remdesivir to allow emergency use in children and hospitalized adults. The findings from the NIAID trial of remdesivir in hospitalized patients with advanced COVID-19 have been published in a peer-reviewed medical journal. These findings support the use of remdesivir in this population, with the largest benefit observed among individuals who required oxygen supplementation but were not mechanically ventilated. The open-label phase 3 SIMPLE trial (n = 397) in hospitalized patients with severe COVID-19 disease not requiring mechanical ventilation showed similar improvement in clinical status with the 5-day remdesivir regimen compared with the 10-day regimen on day 14 (OR=0.75). The first published report concerning remdesivir compassionate use described clinical improvement in 36 of 53 hospitalized patients (68%) with severe COVID-19. At baseline, 30 patients (57%) were receiving ventilation and 4 (8%) extracorporeal membrane oxygenation (ECMO).

Publications:

  • Remdesivir for the Treatment of Covid-19 – Preliminary Report (May 22, 2020) [Link]
  • Remdesivir for 5 or 10 Days in Patients with Severe Covid-19 (May 27, 2020) [Link]
  • Clinical benefit of remdesivir in rhesus macaques infected with SARS-CoV-2 (Jun 09, 2020) [Link]
  • Structural basis for inhibition of the RNA-dependent RNA polymerase from SARS-CoV-2 by remdesivir (Jun 26, 2020) [Link]
  • Compassionate Use of Remdesivir for Patients with Severe Covid-19 (jun 11, 2020) [Link]

Company:Gilead Sciences, Inc

Status: Coordinating closely with the U.S. FDA, Gilead has designed and will soon begin enrollment of an open-label, single-arm Phase 2/3 clinical trial that will evaluate the safety, tolerability, pharmacokinetics and efficacy of remdesivir in treating approximately 50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents. This important trial will be conducted at more than 30 sites in the United States and Europe (Trial ID: NCT04431453).

Remdesivir, Hydroxychloroquine and Chloroquine

Publish Date: March 21, 2020

Source Link

Ivermectin is a medication used to treat many types of parasite infestations [link]. A new study shown that it can also kill coronavirus in a laboratory setting in under 48 hours.

Ivermectin skeletal.svg

Publish Date: April 4, 2020

Source Link

Conclusion: The drug is known as EIDD-2801. It works by interfering with the coronavirus’ ability to make copies of itself once it infects a cell. In that regard it’s similar to remdesivir, a drug currently being tested in COVID-19 patients.

Publish Date: April 6, 2020

Source Link

Company: Emory University

Status: New compound, an orally bioavailable NHC-prodrug (β-D-N4-hydroxycytidine-5′-isopropyl ester)

Conclusion: Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro

Publish Date: March 18, 2020

Source Link

Conclusion: In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care

Publish Date: March 18, 2020

DOI: 10.1056/NEJMoa200128

Source Link

Company: Fujifilm Toyama Chemical/Zhejiang Hisun Pharmaceuticals/numerous trials with Chinese research sponsors

Conclusion: FPV showed significantly better treatment effects on COVID-19 in terms of disease progression and viral clearance

Publish Date: March 18, 2020

Source Link

Conclusion: In ordinary COVID-19 patients untreated with antiviral previously, favipiravir can be considered as a preferred treatment because of its′ higher 7 day′s clinical recovery rate and more effectively reduced incidence of fever, cough except some antiviral-associated adverse effects

Publish Date : March 17, 2020

Source Link

Conclusion: After 4 to 12-day treatment of danoprevir boosted by ritonavir, all eleven patients enrolled, two naive and nine experienced, were discharged from the hospital.

Publish Date : March 24, 2020

Source Link

  • Hydroxychloroquine with antibiotics shows poor clinical outcomes compared to conservative treatment in retrospective cohort study from South Korea [Link] (07/07/20)
  • A new nickel foam air filter catches, heats and kills the SARS-Cov-2 virus and other pathogens [Link] (07/08/20)
  • Corticosteroids lower risk of the primary composite outcome in a single center retrospective study of 205 non-ICU patients hospitalized with COVID-19 pneumonia [Link] (07/04/20)
  • Physician-sponsored cohort study suggests histamine blockers (Cetirizine/Famotidine) may act by minimizing the histamine-mediated cytokine storm [Link] (07/06/20)
  • Dutch study on Convalescent Plasma as therapy (CONCOVID Study) fails as patients already had high neutralizing antibody titers [Link] (07/03/20)
  • Early combination therapy of anti-inflammatory (Corticosteroids and Enoxaparin) and antiviral drugs in moderate to severe COVID-19 cases shows reduced complications and improved clinical outcomes [Link] (06/29/20)
  • Convalescent plasma therapy effective in Iran study with high antibody level donors and patients in early stage of critical illness [Link] (06/29/20)
  • JAK1/JAK2 inhibitor baricitinib can correct immune abnormalities observed in hospitalized patients and reduce mortality [Link] (06/29/20)
  • Multicenter, observational study shows early administration of prolonged methylprednisolone significantly reduces death hazard [Link] (06/20/20)
  • Methylprednisolone, a corticosteroid medication, shows better clinical outcome (composite end point) in partially randomized clinical trial [Link] (06/18/20)
  • Dexamethasone saves lives in COVID-19: Results from the randomized UK RECOVERY trial [Link] (06/16/20)
  • Janus kinase 1/2 inhibitor Ruxolitinib shows positive results in a single arm, non-randomized open phase II trial for patients with defined hyperinflammation [Link] (06/09/20)
  • Retrospective cohort study of 280 patients shows lower mortality in the Ivermectin group especially in patients who required higher inspired oxygen or ventilatory support [Link](06/09/20)
  • Ten consecutive patients on high-dose oral famotidine show marked improvements of disease related symptoms [Link](06/08/2020)
  • Off-label use of commercial cancer drug acalabrutinib (CALQUENCE) leads to rapid improvements in oxygenation [Link] (06/08/20)
  • Treatment with Ruxolitinib, a JAK1/2 inhibitor, leads to faster clinical improvement in a phase II RCT for 43 patients [Link] (05/26/20)
  • Johns Hopkins School of Public Health finds inverse correlations between COVID-19 and BCG. COVID-19-attributable mortality among BCG-using countries was 5.8 times lower [Link] (04/13/20)
  • Johns Hopkins gets FDA approval to test blood plasma therapy to treat COVID-19 patients [Link] (04/04/20)
  • Therapeutics startup Celularity announced Thursday morning that it has received FDA clearance to begin a clinical trial of a proposed stem-cell treatment for COVID-19 [Link] (04/02/20)
  • Seoul Viosys and SETi’s Violeds Technology Proves 99.9% Sterilization of Coronavirus in 30 Seconds (04/02/20) [Link]

The 4-aminoquinoline antimalarials chloroquine and hydroxychloroquine have been promoted and sometimes used in the treatment of COVID-19, alone or combined with azithromycin, based on their immunomodulatory and antiviral properties, despite an absence of methodologically appropriate proof of their efficacy. These drugs, however, might be associated with cardiac toxicity. On June 15, 2020, the FDA revoked the emergency use authorization (EUA) for hydroxychloroquine and chloroquine. The NIH halted the Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) study on June 20, 2020. After the fourth analysis that included more than 470 participants, the NIH data and safety monitoring board determined that, while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19.

A recent FDA warning advises that, based on a recently completed non-clinical study, the co-administration of hydroxychloroquine with remdesivir may interfere with the antiviral activity of remdesivir and reduce remdesivir’s effectiveness. Swiss pharmaceutical company Novartis has also decided to suspend its hydroxychloroquine trial for Covid-19 over enrolment challenges, which made completion of the trial infeasible.

A randomized, placebo controlled trial of hydroxychloroquine for prevention of COVID-19 shows lack of efficacy – The University of Minnesota enrolled health-care workers and others exposed to the disease in the first randomized prevention study of the drug (Post-exposure prophylaxis). Study enrolled more than 800 adults in the United States and Canada who were exposed to someone with covid-19 because of their jobs as health-care workers or first responders, or because they lived with someone with the disease (Source)

FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.

Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.

Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials (Source).

Scientists and clinicians across the globe have responded to the ongoing coronavirus pandemic with a huge, high-quality global research effort to find a treatment for COVID-19. As of June 6, 2020, there are over 3230 trials registered, with up to 1923 Interventional trials and rest comprising mainly of Observational studies (1210), and Diagnosis tests (42).

Additionally, of note is the “Solidarity”, an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners. Based on evidence from laboratory, animal and clinical studies, the following treatment options were selected – Remdesivir, Lopinavir/Ritonavir, Lopinavir/Ritonavir with Interferon beta-1a, Chloroquine or Hydroxychloroquine.

Vaccine makers are racing to develop COVID-19 vaccines, and have advanced ten candidates into clinical trials. As of June 6 2020, the global COVID-19 vaccine R&D landscape includes 133 vaccine candidates, of which 10 are in clinical evaluation stages and 123 in preclinical evaluation. The most advanced candidates have recently moved into clinical development, including mRNA-1273 from Moderna, Ad5-nCoV from CanSino Biologicals, AZD1222 (ChAdOx1) from University of Oxford & AstraZeneca, INO-4800 from Inovio, LV-SMENP-DC and pathogen-specific aAPC from Shenzhen Geno-Immune Medical Institute. The researchers at the University of Oxford and AstraZeneca hope to have the first phase 3 data in hand this summer. Numerous other vaccine developers have indicated plans to initiate human testing in 2020.

Platform Type of candidate Developer Stage Trial ID
Non-Replicating Viral Vector Adenovirus Type 5 Vector CanSino Biological Inc./Beijing Institute of Biotechnology Phase 2 ChiCTR2000031781
Phase 1 ChiCTR2000030906
RNA LNP-encapsulated mRNA (mRNA-1273) Moderna/NIAID Phase 2 NCT04405076
Phase 1 NCT04283461
Inactivated Inactivated Wuhan Institute of Biological Products/ Sinopharm Phase 1/2 ChiCTR2000031809
Inactivated Inactivated Beijing Institute of Biological Products/ Sinopharm Phase 1/2 ChiCTR2000032459
Inactivated Inactivated + alum (PiCoVacc) Sinovac Phase 1/2 NCT04352608
Non-Replicating Viral Vector AZD1222 (ChAdOx1) University of Oxford and AstraZeneca Phase 2b/3 NCT04324606
RNA 3 LNP-mRNAs (BNT162) BioNTech/Fosun Pharma/Pfizer Phase 1/2 NCT04368728; 2020-001038-36
DNA vaccine INO-4800 Inovio Pharmaceuticals Phase 1 NCT04336410
Protein subunit Glycoprotein nanoparticle vaccine + Matrix M (NVX-CoV2373) Novavax Phase 1/2 NCT04368988
Inactivated Inactivated Institute of Medical Biology and Chinese Academy of Medical Sciences Phase 1
Vaccine development programs

Figure | Profile of COVID-19 vaccine developers by type and geographic location. For partnerships, the location is that of the lead developer. *Excluding China.

A broad classification of currently registered trials based on intervention strategies:

COVID-19 Funding Response

The world is facing an unprecedented challenge with communities and economies everywhere affected by the growing COVID-19 pandemic. The world is coming together to combat the COVID-19 pandemic bringing together governments, organizations and individuals from across industries and sectors to help respond to this global outbreak. The outpour of global solidarity and support sparked by this shared challenge has been phenomenal.

The WHO Strategic Preparedness and Response Plan outlines a funding need of at least US$675 million for critical response efforts in countries most in need of help through April 2020. People and organizations who want to help fight the pandemic and support WHO and partners can now donate through the COVID-Solidarity Response Fund for WHO at www.COVID19ResponseFund.org.

The Coalition for Epidemic Preparedness Innovations (CEPI) is a global alliance financing and coordinating the development of vaccines against emerging infectious diseases. The CEPI is collaborating with GSK and will use their pandemic vaccine adjuvant platform technology to enhance the development of an effective vaccine. CEPI has received support from founding member Norway (US$210 million), UK government (US$270 million), Government of Belgium (US$5.5 million), Government of Canada (US$28.2 million), Greece (US$1.6 million) and German Government’s Federal Ministry (US$157 million).

CEPI is investing in partnering agreements with Novavax, Inc. and The University of Oxford ($4.4 million), Institut Pasteur-led consortium that will include Themis and the University of Pittsburgh (US$4.9 million), and The University of Hong Kong (US$620,000). To date, CEPI has provided initial funding to Curevac, Inc., Inovio Pharmaceuticals, Inc., Moderna, Inc., Novavax, Inc., The University of Hong Kong, The University of Oxford, and The University of Queensland to develop COVID-19 vaccine candidates. CEPI partnered with AstraZeneca to manufacture 300 million globally accessible doses of COVID-19 vaccine. CEPI announced an investment of up to $388 million to accelerate the development and manufacturing of Novavax’ NVX‑CoV2373 vaccine candidate against COVID-19.

Through the Bill and Melinda Gates Foundation, the Microsoft founder and philanthropist plan to help fund factories for seven promising vaccines, even before seeing conclusive data. Two of the programs – at most – will make it through to final development and deployment. The Inovio INO-4800 DNA vaccine is the second vaccine to undertake Phase 1 clinical testing on human subjects thanks to backing from the foundation.

Biomedical Advanced Research and Development Authority (BARDA) has updated its Broad Agency Announcements (BAAs) to focus exclusively on addressing the COVID-19 threat.  BARDA’s annual budget of $512 Million has been supplemented by an additional $3.5 billion through the recently passed Coronavirus Aid, Relief, and Economic Security (CARES) Act.  The additional funding is allocated for necessary expenses of manufacturing, production, and purchase of various supplies and services. AstraZeneca recently received $1B in BARDA funding to advance vaccine. Another leading candidate, Moderna received $483 million BARDA award for vaccine development, while it awarded $450 million to Janssen Pharmaceuticals, a division of Johnson & Johnson, to develop a vaccine.

An additional €675 million of EU’s Horizon 2020 funding is to be diverted into research on vaccines, diagnostics and therapeutics against COVID-19, bringing the total investment in pandemic R&D from the programme to €1 billion. European Commission helped raise €7.4B to fund global research on vaccines and treatments for COVID-19.

The Division of Research, Innovation & Ventures (DRIVe) BAA (Budget $750,000) has opportunities for Diagnostic assays, screening and model development, vaccines, advanced manufacturing.

Multiple National Institutes of Health (NIH) Institutes have issued a Notice of Special Interest (NOSI) to provide funding for research topics related to COVID-19. National Institute on Aging (NIA), National Institute of Mental Health (NIMH), The National Heart, Lung, Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of General Medical Sciences (NIGMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Environmental Health Sciences (NIEHS), and National Institute of Drug Abuse (NIDA) are providing opportunities under the NIH.

The National Science Foundation (NSF, $256,000), Department of Defense (DOD) are among other prominent agencies.

Deutsche Forschungsgemeinschaft (German Research Foundation), Nordic Trial Alliance, UK Research and Innovation (UKRI) and several other international funding agencies have also come forward with various initiatives.

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