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FDA Issues New Guidelines for COVID-19 Vaccines, Tests, Drugs
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The emergence of COVID-19 virus variants like the U.K. variant (B.1.1.7), South African variant (B.1.351) and Brazilian variant (B.1.1.28) have raised concerns about the efficacy of some medical products/vaccines that have been authorized for emergency use by the FDA. The FDA has thus issued guidelines to provide recommendations to COVID-19 vaccine/medicines/diagnostic test manufacturers for addressing the emerging and future variants of the COVID-19 virus. The FDA is encouraging companies to evaluate the impact of COVID-19 virus variants on their products and provide information and scientific advice to improve the transparency of their products.
The FDA released separate guidelines for COVID-19 vaccines, tests and antibodies.
For Vaccines
The guidelines are applicable for both vaccines in development as well as those which have already received emergency use authorization (EUA) from the FDA.
Please note that COVID-18 vaccines of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) as well as Moderna (MRNA - Free Report) have received EUA from the FDA for their COVID-19 vaccines. J&J (JNJ - Free Report) has filed an application with the FDA seeking EUA for its single-shot COVID-19 vaccine.
The FDA recommends that the companies conduct clinical immunogenicity studies, which should compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. The data from these studies, which are much smaller than large clinical studies, should be used to support any modifications to vaccines. The studies should be conducted on individuals who have already got the authorized vaccine shot as well as those who have not received the same. Meanwhile, the FDA recommends that safety of the vaccines should be studied to support an EUA for a modified vaccine.
For COVID-19 Tests
The FDA recommends diagnostic test developers to identify the impact of emerging and future viral genetic mutations on their COVID-19 tests. These viral genetic mutations may be the basis of the viral variants. The FDA had earlier warned that the presence of these mutations in a patient’s blood sample can alter the result of the test, thus resulting in a false negative report. The FDA has also recommended test developers to consider the potential for future viral genetic mutations when designing their test and conducting their own routine monitoring to study the impact of new and emerging viral genetic mutations on their tests. Companies like Roche (RHHBY) and Abbott have launched molecular diagnostics, antigen tests and serology tests for COVID-19.
For Monoclonal Antibodies
Lilly’s (LLY - Free Report) bamlanivimab and Regeneron’s (REGN - Free Report) cocktail antibody combination (casirivimab and imdevimab) have been granted EUA by the FDA for the treatment of mild-to-moderate COVID-19. The FDA believes some monoclonal antibodies that have been authorized are less active against some emerging variants of the virus. The guidance discusses some approaches, which the companies may follow to generate non-clinical, clinical, and chemistry, manufacturing and controls data that may support an EUA for monoclonal antibody products that may be effective against emerging variants.
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FDA Issues New Guidelines for COVID-19 Vaccines, Tests, Drugs
The emergence of COVID-19 virus variants like the U.K. variant (B.1.1.7), South African variant (B.1.351) and Brazilian variant (B.1.1.28) have raised concerns about the efficacy of some medical products/vaccines that have been authorized for emergency use by the FDA. The FDA has thus issued guidelines to provide recommendations to COVID-19 vaccine/medicines/diagnostic test manufacturers for addressing the emerging and future variants of the COVID-19 virus. The FDA is encouraging companies to evaluate the impact of COVID-19 virus variants on their products and provide information and scientific advice to improve the transparency of their products.
The FDA released separate guidelines for COVID-19 vaccines, tests and antibodies.
For Vaccines
The guidelines are applicable for both vaccines in development as well as those which have already received emergency use authorization (EUA) from the FDA.
Please note that COVID-18 vaccines of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) as well as Moderna (MRNA - Free Report) have received EUA from the FDA for their COVID-19 vaccines. J&J (JNJ - Free Report) has filed an application with the FDA seeking EUA for its single-shot COVID-19 vaccine.
The FDA recommends that the companies conduct clinical immunogenicity studies, which should compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. The data from these studies, which are much smaller than large clinical studies, should be used to support any modifications to vaccines. The studies should be conducted on individuals who have already got the authorized vaccine shot as well as those who have not received the same. Meanwhile, the FDA recommends that safety of the vaccines should be studied to support an EUA for a modified vaccine.
For COVID-19 Tests
The FDA recommends diagnostic test developers to identify the impact of emerging and future viral genetic mutations on their COVID-19 tests. These viral genetic mutations may be the basis of the viral variants. The FDA had earlier warned that the presence of these mutations in a patient’s blood sample can alter the result of the test, thus resulting in a false negative report. The FDA has also recommended test developers to consider the potential for future viral genetic mutations when designing their test and conducting their own routine monitoring to study the impact of new and emerging viral genetic mutations on their tests. Companies like Roche (RHHBY) and Abbott have launched molecular diagnostics, antigen tests and serology tests for COVID-19.
For Monoclonal Antibodies
Lilly’s (LLY - Free Report) bamlanivimab and Regeneron’s (REGN - Free Report) cocktail antibody combination (casirivimab and imdevimab) have been granted EUA by the FDA for the treatment of mild-to-moderate COVID-19. The FDA believes some monoclonal antibodies that have been authorized are less active against some emerging variants of the virus. The guidance discusses some approaches, which the companies may follow to generate non-clinical, clinical, and chemistry, manufacturing and controls data that may support an EUA for monoclonal antibody products that may be effective against emerging variants.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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