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The Zacks Analyst Blog Highlights: Pfizer, BioNTech, Moderna and Johnson & Johnson
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For Immediate Release
Chicago, IL – February 24, 2021 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Pfizer Inc. (PFE - Free Report) , BioNTech SE (BNTX - Free Report) , Moderna, Inc. (MRNA - Free Report) and Johnson & Johnson (JNJ - Free Report) .
Here are highlights from Tuesday’s Analyst Blog:
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/BioNTech as well as Moderna have received EUA from the FDA for their COVID-19 vaccines. J&J 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.
For Monoclonal Antibodies
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.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights: Pfizer, BioNTech, Moderna and Johnson & Johnson
For Immediate Release
Chicago, IL – February 24, 2021 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Pfizer Inc. (PFE - Free Report) , BioNTech SE (BNTX - Free Report) , Moderna, Inc. (MRNA - Free Report) and Johnson & Johnson (JNJ - Free Report) .
Here are highlights from Tuesday’s Analyst Blog:
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/BioNTech as well as Moderna have received EUA from the FDA for their COVID-19 vaccines. J&J 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.
For Monoclonal Antibodies
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.
See these 7 breakthrough stocks now>>
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.