Why this week's FDA meeting on J&J's coronavirus v
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Posted On: 02/22/2021 8:08:50 PM
Why this week's FDA meeting on J&J's coronavirus vaccine will be important
This Friday, a group of vaccine and infectious disease experts will assemble virtually to discuss whether the Food and Drug Administration should clear Johnson & Johnson's corona virus vaccine for emergency use.
The meeting, convened by the FDA, is likely one of the last steps in the agency's review. The FDA held similar meetings to review study results from Pfizer and Moderna and, each time, authorized the companies' vaccines the very next day.
The advisers are expected to support emergency use of J&J's vaccine, as they did for Pfizer's and Moderna's. But Friday's meeting will be important viewing nonetheless, as the experts are likely to debate emerging issues like protection against new virus variants.
The global effort to beat back the pandemic got a major lift last month, when J&J announced its vaccine prevented COVID-19 in a study of nearly 44,000 volunteers.
A window into the FDA's view on vaccine protection against variants
When the FDA reviewed Pfizer and Moderna's vaccines last year, its scientists were only evaluating how those shots performed against the original version of the coronavirus. The pandemic has shifted since then, with the emergence of viral variants that have spread across the world and appear to weaken the strength of multiple vaccines.
As a result, understanding exactly how variants impact protection has become an important task, as has developing a regulatory framework to update vaccines, if necessary. Friday's meeting on J&J's vaccine should provide the most comprehensive look to date at how the agency views both issues.
J&J has the largest amount of efficacy data against variants of any vaccine developer, giving the agency and outside experts a chance to scrutinize the vaccine's protective effects against different strains. The regulator could also seek experts' advice on how to test updated vaccines specifically tailored to variants. The FDA on Monday released draft guidelines, making the meeting a likely forum for discussion of its plans.
An update on J&J's expected vaccine supply
J&J's vaccine has two key advantages over Moderna's and Pfizer's: doses can be shipped and stored at refrigerator temperatures, rather than ultra-cold conditions; and only one shot is required instead of two. Those attributes could make J&J's vaccine a more efficient way to immunize a greater number of people, but only if there are enough doses to do so.
Unfortunately, that likely won't be the case immediately. News reports have indicated that production was delayed, causing J&J to fall behind a delivery schedule the company outlined when the U.S. pre-ordered 100 million doses last year. Last week, Jeffrey Zients, the White House's Coronavirus Response Coordinator, said only a "few million" doses will be available upon FDA authorization and that the government is working with the company to speed deliveries.
More details on those discussions — and the status of J&J's vaccine supply — could come Friday, giving a more accurate picture of what the U.S.'s supply will look like over the next several months. Though the U.S. has now ordered enough of Pfizer and Moderna's shots to fully vaccinate 300 million Americans, most of those doses are due to be delivered between April and June.
J&J has promised to deliver the 100 million doses ordered by the U.S. by the end of June.
https://www.biopharmadive.com/news/johnson-jo...ng/595366/
This is only a summary of important points from a much larger article.
This Friday, a group of vaccine and infectious disease experts will assemble virtually to discuss whether the Food and Drug Administration should clear Johnson & Johnson's corona virus vaccine for emergency use.
The meeting, convened by the FDA, is likely one of the last steps in the agency's review. The FDA held similar meetings to review study results from Pfizer and Moderna and, each time, authorized the companies' vaccines the very next day.
The advisers are expected to support emergency use of J&J's vaccine, as they did for Pfizer's and Moderna's. But Friday's meeting will be important viewing nonetheless, as the experts are likely to debate emerging issues like protection against new virus variants.
The global effort to beat back the pandemic got a major lift last month, when J&J announced its vaccine prevented COVID-19 in a study of nearly 44,000 volunteers.
A window into the FDA's view on vaccine protection against variants
When the FDA reviewed Pfizer and Moderna's vaccines last year, its scientists were only evaluating how those shots performed against the original version of the coronavirus. The pandemic has shifted since then, with the emergence of viral variants that have spread across the world and appear to weaken the strength of multiple vaccines.
As a result, understanding exactly how variants impact protection has become an important task, as has developing a regulatory framework to update vaccines, if necessary. Friday's meeting on J&J's vaccine should provide the most comprehensive look to date at how the agency views both issues.
J&J has the largest amount of efficacy data against variants of any vaccine developer, giving the agency and outside experts a chance to scrutinize the vaccine's protective effects against different strains. The regulator could also seek experts' advice on how to test updated vaccines specifically tailored to variants. The FDA on Monday released draft guidelines, making the meeting a likely forum for discussion of its plans.
An update on J&J's expected vaccine supply
J&J's vaccine has two key advantages over Moderna's and Pfizer's: doses can be shipped and stored at refrigerator temperatures, rather than ultra-cold conditions; and only one shot is required instead of two. Those attributes could make J&J's vaccine a more efficient way to immunize a greater number of people, but only if there are enough doses to do so.
Unfortunately, that likely won't be the case immediately. News reports have indicated that production was delayed, causing J&J to fall behind a delivery schedule the company outlined when the U.S. pre-ordered 100 million doses last year. Last week, Jeffrey Zients, the White House's Coronavirus Response Coordinator, said only a "few million" doses will be available upon FDA authorization and that the government is working with the company to speed deliveries.
More details on those discussions — and the status of J&J's vaccine supply — could come Friday, giving a more accurate picture of what the U.S.'s supply will look like over the next several months. Though the U.S. has now ordered enough of Pfizer and Moderna's shots to fully vaccinate 300 million Americans, most of those doses are due to be delivered between April and June.
J&J has promised to deliver the 100 million doses ordered by the U.S. by the end of June.
https://www.biopharmadive.com/news/johnson-jo...ng/595366/
This is only a summary of important points from a much larger article.
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