FDA considers using a similar approach to influenza to guide development of Omicron variant booster
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FDA considers using a similar approach to influenza to guide development of Omicron variant booster.
The FDA last week approved a second booster dose of the Covid-19 vaccine for people over 50 without first consulting an external advisory committee of vaccine experts.
The FDA convened the committee on Wednesday (before the decision to approve a second booster dose) to discuss the subsequent development of boosters for Omicron or other mutant viruses.
The FDA said before the meeting that the currently approved vaccines for COVID-19 (from Pfizer, Moderna and Johnson & Johnson) are designed to deal with the virus early in the epidemic, and the accumulating data shows that the composition of the vaccine needs to be updated, “To some extent, to ensure that early A high level of efficacy has been achieved in vaccine clinical trials.”
The FDA is calling for an “orderly, reasonable and transparent process” for boosting the Omicron variant strain, a process that could be similar to how the FDA approves flu strains each year.
Like the flu, strains don’t always appear when they’re expected, and the FDA explained that while any changes to the composition of a COVID-19 vaccine would need to be data-driven and demand-driven, “it remains impossible to predict which virus mutations will occur in Where in the world an outbreak occurs, it is impossible to predict how long the mutation will last.”
Last week’s decision was straightforward, with Israeli data showing that a second dose would reduce hospitalizations and deaths somewhat, citing Peter Marks, head of the CBER (Center for Biologics Evaluation and Research) and acting director of the Office of Vaccines.
But the extent to which the second shot will ultimately achieve that remains unknown. On Friday, the FDA announced that a second shot could be given to people over 50, explaining how to do it:
“The notifier predicts that 1 million booster doses administered to people aged 65 and over every four months will reduce: 5,112 infections (between 1,536 and 10,220) , 1,144 hospitalizations (between 884 and 1,508 ) between) and 468 deaths (between 352 and 612) .”
The FDA also made it clear that authorizing or approving an improved vaccine against a variant requires clinical data to support its safety and efficacy, not just manufacturing information, but data that can be derived from immunogenicity and safety studies ( as outlined in the appendix of the recently updated FDA guidance for COVID-19 vaccine development) .
“These data not only need to support that the modified vaccine is effective against the clinically relevant SARS-CoV-2 variant virus, but also need to provide a clear basis for the use of the modified vaccine in place of the prototype vaccine,” the FDA said in its briefing document.
At Wednesday’s meeting, the FDA asked VRBPAC (Vaccines and Related Biologics Advisory Committee) what experience and data could be translated into an approach to modify strains just by producing information, a process similar to a flu vaccine.
The FDA also pointed out that it may be more beneficial to have a COVID-19 vaccine booster shot at the same time as the annual flu shot, “although whether such a plan will provide the optimal timing of these vaccines still needs careful consideration.”
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Reference:
endpts.com/fda-convenes-committee-of-vaccine-experts-to-consider-a-flu-like-path-for-omicron-specific-boosters/
FDA considers using a similar approach to influenza to guide development of Omicron variant booster
(source:internet, reference only)
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