Originally Posted by
LAXlocal
Is this a game changer , or just another of the vaccines that are being tested and will help fill the hole of the billions of doses needed ?
The latter, most likely. Definitely welcome news, and one would hope that they've had the opportunity to tweak their vaccine for the new variants. I read today that Moderna delivered samples of its tweaked vaccine to the FDA in preparation for testing, and I know Novavax is also on the same course.
Luckily, the FDA has said that the procedure for tweaks/boosters will be the same as it is for the flu shot. Once the design of the basic vaccine has been approved, then manufacturers can tweak it and follow a scaled-down testing regime before putting it into production. No need for another massive clinical trial.
Under the expedited framework announced by the FDA, vaccine makers will administer shots to a few hundred volunteers and then take blood samples. They’ll measure the levels of a specific kind of antibody -- one that can neutralize the targeted variant. This is similar to a Phase 2 clinical trial.
If the updated vaccine produces similar neutralizing antibody levels to the first-generation “prototype” vaccine, it’ll be considered a success. The FDA is essentially allowing companies to estimate or project the efficacy of booster shots based on antibody levels, rather than prove them.
https://www.10news.com/news/coronavi...ainst-variants