The shots have NOT been extensively tested on humans ……
They are using mouse trials…..
But other vaccine upgrades are not extensivly tested before release also….
The Food and Drug Administration on Wednesday authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.
The agency cleared two options aimed at the BA.5 variant of Omicron that is now dominant: one made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older. The doses can be given at least two months since people last received a booster dose or completed their initial series of vaccinations.
Biden administration officials have argued that even as researchers work to understand how protective the new shots might be, inoculating Americans again in the coming weeks could help curb the persistently high number of infections and deaths….
The companies produced the retooled shots with extraordinary speed, a testament to the mRNA technology that Pfizer and Moderna have harnessed since the early months of the coronavirus outbreak. The Food and Drug Administration advised companies only two months ago on the formulation that they should adopt for the new vaccines. By later this week, millions of those doses will be delivered to states.
The tight timeline meant that the companies went to federal regulators this summer with more limited data on the redesigned boosters than a traditional review process would call for, generating some controversy. Regulators authorized the vaccine without results from human trials, which have just started.
Federal officials argue that because the coronavirus is evolving so quickly, human trials would be out of date before they can deliver results that could be used in the F.D.A.’s authorization decision. Instead, they are relying on the results of mouse trials and earlier human trials by Pfizer and Moderna of reformulations aimed at previous versions of the virus.
The Biden administration is casting the shots as a standard upgrade that Americans should embrace ahead of potential surges in cases this winter, just like the flu shot, which is reconfigured every year to target more current versions of the influenza virus….
The CDC has voted to approve the updated vaccines…
They will now be made available in the near future…
They will be free for the time being….
it will be up to Congress or the Biden admin for how long….