CLEVELAND — Earlier this year, the FDA asked Pfizer and Moderna to create the next generation of COVID-19 vaccines that included defenses against the omicron variant. They did just that, starting clinical trials and releasing early data showing it gave a modest boost.
Except by then, omicron's subvariants took center stage.
The FDA then asked for a new vaccine including original COVID and omicron subvariants BA.4 and 5, but this time, they wanted these shots available by September. Both Pfizer and Moderna did what was asked, except their current data is coming from animal models, and human trials are just starting.
Some experts are concerned by the lack of human data, but last yearn the FDA released guidance that said modified vaccines targeting new variants could be authorized without the need for lengthy trials. A similar policy explains why different flu vaccines are produced each year without human testing.
This week, Pfizer asked the FDA to authorize its updated vaccine for people 12 and older. Moderna is about to ask the same for adults.
So why the warp speed? Well, those under age 50 still aren't permitted to get their second booster shot. Their infection protection, even if they had COVID, is waning.
We're heading into cold and flu season, and as kids head back to school and we head indoors to avoid cold weather, it's likely we'll see a bump in COVID cases. Even though the original shots still work at preventing severe disease and death, they're not strong enough to prevent a wicked COVID cold, and BA. 5 is the most contagious of all the variants.
So if updated COVID shots can be given earlier, it may hold off another COVID infection wave.
"It's going to be really important that people this fall and winter get the new shot," White House Coronavirus Response Coordinator. Dr. Ashish Jha said. "It's designed for the virus that's out there, and again, based on everything we have seen so far, all the data suggests it should be highly effective against the new variants."
The FDA says it will review the safety and effectiveness of the shots before granting emergency use approval. However, it's unclear if the independent vaccine advisory board will be part of the review.
Once approval is given, Pfizer says it can begin shipping immediately. The U.S. Government secured 105 million doses of updated Pfizer vaccine and 66 million doses of Moderna's shots.