The FDA has authorized a second COVID-19 booster shot for people aged 50 and older. For those who wish to receive an additional booster, it would mark their fourth injection since COVID-19 vaccines were first rolled out in December of 2020.
Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this “especially fragile group” can also get an additional booster, a fifth shot. The latest expansion authorizes an additional shot for all Americans aged 50 years or older, regardless of health status.
The announcement was expected after Pfizer CEO Albert Bourla said a fourth dose would be “necessary” due to waning immunity just over two weeks ago. Additionally, Bourla lobbied for an eventual authorization of a second dose for all age groups regardless of health status. “Right now, the protection that you’re getting from the third [dose], it is good enough — actually quite good for hospitalizations and deaths — it’s not that good against infections, but doesn’t last very long,” Bourla claimed.
The Pfizer CEO went on to claim that the Omicron variant is the first variant that was able to “evade” their vaccine. Furthermore, Dr. Anthony Fauci repeatedly claimed that a third booster injection, or a singular COVID-19 booster shot, would offer protection against future variants when the shots were beginning to roll out last December.
FDA chief Dr. Peter Marks urged Americans who have not received a first booster shot to do so “immediately”, claiming that the jab will offer vital protection. But the second booster is only for these higher-risk groups because “current evidence suggests some waning of protection” for them.
Pfizer had asked the FDA to clear a fourth shot for people 65 and older, while Moderna requested another dose for all adults “to provide flexibility” for the government to decide who really needs one, according to the Associated Press. The FDA set age 50 as the threshold for a second COVID-19 booster shot for both companies. As for the immune-compromised, only the Pfizer vaccine can be used in those as young as 12; Moderna’s is for adults.
There’s limited evidence to tell how much benefit another booster could offer right now. FDA made the decision without input from its independent panel of experts that has wrestled with how much data is required to expand shots, reports the AP.
Both pharmaceutical giants, as well as the FDA, are “concerned” about an Omicron-sibling variant that is leading to increased case rates in Europe. In Austria, the government reinstated its vaccine passport system, as well as its mask mandate, just two weeks after lifting them in response to the new variant.