US authorizes 2nd booster for people 50 and older

The FDA on March 29 amended emergency use authorizations to clear second booster doses of Pfizer and Moderna's COVID-19 vaccines for people 50 and older. The CDC has also cleared the additional shotsfor those eligible. 

The agency said the additional shots are authorized to be administered at least four months after receiving the first booster among those in the designated age group, according to a news release. The FDA also authorized a second booster of Pfizer's vaccine for those 12 and older with certain immunocompromising conditions and a second booster of Moderna's vaccine among immunocompromised adults. This means some immunocompromised people would be able to get a fifth shot, as the primary series for this group includes three doses and one booster had already been approved. 

"Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research. "Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID. So those who have not received their initial booster are strongly encouraged to do so." 

The CDC has signed-off on the additional doses, saying it has updated its recommendations "to allow certain immunocompromised individuals and people over the age of 50 who recieved an initial booster dose" to be elible for a second to "increase their protection against severe disease." The agency stopped short of an explicit recommendation, instead saying those eligible may get the additional booster. 

"Boosters are safe, and people over the age of 50 can now get an additional booster four months after their prior dose to increase their protection further," said CDC director Rochelle Walensky, MD. "This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time." 

The authorization covers a wider group than anticipated. People familiar with the matter told Politico on March 23 they expected a second booster dose authorization for people 65 and older. 

The FDA's second booster authorization comes amid concerns about a potential increase in COVID-19 cases driven by the omicron subvariant BA.2, which accounts for about 55 percent of new cases, the latest CDC estimates show. 


 

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