Pharmaceutical giant Pfizer and its partner, BioNTech, will seek emergency authorization for a second booster shot of their coronavirus vaccine for people 65 and older, an effort to bolster waning immunity that occurs several months after the first booster, according to three people familiar with the situation.
The submission to the Food and Drug Administration, anticipated as soon as Tuesday, is expected to include “real world data” collected in Israel, one of the few countries that has authorized a second booster for older people, said the individuals, who spoke on the condition of anonymity because they were not authorized to discuss the issue. The decision from the FDA could come relatively quickly, especially if officials conclude the data is straightforward and does not have to be reviewed by a panel of outside vaccine experts.
In a separate move aimed at answering longer term questions about booster strategies, the FDA plans to convene its outside advisers in early April to consider whether there should be an October or November campaign to encourage some or all adults to get additional boosters and whether the shots should be the same as the current vaccine or retooled to counter new variants, according to a federal official who spoke on the condition of anonymity to discuss administration plans….Read More
