Pfizer Asks FDA to Authorize Extra COVID Booster for Older Adults

Pfizer and BioNTech submitted data to the US Food and Drug Administration for an additional COVID-19 booster dose in adults age 65 and older, the companies said Tuesday. 

If the FDA authorizes Pfizer's request and it is recommended by the US Centers for Disease Control and Prevention, older adults would be able to get another booster regardless of which COVID-19 vaccine they received for their first booster shot. 

Pfizer and BioNTech said their submission is based on real-world data from Israel when the omicron variant was circulating. COVID-19 infections were two times lower and rates of severe illness were four times lower in people age 60 and up in Israel who received an extra shot of Pfizer at least four months after the third dose, compared with people the same age who received only one booster, or three shots total, the companies said.

Results from another study found that the antibody response in adults age 18 and up who received a fourth dose had a significantly higher antibody response in the weeks that followed their fourth dose, according to the companies. 

Older age is one of the biggest risk factors that increases someone's risk for getting severely ill with COVID-19. Research also shows that older age groups are likely to benefit most from COVID-19 boosters. 

While the COVID-19 vaccines maintain good protection against severe disease and death, booster shots have been encouraged as the omicron variant became dominant worldwide and has evaded some immune protection. 

Pfizer CEO Dr. Albert Bourla said this week that fourth shots are "necessary." Some scientists have questioned the push for additional boosters of vaccines created for earlier variants for the whole population (everyone 12 and up in the US is eligible) and have encouraged other solutions like further development of pan-coronavirus vaccines that could work against all variants.