The next step is for CDC Director Rochelle Walensky to endorse the booster guidelines, which will then allow the shots to go into use. Walensky’s action could come as early as tonight.
Members of the CDC advisory panel largely agreed that J&J recipients need a second shot to boost their protection from Covid-19. Some applauded FDA’s authorization of “mix-and-match” boosters given concerns about rare but serious side effects associated with the different vaccines: heart inflammation known as myocarditis after Pfizer or Moderna vaccination in young men, and a rare type of blood clots most commonly found in 30-to-39-year-old women after receiving the J&J shot.
The U.S. is at a point in the pandemic where policymakers can take more time to weigh the benefits and risks of administering the vaccines as more data emerges on side effects unique to certain age groups and sexes, said Keipp Talbot, an associate professor of medicine at Vanderbilt University. Talbot and Pablo Sanchez, professor of pediatrics at The Ohio State University, registered strong concerns about some of the risks associated with the J&J vaccine.
“I think the opportunities for these heterologous boosts are priceless,” Talbot said.
Safety updates: One of the CDC’s vaccine surveillance programs, Vaccine Safety Datalink, identified the overall risk for myocarditis after the primary vaccine series as higher for Moderna recipients than people who got Pfizer. But both vaccines are linked to elevated rates of the condition.
The finding puts that system, a project between the agency and nine health organizations across the country, on par with watchdogs in other countries that have drawn a similar link and limited the age range of citizens who can get the Moderna shots.
Committee members raised issues with Moderna’s plan to allow vaccine providers to draw booster doses from the same vials used to procure full primary series doses, expressing concern about the sterility of the solution after multiple vial uses and the ability to track the safety and effectiveness of the booster dose when it doesn’t have a unique code.
New Pfizer booster data: Pfizer and BioNTech announced earlier Thursday that a controlled clinical booster trial showed that a third dose of their vaccine bumped its efficacy up to 95.6 percent. But the median time between the second dose and the booster was about 11 months, well past the six-month mark currently permitted by the FDA and the CDC.
The companies plan to submit the data, which wasn’t publicized within the announcement, to the FDA.