Global Regulatory Harmonization Discussions Ongoing About COVID-19 Vaccine Boosters
US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.
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ACIP will discuss possible boosters for immunocompromised people next week. Pfizer’s head of vaccine R&D and BioNTech co-founder and CEO discuss whether neutralizing antibodies are necessary for protection against SARS-CoV-2, indication in children, and the low and high points of their collaboration at Stat summit.
Unlike its response to incidents of blood clots with J&J’s vaccine, the US FDA is not calling for a pause in its administration following reports of about 100 cases of Guillain-Barré syndrome. CDC advisory panel is to discuss the issue at an upcoming meeting.
Pfizer’s bid for third dose appears to get pushback from the US government, but reticence about the booster may reflect PR considerations more than any fundamental concern about the vaccine.