Moderna is seeking permission for a 50 microgram booster dose – half of the 100 microgram doses used in the primary two-dose vaccine series – at least six months after the second dose, and only for certain groups: people 65 years of age and over; people aged 18 to 64 who are at high risk of severe Covid-19; and people aged 18 to 64 whose exposure to the coronavirus in their environment or work exposes them to complications or serious illness from Covid-19.
Hey also heard from Israeli researchers who had previously spoken in favor of Pfizer’s recall request.
Most Israelis received the Pfizer vaccine, and the country began rolling out boosters long before the United States. Dr Sharon Alroy-Preis of the Israeli Ministry of Health told FDA advisers on Thursday that, as it began offering booster doses to more age groups, the percentage of tests positive for Covid-19 fell to 2.6%, and the overall incidence of severe cases decreased.
“The booster dose in Israel has been effective and, so far, has a similar safety profile to other doses,” Alroy-Preis said.
“We have improved protection against confirmed infections for all ages 16 and over. We have improved protection against serious illnesses for those 40 and over,” said Alroy-Preis. “It could impact even those under 40 for serious and critical illness and death.”
The FDA’s committee of independent advisers typically discusses and makes recommendations to the agency regarding vaccine authorizations and approvals, and the agency then makes the final decision on whether or not to accept a vaccine. If the FDA grants emergency use clearance for Moderna boosters, vaccine advisers from the U.S. Centers for Disease Control and Prevention will meet to discuss which groups to recommend them to. Typically, shots can be administered after the CDC Director has approved the recommendation.
Jacqueline Howard of CNN contributed to this report.
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