FDA Advisers Considering Moderna Covid-19 Booster Shot – The Wall Street Journal

Vaccine experts advising the Food and Drug Administration are scheduled to vote on Thursday whether the agency should authorize an extra dose of Moderna Inc.’s MRNA 2.39% Covid-19 shot, a key step in making booster doses available to millions more people.

The meeting is a regular part of the federal government’s evaluation of the vaccines and the latest move toward authorizing Covid-19 boosters. The FDA often asks its expert advisers to share their views before the agency decides whether to clear a medicine, and the agency usually follows the advisers’ recommendations.

After clearing Covid-19 vaccines for adults starting late last year, the FDA has been in recent months evaluating applications to expand use of the shots to younger ages and to add an extra dose to bolster vaccinated people’s immune defenses, especially against the Delta variant.

The FDA has authorized the vaccine from Pfizer Inc. and partner BioNTech SE for adolescents. The agency also has already greenlighted booster doses of the Pfizer-BioNTech vaccine for seniors and adults at high risk of Covid-19 who received the shots already and are at least six months past their first vaccination.

It also has authorized boosters of the Pfizer-BioNTech and Moderna vaccines for certain people with weakened immune systems.

The FDA is expected to issue its decision on the Moderna booster in the days after the vote. The Centers for Disease Control and Prevention will then also weigh endorsing an additional Moderna dose, before it becomes available to the general public.

The meeting of the panel, called the Vaccines and Related Biological Products Advisory Committee, comes as Covid-19 cases caused by the contagious Delta variant drop from highs in many parts of the country, though they are increasing in some states.

Federal health officials have pushed for boosters to sustain the immune protection in people who have been previously vaccinated, especially against Delta.

Up to 60 million people will become eligible for Pfizer’s booster shot in the coming weeks, the Biden administration has said.

As the FDA nears a decision on authorizing Pfizer’s Covid-19 vaccine for children 5-11 years old, public-health officials and pediatricians are sharing research with families to assure hesitant parents of the shot’s safety. Photo: John Locher/Associated Press

Adding Moderna’s additional shot would significantly expand the U.S. booster campaign. More than 69 million people in the U.S. are fully vaccinated with Moderna’s shot, according to the CDC.

Moderna has asked the FDA to authorize a booster that is half the dosage of the first two vaccine doses, and is taken at least six months after the second dose.

In a review posted online ahead of the advisory committee’s meeting, FDA staff didn’t take a firm stance on Moderna’s application, and indicated there may not be sufficient data to support the extra dose.

The staff also didn’t take a position on Pfizer’s booster request, which was later granted. FDA staff reviews are part of the normal process before the agency makes a decision whether to clear a product.

The advisory panel will meet again on Friday to consider Johnson & Johnson’s application for a second dose and to review data on mixing and matching vaccines and boosters.

Covid-19 vaccines from Moderna and J&J are authorized for use in people 18 years and older, while the Pfizer-BioNTech vaccine is cleared for people 12 years and over.

Outside the U.S., Israel, the U.K. and the European Medicines Agency have cleared use of boosters, and many countries have been rolling out the shots. The World Health Organization, however, has encouraged rich nations to delay booster campaigns and send doses to countries with limited supplies.

Covid-19 Vaccines

Write to Felicia Schwartz at felicia.schwartz@wsj.com

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