F.D.A. Allows Second Coronavirus Boosters for Everyone 50 and Older
The agency also allowed a second booster for people 12 and older. with certain immunodeficiencies.
The decision means tens of millions of Americans are now eligible for what will be their fourth shot.
The FDA made its decision based on very limited data, mostly from Israel. There is significantly less data on whether a second amplifier will provide such protection and for how long. Regulators have said that another dose does not create new safety concerns.
The idea is that just six months after federal regulators sanctioned the first round of boosters, another booster vaccine is already needed, which could increase population fatigue from Covid vaccines.
Among the 234,868 people who received just one booster shot, 232 people died from Covid. Among the 328,597 people who received the second booster, 92 died from Covid. The researchers said the mortality rate “was significantly lower among those who received the extra booster dose.”
The CDC has singled out Johnson & Johnson recipients for special treatment. The agency has already recommended Moderna and Pfizer vaccines over Johnson & Johnson vaccines due to safety concerns.
Adults who received an initial dose plus a booster dose of a Johnson & Johnson vaccine at least four months ago — a group that could include more than 1.4 million people — were said Tuesday to be eligible for a second booster dose of one of the mRNA vaccines. The agency cited new data that showed Johnson & Johnson’s vaccine was less effective than the other two.
Both Pfizer and Moderna were in favor of a second launch vehicle. Data from Israel suggests that a second booster restores protection, but the researchers did not track the recipients of these boosters for long.
Dr. Paul Burton, Moderna’s chief medical officer, told CNN on Monday that virus mutations have weakened vaccine protection. “The only way we’re going to reach a period of stability and eventually endemic disease is to keep people protected, keep their antibody levels high, and I’m afraid that means regular immunizations,” he said.
Both Pfizer and Moderna have an obvious financial incentive to push for more injections: They plan tens of billions of dollars in Covid vaccine sales this year alone. Pfizer and BioNTech said they expect results from a trial of a three-dose regimen for children under 5 next month.
Dr. Marks said on Tuesday that the FDA will seek the opinion of its advisory committee before making decisions about vaccinations for the youngest children.
It is not clear how much public demand exists for another booster. As the pandemic lulls, the nation’s enthusiasm for vaccines is waning. The number of newly reported infections has been declining since the third week of January when the Omicron wave peaked.
CDC estimates on Tuesday, an even more contagious sub-variant of Omicron known as BA.2 currently dominates new US cases. The sub-option has led to a surge in new cases in Europe. But some experts believe the United States can avoid the brunt, in part because the Omicron variant has infected so many Americans.
Cheryl Schell, a 71-year-old retiree from the southern Michigan town of Spring Arbor, said she didn’t wait to find out.
Kate Bedingfield, director of public affairs for the White House, said the new permit is “nice and simple.” She said the government has enough stocks to offer second boosters to those who are now eligible.
Noah Weiland as well as Adil Hassan made a report.