A Food and Drug Administration advisory panel recommended booster shots for all adult recipients of the Johnson & Johnson COVID-19 vaccine Friday, less than 24 hours after determining a narrower group of people who received Moderna’s vaccine should get another dose.
The FDA and the Centers for Disease Control and Prevention previously recommended boosters for Pfizer vaccine recipients 65 and older, those with underlying medical conditions, and those who live or work in high-risk settings. The guidance from the FDA’s Vaccines and Related Biological Products Advisory Committee Thursday for a half size booster dose of the Moderna vaccine covered the same categories.
At Friday’s meeting, the committee concluded anyone 18 and older who got the Johnson & Johnson vaccine should receive another dose of it two months after the first. FDA officials and advisers discussed whether those who got the Johnson & Johnson shot should get a booster of Pfizer or Moderna’s mRNA-based vaccines instead, but they did not make a recommendation.
The FDA will now consider the committee’s guidance before issuing a recommendation, and the CDC will weigh its decision next week. More than 9 million people in the U.S. have received booster doses of the Pfizer vaccine since August, but tens of millions more could soon be eligible for additional shots.
Still, the public deliberations over the Moderna and Johnson & Johnson boosters and the divergent recommendations reveal continued uncertainty about who truly needs another shot and how much protection additional doses provide. The Biden administration had initially hoped to make boosters available to all adults by late September, but resistance from experts inside and outside the government curtailed that plan.
Officials and vaccine manufacturers have cited data from the U.S. and Israel suggesting protection against COVID-19 infection from mRNA vaccines may wane after several months, although they still appear to effectively prevent severe symptoms or death. With breakthrough cases rising, regulators concluded the most vulnerable populations should get boosters.
It’s more a gut feeling rather than based on really truly serious data. The data itself is not strong, but it is certainly going in the direction that is supportive of this vote,” Patrick Moore, a biochemist and member of the FDA advisory panel, said Thursday, according to The Wall Street Journal.
The question with Johnson & Johnson’s vaccine was somewhat different. There is less reason to believe protection from the initial single-shot dose has faded, but it was not as effective as the Moderna and Pfizer vaccines from the start. The company claimed a second dose could boost protection against infection from less than 60% to 94%.
At Friday’s meeting, regulators pointed to several gaps in the data Johnson & Johnson submitted to support its application for emergency use authorization. However, Dr. Peter Marks, the FDA’s top vaccine official, said it would have taken another month to verify all the data, and officials believed action was needed sooner.
There is some urgency here to do something,” said Dr. Arnold Monto, chair of the FDA advisory committee.
Regulators in Europe and Israel have backed broad booster use, even as the World Health Organization urges wealthy nations to hold off on additional doses until more people in developing countries are vaccinated. Experts say the U.S. approach of prioritizing those who are at the highest risk of hospitalization and death is consistent with the limited data available.
“For the Pfizer and Moderna vaccines, the first recommendations of boosters are for those whose immune systems are less likely to fight off disease successfully and so need more protection,” said Dr. Laura Hungerford, a public health expert at Virginia Tech. “For younger people and those not at high risk, we don’t want to give unnecessary vaccines.”
According to Dr. Susan Kline, an infectious disease physician at the University of Minnesota Medical School, there is insufficient evidence on younger, healthier people to determine whether they need boosters at this time and whether an extra shot is safe. In young men, in particular, there are concerns the mRNA vaccines could cause myocarditis.
You have to weigh the risk of a potential side effect versus the added benefit of getting a booster dose. For older individuals, it really tilts in favor of getting the booster,” Kline said.
The federal government has drawn criticism forconfusing and sometimes conflicting public messaging about boosters since President Joe Biden promised boosters for all adults in August. Although some have questioned the FDA and CDC for moving methodically and delaying some much-anticipated decisions amid a public health emergency, others say these are complicated questions and regulators need time to review all relevant data.
“We want FDA and CDC to require data and find the optimal timing for boosters rather than just recommend giving them when they might not be needed,” Hungerford said.
As public health officials struggle to convince those who are still hesitant to get their first shots of COVID-19 vaccines, there are signs the focus on boosters has hindered those efforts. A Kaiser Family Foundation poll last month found 71% of the unvaccinated believe the need for boosters means the vaccines do not work.
Experts stress all authorized vaccines have proven highly effective, even if some people need an extra dose. A CDC report published Thursday estimated the unvaccinated were 11 times more likely to die from COVID-19 than fully vaccinated adults in August, 19 times more likely to be hospitalized, and six times more likely to be infected.
“The data is strong that you’re much better protected if you’ve been vaccinated,” Kline said.
Booster shots are required for many vaccines over time, and discussions about how and when to administer them are common. Federal officials still believe COVID-19 boosters will be recommended for the whole population eventually, either because initial protection fades or more aggressive strains of the virus emerge.
“The data suggest that younger people will need boosters at some point, but their better immune responses give them longer protection than older adults,” Hungerford said.