An advisory panel of the US Food and Drug Administration (FDA) has endorsed booster jabs of Johnson Johnson’s COVID-19 vaccine amid concerns the JJ single-dose jab is less effective than previously thought.
The FDA’s influential 19-member advisory panel voted unanimously on Friday to recommend a second jab for about 15 million people in the United States who have received a first dose of the JJ vaccine.
A day earlier, the panel recommended a third dose of Moderna’s two-dose vaccine, and it previously endorsed boosters of the Pfizer-BioNTech jab.
Nearly 10 million people have already received Pfizer booster jabs in the US, where 188 million people, or about 57 percent of the population, are fully vaccinated, according to data collected by the US Centers for Disease Control and Prevention (CDC).
COVID-19 vaccines and booster jabs are free and widely available to US citizens who want them.
The FDA will use its advisers’ recommendations to decide formally whether to authorise boosters for JJ and Moderna.
JJ officials told the advisory panel on Friday that the second dose would help boost people’s immune protection beginning two to six months after their first dose.
The company presented study results to the panel that showed a second dose two months after the first bumped protection against COVID-19 from 70 percent up to 94 percent. Administering the booster jab six months later prompted an even bigger jump in virus-fighting antibodies, JJ said.
But FDA scientists are challenging the company’s claims.
“There are data that suggest the effectiveness of this vaccine is actually less robust than the company’s presentation here,” said Dr Peter Marks, the FDA’s top vaccines official. “And that is a finding of concern particularly because that’s been seen in minority communities potentially and others.”
The FDA’s reviewers found no new safety concerns after a second JJ dose, but again, they cautioned about a small number of patients in JJ’s study and limited follow-up with patients.
The JJ vaccine was highly anticipated for its one-and-done formulation.
But its rollout earlier this year was hurt by a series of troubles, such as manufacturing problems and some rare but serious side effects, including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome.
In both cases, regulators decided the shot’s benefits outweighed those risks.
Separately, the FDA on Friday delayed authorising Moderna’s COVID-19 vaccine for adolescents to assess whether the shot may lead to a heightened risk of heart inflammation, the Wall Street Journal newspaper reported, citing people familiar with the matter.
US President Joe Biden is pushing Americans to get vaccinated, as some 66 million adults have yet to receive a jab, according to White House data.