F.D.A. Panel Unanimously Recommends Johnson & Johnson Booster Shots - The New York Times
Oct 16, 2021 3 mins, 22 secs
recipients might also benefit from the option of a Pfizer-BioNTech or Moderna booster, an action that an F.D.A.

“Today, we are seeking authorization for use of Janssen’s Ad26 Covid vaccine as a homologous booster in those individuals who were previously vaccinated with the single dose.” “Do available data support the safety and effectiveness of Janssen’s Covid-19 vaccine for use under EUA as a booster dose in individuals 18 years of age and older, at least two months after a single dose primary vaccination?” “We do have 19 out of 19 unanimous yes votes for this question.

WASHINGTON — A key federal advisory committee voted unanimously Friday to recommend Johnson & Johnson booster shots, most likely clearing the way for all 15 million people who got the company’s one-dose coronavirus vaccine to receive a second shot.

But many committee members made clear that they believed Johnson & Johnson recipients might benefit from the option of a booster of the Pfizer-BioNTech or Moderna vaccine, something a top F.D.A.

But the panel members appeared swayed by the argument that it would be unfair to deny Johnson & Johnson recipients an additional shot after endorsing boosters for recipients of the other two vaccines, especially in the face of evidence that Johnson & Johnson offers the weakest protection of the three.

In its second successive day of discussion on boosters, the group wavered on whether it would be wise to soon offer extra shots to younger recipients of the Pfizer and Moderna vaccines.

The panel also seemed intrigued by preliminary data suggesting that Johnson & Johnson recipients may be better off with a booster shot from Moderna or Pfizer.

to move quickly with what has fast become known as a mix-and-match approach, especially for recipients of Johnson & Johnson’s vaccine, which is much less widely available.

Others said they worried that the public would end up bewildered if the government kept broadening the categories of people eligible for boosters and which vaccine could be used for extra shots.

medical officer, said a single dose of Johnson & Johnson’s vaccine offered less protection than two doses of the mRNA vaccines made by Pfizer or Moderna — a gap that would only grow if it remained a one-shot regimen while the other two-shot vaccines were followed by a booster.

Marks emphasized that the one-shot, easily stored Johnson & Johnson shot had served partly as an “outreach” vaccine — suggesting that refusing to offer a booster would disadvantage vulnerable populations.

The government decided last month to offer booster shots of Pfizer’s vaccine to older Americans and other high-risk groups, and the panel voted Thursday to recommend the same approach for Moderna recipients.

More than eight million people in the United States have already obtained Pfizer booster doses, and about 1.6 million have received third doses of Moderna’s, even though only Moderna recipients with immune deficiencies are officially eligible.

For Johnson & Johnson recipients, the committee recommended an additional shot for everyone who had received the vaccine — a reflection of its lower efficacy.

People with weakened immune systems are eligible for a third dose of either Pfizer or Moderna four weeks after the second shot.

Regulators have not authorized booster shots for recipients of Moderna and Johnson & Johnson vaccines yet.

14 to recommend a third dose of the Moderna coronavirus vaccine for many of its recipients.

15 to recommend booster shots of Johnson & Johnson’s one-dose vaccine for all adult recipients.

For now, Pfizer vaccine recipients are advised to get a Pfizer booster shot, and Moderna and Johnson & Johnson recipients should wait until booster doses from those manufacturers are approved.

says the Covid vaccine may be administered without regard to the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.

Preliminary findings showed Johnson & Johnson recipients who got a booster with the Moderna vaccine saw their antibody levels rise 76-fold within 15 days, compared with only a fourfold rise if they received a booster shot of Johnson & Johnson.


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