The FDA team unanimously recommends Johnson & Johnson’s Covid booster injections to adults who have already received the first dose

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On the first day when the Johnson & Johnson vaccine was resumed at the site, a nurse administers the injection at the COVID-19 vaccination site supported by FEMA at Valencia State University.

Paul Hennessy | Light Rocket | Getty Images

On Friday, an influential Food and Drug Administration Advisory Committee stated that the agency should authorize Johnson & Johnson’s single Covid-19 vaccine booster to more than 15 million Americans who have received the initial dose.

The unanimous vote of the agency’s vaccine and related biological products advisory committee is a key step before the United States begins to provide second shots to Johnson & Johnson recipients, some of whom said they are eager to obtain additional protection. Studies have shown that one dose of Johnson & Johnson’s vaccine is less effective than two doses of messenger RNA vaccines produced by Pfizer BioNTech and Moderna. The team recommends this dose to all people 18 years and older. They have received the first dose of Johnson & Johnson’s vaccine. Many committee members said it should be treated as a two-dose vaccine, just like Moderna and Pfizer’s. Same as the vaccine.

On Thursday, the same committee recommended Moderna booster injections to people 65 years and older and other high-risk adults based on Pfizer vaccine guidelines.

The FDA usually follows the committee’s recommendations, and its regulatory agency may make a final decision within a few days. However, the agency is not the final approval. Next week, the Vaccine Advisory Group of the Centers for Disease Control and Prevention will decide who should receive additional Johnson & Johnson vaccines. If it issues a recommendation and the CDC Director Dr. Rochelle Walensky signs and agrees, the booster injection can begin immediately.

Johnson & Johnson obtained the vaccine authorization in late February and asked the agency to approve a booster shot of its vaccine on October 5 for people 18 years and older. The data it submitted showed that the performance of the second dose of vaccine and mRNA vaccine, two months after the first vaccination in the United States, increased the protection rate of symptomatic infection from 72% to 94%.

A few days before the Friday meeting, FDA scientists published an analysis of Johnson & Johnson’s application for boosters, questioning the strength of the data. The FDA stated that people might benefit from the second dose, but added that the information provided by the company is limited and the agency has not verified all of it. It acknowledged that in clinical trials and real-world research, the effect of a single-dose Johnson & Johnson vaccine has always been inferior to that of the mRNA vaccine.

Before the vote, some committee members asked whether the FDA could postpone the decision on the booster, saying that it may be too early because there are still many unanswered questions. Other members wanted to know why the agency submitted Johnson & Johnson’s application to the committee before it was able to verify all the data.

Dr. Cody Meissner of Tufts University said: “Can it be said that it is a bit early? There are still many issues that have not been resolved.” “There are a lot of uncertainties, so it is difficult to vote for or against tonight.”

In explaining the speed of the review, Dr. Arnold Monto, the chairman of the committee, pointed out that Johnson & Johnson’s disposable vaccines performed poorly compared to Pfizer and Moderna.

He said: “There is a public health priority here, because what we see is that this is a group whose overall efficacy is lower than what we see in mRNA vaccines, so some measures are urgently needed.”

FDA officials admitted in a speech in front of the expert panel that Johnson & Johnson’s trial was completed with a small sample of participants, so it is difficult to draw conclusions on the data. Dr. Peter Marks, the agency’s top vaccine regulatory agency, asked the group to advance the meeting and resolve any outstanding issues of the members at the end.

Dr. Johan Van Hoof, director of vaccine development at Johnson & Johnson, told the committee that a booster immunization 6 months after the initial vaccination resulted in a 12-fold increase in antibodies.

Van Hoof said that the booster dose six months later also increased the vaccine’s effectiveness against Covid variants (including the highly transmitted delta strain) proportionally. The company’s data is based on 17 volunteers between the ages of 18 and 55. A larger study of 51 trial participants found that after the Johnson & Johnson booster was given two months after the first dose, antibodies increased by nearly five times.

FDA medical officer Dr. Timothy Brennan told the agency’s advisory committee that the 17 participants in the Johnson & Johnson 6-month trial had no new adverse side effects. After receiving the Johnson & Johnson booster, approximately 47% of participants reported headache symptoms, 26% reported fatigue, and 21% reported myalgia or muscle pain.

Johnson & Johnson executive officer Dr. Macaya Douoguih said that there is no data showing that people are at increased risk of rare but severe blood clots after receiving a second dose of Johnson & Johnson vaccine.

She provided data on the second dose of AstraZeneca vaccine in the UK, which uses a platform similar to Johnson & Johnson. Data show that the incidence of immune thrombotic thrombocytopenia (VITT) caused by the vaccine after the second vaccination is lower than the first.

“Although the vectors are not exactly the same, the data may provide some insights into potential risks,” Douoguih said.

This is a story of development. Please check for updates.

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