A nurse will give a syringe to the FEMA-sponsored COVID-19 vaccination site at Valencia State College on the first day the site resumes offering the Johnson & Johnson vaccine.
Paul Hennessy | LightRakete | Getty Images
An influential advisory committee to the Food and Drug Administration said Friday the agency should approve booster shots of Johnson & Johnson’s Covid-19 vaccine for the more than 15 million Americans who have already received the starting dose.
The unanimous vote – by the Agency’s Advisory Committee on Vaccines and Related Biological Products – is a critical step before the US can begin giving J&J recipients a second chance, some of whom have said they are anxious to get additional To get protection. One dose of J & J’s vaccine has been shown in studies to be comparatively less effective than the two-dose messenger RNA vaccines from Pfizer-BioNTech and Moderna.
The panel recommended the boosters to anyone aged 18 and over who had received their first injection of J&J at least two months after their starting dose. Many committee members said it should be viewed as a two-dose vaccine, similar to that used by Moderna and Pfizer.
The same committee on Thursday recommended Moderna booster vaccinations for people 65 years and older and other high-risk adults in line with Pfizer’s vaccine guidelines.
The FDA usually follows the committee’s advice, and a final decision by its regulators could be made within days. However, the agency is not the final go-ahead. Next week, a vaccine advisory group from the Centers for Disease Control and Prevention will decide who should receive the additional J&J shots. If there is a recommendation and CDC Director Dr. Rochelle Walensky signs off, the booster shots could begin immediately.
J&J, which received approval for its vaccine in late February, asked the agency to approve a booster of its single-dose vaccine for people 18 years and older on October 5th. It has presented data showing that a second dose performs similarly to the mRNA vaccines, increasing protection against symptomatic infections from 72% to 94% when given two months after the first dose in the US.
Days before the Friday meeting, FDA scientists released an analysis of J & J’s application for a booster, questioning the strength of the data. The FDA said people could benefit from a second dose, but added that the information the company provided was limited and the agency had not yet reviewed everything. It confirmed that a single dose of J&J was consistently less effective than the mRNA vaccines in clinical trials and real-world trials.
Before the vote, some committee members asked the FDA if they could postpone a booster decision, saying it might be too early as a number of open questions remained. Other members wondered why the agency brought J & J’s application to the committee before they could review all of the data.
“Is there a way to say that it is still a little early? There are a number of questions that remain open,” said Dr. Cody Meissner from Tufts University. “At this point there are a lot of uncertainties that make it difficult to vote for or against tonight.”
Although committee member Dr. Michael Nelson said that J & J’s data were “a bit immature and a little sparse in several areas,” he said that the safety and efficacy data they had so far were sufficient to support the emergency application in the US
“I certainly agree with my colleagues that this looks more like a two-dose vaccine,” he said.
In explaining the speed of the review, the chairman of the committee, Dr. Arnold Monto noted the lower performance of the J&J single-use vaccine compared to that of Pfizer and Moderna.
“There is a public health imperative here,” he said, “because we see that this is an overall less effective group than the mRNA vaccines, so there is an urgent need to do something.”
FDA officials during their presentations to the panel confirmed that J & J’s studies were completed with small samples of participants, making it difficult to draw conclusions from the data. Dr. Peter Marks, the agency’s chief vaccine regulator, urged the panel to continue the meeting and, at the end, address outstanding concerns from members.
Dr. Johan Van Hoof, a senior vaccine development officer at J&J, told the committee that boosters given six months after the primary dose resulted in a 12-fold increase in antibodies.
Administering boosters after six months also resulted in a proportional increase in the vaccine’s effectiveness against variants of Covid, including the highly transmissible Delta strain, Van Hoof said. The company’s data is based on a group of 17 volunteers aged 18 to 55 years. A larger study of 51 subjects found an almost 5-fold increase in antibodies from a J&J booster given two months after the first dose.
The 17 participants in J & J’s six-month study had no new side effects, said FDA doctor Dr. Timothy Brennan to the agency’s advisory committee. Of the participants, approximately 47% reported headache, 26% fatigue, and 21% myalgia or muscle pain after receiving a J&J booster.
According to Dr. Macaya Douoguih, director of J&J, there is no data to suggest that people are at increased risk of developing a rare but serious blood clot disease after a second dose of the J&J vaccine.
She presented data from the UK on second doses of AstraZeneca’s vaccine, which uses a platform similar to that of J&J. The data show the rate of vaccine-induced immunothrombotic thrombocytopenia (VITT) less frequently after a second dose than after the first.
“While the vectors are not exactly the same, the data can provide insight into potential risks,” Douoguih said.
This is a developing story. Please check again for updates.
