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The FDA Panel unanimously recommends J & J Covid booster shots for adults who have already received their first dose.

The nurse will manage the shots at the FEMA-sponsored COVID-19 vaccination site at Valencia State University on the first day of resuming Johnson & Johnson vaccine delivery.

Paul Hennessy | LightRocket | Getty Images

Friday’s influential Food and Drug Administration advisory board said authorities need to approve boosters Johnson & JohnsonA single Covid-19 vaccine for more than 15 million Americans who have already received their first dose.

A unanimous vote by the authorities’ Vaccine and Related Biological Products Advisory Board is an important step before the United States begins offering second shots to J & J recipients, with some recipients receiving additional protection. He says he is anxious. Studies have shown that a single dose of the J & J vaccine is relatively less effective than the double dose messenger RNA vaccine made by. PfizerBioNTech When Modana..

The panel recommended boosters for anyone over the age of 18 who had already taken the first shot of J & J at least two months after the first dose. Many committee members said it should be considered a double-dose vaccine, similar to the Moderna and Pfizer vaccines.

Same committee on thursday Recommended Moderna booster shots For people over the age of 65 and other high-risk adults, in line with Pfizer’s vaccine guidelines.

The FDA usually follows the advice of the Commission and the final decision by the regulatory agency may be made within a few days. However, the agency is not the final approval. Next week, the Centers for Disease Control and Prevention’s Vaccine Advisory Group will decide who will get additional J & J shots. If it makes a recommendation and is approved by CDC Director Dr. Rochelle Walensky, booster shots could begin soon.

J & J, which received the vaccine approval in late February, asked the agency to approve a booster shot of a single-dose vaccine for people over the age of 18 on October 5. The mRNA vaccine increases protection against symptomatic infections from 72% to 94% when given 2 months after the initial dose in the United States.

FDA scientists a few days before Friday’s meeting Publish analysis About J & J booster application that doubts 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 authorities had not yet verified everything. Clinical trials and hands-on studies have shown that a single dose of J & J is consistently less effective than the mRNA vaccine.

Prior to the vote, some committee members asked the FDA if they could postpone the booster decision and said it might be premature as there are still many open questions. Other members wondered why the agency submitted the J & J application to the committee before validating all the data.

“Is there an option to say a little faster? There are still some open issues,” said Dr. Cody Meissner of Tufts University. “There is a lot of uncertainty at this point and it’s difficult to vote for or against tonight.”

Dr. Michael Nelson, a member of the committee, said J & J’s data was “slightly immature and somewhat lacking in multiple areas,” but safety and efficacy data to date are from the United States. He said it was sufficient to support emergency use in.

“I certainly agree with my colleague that this looks like a double dose vaccine,” he said.

In explaining the speed of the review, Chairman Dr. Arnold Monto noted that J & J’s one-shot vaccines performed poorly compared to Pfizer and Modana.

“There is a public health obligation here, because it’s a group that is generally less effective than we’ve seen with mRNA vaccines, and there’s an urgent need to do something,” he said. rice field.

In a pre-panel presentation, FDA officials acknowledged that the J & J study was completed with a small sample group of participants, making it difficult to draw conclusions about the data. Dr. Peter Marks, the authority’s top vaccine regulator, called on the panel to proceed with the meeting and finally address the unresolved concerns of its members.

Dr. Johan Van Hoof, J & J Vaccine Development Executive, told the Commission that boosting immunization 6 months after the initial dose increased antibodies 12-fold.

After 6 months, boosting was given a proportional increase in the effectiveness of the vaccine against Covid mutants, including the highly contagious Delta strain, Van Hoof said. The company’s data is based on a group of 17 volunteers aged 18-55. In a large study of 51 study participants, antibodies from J & J boosters increased approximately 5-fold two months after the first dose.

Seventeen participants in J & J’s six-month trial did not experience any new adverse side effects, FDA medical director Dr. Timothy Brennan told the authorities’ advisory board. Of the participants, about 47% reported symptoms of headache, 26% reported malaise, and 21% reported myalgia or myalgia after receiving a J & J booster.

According to J & J executive Dr. Macaya Douoguih, there are no data suggesting an increased risk of rare but severe thrombotic conditions after two doses of J & J vaccine.

She presented data from the United Kingdom on a second dose of AstraZeneca’s vaccine using a platform similar to J & J. The data show the proportion of vaccine-induced immunothrombogenic thrombocytopenia (VITT) after the second dose was less frequent than the first dose.

“The vectors are not exactly the same, but the data may provide insight into potential risks,” said Douoguih.

This is a developing story. Please check for updates.

The FDA Panel unanimously recommends J & J Covid booster shots for adults who have already received their first dose.

Source link The FDA Panel unanimously recommends J & J Covid booster shots for adults who have already received their first dose.

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