FDA advisory committee to consider boosters for Moderna, J&J COVID vaccines

- Advertisement -


A federal advisory committee will meet for two days this week to discuss safety and the need for a booster shot for people who have already received Moderna or Johnson & Johnson’s COVID-19 vaccine.

- Advertisement -

Members of the federal advisory panel, called the Vaccines and Related Biological Products Advisory Committee, will also hear data about the potential safety and effectiveness of giving people a booster shot from a different vaccine manufacturer than their original dose.

While considered safe, there is little data so far and the government has encouraged people to stick with a single vaccine.

advertisement

booster dose of pfizer-biontek vaccine, which has been given to more than 230 million Americans Since December, the last month was approved for people over 65 as well as underage people whose medical conditions or jobs put them at high risk for the disease.

So far, those who have received Moderna or J&J for their first round of shots have been told sit tight.

- Advertisement -

The data for Pfizer-BioNTech is clear, as much of Israel’s population of 9.2 million people received the vaccine earlier that year and was carefully tracked.

The country began giving everyone booster shots this summer after data suggested vaccine protection against infectionwas disappearing. It is not clear whether people were also vulnerable to serious illness, but the data suggested that protections were also beginning to dwindle.

Qatar experienced a similar decline in effectiveness against mild and moderate disease, according to Another recent study.

There is no similar nationwide “natural experiment” for Moderna or J&K vaccines.

Instead, the FDA Panel Will Have to ConsiderSmall-scale data during its Thursday and Friday meetings suggests that Moderna Vaccine is on a similar, though perhaps slower, trajectory than Pfizer-BioNtech.

Shirell Ritter, a certified nursing assistant at the Hebrew Home in Riverdale, receives her COVID-19 booster shot at her workplace on Monday, September 27, 2021 in New York.

Moderna and Pfizer-BioNTech vaccines are both based on mRNA technology and are similar to each other.

one in follow-up study Of participants in an earlier research trial, Moderna found that a third shot, along with half the dose of the first two, provided a major immunity boost. Levels of the so-called neutralizing antibody were significantly reduced before the booster, which was given about six months after the second shot.

According to the company’s study, which was released last month but has not yet been independently reviewed, the third shot brought antibody levels significantly up in people of various ages and health conditions, where they were after the second shot. Were. The safety profile after that third dose was similar to that of the previous two doses.

In Another Moderna study conducted this summer As the delta version was growing, participants who had received two doses of the active vaccine 13 months earlier were compared to those who had received the vaccine. Shot eight months ago.

In the analysis, there were 88 cases of COVID-19 among those who were in the recently vaccinated group, compared to 162 cases among those who were vaccinated last year. Only 19 people saw serious infections, with the group being vaccinated slightly longer.

None of the studies have been reviewed by independent experts.

J&J, which was initially given as a single shot, may require a second dose to provide better long-term protection, company data shows. Preliminary trial data showed that the single shot protected more than 70% of infections and almost 100% of deaths in the US.

In a study released last month, the company found that the second dose given two months after the first provided 94% protection against moderate to severe COVID-19 symptoms. The company said a booster dose given six months after a single shot provides even greater protection.

All COVID-19 . withVaccines and supplements appear to be as safe as ever, although it is possible that rare side effects will occur as millions more boosters are available.

A similar independent advisory group from VRBPAC and the Centers for Disease Control and Prevention decided last month that booster doses should not be recommended to everyone because of the unclear need and potential for rare side effects.

Both groups said they may reconsider a recommendation as more data becomes available about the long-term effectiveness of vaccines in the general population.

President Joe Biden receives a COVID-19 booster shot at the South Court Auditorium on the White House complex on Monday, September 27, 2021.

The FDA committee will also consider a new report looking at the risks and benefits of combining different vaccines.

The CDC has already said that it is better to take the second and third doses with the same vaccine as the first dose. butThe new study, though small, is expectedIndicate whether combining different types of vaccines is safe and perhaps more effective than sticking with a single shot.

Experts said a study in the United Kingdom found mixing and matching of vaccines to be safe and effective, but that its protocol for the use of vaccines was different – with a wide gap between the first and second doses, which could change long-term effectiveness, experts said. Maybe, experts said.

VRBPAC will vote to authorize booster shots but will not vote on mixing vaccines. Assuming that FDA commissioners sign off on the group’s recommendations, the CDC committee will consider who should be eligible for the Moderna and J&J boosters on October 20 and 21, with shots likely to be available within days of its decision.

Later in the month, VRBPAC will consider whether to authorize the Pfizer-BioNTech vaccine for use in children ages 5-11, a topic a CDC committee will take up early next month.

Contact Karen Weintraub at [email protected]

Health and patient safety coverage at Granthshala is made possible by a grant from the Massimo Foundation for Ethics, Innovation and Competition in Healthcare. The Massimo Foundation does not provide editorial input.

- Advertisement -
Mail Us For  DMCA / Credit  Notice

Recent Articles

Stay on top - Get the daily news in your inbox

Related Stories