FDA evaluates Moderna, J & J booster shot approval

Robin Foster Health Day Reporter

Wednesday, October 13, 2021

Millions of Americans infected with Moderna and Johnson & Johnson coronavirus vaccination Had to see who received Pfizer vaccination Roll up your sleeves for a booster shot and wonder when you get the same chance with additional protection.

This Thursday and Friday, the US Food and Drug Administration Advisory Board will address the pressing issue.

Panel deliberations will be the first step taken in deciding whether to use two additional doses vaccination Should be given. When the FDA Advisor makes a recommendation, the FDA itself decides whether to approve boosters for these shots. If the FDA approves an additional dose, a panel will be convened by the US Centers for Disease Control and Prevention next week. Prevention We recommend more detailed information about who needs to get them.

As a final step, the CDC Panel’s decision must be approved by Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention. Prevention..

The process may sound simple and simple, but a document released by the FDA on Tuesday shows that these decisions may not be easy.

What is the most difficult question? When the FDA panel meets this week to consider whether to recommend booster shots from Moderna and J & J vaccination, Experts discuss whether the third Moderna shot should contain only half of the original dose, and the optimal timing for the second shot of J & J in a single dose. vaccination, NS Associated Press report. The panel will also consider the safety and efficacy of mixing and adapting different brands of vaccines that have not been previously approved by regulatory agencies.

Beyond the problem of reduced efficacy COVID-19 (New Coronavirus Infection) vaccination, Some experts say that the country’s booster strategy needs to be “harmonized.”

“We are in this very complex situation right now. People go to pharmacies and places. vaccination Dr. H. Cody Meissner, an infectious disease expert at Tufts Medical Center and a member of the FDA Advisory Board, said:Said New York Times.. “I don’t think anyone doubts that booster immunity will be needed for these. vaccination.. What we don’t know is how urgent the need is. “

An estimated 103 million Americans have been fully vaccinated with Pfizer’s prescription, 69 million have been vaccinated with Moderna, and 15 million have been vaccinated with J & J. CDC.. Regulators first addressed the Pfizer booster issue as the company submitted the data ahead of other vaccine manufacturers.

With the latest new review of Moderna dataThe FDA did not indicate whether it was leaning towards approving the company’s booster shots. Authorities said the vaccines used in the United States still provide protection, questioning some of Moderna’s efficacy data. AP report.

The two first Moderna shots each contain 100 micrograms of vaccine. However, pharmaceutical companies have stated in a document filed with the FDA that 50 micrograms is sufficient for boosters in healthy people.

In a company study of 344 people, 50 micrograms of shots were given 6 months after the second dose, resulting in a surge in levels of antibodies that fight the virus.Boosters even caused a 42-fold increase in highly targetable antibodies, according to Modana. Infectious Delta variant.

Side effects heat According to the company, the pain that Moderna recipients often experience after the second regular shot.

Those who received the J & J vaccine were submitted by the company. data To the FDA for two different options: booster shots in 2 or 6 months. The company said in an FDA submission that a 6-month booster was recommended, but in some circumstances a second dose could be given in 2 months. AP report.

J & J released data in September showing that the booster given in two months provided 94% protection against moderate to severe. COVID-19 (New Coronavirus Infection) infection. The company does not disclose patient data on a 6-month booster, but early measures against the virus-fighting antibody suggest that it provides even higher protection.

Even without a booster, according to J & J, the vaccine is about 80% effective in prevention. COVID-19 (New Coronavirus Infection) hospitalization.

Scientists emphasize that all three vaccines still provide strong protection against serious illness and death. COVID-19 (New Coronavirus Infection).. The tricky question is how quickly and how much the defense against mild infections diminishes.

For more information

For more information, please visit the US Food and Drug Administration COVID vaccine..

sauce: Associated Press; New York Times

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FDA evaluates Moderna, J & J booster shot approval

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