FDA panel supports Moderna booster shots

Arnie Mandel and Robin Foster’s Health Day Reporter

Friday, October 15, 2021

Reflects similar recommendations issued to Pfizer last month COVID-19 (New Coronavirus Infection) vaccinationOn Thursday, the U.S. Food and Drug Administration Expert Advisory Board recommended a half-dose booster shot of Moderna. vaccination Given to a specific recipient 6 months after the second shot.

Panelists recommended a third dose for all persons aged 65 years and older who received a double dose of the Moderna regimen, as well as young adults at high risk. COVID-19 (New Coronavirus Infection) For work that increases medical conditions or their exposure SARS-CoV-2, New York Times report.

The FDA is not obliged to follow the decisions of the Advisory Board, but usually does.

Commission members said the data presented were not particularly definitive, but the FDA granted urgent permission to booster shots of millions of Americans vaccinated with the Pfizer-BioNTech vaccine in September. Said that a precedent was set in.

However, evidence of the need for booster shots was clearer with the Pfizer vaccine.Data presented to panelists last month shows that with the US Centers for Disease Control and Prevention Prevention Four months after the second dose of Pfizer vaccine, it was found that its effectiveness in preventing hospitalized illnesses decreased from 91% to 77%.

However, with the Moderna vaccine, the decline over time was less dramatic and the booster shots were much less legitimate.

Acknowledging that, Moderna instead argued that boosters could still be useful in preventing mild or moderate forms. COVID-19 (New Coronavirus Infection)..

As part of the data presented, Moderna found that its studies showed that antibody levels were SARS-CoV-2 rose 1.8 times after people received booster shots. However, the company slightly missed another threshold set by the advisory board. The Commission wanted to see a 4-fold increase in neutralizing antibodies in 88.4% of study participants who received boosters, but a Moderna study observed such an increase of 87.9%. Times report.

One infectious disease expert suspected the need for booster immunization for young and healthy modelna vaccinated individuals.

Dr. Ameshua Dalha, a senior scholar at the Johns Hopkins Health and Security Center in Baltimore, said: “In the age or risk group where this happened, boosters may be justified.”

However, he said, “There is not enough data to show that boosters protect against mild breakthrough infections for a significant amount of time, so it is unclear what benefits people at low risk of hospitalization will benefit from boosters.” Stated.

Adalja states that this is especially true for Moderna products. [of protection] Than other COVIDs vaccination.. “

Millions of Americans infected with Moderna and Johnson & Johnson coronavirus vaccination Watching Pfizer vaccinated people roll up their sleeves for booster shots, I was wondering when they would get the same chance with additional protection.

As the FDA advisor made recommendations, the FDA will decide whether to allow booster immunization to at least some people immunized with the Moderna vaccine.

If the FDA approves an additional dose, a panel will be convened by the US Centers for Disease Control and Prevention next week. Prevention Then 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.

One of the tricky points before the advisory board was the dose of Moderna booster. 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.

On Friday, the same advisory board will issue recommendations on whether about 15 million Americans who have received a single Johnson & Johnson vaccination need booster shots.

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. In a study published on a site that was not peer-reviewed Thursday, people who received the Johnson & Johnson vaccine had greater protection if the second dose was either Pfizer or Moderna Shot instead of the second. Data suggest that it may improve J & J dose.

Beyond the problem of reduced efficacy COVID-19 (New Coronavirus Infection) vaccination, Some experts say that the country’s booster strategy also 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 the Tufts Medical Center in Boston and working for the FDA, said 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.

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. Associated Press 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 has not disclosed patient data on a 6-month booster, but early measures against the virus-fighting antibodies 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, all three vaccination Nevertheless, it provides strong protection against serious illness and death from COVID-19. 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..

source: Associated Press; New York Times; Ameshua Darha, MD, Senior Scholar, Johns Hopkins Center for Health Security, Baltimore

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FDA panel supports Moderna booster shots

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