Tuesday, October 26, 2021

The FDA unanimously recommends Modern Covid amplifiers for adults at risk

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The Food and Drug Administration’s main advisory committee on Thursday unanimously recommended giving photos of people over the age of 65 and other vulnerable Americans to the Modern Covid-19 booster before the U.S. launched its third shot at more than 69 million people. people who first received the vaccine.

The non-binding decision of the FDA Advisory Committee on Vaccines and Related Biological Products follows the guidelines for Moderna for the third stroke of the Pfizer and BioNTech vaccines. These shootings were allowed less than a month ago by most Americans, including the elderly, adults in critical condition, and those who work or live in hazardous conditions such as health and food workers.

Although the agency has not always followed the recommendations of its committee, it often does. The FDA’s final decision on Modern Amplifiers could come in a matter of days. The CDC Vaccine Advisory Committee is expected to vote on the FDA proposal next week. If he recommends approval and the CDC approves it, a booster shot could be launched for Americans who completed the vaccination at least six months ago.

Because many people inside and outside the government, especially in the U.S. and elsewhere in the world, have not yet received a single dose of the vaccine, augmentative images have been a contentious issue for scientists. The World Health Organization is urging wealthy countries to stop distributing stimulants, and some scientists say most Americans do not need boosters right now.

When the FDA committee met last month, they rejected a proposal to release copies of the Pfizer and BioNTech vaccine to the general public. At the time, some committee members were concerned that there was not enough information to make a recommendation, while others argued that the third shot should be limited to specific groups.

After a unanimous vote in Moderna on Thursday, committee member Dr. Patrick Moore said the information the company had provided to confirm the amplifier was “not well explained” and that it was more of a “gut feeling.”

“The data itself isn’t strong, but it’s going in a direction that supports voice,” he said.

The Biden administration hopes that providing additional doses to the U.S. population will provide long-term and enduring protection against serious illness, hospitalization, and death as the rapidly changing variant of the delta continues to spread.

Dr. Peter Marks, the FDA’s best vaccine regulator, told the committee Thursday before the vote that the agency would encourage “different views” on “complex and evolving” data.

“This means that as we continue, we will focus our powers not on operational issues related to the global vaccine campaign, but on the science associated with the application under consideration today. I ask that we try to focus. ” he added.

Moderna filed an application with the FDA on Sept. 1 for approval of the booster dose. The company said the results were based on clinical trials of about 170 adults. Moderna said the third shock, which was half the dose of 50 micrograms in the first dose, was a safe and strong immune response.

Once approved, the company plans to send a letter to health care workers explaining the dose difference for the third bullet, said Dr. Jacqueline Miller, head of the company’s infectious disease research department, at a presentation on Thursday.

The side effects of modern amplifiers were comparable to those experienced after the second dose, the company wrote in a document released by the FDA on Tuesday. Most adverse reactions were low in severity, and no rare cases of inflammation, myocarditis, or pericarditis in the heart were reported in Modern test participants up to 29 days after receiving the amplifiers.

Before recommending the third frame, the panel listened to many presentations, including Israeli health agencies, which began offering amplifiers to their population before other countries. Pfizer vaccine was mainly used in the country, but some Modern boosters have been given.

The country has fired 3.7 million third shots since it launched its augmentation campaign in late July, with a third of the additional photos being of people aged 60 and over, Sharon Alroy-Preis, Israeli health ministry spokesman. service director, told the panel.

It has been reported that people who took the booster dose were less likely to become ill with Covid or become seriously ill. He said officials have identified 17 cases of myocarditis or pericarditis so far after the third dose.

“I think if we look at all the data in Israel so far, we can say that the use of booster doses has helped Israel reduce infections and serious cases,” he said.

It’s an evolving story. Please check for updates.

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