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Thursday, December 2, 2021

FDA Approves Moderna, Pfizer’s COVID-19 Vaccine Boosters For All Adults

The Food and Drug Administration (FDA) authorized the Moderna and Pfizer COVID-19 vaccine boosters for all Americans age 18 and older on Friday.

“The FDA has determined that currently available data supports expanding the eligibility for a single booster dose of Moderna and Pfizer-BioNTech COVID-19 vaccines for those 18 years of age and older,” said Dr. Peter Marks , director of the FDA center. for the evaluation and research of biologicals, the statement said.

This decision was confirmed by an analysis of the FDA’s immune response data. For the Moderna vaccine, the FDA analyzed how 149 participants in the initial clinical trials responded to the third dose of the vaccine. For the Pfizer vaccine, the FDA analyzed the immune response of approximately 200 participants who received the booster vaccine.

Those who received the booster had higher antibody levels than those who did not.

Research and real-world data show that vaccines protect well against infection and hospitalization for several months after the initial batch. But after a certain point, antibody levels begin to fall, and the effectiveness against infection drops sharply and decreases to a lesser extent against severe diseases.

This decline is more noticeable in older adults and those with serious health problems such as obesity.

Earlier, health officials tried to expand access to boosters for everyone, but were effectively blocked by the FDA’s vaccine advisory group, which voted against the move. The FDA could have revoked the recommendation, but it did not. Instead, the agency has made a separate recommendation to make the booster available to everyone over 65 and certain groups under 64.

The FDA has now bypassed its vaccine advisory group by making boosters available to everyone ages 18 and older.

United States Food and Drug Administration, FDA Headquarters, White Oak, Maryland
The FDA headquarters is visible in White Oak, Maryland, in archive photo. (Andrew Kelly / Reuters) #

“I think it would be helpful for the public to hear an open discussion about the need for accelerators. I wish we had a chance to discuss this, ”Dr. Paul Offit, director of the Vaccination Education Center at Children’s Hospital of Philadelphia and a commissioner, told The Epoch Times by email.

Dr. Paul Spearman, an infectious disease specialist at Cincinnati Children’s Hospital, and another panelist, told The Epoch Times that increased access to booster drugs is being driven by “lower antibody levels and breakthrough infections.”

He said in an email that he was not sure why the FDA did not call the panel.

“There was some reluctance in the committee to say that everyone needs accelerators, and maybe they wanted to move forward without much controversy, but these are just assumptions,” he said. “I think the data supports the presence of boosters, and with the rise in cases in some parts of the US, it makes sense to strengthen protection rather than waiting for antibody levels to drop to the point where a person is at risk of serious illness.”

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The FDA said it did not meet because “the agency had previously convened a committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines, and after reviewing EUA requests from Pfizer and Moderna, the FDA concluded that the requests were indeed appropriate. not to raise issues that could be useful for additional discussion by the committee members. “

Both vaccine boosters are available with an Emergency Use Authorization or EUA.

One Moderna is 50 micrograms, which is half the dose of each primary series of injections. Pfizer unchanged at 30 mcg.

Albert Burla, CEO of Pfizer, said he hopes the means of support for all “will help accelerate our journey out of this pandemic.”

Moderna CEO Stéphane Bansel said the expansion in booster access “comes at a critical moment as we enter the winter months and face an increase in COVID-19 cases and hospitalizations across the country.”

The number of COVID-19 cases across the country began to decline in early September. According to federal data, by October 24, they fell by 88%. Since then, the number of such cases has increased, and on November 17, the number reached 110,000.

The number of hospitalizations with COVID-19 was similar but hardly increased, reaching its lowest number since late July on November 6.

In recent months, there has been a growing proportion of both rates among those vaccinated, as well as the number of deaths from COVID-19.

COVID-19 is a disease caused by the CCP (Chinese Communist Party) virus.

Approximately 228.5 million Americans (68.8 percent of the population) have completed a full series of vaccinations – two doses of Pfizer or Moderna shots or a single shot from Johnson & Johnson – as of November 18. All but 17 million received the vaccine. Pfizer or Moderna vaccines.

Zachary Stieber

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Zachary Stieber covers US news, including politics and court cases. He started out at The Epoch Times as a New York subway reporter.

World Nation News Deskhttps://www.worldnationnews.com
World Nation News is a digital news portal website. Which provides important and latest breaking news updates to our audience in an effective and efficient ways, like world’s top stories, entertainment, sports, technology and much more news.
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