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FDA Approves Moderna and Pfizer Covid Booster Vaccines for All US Adults

Lisl Eibschutz, a medical student at the University of Dartmouth, charges a syringe with Pfizer’s COVID-19 vaccine before giving it to people on the first day that people 16 and older can get the vaccine at Kedren Health on Thursday, April 15, 2021 d., in Los Angeles. Angeles, California.

Allen J. Chaben | Los Angeles Times | Getty Images

The FDA authorized the Moderna and Pfizer Covid booster vaccines for all U.S. adults on Friday – two months later than the Biden administration wanted additional doses to begin – as growing data show vaccines are effective against decreasing over time.

Permission for use in emergency comes after companies released new data last week in support of third doses… Scientists who told the FDA rejected the administration’s initial plans to begin distributing boosters to all adults in the week of September 20, citing a lack of supporting data. Moderna resubmitted just two days ago.

Acting FDA Commissioner Janet Woodcock approved the doses without the usual public meeting to review the new data. The companies announced their decision on Friday morning.

“This authorization for emergency use comes at a critical juncture as we enter the winter months and face an increase in COVID-19 cases and hospitalizations across the country,” Moderna CEO Stefan Bansel said in a statement.

Woodcock said the agency has taken swift action to protect the population as the pandemic develops. She said booster shots are the best way to keep people from being hospitalized or dying from Covid.

The Centers for Disease Control and Prevention still has to authorize the distribution of booster doses before people can start receiving vaccinations, which could begin this weekend. The CDC’s independent vaccine expert group is due to meet on Friday to review the new data and is expected to quickly approve the third doses. CDC director Rochelle Walenski said Wednesday that the public health agency will “act promptly” after the FDA approves the injections.

The FDA’s advisory group initially met in September to consider recommending Pfizer boosters to the general public, but decided not to do so due to fears by some that the data was insufficient. Instead, they recommended an abbreviated distribution plan for seniors and adults who face a high risk of contracting Covid. The CDC approved Pfizer booster vaccines for these groups in September and Moderna and J&J recipients last month.

“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, agency employee. lead vaccine regulator as head of the FDA Center for Biological Evaluation and Research. “Streamlining the eligibility criteria and providing booster doses to all individuals 18 years of age and older will also help remove confusion over who can receive a booster dose and ensure that booster doses are available to all who may need it.”

The widespread use of revaccination is controversial among public health authorities. The World Health Organization has criticized rich countries for using third vaccines when people in poorer countries have very limited access to Covid vaccines.

WHO is pushing for more focus on helping immunization efforts in developing countries, warning that new variants of the virus could emerge and undermine protection in countries that have already achieved high levels of vaccination.

Booster shots have also sparked some controversy in the US as they emerge at a time when the country is struggling to convince millions of people to even get their first dose. More than 60 million Americans remain unvaccinated.

However, many Americans need an extra layer of protection as evidence increasingly shows that vaccine effectiveness against infection diminishes over time. A study published in the journal Science this month found that the effectiveness of the Pfizer vaccine, created by the German biotechnology company BioNTech, dropped from 86% to 43% between February and October this year. Moderna vaccine efficacy against symptomatic infection fell from 89% to 58%, and Johnson & Johnson’s vaccine efficacy dropped from 86% to 13%.

However, according to scientists, vaccines still provide a high level of protection against hospitalization and death.

Public health experts expect Covid infections to rise as the weather changes and Americans gather indoors for the holidays and escape the winter chill. Scientists believe booster doses can help reduce transmission rates, which are already high, helping prevent breakthrough infections in people who are already vaccinated.

The CDC has already approved booster vaccinations for people 18 and older who receive a single injection of J&J.

Moderna reapplied to the FDA for approval for a third dose of the vaccine for adults 18 and older on Wednesday.

More than 169 million doses of Moderna vaccine, more than 258 million doses of Pfizer vaccine and more than 16 million doses of Johnson & Johnson have been administered in the United States.

Nearly 80% of Americans age 12 and older have received at least one dose of three vaccines, according to the CDC. The data shows that more than 31.4 million people in the United States have already received the vaccines. President Joe Biden received a booster shot in September.

White House chief medical adviser Dr. Anthony Fauci on Wednesday urged Americans to get vaccinated and sign up for boosters if they are eligible.

“Not too late. Get vaccinated now. And importantly, if you were already vaccinated six months or more ago and are eligible for the vaccine, get vaccinated, ”Fauci said.

“The Israelis have shown that when you level up, you greatly reduce the chances of infection, illness or death,” he said, citing an Israeli study published in the Lancet in October.


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