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FDA Approves Moderna and Pfizer Covid Vaccine Booster for all U.S. adults

Liesl Eibschutz, a Dartmouth University medical student, loads a syringe of Pfizer COVID-19 vaccine before giving the vaccine on the first day people 16 and older get the vaccine at Kedren Health on Thursday, Angeles, California.

Allen J. Cockroaches | Los Angeles Times | Getty Images

The Food and Drug Administration on Friday approved Moderna and Pfizer’s Covid booster vaccinations for all U.S. adults – two months later, when the Biden administration was about to begin giving the extra doses – as growing data shows they are effective of vaccines decreases over time.

Emergency clearance comes after companies released new data last week supporting the third dose. Scientists advising the FDA had rejected the government’s original plans to begin distributing boosters to all adults by the week of September 20, citing a lack of supporting data. Moderna only resubmitted its application two days ago.

Acting FDA Commissioner Janet Woodcock approved the doses without the usual public session to review the new dates. The company announced on Friday morning.

“This emergency clearance comes at a critical time as we enter the winter months and face rising COVID-19 case numbers and hospitalizations across the country,” said Stephane Bancel, CEO of Moderna, in a statement.

Woodcock said the agency acted quickly to protect the public as the pandemic evolved. She said booster shots are the best way to prevent people from being hospitalized or dying from Covid.

The Centers for Disease Control and Prevention has yet to approve the distribution of the booster doses before people can start the vaccinations, which could start this weekend. The CDC’s independent panel of vaccine experts is due to meet on Friday to review the new data and quickly approve the third doses. CDC director Rochelle Walensky said Wednesday the health agency would “act quickly” after the FDA clears the shots.

The FDA advisory panel originally met in September to consider recommending Pfizer’s boosters to the general public, but decided against it because some were concerned that insufficient data was available. Instead, they recommended a reduced distribution plan for the elderly and adults at high risk from Covid. The CDC approved Pfizer’s booster vaccinations for these groups in September and Moderna and J&J recipients last month.

“The FDA has determined that the data currently available support an extension of the suitability of a single booster dose of the COVID-19 vaccines Moderna and Pfizer-BioNTech to include people 18 years of age and older,” said Dr. Peter Marks, who heads the agency as head of the FDA’s Center for Biologics Evaluation and Research. “Streamlining the eligibility criteria and making booster doses available to anyone aged 18 and over will also help remove confusion about who can receive a booster dose and ensure that booster doses are available to anyone who may need one.”

The wide distribution of booster vaccinations is controversial among health authorities. The World Health Organization has criticized wealthy nations for introducing third vaccinations when people in poorer countries have very limited access to Covid vaccines.

WHO has urged greater focus on supporting vaccination efforts in developing countries, warning that new variants of the virus may emerge and undermine protection in countries that have already achieved high levels of vaccination.

Booster shots have also caused some controversy in the US, as they are being introduced 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 want some extra protection as data increasingly shows that vaccines become less effective against infection over time. A study published this month in Science magazine found that the effectiveness of Pfizer’s vaccine, which was made with German biotech company BioNTech, decreased from 86% to 43% from February to October this year. The effectiveness of Moderna’s vaccine against symptomatic infections decreased from 89% to 58% and that of Johnson & Johnson decreased from 86% to 13%.

However, the vaccines still offer high levels of protection against hospitalization and death, scientists say.

Public health experts expect Covid infections to spike as the weather changes and Americans gather indoors for the holidays and escape the winter chill. Booster doses could help reduce what is already high transmission by preventing breakthrough infections in people who have already been vaccinated, scientists say.

The CDC has already approved booster doses for people 18 years and older who received the single dose from J&J.

Moderna resubmitted its application to the FDA on Wednesday for approval of a third dose of its shot for adults ages 18 and older.

The US has administered more than 169 million doses of Moderna vaccine, more than 258 million doses from Pfizer, and more than 16 million doses from Johnson & Johnson.

Nearly 80% of Americans 12 and older have received at least one dose of the three vaccines, according to CDC data. More than 31.4 million people in the US have already received their booster vaccinations, the data shows. President Joe Biden received his booster dose in September.

The Senior Medical Advisor to the White House, Dr. Anthony Fauci, on Wednesday urged Americans to get vaccinated and sign up for their booster vaccinations if they are eligible.

“It’s not too late yet. Get vaccinated now. And most importantly, if you were vaccinated six months or more ago and are eligible for a booster, you will be given a booster, ”said Fauci.

“The Israelis have shown that increasing the dose is many times less likely to become infected, sick or die,” he said, referring to an Israeli study published in the Lancet in October became.

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