FDA clears Moderna and Pfizer’s Covid vaccine booster shots for all U.S. adults

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  • The CDC still has to authorize the distribution of booster doses before people can start receiving the shots, which could begin as early as this week.
  • The CDC’s independent panel of vaccine experts is due to meet on Friday to review the new data.
  • CDC Director Rochelle Valensky said Wednesday that the public health agency will “act swiftly” after the FDA reviews the data and provides its authorization.

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The Food and Drug Administration on Friday authorized Moderna and Pfizer’s COVID booster shots for all US adults, completing a significant part of the Biden administration’s plan to deliver additional doses to the general public as data grows over time. Demonstrate the efficacy of vaccines.

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Approval comes nearly two months late — scientists advising the FDA rejected the administration’s original plans to begin distributing the booster to all adults in the week of September 20, citing a lack of data supporting a third dose. Gave. FDA Acting Commissioner Janet Woodcock also approved the supplements without a general public meeting to review the new data. Submitted by companies in the last week, Moderna resubmitted its application two days ago. The companies announced the decision on Friday morning.

“This emergency use authorization comes at a critical time as we enter the winter months and face rising COVID-19 cases and hospitalizations across the country,” Moderna CEO Stephen Bansell said in a statement. “

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The Centers for Disease Control and Prevention still has to authorize the distribution of booster doses before people can start receiving shots, which could begin as late as this week. The CDC’s independent panel of vaccine experts is due to meet on Friday to review the new data. CDC Director Rochelle Valensky said Wednesday that the public health agency will “act swiftly” after the FDA fixes the shots.

The FDA originally met in September to consider authorizing Pfizer’s boosters for the general public, but decided against doing so amid concerns from some experts that there was not enough data. He recommended a scale back delivery plan instead of the elderly and adults at high risk from COVID. The CDC earlier this month approved booster shots for those groups.

The widespread distribution of booster shots is controversial among public health officials. The World Health Organization has criticized wealthy countries for rolling out the third shot when people in poorer countries have very limited access to COVID vaccines.

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WHO has called for increased focus on aiding vaccination efforts in developing countries, warning that new forms of the virus could emerge and undermine protection in countries that have already achieved high levels of vaccination. have taken.

Booster shots have also sparked some controversy in the US, as they are underway at a time when the country is struggling to convince millions of people to take their first dose. More than 60 million Americans have not been vaccinated.

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

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

Public health experts expect an increase in Covid infections as the weather turns and Americans gather indoors for the holidays and winter. Scientists say the booster dose could help reduce transmission, which is already high, helping prevent breakthrough infections among people who have already been vaccinated.

The CDC has already authorized a booster dose for people 18 years of age and older who have received the single-dose J&J shot. Moderna on Wednesday resubmitted its application to the FDA to approve a third dose of its shot for adults 18 and older.

The US has given more than 169 million doses of Moderna’s vaccine and more than 258 million doses of Pfizer’s shot. Health officials have given Johnson & Johnson more than 16 million doses of the vaccine.

According to CDC data, about 80% of Americans age 12 and older have received at least one dose of three vaccines. Data shows that more than 31.4 million people in the US have already received their booster shots. President Joe Biden received a booster dose in September.

White House Chief Medical Adviser Dr. Anthony Fauci on Wednesday urged Americans to get vaccinated and sign up for their boosters if they are eligible.

Fauci said, “It’s not too late. Get vaccinated now. And more importantly, if you’ve already been vaccinated six months or more ago and are eligible for a boost, give a boost.” “Israelis have shown that when you boost, you reduce your chances of getting infected, getting sick or dying many times over.”

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