4th COVID shot approved by the FDA for over 50s

The Food and Drug Administration on Tuesday approved a second round of booster shots for everyone over the age of 50, beginning a regulatory process to make shots available at pharmacies sometime this week.

Everyone 12 years of age or older is eligible for a booster shot five months after their initial vaccine series, if they receive the mRNA vaccine, such as Pfizer or Moderna, or two months after receiving the J&J vaccine.

But for those over the age of 50, who are determined to be a weaker age group, officials have decided that immunity reduction data justifies providing another shot for them four months after their first increase.

The decision has now moved to the Centers for Disease Control and Prevention for CDC Director Rochelle Wallensky to provide guidance on how to implement the approval.

He is expected to announce that the fourth shots should be made available to anyone over the age of 50 who wants one, but do not recommend it directly, the decision will be left to individuals and their doctors. Shots can then be administered within weeks.

So far the second boosters have limited US data. But data from Israel indicates that an additional booster shot could give a temporary push to safety, reducing the risk of death for those over 60.

Several countries, including Israel, Chile and Sweden, have begun offering fourth-dose COVID-19 doses for older adults and other at-risk groups.

Dr. Anthony Fawcett, the White House’s chief medical adviser, said he hoped the extra boosters would “restructure” people to return to the highest levels of antibodies, instead of making people higher than their previous immunity to any of the previous shots.

But he said the body’s response to B cells and T cells, which have a greater impact on the duration of immunity, could increase exponentially with each additional boost.

And while Tuesday’s announcement only applies to older Americans, a decision for the rest of the population is imminent.

The FDA will call a panel of vaccine experts on April 6 to discuss the plan. Experts will talk about the effectiveness of booster shots and the potential need for an alternative-specific booster instead of continuous booster shots designed for the initial strain of COVID-19.

A decision will probably be made later this summer or in the fall.

Older people who get a booster this spring will probably be advised to get another booster in the fall as well as the general public, if it is recommended, said an official familiar with the booster discussion.

But too frequent growth can cause fatigue, a dilemma that many public health experts are weighing.

“At some point we need to learn to live with mild disease,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital in Philadelphia, told ABC News. Frequent boosting “is not a reasonable thing to do, and it is not something that most people will do.”

Albert Borlao, CEO of Pfizer, acknowledges the impracticality of staying strictly up to date with shots every few months.

“We can’t have the vaccine every five or six months,” Borla told CNBC. But until their new-advanced booster is ready, Pfizer and Modern executives argue that at least some older Americans will soon need a fourth dose.

Of course, the vast majority of Americans still haven’t gotten a first booster shot. Of the nearly 90 million fully vaccinated Americans, about half received their shot more than five months ago but have not yet received a booster shot.

Among those 65 and older, adoption has been a huge success. About two-thirds of seniors have received their first booster shot so far.

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