Thursday, October 6, 2022

FDA authorizes second boosters for select people as omicron subvariant dominates U.S.

Second boosters have been authorized by the FDA for people over 50 and the immunocompromised who received their last shot at least four months ago. (Courtesy photo)

Some individuals will receive more protection against Covid-19 with the U.S. Food and Drug Administration’s authorization of second boosters of both mRNA vaccinations.

On Tuesday, the FDA signed off on people over 50, as well as those who are immunocompromised, to receive another booster shot at least four months after their last dose, regardless of which vaccine they received. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated in a release that protection from vaccines seems to wane after four months, putting older adults and the immunocompromised at risk.

“Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Marks said in the release. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”

To become available Wednesday, the FDA authorized the additional shot for:

  • Pfizer-BioNTech COVID-19 or Moderna given to individuals 50 years of age and older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine
  • Pfizer-BioNTech given to individuals 12 years of age and older with certain kinds of immunocompromise at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine
  • Moderna given to individuals 18 years of age and older with the same certain kinds of immunocompromise at least four months after the first booster dose of any authorized or approved COVID-19 vaccine

The U.S. Centers for Disease Control and Prevention updated its website to reflect the FDA’s broadened eligibility. It noted that during the recent omicron surge, individuals boosted were 21 times less likely to die from a Covid-19 infection and seven times less likely to be hospitalized.

“Boosters are safe,” CDC’s director Dr. Rochelle P. Walensky said in a release. “This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time.”

The move to green light an additional dose comes as the CDC also announced the omicron subvariant is the dominating strain in the United States. It makes up 55% of Covid-19 cases, though has not proven to be more threatening.

The FDA did not consult any advisory panels or outside committees to make its decision on the second booster. Instead it relied on surveillance data from the Ministry of Health in Israel. The study showed second boosters of the Pfizer-BioNTech vaccine were administered to approximately 700,000 people over 18 years, four months after the third dose. It also administered shots to those 60 and older to 600,000 people, with neither group showing new safety concerns. 

“The safety of Moderna COVID-19 Vaccine, when administered as a second booster dose, is informed by experience with the Pfizer-BioNTech,” the release stated.

An independent study revealed 120 participants 18 and older took a fourth dose four months after the third shot, again without any alarm over safety.

There is no indication of how long protection from another shot will last. A study published earlier in the month by the New England Journal of Medicine showed two shots of Pfizer or Moderna vaccines would not prevent symptomatic illness against omicron. While a booster would prolong protection, it noted it would wane over time.

Approximately 40 percent of those in the 50-to-64 age bracket have received the first booster.

The FDA said it will continue to evaluate additional boosters for other age groups as more data becomes available. It will meet next week to discuss and possibly expand the age groups by fall.


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Shea Carver
Shea Carver is the editor in chief at Port City Daily. A UNCW alumna, Shea worked in the print media business in Wilmington for 22 years before joining the PCD team in October 2020. She specializes in arts coverage — music, film, literature, theatre — the dining scene, and can often be tapped on where to go, what to do and who to see in Wilmington. When she isn’t hanging with her pup, Shadow Wolf, tending the garden or spinning vinyl, she’s attending concerts and live theater.

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