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Tuesday, December 7, 2021

FDA approves mixing of COVID vaccines; supports boosters Moderna, J&J

MATTHEW PERRON and LAURENT NIRGAARD

WASHINGTON (AP) – US regulators on Wednesday approved distribution of COVID-19 boosters for Americans who received the Moderna or Johnson & Johnson vaccine and said anyone eligible for the extra dose could get a different brand from the one they received initially.

The FDA’s decisions mark a big step towards expanding the US revaccination campaign, which began with additional doses of Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult with a panel of experts on Thursday before finalizing formal guidelines on who should get boosters and when.

The latest moves will increase by tens of millions the number of Americans eligible for boosters and formally allow “mix and match” shots, making it easier to get a different dose, especially for people who have had side effects from one brand but still want proven protection. vaccination.

Specifically, the FDA authorized the third Moderna vaccine for seniors and others at high risk of contracting COVID-19 due to their health, work, or living conditions – six months after their last vaccination. One big change: The Moderna booster will be half the dose used for the first two shots, based on company data showing that it was enough to boost immunity again.

Regarding the J&J single-dose vaccine, the FDA has said that all US recipients, regardless of age, can receive a second dose at least two months after their initial vaccination.

The FDA’s decisions differ because vaccines are manufactured in different ways, with different dosage regimens – and J&J has consistently shown a lower level of efficacy than either of the Moderna and Pfizer dual vaccines.

In terms of mixing and matching, the FDA has stated that any brand of booster can be used, regardless of which vaccination was given in the first place. Vaccine interchangeability is expected to accelerate the revaccination campaign, especially in nursing homes and other settings where residents have received different vaccinations over time.

FDA officials said they want to make the booster guide as flexible as possible, given that many people don’t remember what brand of vaccine they got.

“The ability to swap out these vaccines is good – it’s the same thing we do with flu vaccines,” FDA’s Dr. Peter Marks told reporters Wednesday night. “Most people don’t know what brand of flu vaccine they’ve got.”

However, he added that many people will choose to get a booster shot from the same company as their initial vaccination.

The agency’s decision to mix and match was based on preliminary government research into various combinations of boosters, which showed that an additional dose of either type increased levels of antibodies that fight the virus. This study also showed that single J&J vaccine recipients had a much greater response if they received the full Moderna booster or Pfizer booster, rather than the second J&J vaccine. The study did not test the Moderna half-dose booster.

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Health authorities emphasize that getting the first shots is still a priority for the roughly 65 million eligible Americans who have not yet been vaccinated. But the revaccination campaign is meant to bolster protection against the virus amid signs that the vaccine’s effectiveness against mild infections is waning, while all three brands continue to protect against hospitalization and death.

“The available data today suggest a decrease in immunity in some populations of fully vaccinated people,” said Acting FDA Commissioner Dr. Janet Woodcock. “The availability of these approved boosters is essential for continued protection against COVID-19.”

Moderna’s decision to use a booster vaccine is essentially in line with the FDA’s ruling that high-risk groups are eligible for Pfizer’s vaccine, which is produced using the same technology.

The FDA recommended that anyone who received the J&J single-shot vaccine get a booster vaccine because it consistently showed a lower level of protection than its double-shot competitors. And several independent FDA consultants who supported the revaccination decision suggested that the J&J vaccine should have been originally designed for two doses.

Experts continue to debate the rationale behind the pressure-raising campaign. Some warn that the US government has not clearly articulated the goals of the boosters, given that the shots continue to ward off the worst effects of COVID-19, and question whether the goal is to contain the spread of the virus by containing, at least temporarily, milder infections.

FDA regulators have said they will quickly move to expanding boosters to lower age groups, such as those in their 40s and 50s, if warranted.

“We are monitoring this very closely and will take appropriate measures to ensure maximum protection for the population,” said Marks, a senior FDA spokesman for vaccines.

In August, the Biden administration announced plans for a widespread support campaign targeting all US adults, but outside experts have repeatedly opposed such a massive effort.

On Thursday, an influential group convened by the CDC is expected to offer more specific information on who should receive boosters and when. Their recommendations are subject to approval by the director of the CDC.

The vast majority of the nearly 190 million Americans fully vaccinated against COVID-19 received the Pfizer or Moderna vaccine, and about 15 million received the J&J vaccine.

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Associated Press author Mike Stobbe contributed to this story from New York.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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