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The Food and Drug Administration approved booster doses of Moderna and Johnson & Johnson’s COVID-19 vaccines following unanimous votes by a committee of independent advisors who supported the booster last week.
In a related decision, the FDA has also approved booster vaccination, which is different from the vaccine originally used to immunize people against COVID-19. For example, a person who received a Johnson & Johnson vaccine could get one from Moderna or Pfizer-BioNTech as a booster.
The regulatory steps open the door to wider use of boosters. In September, the FDA approved a booster for the Pfizer-BioNTech COVID-19 vaccine.
“The available data suggest decreased immunity in some populations who are fully vaccinated,” Acting FDA Commissioner Janet Woodcock said in a statement. “The availability of these approved boosters is important for continued protection against COVID-19 disease.”
An advisory committee from the Centers for Disease Control and Prevention is scheduled to meet on Thursday to discuss booster vaccinations against COVID-19 and make recommendations on how to use them. The CDC director makes the final call on vaccine guidelines. After the CDC has issued its guidelines, the rollout can officially begin.
A study of the mix-and-match approach funded by the National Institutes of Health found no safety concerns with using different vaccines as a boost. The boosts with a mixed vaccine combination were at least as good as matched vaccines at stimulating antibodies, and in some cases the mixed approach appeared to be much better.
By blessing the use of a mixed vaccine combination, the FDA is making it easier to give booster vaccinations in nursing homes where residents did not all get the same original vaccinations.
“From a public health perspective, there is clearly a need in some situations for some people to receive a different vaccine,” said Dr. Amanda Cohn, chief medical officer at the CDC’s National Center for Immunizations and Respiratory Diseases, during Friday’s FDA meeting.
The decision could also make it easier for a wide variety of people to get a booster, as any available shot would be enough.
Dr. Mark Sawyer, a committee member from Rady Children’s Hospital in San Diego, cited the ease of access provided by the mix-and-match approach during the committee’s deliberations. “I’m already sold,” he said, “and that’s because I fully agree with Dr. Cohn’s comments that we need flexibility and improved access for all that allows the flexibility to mix and match.”
Moderna approval includes a booster vaccination for people who have been vaccinated at least six months previously with the company’s two-shot vaccine and are 65 years and older, 18 to 64 years old and are at or at high risk for severe COVID-19 Are of the same age group and whose work or institutional exposure puts them at high risk of COVID-19.
Approval comes after an FDA advisory committee voted 19-0 last Thursday for the refresh. The scope of Moderna approval is the same as that granted by the FDA to Pfizer-BioNTech’s COVID-19 booster doses in September.
One difference: Moderna’s COVID-19 vaccine booster is half the dose of the initial vaccinations used in its two-shot vaccination – 50 micrograms of mRNA versus 100 micrograms per initial shot. The Pfizer vaccine uses a third identical dose.
The FDA also approved a booster dose of the J&J vaccine at least two months after the first vaccination for people 18 years of age and older. A study published by the CDC in September showed that the J&J vaccine had about 68% effectiveness in keeping people out of hospital for COVID-19, compared to more than 90% for Moderna’s vaccine and about 77% for the Pfizer-BioNTech after about four months.
Several committee members noted that people were given booster doses and used a mix-and-match approach.
“Many Americans are taking matters into their own hands,” said Dr. Ofer Levy, Professor of Pediatrics at Harvard Medical School. “I read in the media that people get boosters or mix different products through their GP or don’t reveal what they got before. All these kinds of combinations of additional boosters already exist in the real world. “
According to data from the Centers for Disease Control and Prevention, more than 9 million people have received a Pfizer booster. Even ahead of FDA approval, CDC data shows that more than 1.6 million people received a Moderna booster vaccination and more than 11,000 received another vaccination from J&J.
Ofer urged the FDA to act quickly: “I think there is an urgent need for the FDA to help clarify what is an admittedly complex and challenging scenario. We cannot hide from the public. “