FDA clears booster doses of Moderna and Johnson & Johnson vaccines, says mix and match OK – .

Covid-19 booster shots available for some, but Johnson & Johnson vaccine recipients said to wait – .

But that left a complex formula in place for who should get recalls and when, with officials saying they could simplify the framework as more safety data arrives.

Now, vaccine advisers from the U.S. Centers for Disease Control and Prevention will review the FDA clearance and offer their own advice. If CDC director Dr. Rochelle Walensky signs, people could start receiving Moderna and J&J boosters within days.

The FDA has granted emergency use authorization for a half-dose of Moderna’s vaccine as a booster for people fully vaccinated at least six months ago who are also at least 65 years old, or who are at least 18 years old and at high risk of severe Covid-19 or have frequent institutional or occupational exposure to the virus.

He also authorized booster doses of the Johnson & Johnson vaccine for anyone who received this vaccine, so people 18 years and older, at least two months ago.

And he said one of the three licensed vaccines could be used to boost. Pfizer already has clearance for booster shots of its vaccine for people vaccinated at least six months ago – with the same restrictions as Moderna’s vaccine: those 65 and over and those at higher risk of disease serious.
“As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of illness, such as hospitalization and death, ”Acting FDA Commissioner Dr. Janet Woodcock said in a statement.

“The available data suggest a decrease in immunity in some populations that are fully vaccinated. The availability of these authorized recalls is important for continued protection against COVID-19 disease. “

Dr Peter Marks, director of the vaccines arm of the FDA, Center for Biologics Evaluation and Research, said being able to use any licensed vaccine as a booster will make it easier for people.

“Being able to share these vaccines is a good thing. It’s like what we do with flu shots. Most people don’t know which brand they got the flu shot from, ”Marks told reporters in a telephone briefing.

Marks said the FDA will consider lowering the age ranges for booster shots as more safety data comes in.

“We want to make sure that if we deploy the boosters in all age groups, we are really doing an advantage outweighing any risk,” Marks said. “We will not hesitate to drop this age bracket as we see that this advantage outweighs the risk, and due to the EUA authority that we have, we can do it within a short period of time. relatively fast. “

CDC’s vaccine advisers, the Advisory Committee on Immunization Practices, meet Thursday to decide whether to recommend FDA clearance for the American people, then CDC director to decide whether to approve the guidelines of ACIP.

The FDA said it decided to allow mixed boosters after researchers at the National Institutes of Health presented their findings last week to its vaccine advisers. Although the results were limited, they made it clear that mixing the different vaccines was safe.

The agency gave some examples of how this might work.

“For example, Janssen COVID-19 vaccine recipients aged 18 and over may receive a single booster dose of Janssen COVID-19 vaccine, Moderna COVID-19 vaccine (half dose), or Pfizer-BioNTech COVID vaccine. -19 for at least two months. after receiving their primary Janssen COVID-19 vaccine, ”he said.

“In another example, recipients of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine falling into one of the categories allowed for recalls (65 years and over, 18 to 64 years at high risk of COVID- 19 severe) 19 and 18 to 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2) may receive a booster dose of Moderna COVID-19 vaccine (half-dose), Pfizer-BioNTech COVID-19 vaccine or Janssen COVID-19 Vaccinate at least six months after completing their primary vaccination, ”he added.

The instructions are confusing, said Dr David Dowdy, an infectious disease epidemiologist at the Johns Hopkins Bloomberg School of Public Health.

“It’s hard for the average person to navigate all of this and figure out what’s the right thing to do,” Dowdy told CNN.

Dowdy said he hopes the CDC will provide clearer advice to the public on boosters. But he also said the focus on reminders distracted the public from the greater need to vaccinate more people in the first place.

“The pressure to have these recommendations released so quickly comes from the public, from the pharmaceutical companies. It is not from the virus, ”he said.

The initial two doses of Pfizer’s or Moderna’s vaccines are very effective in preventing serious illness, Dowdy noted.

“If you’re a little confused by this, it’s not the worst thing in the world to wait a little while until you’ve had that first round of vaccines,” he said.


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