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FDA Authorizes Booster Doses Of Moderna And Johnson & Johnson Vaccines, Says Mix And Match OK

By Maggie Fox, Oct. 21 (CNN): The US Food and Drug Administration on Wednesday approved booster doses of Covid-19 vaccines made by Moderna and Johnson & Johnson, as well as a “mix and match” method in which any of the three approved vaccines could be used as a booster.

However, it left in place a complicated mechanism for determining who should receive boosters and when, with officials indicating that the framework may be simplified as more safety data becomes available.

Vaccine experts to the US Centers for Disease Control and Prevention will now evaluate the FDA’s approval and provide their own recommendations. People might start taking Moderna and J&J boosters within days if CDC chief Dr. Rochelle Walensky authorizes permission.

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

It also allowed booster doses of Johnson & Johnson’s vaccination for anyone who received the vaccine at least two months ago, i.e., those aged 18 and over.

It also said that any of the three approved vaccines might be used to increase immunity. Pfizer has previously received approval for booster shots for its vaccine for anyone who were vaccinated at least six months ago, with the same limits as Moderna’s vaccine: those 65 and older, as well as those at increased risk of severe disease.

“As the pandemic continues to spread across the country, science has demonstrated that vaccination remains the safest and most effective way to prevent COVID-19, including the disease’s most serious consequences, such as hospitalization and death,” FDA Acting Commissioner Dr. Janet Woodcock said in a statement.

“According to the existing statistics, some fully vaccinated populations’ protection is diminishing. The availability of these approved boosters is critical for maintaining COVID-19 disease protection.”

The option to use any permitted vaccination as a booster, according to Dr. Peter Marks, director of the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, will make things easier for individuals.

“It’s a good thing that these immunizations can be swapped out. It’s similar to how we administer flu shots. The majority of people are unaware of the flu vaccination brand they received “In a telephone conference, Marks told reporters.

As more safety data becomes available, Marks said the FDA may consider decreasing the age limits for booster doses.

“We want to make sure that if we implement the boosters across all age groups, the benefits genuinely outweigh the dangers,” Marks added. “We will not hesitate to lower this age range if we believe the value outweighs the risk, and because we have EUA authorization, we can do so in a reasonably short period of time.”

The Advisory Committee on Immunization Practices, the CDC’s vaccine advisers, will meet on Thursday to decide whether to recommend the FDA’s approval for the American people, and then the CDC director will decide whether to sign off on ACIP’s guidance.

After National Institutes of Health researchers presented their findings to the FDA’s vaccine advisers last week, the agency opted to allow mix-and-match boosters. Although the results were limited, they demonstrated that combining vaccinations was safe.

The agency provided some examples of how this could be implemented.

“For example, Janssen COVID-19 Vaccine recipients aged 18 and up may receive a single booster dose of Janssen COVID-19 Vaccine, Moderna COVID-19 Vaccine (half dose), or Pfizer-BioNTech COVID-19 Vaccine at least two months after receiving their Janssen COVID-19 Vaccine primary vaccination,” it stated.

“In another example, Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters (65 years of age and older, 18 through 64 years of age at high-risk of severe COVID-19, and 18 through 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 Vaccine at least six months after completing their primary vaccination,” it added.

According to Dr. David Dowdy, an infectious diseases epidemiologist at the Johns Hopkins Bloomberg School of Public Health, the directions are perplexing.

Dowdy told CNN, “It’s difficult for the typical person to traverse all of this and find out what the appropriate thing to do is.”

Dowdy expressed his hope that the CDC would provide more public recommendations on boosters. However, he claims that the focus on boosters is diverting attention away from the greater need to vaccinate more people in the first place.

“The public, as well as pharmaceutical corporations, are under pressure to get these suggestions out as soon as possible. It isn’t caused by the virus ” he stated.

Pfizer’s or Moderna’s vaccinations are highly efficient at avoiding serious disease after the first two doses, according to Dowdy.

“It’s not the worst thing in the world if you’re a little confused by this — it’s not the worst thing in the world to wait a little time as long as you’ve gotten that first series of immunizations,” he said.

source: risingnepal

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