Health

The FDA approves Moderna and J&J Covid vaccine boosters and permits mix-and-match pictures

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The Food and Drug Administration approved booster shots of Covid vaccines from Johnson & Johnson and Moderna on Wednesday evening, another major step in distributing additional doses to tens of millions of people.

At the same time, US regulators approved “mixing and matching” vaccines, which allowed Americans to get a booster shot from a drug company other than the one who made their starting doses.

“Today’s actions demonstrate our commitment to public health in proactively combating the COVID-19 pandemic,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement.

“As the pandemic continues to affect the country, science has shown that vaccinations continue to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease such as hospitalization and death,” she added.

The expected FDA approval came after the agency’s Advisory Committee on Vaccines and Related Biological Products unanimously recommended additional vaccinations for both vaccines last week. The committee recommended the Moderna booster for the elderly and at-risk adults six months after completing their first series of vaccinations to align with the distribution plan for Pfizer and BioNTechs boosters. It also advocated J&J boosters for anyone 18 and older who received their first vaccination at least two months ago.

The verdict is now being passed to the Centers for Disease Control and Prevention and their Vaccine Advisory Committee, which has scheduled a meeting for Thursday to discuss Moderna and J & J’s booster data. If the committee makes a recommendation and CDC Director Dr. Rochelle Walensky signs, additional vaccinations for these vaccines could be distributed to eligible individuals immediately.

The approval would open booster doses to the more than 15 million people vaccinated with J & J’s vaccine and the more than 69 million people who were fully vaccinated with Moderna’s vaccine.

Eligible Americans will also be able to “mix and match” vaccines. A highly anticipated study by the National Institutes of Health published last week showed that all combinations of boosters raised antibody levels, although the Pfizer and Moderna boosters appeared to work the best.

The FDA said Wednesday that it has found an increased risk of rare inflammatory heart disease, myocarditis and pericarditis after being vaccinated with the Moderna vaccine, especially after the second dose. Usually symptoms began a few days after vaccination, it said. The observed risk is higher in men under 40 years of age, especially in men between 18 and 24 years of age.

Pfizer boosters were approved for a wide variety of Americans less than a month ago, including the elderly, adults with pre-existing medical conditions, and those who work or live in high-risk environments such as people’s homes. B. in health care and in the grocery trade.

Booster vaccination has been a controversial issue for scientists – inside and outside of government – especially since many people in the US and other parts of the world have not yet received a single dose of a vaccine. The World Health Organization has asked wealthy countries to wait before distributing boosters, and some scientists say they are not convinced that most Americans need them now.

Some committee members said Thursday the boosters should prevent what are known as breakthrough infections, which they believe are critical to protecting healthcare facilities from being overloaded, while other members said the third vaccinations should ensure high-risk patients don’t have serious illnesses. Some committee members also suggested that young people may not need a booster vaccination as the first shots in these groups still continue.

The Biden government hopes the extra dose will ensure long-term and permanent protection from serious illness, hospitalization, and death for the U.S. population as the fast-paced Delta variant continues to spread.

Unlike Pfizer and Moderna’s two-shot messenger RNA vaccines, J&J hoped to offer a one-shot solution that would protect the public sufficiently to end the coronavirus pandemic. But its 72% protection in the US was viewed by some as inferior to the Moderna and Pfizer vaccines, both of which touted efficacy rates of over 90%.

A second dose of J & J’s Shot provides similar performance to the mRNA vaccines and increases protection against symptomatic infection to 94% when given two months after the first dose in the US, according to data the company presented to the FDA Has. J & J’s vaccine uses a modified adenovirus to induce an immune response.

Still, FDA scientists released an analysis of J & J’s booster application last week questioning the strength of the data. The FDA said people could benefit from a second dose, but the information the company provided was limited and the agency had not yet reviewed all of them.

Prior to Friday’s vote, many committee members said that J&J should be viewed as a two-dose vaccine, similar to that used by Moderna and Pfizer.

Some committee members even asked the agency if they could postpone a decision on boosters for J&J recipients. Other members wondered why the agency brought J & J’s application to the committee before they could review all of the data.

“Is there a way to say that it is still a little early? There are a number of questions that remain open,” said Dr. Cody Meissner from Tufts University. “At this point there are a lot of uncertainties that make it difficult to vote for or against tonight.”

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