FDA clears Moderna and J&J Covid vaccine recalls, clears ‘mix and match’ injections – .

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FDA clears Moderna and J&J Covid vaccine recalls, clears ‘mix and match’ injections – .


On Wednesday evening, the Food and Drug Administration authorized booster injections of the Covid vaccines from Johnson & Johnson and Moderna, another critical step in delivering additional doses to tens of millions of people.
At the same time, US regulators have cleared “mix and match” vaccines, allowing Americans to get a recall from a different drug maker than the one that made their initial doses.

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

“As the pandemic continues to impact the country, science has shown that vaccination remains 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 clearance came after the agency’s Vaccines and Related Biologics Advisory Committee unanimously recommended additional injections of both vaccines last week. The committee recommended the Moderna booster for seniors and at-risk adults six months after completing their first round of vaccines, aligning it with Pfizer and BioNTech’s booster distribution plan. He also endorsed J&J boosters for anyone 18 and over who received the initial blow at least two months ago.

The decision will now be turned over to the Centers for Disease Control and Prevention and its Vaccine Advisory Committee, which has a meeting scheduled for Thursday to discuss recall data from Moderna and J&J. If the committee makes a recommendation and CDC director Dr. Rochelle Walensky approves, additional injections for these vaccines could be distributed immediately to eligible people.

The authorization would open booster doses to the more than 15 million people who have been inoculated with J&J’s vaccines and to the more than 69 million people who have been fully immunized with Moderna’s vaccine.

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

The FDA said on Wednesday it had identified an increased risk of rare inflammatory heart disease, myocarditis and pericarditis, following vaccination with the Moderna vaccine, especially after the second dose. Usually, the onset of symptoms occurred a few days after vaccination, he said. The observed risk is higher in men under 40, especially men between 18 and 24 years old.

Pfizer’s boosters were licensed less than a month ago to a wide range of Americans, including the elderly, adults with underlying health conditions, and those who work or live in high-pressure environments. risk, such as healthcare workers and grocery stores.

Booster shots have been a controversial topic for scientists – inside and outside of government – especially since many people in the United States and other parts of the world have yet to receive them. even one dose of vaccine. The World Health Organization has pleaded with wealthy countries to halt the distribution of boosters, and some scientists say they’re not convinced most Americans need them right now.

Some committee members said on Thursday that the boosters should prevent so-called breakthrough infections, which they say is essential to protect healthcare facilities from overflow, while other members said third injections should ensure that people at high risk do not suffer from serious illness. . Some committee members also suggested that young people may not need boosters, as the initial injections still fit in these groups.

The Biden administration hopes that giving the U.S. population additional doses will provide long-term, lasting protection against serious illness, hospitalization, and death as the rapidly evolving delta variant continues to spread.

Unlike the two-shot messenger RNA vaccines from Pfizer and Moderna, J&J hoped to offer a unique solution that would protect the public enough to help end the coronavirus pandemic. But its 72% protection in the United States has been viewed by some as inferior to vaccines from Moderna and Pfizer, both of which have touted efficacy rates above 90%.

A second dose of J & J’s vaccine offers similar performance to mRNA vaccines, increasing protection against symptomatic infections to 94% when given two months after the first dose in the United States, according to data submitted to the FDA by the company. J & J’s vaccine uses a modified adenovirus to induce an immune response.

Still, FDA scientists last week released an analysis on J & J’s request for a recall, 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 yet to verify everything.

Ahead of Friday’s vote, many committee members said J&J should be considered a two-dose vaccine much like Moderna and Pfizer.

Some committee members even asked the agency if they could postpone a decision on recalls for J&J beneficiaries, saying it may be too early as there were still a number of outstanding issues. Other members questioned why the agency filed J&J’s request with the committee before it could verify all the data.

“Is it possible to say that it is a little early?” There are a number of issues that are still unresolved, ”said Dr Cody Meissner of Tufts University. “There are a lot of uncertainties at this point which makes it difficult to vote for or against tonight. “

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