Moderna resubmits FDA to approve third syringes for all adults

Moderna’s Covid-19 vaccine.

Paul Hennessy | LightRakete | Getty Images

Moderna on Wednesday resubmitted its application to the Food and Drug Administration to approve booster doses for all adults aged 18 and over.

FDA approval would open the doors to millions of Americans to get a third vaccination as a growing body of data shows that the vaccine’s effectiveness wears off over time. The FDA and the Centers for Disease Control and Prevention last month approved vaccinations for anyone aged 65 and over, as well as adults who are at higher risk of developing severe Covid or who work or live in environments where they are are at higher risk of contracting the virus.

Moderna’s revised application, which was originally filed in September, comes because the FDA is expected to approve Pfizer and BioNTech booster vaccinations for all adults later this week. If the CDC gives the OK, Pfizer’s third syringes could be given this weekend to adults who completed their first two syringes at least six months ago.

Pfizer’s boosters, like Moderna’s previously, were approved for the elderly and people at high risk. Individuals aged 18 and over who received the Johnson & Jonson single-dose vaccine are already entitled to a booster vaccination.

CDC director Rochelle Walensky said Wednesday the agency plans to “act quickly” on booster doses once the FDA reviews the data and gives approval.

When the FDA’s principal vaccines committee first met in September on Pfizer’s application to approve boosters for the general public, they turned down a proposal to distribute them to the general public and recommended a scaled-down distribution schedule instead. Some committee members said at the time they were concerned that there wasn’t enough data to make a recommendation, while others argued that third shots should be restricted to specific groups.

When the panel met on Moderna’s booster data last month, committee member Dr. Patrick Moore, the data submitted by the company was “not well explained” and added that he agreed to the reduced plan more on a “gut feeling” basis.

“The data itself is not strong, but it is certainly going in a direction that supports this vote,” he said at the time.

The general administration of booster doses for all adults is controversial among health authorities. The World Health Organization has repeatedly criticized rich nations for getting ahead with third vaccinations as many people in poorer countries still have limited access to vaccines.

WHO has warned that failure to push for widespread access to vaccines in developing countries could lead to future variants of the virus that would then undermine protection in countries that have largely immunized their populations and threaten progress .

Booster doses have also created some controversy in the US with more than 60 million Americans remaining unvaccinated. The Chief Medical Advisor to the White House, Dr. Anthony Fauci, on Wednesday, encouraged Americans not only to get vaccinated, but also to get their booster vaccinations if they are eligible.

“It’s not too late yet. Get vaccinated now. And most importantly, if you were vaccinated six months or more ago and are eligible for a booster, you will be given a booster, ”said Fauci. “The Israelis have shown that if you increase the dose, the chances of getting infected, getting sick or dying are reduced many times over.”

The US has administered more than 168 million doses of Moderna vaccine and more than 257 million doses of Pfizer vaccine. Health officials have administered more than 16 million doses of Johnson & Johnson’s vaccine.

Nearly 80% of Americans 12 and older have received at least one dose of the three vaccines, according to CDC data. More than 30.7 million people in the US have already received their booster vaccinations, the data shows.

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