Moderna asks FDA to expand COVID-19 booster access to all adults 18 and older

Moderna announced on Wednesday that it has filed an emergency use authorization request with the U.S. Food and Drug Administration for its COVID-19 booster to be expanded to all adults 18 and older.

In October, the FDA approved emergency use authorization of Moderna’s COVID-19 booster for people 65 and older and people 18 to 64 who are at high risk for severe COVID-19, according to a company news release.

Moderna’s request comes just a little over a week after Pfizer submitted a similar emergency use authorization request to the FDA on Nov. 9, asking the agency to expand access to its booster shot to all adults over 18.

Members of the Advisory Committee on Immunization Practices will discuss expanding eligibility for COVID-19 vaccine booster shots to all adults Friday, a move that could make the shots available nationwide as early as this weekend.

The panel advises the U.S. Centers for Disease Control and Prevention in setting vaccination recommendations for U.S. doctors and the general public.

The move to approve either company’s booster for all adults would greatly expand who is eligible. Boosters are now recommended for people who initially received their second Pfizer or Moderna shots at least six months ago if they’re 65 or older or are at high risk of COVID-19 because of health problems or their job or living conditions. Boosters are also recommended for people who received the single-dose Johnson & Johnson vaccine at least two months ago.

Also, anyone eligible for a booster doesn’t have to stick with their initial vaccination type and can get a different company’s vaccine, what’s called mixing and matching, according to the CDC.

Nearly 31 million Americans have already received a dose beyond their original two-dose vaccination, including those with weakened immune systems, such as cancer patients and organ transplant recipients who need an extra dose to be fully vaccinated.

Pfizer’s request last week to allow boosters of its COVID-19 vaccine for anyone 18 or older was submitted with early results of a booster study in 10,000 people to make the company’s case that it is time to further expand the booster campaign.

While all three vaccines used in the U.S. continue to offer strong protection against severe COVID-19 illness and death, the shots’ effectiveness against milder infection can wane over time.

Pfizer’s study concluded a booster could restore protection against symptomatic infection to about 95%, even as the extra-contagious delta variant was surging. Side effects were similar to those seen with the company’s first two shots.

Dr. Anthony Fauci, the country’s top infectious disease expert, believes COVID-19 vaccine boosters will be needed to avoid a possible "double whammy" of the highly transmissible coronavirus delta variant and waning immunity this winter — possibly putting even vaccinated people at risk.

FILE - A nurse shows the vial of the Moderna novel Coronavirus vaccine.

"The somewhat unnerving aspect of it is that if you keep the level of dynamics of the virus in the community at a high level — obviously the people who are most, most vulnerable are the unvaccinated — but when you have a virus as transmissible as delta, in the context of waning immunity, that dynamic is going to negatively impact even the vaccinated people. So it's a double whammy," Fauci saidin a pretaped interview aired at the 2021 STAT Summit Tuesday.

"You're going to see breakthrough infections, even more so than we see now among the vaccinated," he added. Fauci even suggested that a third COVID-19 vaccine shot may no longer be a "luxury," but part of the required vaccination process.

"I happen to believe... that a third shot boost for an mRNA is likely should be part of the actual standard regimen," he said.

The seven-day average of COVID-19 cases in the U.S. has jumped more than 26% over the last three weeks, according to data from the CDC. On Oct. 24, the CDC reported the country’s seven-day average of cases at 63,800. Three weeks later, on Nov. 14, the CDC was reporting the seven-day average had jumped to 80,800 — an increase of 26.5%.

Meanwhile, the Biden administration is making billions of dollars available to drugmakers to scale up domestic production of COVID-19 vaccines (https://apnews.com/hub/coronavirus-vaccine) in the hopes of building capacity to produce an additional 1 billion shots per year to share with the world.

Under the new initiative, the Department of Health and Human Services' Biomedical Advanced Research and Development Authority is soliciting pharmaceutical companies that have demonstrated the ability to make the more-effective mRNA vaccines to bid for government investment in scaling up their manufacturing abilities. Drugmakers Pfizer and Moderna produce the two U.S.-approved mRNA shots.

The Biden administration believes the boosted capacity of COVID-19 shots will help ease a global shortage of doses, particularly in lower- and middle-income nations, stopping preventable death and limiting the development of potentially new, more dangerous variants of the virus.

"The goal of this program is to expand existing capacity by an additional billion doses per year, with production starting by the second half of 2022," White House COVID-19 coordinator Jeff Zients said.

The initiative comes as the Biden White House has faced growing pressure at home and abroad over inequity in the global vaccine supply — as the U.S. moves toward approving booster shots for all adults (https://apnews.com/article/coronavirus-pandemic-science-health-coronavirus-vaccine-centers-for-disease-control-and-prevention-54dcd950608a9145292eb59a6ba6bf88) while vulnerable people in poorer nations (https://apnews.com/article/africa-coronavirus-pandemic-health-a4e722e082aa06a2c25f59f24b0a8eaf) wait for their first dose of protection.

There are no firm agreements yet with Moderna or Pfizer to take up the U.S. on the investment, but the Biden administration hopes that the enhanced manufacturing capacity, through support for the company's facilities, equipment, staff or training, will be available by mid-2022 to allow more COVID-19 doses to be shared overseas as well as to prepare for the next public health emergency.

The Associated Press and Chris Williams contributed to this report.

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