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

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

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

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

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

Members of the Advisory Committee on Immunization Practices will discuss Friday whether all adults are eligible for booster shots for COVID-19 vaccination, 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 preparing vaccination recommendations for U.S. physicians and the general public.

The move to approve both companies’ booster for all adults would vastly expand who qualifies. Boosters are now recommended for people who received their second Pfizer or Moderna shot at least six months ago if they are 65 years of age or older or are at high risk for COVID-19 due to health conditions or their working or living conditions. Boosters are also recommended for people who received the Johnson & Johnson single-dose vaccine at least two months ago.

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Also, anyone eligible for a booster doesn’t have to stick to their original vaccination type and can get a vaccine from another company, which is called mixing and matching, according to the CDC.

Nearly 31 million Americans have already received a dose higher than 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 to anyone 18 years of age or older was made with the first results of a booster study of 10,000 people to tell the company it’s time to further expand the booster campaign.

While all three vaccines used in the US continue to provide strong protection against severe illness and death from COVID-19, the effectiveness of the injections against milder infections may diminish over time.

RELATED: Pfizer asks FDA to approve covid-19 booster injection for all adults over 18

Pfizer’s study concluded that a booster could restore protection against symptomatic infection to about 95%, even while the extra-infectious delta variant was on the rise. Side effects were similar to those seen in the company’s first two shots.

dr. Anthony Fauci, the country’s top infectious disease expert, believes vaccine boosters against COVID-19 will be needed to avoid a potential “double whammy” of the highly transmissible coronavirus delta strain and waning immunity this winter – potentially putting even vaccinated people at risk.

FILE – A nurse shows the vial containing Moderna’s novel Coronavirus vaccine.

RELATED: Fauci says COVID-19 vaccine boosters will help avoid winter’s ‘double whammy’

“The somewhat unnerving aspect of it is that if you keep the level of the virus dynamics in the community at a high level – obviously the people who are the most and most vulnerable are the unvaccinated – but if you have a virus that As transmissible as delta, in the context of waning immunity, that dynamic will negatively affect even the vaccinated people. So it’s a double whammy,” Fauci said in a pre-recorded interview broadcast on the 2021 STAT summit Tuesday.

“You’ll see breakthrough infections, even more than we’re seeing now in the vaccinated,” he added. Fauci even suggested that a third shot of the COVID-19 vaccine may no longer be a “luxury” but part of the required vaccination process.

“I happen to believe … that a third injection boost to an mRNA should probably be part of the actual standard regimen,” he said.

The seven-day average of COVID-19 cases in the US is up more than 26% in the past three weeks, according to data from the CDC. On October 24, the CDC reported the country’s seven-day average of cases at 63,800. Three weeks later, on Nov. 14, the CDC reported that the seven-day average had risen to 80,800 — a 26.5% increase.

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Meanwhile, the Biden administration is making billions of dollars available to drug makers to scale up domestic production of COVID-19 vaccines ( in hopes of building capacity to deliver another 1 billion to produce. shots per year to share with the world.

Under the new initiative, the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services is asking pharmaceutical companies that have demonstrated their ability to make the more effective mRNA vaccines to bid for government investment in the scale up their production capacities. Drug makers Pfizer and Moderna produce the two US-approved mRNA shots.

The Biden administration believes the increased capacity of COVID-19 injections will help reduce a worldwide dose shortage, particularly in low and middle-income countries, halt preventable deaths and develop potentially new, more dangerous variants of the drug. virus will limit.

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

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The initiative comes as Biden’s White House comes under increasing pressure at home and abroad over inequalities in global vaccine supply — while the US is on track to approve booster shots for all adults ( /article/coronavirus-pandemic- science-health-coronavirus-vaccine-centers-for-disease-control-and-prevention-54dcd950608a9145292eb59a6ba6bf88) while vulnerable people in poorer countries ( pandemic-health-a4e722e082aa06a2c25f59 for their first dose of protection.

There are no firm agreements yet with Moderna or Pfizer to take on the investment in the US, but the Biden administration hopes the improved manufacturing capacity, through support of the company’s facilities, equipment, personnel or training, will be available by mid-2022. will be. to share more COVID-19 doses abroad and to prepare for the next public health emergency.

The Associated Press and Chris Williams contributed to this report.