Moderna Just Made This Major Announcement About Its Booster
The potential for a massive change with COVID booster shots is now on the horizon.
Just a few months ago, boosters weren't even a consideration in the country's COVID vaccine regimen. But now, more than 30 million people in the U.S. have gotten an additional shot, according to the latest data from the Centers for Disease Control and Prevention (CDC). Only certain groups of people are currently eligible to get a booster: The CDC and the U.S. Food and Drug Administration (FDA) have authorized an additional dose for Moderna and Pfizer recipients who are 65 years old and older or younger and at higher risk. But as more and more virus experts note that boosters might be essential to the vaccine process, changes to existing requirements could be on the way.
On Nov. 17, Moderna released a statement announcing that it had filed for an expansion of its booster's emergency-use authorization. The vaccine manufacturer is asking the FDA to authorize its 50-microgram booster dose for all adults 18 and older once they are at least six months out from their second shot, with no stipulations.
"The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets," the vaccine manufacturer noted in its announcement.
Pfizer also recently filed an application with the FDA to expand eligibility for its booster. The agency is aiming to grant this authorization as early as Nov. 18, and a CDC committee is scheduled to meet Nov. 19 about boosters, which could allow younger adults to get a Pfizer booster as early as this weekend, The New York Times reported on Nov. 16. And Moderna's may not be far behind. CDC Director Rochelle Walensky said on Nov. 17 that the agency plans to "act swiftly" on expanding booster doses as soon as the FDA reviews the data and provides authorization, per CNBC.
Some states are no longer waiting for official guidance from the FDA and CDC, however. According to ABC News, officials from nine states in the U.S. have already moved to either formally or informally offer booster shots to their residents 18 and older: Arkansas, California, Colorado, Minnesota, New Jersey, New Mexico, New York, Rhode Island, and West Virginia.
"I've been very frustrated with the convoluted messaging out of the CDC and the FDA. Everybody should get the booster after six months," Colorado Gov. Jared Polis said during an episode of CBS News' Face the Nation on Nov. 14 The data is incredibly clear that it increases your personal protection level. That's why my parents got it. I got it. My family members got it."
Even top White House COVID adviser Anthony Fauci, MD, recently said that there should be no limits on which adults are allowed to get an additional shot anymore. "Right now, don't make it complicated," he told Insider on Nov. 16. "Make it really simple. If you had a primary vaccination, get a booster."
According to Fauci, most adults who are currently eligible for boosters in accordance with FDA and CDC guidance have not gotten boosted, likely because they're confused about the eligibility requirements. The latest data from the CDC shows that only around 15 percent of all fully vaccinated people have gotten an additional shot, including just 36 percent of those 65 years and older, despite everyone in this age group being eligible.
"We have got to get almost everybody who's gotten the primary vaccination regimen, we've got to get all of them boosted," Fauci told Insider.
Some health experts have asked that more safety data be released before individuals more at risk for the rare but severe vaccine reaction myocarditis get another shot. That includes young men under the age of 30, who are slightly more likely to experience heart inflammation after an mRNA vaccine, and Moderna's vaccine in particular.
Fauci told Insider it's important to note "that all the safety data indicate that the benefit-risk ratio for younger people" will "still weigh heavily in the form of the benefit." He is confident that for the vast majority of people, it will be safe and effective to get a booster dose.