- The FDA expanded authorization for mRNA boosters to include all adults who have completed their primary series of any COVID-19 vaccine approved in the U.S.
- The news comes as COVID-19 cases are increasing in the U.S.
- Experts are concerned that cases could surge again during the holidays.
The Food and Drug Administration (FDA) signed off on COVID-19 boosters for all fully vaccinated adults, opening up extra doses to millions more people in the United States.
This comes as the country prepares for a possible winter COVID-19 surge as the holidays approach.
On Nov. 19, the FDA amended its emergency use authorization of the Pfizer-BioNTech and Moderna mRNA boosters to include all people ages 18 and older who have completed their primary series of any COVID-19 vaccine approved or authorized in the United States.
“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” he said.
People who got one of the mRNA vaccines for their primary series would be eligible for a booster at least 6 months after their second dose, the FDA said.
People who got the Johnson & Johnson vaccine would be eligible for a booster at least 2 months after their first dose.
The FDA and Centers for Disease Control and Prevention (CDC) previously approved mix-and-match boosters. This means people who are eligible for a booster can choose any of the approved or authorized vaccines.
The CDC vaccine advisory panel is
If this panel approves mRNA boosters for all adults and CDC Director Dr. Rochelle Walensky concurs, booster doses could be available right away.
The FDA and CDC previously approved mRNA boosters for certain high-risk adults, including those over age 65 and younger people with underlying medical conditions that put them at risk of severe COVID-19.
But concerns over waning vaccine protection against infection and a surge in cases heading into the holidays led some states to move ahead of federal health authorities.
Several states, including Arkansas, California, Colorado, Kentucky, Kansas, and New Mexico, have already broadened access to COVID-19 boosters to virtually all vaccinated adults.
New York City also announced it was ordering healthcare professionals not to turn away any adults seeking booster doses.
Dr. Albert A. Rizzo, chief medical officer of the American Lung Association, said expanded booster eligibility is a way for health officials to mitigate risk as some parts of the country see coronavirus surges.
“You have some local and state authorities who are opening up [boosters] to all residents because their healthcare systems seem to be on the verge of having another issue due to the rise in COVID cases,” he said.
As of Nov. 17, reported new U.S. cases had averaged over 88,000 a day over the past week, a 26 percent increase from 2 weeks earlier.
In Europe, where COVID-19 trends often hint at what is to come in the United States, cases are rising sharply, with many countries instituting further restrictions.
Even before boosters were available to all adults, many Americans who did not qualify had sought out extra doses on their own, reported The New York Times.
Around 17 percent of all adults have received a booster, according to the CDC, with more than one-third of people over age 65 having received an extra dose.
Some experts were concerned that offering boosters just to certain adults created additional health disparities in the country, with historically marginalized groups less likely to access an extra dose.
The CDC is not yet reporting race and ethnicity data for people who have received a booster.
However, Dr. Thomas LaVeist, dean of the School of Public Health and Tropical Medicine at Tulane University, said states like Louisiana have shown it’s possible to distribute COVID-19 vaccines in an equitable way.
The key to this, he said, is planning in a way that ensures all residents can easily access the vaccines.
“[In Louisiana], the equity issue was on the plate from the very beginning,” he said. “The fact that we’re one of the states that doesn’t have disparities in their vaccination rates is a reflection of that.”
Vaccination rates in Louisiana for the primary series are similar for Black people and for white people, according to Kaiser Family Foundation.
Dr. Brandi Freeman, a pediatrician at Children’s Hospital of Colorado and associate vice chair for diversity, equity, and inclusion at the University of Colorado Medicine, said it’s also important to continue having conversations with people about the vaccines.
“Here in Colorado, I volunteer with one of our health systems that is going into minority communities to vaccinate there,” she said. “I made it a priority to be there, because I think it’s important to make vaccination accessible and not put barriers in front of people.”