Additional COVID-19 boosters get FDA clearance

US regulators on Tuesday authorized another booster dose of the Pfizer or Moderna COVID-19 vaccines for older Americans and people with weakened immune systems.

The Food and Drug Administration has also taken steps to make coronavirus vaccinations simpler for everyone, saying anyone who gets a dose of Pfizer or Moderna — whether it’s a booster or their very first vaccination – will receive the latest formula, not the original injections.

The FDA said people 65 or older can choose to roll up their sleeves for another booster as long as it’s been at least four months since their first dose of the so-called bivalent vaccine that targets strains of omicron.

And most immunocompromised people can also choose this additional spring booster at least two months after their first, with additional doses in the future at their doctor’s discretion, the agency said.

If the Centers for Disease Control and Prevention approves, these spring recalls could begin within days. CDC advisers are scheduled to meet on Wednesday.

“COVID-19 remains a very real risk for many people,” said FDA vaccine chief Dr. Peter Marks.

It’s too early to tell if younger, healthy people will eventually be offered another shot, but the extra dose for the most vulnerable is one of many steps the FDA is taking to simplify COVID-19 vaccinations. 19 in the future.

Here are a few things to know:


COVID-19 vaccines have saved millions of lives, but protection wanes over time and new, more contagious variants have emerged. So last fall, Pfizer and Moderna rolled out updated “bivalent” boosters that added protection against omicron strains then circulating in the original vaccine recipe. On Tuesday, the FDA said an updated formula would be used for anyone receiving a Pfizer or Moderna vaccine. For unvaccinated adults, this means that a single combination shot would replace having to get several doses of the original vaccine first.


Anyone who received their original vaccines but has not yet received an updated booster can still get one. Only 42% of Americans 65 and older — and just 20% of all adults — have received one of these updated boosters since September. “These people could definitely go out and get a bivalent booster now to improve their protection,” Marks said.


For many Americans, COVID-19 has become less of a health fear than an inconvenience, and masking, routine testing and other precautions have largely been abandoned. But at least 250 people in the United States are still dying from COVID-19 every day, and high-risk Americans who last received a dose in the fall have anxiously wondered when they might get another one.

Letting the elderly and immunocompromised get an extra booster dose puts the United States in line with Britain and Canada, which also offer some vulnerable populations a spring shot. It’s a reasonable choice, said Dr. Matthew Laurens of the University of Maryland School of Medicine.

“We have vaccines available to protect against these serious consequences, so why not use them?” he said. “They’re no use sitting on a shelf.”


Stay tuned. The FDA will hold a public meeting in June to determine whether the vaccine recipe needs to be further adjusted to better match the latest strains of coronavirus — just as it adjusts flu shots every year. And part of that discussion will be whether younger, healthier people also need a booster.

The updated Pfizer and Moderna plans used now target the BA.4 and BA.5 omicron versions, which have been replaced by an ever-growing list of omicron descendants. Still, although protection against mild infections is short-lived, these updated doses continue to do a good job of fighting serious illness and death, even against the newest variants, Marks said.

Whether or not the recipe is adjusted again, Tuesday’s decision “essentially prepares to have a simpler, more direct way to vaccinate people,” he said. “It’s essentially a single dose of the properly strained vaccine as we enter the fall and winter months.”


Millions of American children still haven’t received their first COVID-19 shots, but Tuesday’s milestone means they too can get the most up-to-date version of vaccines. Toddlers aged 6 months to 5 years who are not vaccinated can choose two Moderna injections or three of the Pfizer-BioNTech version. Five-year-olds can get two doses of Moderna or a single injection of Pfizer.

Children already fully or partially vaccinated with the original Pfizer or Moderna shots can receive a bivalent vaccine, but the number of doses will depend on their vaccination history, the FDA said.


Novavax makes a more traditional type of COVID-19 vaccine, and its original formula remains available for people who don’t want the Pfizer or Moderna option. Novavax said Tuesday it is also preparing in case the FDA requests an update in the fall, by making several additional formulas.


The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Science and Education Media Group. The AP is solely responsible for all content.

Leave a Comment