Pfizer and BioNTech are expected this week to apply for regulatory approval for a booster shot of their coronavirus vaccine for 16- and 17-year-olds, according to people familiar with the company’s plans. If approved, the shot would be the first booster available to people under 18.
The Food and Drug Administration could authorize extra shots within roughly a week, the people said.
The move would come as President Biden seeks to reassure the nation about Omicron, a new variant of the coronavirus. On Monday, he called the variant “a cause for concern, not a cause for panic.”
“I’m sparing no effort, removing all roadblocks to keep the American people safe,” Mr. Biden said at the White House.
The news of Pfizer’s plans was first reported by The Washington Post.
The new variant has yet to be detected in the United States, and scientists have not determined how much of a threat it will pose. Vaccine manufacturers are racing to figure out whether their existing products will work against it or whether modified vaccines will be required.
About 10 days ago, federal health agencies authorized booster shots of both the Pfizer-BioNTech and Moderna vaccines for everyone 18 and older. That opened up eligibility for extra injections to tens of millions more fully vaccinated adults. All adults who were vaccinated with Johnson & Johnson vaccine, a single shot, were already eligible for a booster.
Last month’s regulatory moves simplified eligibility and formally allowed a practice already in place in numerous states. Multiple governors had already offered boosters to everyone 18 and older ahead of the holidays.
Asked about the plan to request broader access, a Pfizer spokeswoman said the company would provide an update when available.
Prompted by growing concerns about the Omicron variant, the Centers for Disease Control and Prevention on Monday said that all American adults “should” get booster doses of the available coronavirus vaccines.
Adults aged 18 and older should get a booster shot when they are six months past the initial immunization with the Pfizer-BioNTech or Moderna vaccines, or two months after the single-shot Johnson & Johnson vaccine, the agency said.
The C.D.C. had previously said that Americans over age 50, as well as those ages 18 and older living in long-term care facilities, “should” get booster shots while all other adults “may” decide to do so based on their individual risk.The shift in language signals a growing concern about Omicron, despite the limited information available about the variant.
Scientists do not yet know whether vaccines will continue to protect people from Omicron. The variant contains many mutations that suggest the shots may be less effective against Omicron than against other variants, though evidence to support those fears has yet to be established.
Dozens of labs worldwide are now trying to assess exactly how much less effective the vaccines might be. They are not expected to have results for at least two weeks.
“Early data from South Africa suggest increased transmissibility of the Omicron variant, and scientists in the United States and around the world are urgently examining vaccine effectiveness related to this variant,” Dr. Rochelle Walensky, director of the C.D.C., said in a statement.
“I strongly encourage the 47 million adults who are not yet vaccinated to get vaccinated as soon as possible and to vaccinate the children and teens in their families as well.”
Pfizer-BioNTech and Moderna plan to test whether booster shots of their vaccines will bolster the immune system enough to fend off the new variant. The boosters have been shown to raise antibody levels significantly. Those antibodies may not be able to neutralize Omicron entirely, but having more antibodies is generally beneficial, experts have said.
Dr. Walensky also urged Americans to get tested for the virus if they develop symptoms, and to practice prevention strategies known to limit transmission of the virus.
In just the week after it was first detected, the Omicron variant has been spotted in at least 16 countries. The variant has about 50 mutations, including more than 30 in the spike, a viral protein on its surface that the vaccines train the body to recognize and attack.
President Biden sought to reassure the nation on Monday about the new Omicron variant of the coronavirus as crucial questions about it remain, telling Americans that the variant is “a cause for concern, not a cause for panic,” and that his administration was working with vaccine manufacturers to modify vaccines and booster shots should that prove necessary.
“We’re throwing everything we have at this virus, tracking it from every angle,” Mr. Biden said at the White House, adding, “I’m sparing no effort, removing all roadblocks to keep the American people safe.”
The president is expected to visit the National Institutes of Health on Thursday, and said he would outline “a strategy for how we are going to fight Covid this winter, not with shutdowns or with lockdowns, but with more widespread vaccinations, boosters, testing and more.” The variant has yet to be detected in the United States.
Mr. Biden has already restricted travel from eight nations, including South Africa, a move that experts said would buy the United States time in determining how to respond. But it will likely be a week, possibly two weeks, before experts know more about the new variant. It has mutations that scientists fear could make it more infectious and less susceptible to vaccines, though evidence to support those fears has yet to be established.
Despite significant questions about the variant itself — including whether it causes mild or severe disease — countries around the world have rushed to defend against its spread, with a cascade of border closures and travel restrictions that recalled the earliest days of the pandemic.
Mr. Biden was elected on a promise to bring the pandemic under control — a task that is proving easier said than done. Viruses are dedicated to ensuring their own survival, and that is especially true of the virus that causes Covid-19. Just as Mr. Biden was about to declare “independence from the virus” on the July 4 holiday, the Delta variant swept across the United States, causing another wave of hospitalizations and deaths.
Now there is Omicron, discovered in southern Africa and designated by the World Health Organization on Friday as a “variant of concern,” popping up just as the holiday travel season gets underway.
Mr. Biden is trying to project calm and keep the country from panicking while also ensuring that Americans get vaccinated and take other precautions, including masking and social distancing. He was joined at the White House by Dr. Anthony S. Fauci, the nation’s top infectious disease expert, who said that current P.C.R. tests were able to detect the new variant.
The emergence of the new variant is also increasing pressure on Mr. Biden and his administration to do more to share vaccines with the rest of the world.
South Africa, whose scientists detected the variant, has fully vaccinated only 24 percent of its population, according to the Our World in Data project at the University of Oxford. It has a better vaccination rate than most countries on the continent, but has asked vaccine makers to stop sending doses: It is having trouble getting shots into arms, in part because of distribution bottlenecks and in part because many people are hesitant to take them.
Covid Live Updates: Pfizer to Seek Approval for Boosters for 16- and 17-Year-Olds