WASHINGTON -- Pfizer has submitted research to the Food and Drug Administration on the effectiveness of its covid-19 vaccine in children, but when those shots may be available is a question.
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The company said Tuesday that it provided health regulators with data from a recent study of the use of its shot for children 5 to 11 years old.
Once the company files its application to authorize this use, U.S. regulators and public health officials will review the evidence and consult with their advisory committees in public meetings to determine if the shots are safe and effective enough to recommend.
That process may mean the shots may not be available until close to Thanksgiving, according to a person familiar with the process but not authorized to discuss it publicly. But it is possible that, depending on how quickly the FDA acts, the shots could become available earlier in November, the person said.
The drugmaker and its partner, Germany's BioNTech, say they expect to request emergency-use authorization in children 5 to 11 "in the coming weeks." The companies also plan to submit data to the European Medicines Agency and other regulators.
The two-shot Pfizer vaccine is currently available for those 12 and older. An estimated 100 million people in the U.S. have been fully vaccinated with it, according to the Centers for Disease Control and Prevention.
Pfizer tested a lower dose of the shots in children. The drugmaker said last week that researchers found the vaccine developed coronavirus-fighting antibody levels in children that were just as strong as those found in teenagers and young adults getting regular-strength doses.
Another U.S. vaccine-maker, Moderna, also is studying its shots in elementary school-aged children. Results are expected later in the year.
400,000 BOOSTERS
Meanwhile, at least 400,000 people in the United States have received booster shots since the extra injections were authorized last week, the Biden administration said Tuesday.
"Our planning and preparation on boosters have propelled a strong start," Jeff Zients, a White House covid-19 response coordinator, told reporters during a livestreamed news conference.
Zients said most of the 400,000 injections were administered over the weekend, and nearly 1 million people have scheduled appointments to get their third shots of the Pfizer-BioNTech vaccine. The administration's partnerships with states, long-term care facilities, doctors and pharmacies enabled it to immediately roll out boosters after last week's approval of the shots by the federal government, Zients said.
"We are off to a very strong start with the booster campaign," Zients said. "We will continue working with our partners to execute so we can efficiently and equitably provide the added protection of booster shots to eligible Americans."
The CDC on Thursday approved boosters of Pfizer's vaccine for people older than 65, people living in long-term care facilities and other adults with certain underlying health conditions, as well as adult workers facing a high risk of contracting the virus. Eligible Americans can get the third shot six months after they received their second.
A majority of vaccinated Americans have taken the Pfizer shot, according to the CDC. Regulators are expected to eventually approve some form of booster shots for those who received the Moderna and Johnson & Johnson vaccines.
Despite the recent focus on booster shots, Zients said increasing overall vaccination rates remains the government's top priority.
About 77% of eligible adult Americans have gotten at least one shot, according to federal statistics, with about 65% considered fully vaccinated. About 23% haven't gotten any shots, President Joe Biden said Monday just before getting his booster on national television.
Earlier this month, a panel of experts that advises the FDA rejected a plan that would have made booster shots available to most Americans because it is unclear how it would substantially slow the spread of the deadly virus, they said.
Experts have urged the White House to focus on increasing vaccination around the world to limit the chances that new and potentially more deadly variants emerge.
Zients said the administration is "laser-focused on getting more Americans vaccinated," but is also determined to increase manufacturing and shipping capacity to help other countries obtain vaccines.
In the past 10 days, the U.S. has shipped millions of doses to Mexico, Vietnam, Honduras, South Africa and the Philippines, Zients said. Biden pledged to ship more than 1 billion doses to other countries by next fall, a fraction of what experts say is needed to safeguard the world.
"This virus knows no borders," Zients said, "and stamping out the virus everywhere protects our health and our economy here at home."
MIX AND MATCH
The CDC will decide whether to recommend that people "mix and match" their initial vaccine with a booster shot from a different manufacturer in late October, CDC Director Rochelle Walensky said Tuesday.
The National Institutes of Health has been conducting studies on every combination of coronavirus vaccines in order to test the safety and effectiveness of the pairings.
The CDC currently recommends that people eligible for boosters use the same vaccine they received for their initial doses.
But the new studies may conclude that it is safe, or even preferable, for people to mix and match their first doses of Pfizer-BioNTech, Moderna or Johnson & Johnson vaccine with another product as their booster shot.
"NIH is running the mix-and-match studies, and they're doing all nine combinations -- of three of what you got with your first dose, and three of what's possible with the second dose," Walensky said.
"Those will be available later in October. And once we see those data, then we will have decisions about who should be getting mixes-and-matches."
However, "Even those people who are currently eligible, I have sort of said, 'Walk, don't run,'" Walensky said. "This is not something that you need to immediately do tomorrow, because our vaccines are continuing to work very well."
Last week, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the ability to mix and match vaccine products could expand access to booster shots for some people.
"We have not abandoned that concept, because we realize there will be situations for one reason or another where a person may not have the availability to be boosted with the same product that they were originally vaccinated with," Fauci said.
At a news briefing with other members of the White House coronavirus response team Tuesday, Fauci said data would be available on boosting with Johnson & Johnson doses next week, and that data on boosting with Moderna would be available shortly after that.
"Of course, as with all things we do, they must be submitted to the FDA for regulatory approval. So you don't want to get ahead of the FDA, but at least that's where the data are right now," Fauci said.
Eligibility is expected to expand over time to the entire population, Walensky said.
"There's urgency to making decisions, because we know the American public is interested," Walensky said. "But our current vaccines continue to do an extraordinary job in protecting people against severe disease and hospitalization, but also against infection."
Alongside its vaccine booster program, the administration began a push last month to require vaccinations for most federal workers, and said it would issue federal rules mandating that workplaces with more than 100 employees require vaccinations for their workforces.
The CDC also may review whether to mandate proof of vaccination for domestic airline travelers in November, after it issues new guidance requiring vaccination for travelers from the European Union, Walensky said.
"I think we'll see where those policies land in early November for international travel, and then potentially have discussions for domestic travel," she said.
Outside public health advisers to the administration have been encouraging federal vaccination requirements for domestic air travel in recent weeks. Fauci also has come out in support of vaccination requirements for domestic air travel in recent weeks.
Walensky said her most urgent priority is getting more than 70 million Americans to get their first doses.
"We want to increase the number of people who are vaccinated, decrease the amount of community transmission, truly decrease the amount of disease in the community," she said.
"At this very moment, we have I think much of the science and many of the tools at our disposal to crush this pandemic -- to do what it is we need to do," Walensky said.
"And right now, our inability to do so is really because of our inability to unify as a nation, to unify as a people, to do the right thing against this virus, which is in fact the common enemy," she said.
NO-VACCINATION FIRINGS
A North Carolina hospital system announced Monday that roughly 175 unvaccinated employees were fired for failing to comply with the organization's mandatory vaccination policy, the latest in a series of health care dismissals over coronavirus immunization.
Novant Health said last week that 375 unvaccinated workers -- across 15 hospitals and 800 clinics -- had been suspended for not getting immunized. Unvaccinated employees were given five days to comply.
Novant Health spokeswoman Megan Rivers tweeted Monday that almost 200 of the suspended workers, including those who had submitted approved exemptions, received their first dose by Friday. The hospital confirmed that the rest of the suspended employees who did not comply were fired, although the exact number of those dismissed was not specified.
"We stand by our decision to make the vaccine mandatory as we have a responsibility to protect our patients, visitors and team members, regardless of where they are in our health system," Novant Health said in a statement. "We couldn't be prouder of our team members who made the choice to receive the covid-19 vaccine and remain part of our team at Novant Health."
More than 99% of the system's roughly 35,000 employees have followed the mandatory vaccination program, Rivers said.
The mass termination of unvaccinated hospital system employees is among the largest of its kind to date.
More than 150 health care workers who did not comply with a vaccination mandate at Houston Methodist -- one of the first health systems to require the coronavirus shots -- were fired or resigned in June after a federal judge upheld the policy.
ChristianaCare, a Delaware health system, announced this week that 150 employees were fired for not adhering to its mandate.
The move by the Winston-Salem, N.C.-based system was taken as some health care workers continue to push back on employers' vaccination mandates. And as hospitals have been pushed to their limits in recent months, the opposition has further complicated an already difficult situation for the nation's doctors and nurses.
Novant Health introduced its mandatory policy July 22, saying employees were given until Sept. 15 to comply.
"We agree with the North Carolina Healthcare Association, the Infectious Diseases Society of America, and many other health-care systems in the region that a mandatory vaccine program is in the best interest of public health," the health system said in a news release. "Simply put, it is essential to ensure the safety of our patients, team members and communities."
Novant Health has urged the community to get vaccinated. It joined other health systems in the Charlotte area in releasing data this month showing how more than 90% of their covid-19 patients had not been vaccinated.
David Priest, Novant Health's chief safety, quality and epidemiology officer, acknowledged that the recent wave of covid patients had overwhelmed the hospital system.
"They're tired. I'm tired. We're all tired," he said.
Information for this article was contributed by Jonathan Lemire of The Associated Press; by Erin B. Logan of the Los Angeles Times (TNS); by Michael Wilner of the McClatchy Washington Bureau (TNS); and by Timothy Bella of The Washington Post.