September 11, 2023

New COVID vaccines get FDA approval


Article origination All Things Considered
Another round of COVID-19 vaccines is on the way. The Food and Drug Administration approved vaccines from Pfizer and Moderna that target an omicron subvariant called XBB.1.5. Vaccination campaigns, like this one in San Rafael, Calif., in 2022, could resume soon. - WFYI file photo

Another round of COVID-19 vaccines is on the way. The Food and Drug Administration approved vaccines from Pfizer and Moderna that target an omicron subvariant called XBB.1.5. Vaccination campaigns, like this one in San Rafael, Calif., in 2022, could resume soon.

WFYI file photo

The Food and Drug Administration approved a new round of vaccines against COVID-19.

The vaccines from Moderna and Pfizer and its partner BioNTech were approved Monday for people 12 and older and under an emergency use authorization for children ages 6 months to 11 years old.

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."

The vaccines target the omicron subvariant called XBB.1.5, which is no longer the most common strain in circulation. The vaccine makers and FDA say that the vaccine should still provide good protection against COVID. Recent studies support that.

"The data so far suggest that the new COVID vaccines should be really quite effective against even the new emerging variants that we have seen come up in the last weeks," Dr. Ashish Jha, the dean of the Brown School of Public Health who served as the White House COVID-19 Response Coordinator. "So I'm actually quite optimistic this new vaccine is going to be protective."

The shots would be given as a single dose for most people 5 years of age and older, regardless of prior COVID-19 vaccination history.

Children younger than 5 may be eligible for multiple doses of this season's vaccine if they had not previously finished a three-dose series with earlier COVID-19 vaccines.

Moderna and Pfizer say they have produced ample supplies of their vaccines.

Recommendations for vaccine rollout are in the works

A panel of advisers to the Centers for Disease Control and Prevention meets Tuesday to make recommendations on the rollout of the vaccines.

The CDC is likely to recommend the shots for anyone who's at high risk for serious complications from COVID, such as older people and those with weaker immune systems or other health problems.

It's unclear what the CDC will recommend for younger, otherwise healthy people, including children.

Some outside experts think everyone who's eligible should get boosted, especially because the number of people catching the virus and getting so sick they're ending up in the hospital and dying has been rising again for weeks.

"When it comes out, I will get one. I will encourage friends and family to get one," says Dr. Robert Wachter of the University of California, San Francisco. "I think it's important for us to maintain our immunity because COVID is still around and as we're seeing now it's still capable of infecting a lot of people and hurting and killing some of them."

Jha agrees.

"For younger, healthy people, I say: Look, getting the vaccine will reduce your risk of, you know, just being out of school, being out of work for a while. It reduces how much you transmit it. There are a lot of good reasons to get your annual COVID shot," Jha says.

"I understand that, you know, it's been a long pandemic and people just want to move on. The best way to move on is just to get your COVID shot and know that's going to provide a good amount of protection," Jha says.

How many people will get the new vaccines?

Others argue the focus should be on those at high risk because most people are still well protected against severe disease from previous vaccinations and infections.

"Protection against severe disease is already quite strong so an additional booster doesn't add all that much protection," says John Moore, an immunologist at Weill Cornell Medical College in New York. "So it's less important for healthier people compared to people in frail health."

It's unclear how many people want another shot. Only 17% of those eligible for the last booster got one.

"I am worried about whether Americans are going to agree to take this booster in large numbers, and if they do whether they'll walk not run," says Dr. Peter Hotez of the Baylor College of Medicine and Texas Children's Hospital. "It's really important that Americans get this booster. It's the single most important thing you can do to protect yourself and your family."

The FDA says people should wait at least two months since their last shot to get boosted. Some experts say people should wait at least three months since the last vaccination or infection, while others recommend waiting four to six months.

But some people may want to wait until a couple weeks before when they may be most likely to catch the virus, such as when they're planning to travel, some experts say. Others warn that could be risky because they could catch the virus in the meantime.

"To me some of this gets to be like amateurs trying to time the stock market, which usually goes badly," Wachter says.

Scott Hensley contributed to this report.

 

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