CDC expands booster eligibility to include teens ages 12 to 15

The U.S. Centers for Disease Control and Prevention has expanded eligibility for booster doses of Pfizer’s COVID-19 vaccine to include adolescents ages 12 to 15. The announcement comes days after the U.S. Food and Drug Administration authorized the expansion to this age group, meaning that shots can now be rolled out immediately.

The agencies also authorized booster doses five months after full vaccination rather than the six month interval that was originally authorized. Additionally, they authorized a third dose of Pfizer’s vaccine for children ages 5 to 11 with certain conditions that compromise their immune systems, including those who have undergone solid organ transplants.

“It is critical that we protect our children and teens from COVID-19 infection and the complications of severe disease,” said CDC Director Rochelle Walensky in a statement. “This booster dose will provide optimized protection against COVID-19 and the Omicron variant.”

The FDA previously said that the data show that an additional dose may provide better protection against the Omicron and Delta variants and that real-world data from Israel’s vaccination campaign shows no new safety concerns for a booster dose in the younger teenage population, with no new cases of myocarditis or pericarditis reported to date.

— Amy McKeever, 1/6/2022

FDA authorizes Pfizer’s COVID-19 booster for teens ages 12 to 15 ❯❯

The U.S. Food and Drug Administration has expanded eligibility for booster doses of Pfizer’s COVID-19 vaccine to include adolescents ages 12 to 15. The agency also announced that all people can now get a booster dose five months after they were fully vaccinated rather than the six month interval that was originally authorized.

Additionally, the FDA authorized a third dose of Pfizer’s vaccine for children ages 5 to 11 with certain conditions that compromise their immune systems, including those who have undergone solid organ transplants.

The FDA has determined that these steps are necessary to help combat the spread of the Omicron variant, which has driven a surge in cases that has already surpassed last year’s winter peak. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that the data show that an additional dose may provide better protection against the Omicron and Delta variants.

The FDA also said that real-world data from Israel’s vaccination campaign shows no new safety concerns for a booster dose in the younger teenage population, with no new cases of myocarditis or pericarditis reported to date.

In a press conference following the announcement, Marks also urged everyone who has not been vaccinated yet to do so, emphasizing that even a single dose can help prevent the worst outcomes of COVID-19. “It’s not too late to start to get vaccinated,” he said.

— Amy McKeever, 1/3/2022

FDA authorizes Merck's COVID-19 antiviral pill ❯❯

The U.S. Food and Drug Administration has authorized the emergency use of Merck’s antiviral pill for adults over the age of 18 who have tested positive for COVID-19 and are at high risk for severe disease. The decision comes a day after the agency authorized the emergency use of Pfizer’s antiviral pill for people 12 and older.

These drugs work by interfering with the virus’s genome as it multiples, creating mutations that disrupt replication and ultimately kill the virus. In clinical trials, Merck’s drug, called molnupiravir, was shown to reduce the risk of hospitalization and death by 30 percent. 

That is a drop in efficacy from Merck’s original announcement that people who took the pill were half as likely to be hospitalized or die than those who took the placebo. It’s also lower than the stated efficacy of Pfizer’s pill, which the company says reduces the risk of hospitalization and death by 89 percent. It’s unclear how effective either drug will be against the new Omicron variant. 

The U.S. government has made a deal to purchase about 3.1 million courses of the treatment, most of which will be available by the end of January. The treatment is administered as four pills taken every 12 hours for five days. It should be started as soon as possible after a COVID-19 diagnosis and within five days of when a patient begins to show symptoms.

— Amy McKeever, 12/23/2021

FDA authorizes Pfizer’s COVID-19 antiviral pill ❯❯

The U.S. Food and Drug Administration has authorized the emergency use of Pfizer’s antiviral pill for adults and children older than 12 who have tested positive for COVID-19 and are at high risk of severe disease. The drug—which has been shown to reduce the risk of hospitalization and death—is the first of its kind to be approved for use in the United States. 

It’s unclear how effective the drug will be against the new Omicron variant. But health officials hailed the FDA authorization as one more tool available to doctors and patients who are fighting the disease.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally—a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement.

As National Geographic has previously reported, these drugs work by interfering with the virus’s genome as it multiples, creating mutations that disrupt replication and ultimately kill the virus. In clinical trials, Pfizer says its pill, called Paxlovid, was shown to reduce the risk of hospitalization and death by 89 percent. The drug is administered as three tablet dose taken twice a day, for five days.

The drug will be available for use after it receives a final signoff from the Centers for Disease Control and Prevention, which is expected shortly.

— Amy McKeever, 12/22/2021

Pfizer extends COVID-19 vaccine clinical trials for children under 5 ❯❯

Parents will have to continue to wait for COVID-19 vaccines for children ages six months to five years. On December 17, Pfizer announced that it is extending its clinical trials among this age group to test the efficacy of three doses rather than two.

The company said that an analysis of its ongoing study found that two doses of the vaccine did not produce a similarly robust immune response in children ages two to five as it did with older age groups. The jab did, however, produce an adequate immune response in children younger than two. There were also no safety concerns identified.

Pfizer said it expects to submit data to federal regulators for emergency use authorization of vaccines for children ages six months to five years in the first half of 2022. It will also test the efficacy of a third dose for older children.

However, parents who are anxious for the vaccine to be authorized in young children can take solace in another announcement made the same day. Tthe U.S. Centers for Disease Control and Prevention has said that it’s safe for children of all ages who have been exposed to COVID-19 to attend school in person if they are regularly tested for the virus at school. The Washington Post reports that new studies show that this practice is effective in protecting against the spread of the disease. 

— Amy McKeever, 12/17/2021

FDA authorizes Pfizer booster doses for teens ages 16 and 17 ❯❯

The U.S. Food and Drug Administration has expanded its emergency use authorization of Pfizer’s COVID-19 booster shots to include people ages 16 and 17. The agency said that it has new evidence that vaccine effectiveness against COVID-19 wanes after the second dose, including among people in this age group. Boosters will help provide continued protection.

“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic,” said acting FDA Commissioner Janet Woodcock in a statement announcing the decision. “With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.” 

This population will be eligible to get a booster dose at least six months after they were fully vaccinated. Unlike the mix-and-match approach the agency approved for older populations, however, the FDA has only authorized the boosters for teens who originally received Pfizer’s vaccine.

The FDA also said it assessed the safety of the booster doses and determined that the benefits of getting a booster outweigh the risks of myocarditis and pericarditis among people ages 16 and 17.

The Centers for Disease Control and Prevention has also signed off on the FDA decision.

— Amy McKeever, 12/9/2021

Read more of our coverage on the coronavirus pandemic here.