FDA authorizes COVID-19 vaccine boosters for all adults

Jabs will be available to roll out as soon as this weekend.

On November 19, the FDA announced that all American adults are now eligible for a booster dose of a COVID-19 vaccine. The agency has amended the emergency use authorization of both the Moderna and Pfizer vaccines to allow people over the age of 18 to receive another jab. The Centers for Disease Control and Prevention signed off on the agency’s recommendations and said the boosters would be available immediately.

“COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” said FDA acting commissioner Janet Woodcock in a statement. She added that the booster dose will provide continued protection against hospitalization and death. 

Booster doses of the Johnson & Johnson vaccine have already been approved for all adults. Previously, the FDA had only authorized third jabs of the Moderna and Pfizer vaccines for people age 65 and older and people at risk of severe disease, such as adults with underlying conditions or in high-risk jobs. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in today’s statement that the decision to make Moderna and Pfizer boosters available will help to eliminate confusion about who can receive a booster dose.

— Amy McKeever, 11/19/2021

Editor’s note: This story has been updated to reflect the CDC’s decision.

U.K. authorizes Merck COVID-19 antiviral pill ❯❯

On November 4, the United Kingdom became the first country in the world to grant conditional authorization to a Merck antiviral pill used to treat COVID-19. In clinical trials, the pill has been shown to reduce the risk of hospitalization and death in people with mild to moderate COVID-19 who are at risk of developing more severe disease. It is the first treatment of its kind found to be effective against SARS-CoV-2.

“This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment,” Sajid Javid, the country’s chief of Health and Social Care, said in a statement.

As National Geographic has previously reported, the drug, called molnupiravir, works by interfering with the virus’s genome as it multiples, creating mutations that disrupt replication and ultimately kill the virus. In clinical trials, people who took four pills twice a day for five days within five days of showing symptoms of a COVID-19 infection were half as likely to be hospitalized as those who took the placebo.

The U.K. has authorized the pill for conditional use in adults with mild to moderate COVID-19 and at least one underlying condition that puts them at risk for more severe disease, including obesity, diabetes, heart disease, as well as those who are older than 60.

Merck has also filed an application for emergency use authorization of the drug in the United States. The application is under review by the U.S. Food and Drug Administration.

— Amy McKeever, 11/4/2021

CDC director signs off on Pfizer's COVID-19 vaccine for children ages 5 to 11 ❯❯

On November 2, Centers for Disease Control and Prevention director Rochelle Walensky signed off on the unanimous recommendation from the agency’s advisory panel to administer Pfizer’s  vaccine to children ages five to 11. The decision comes just days after the U.S. Food and Drug Administration granted emergency use authorization to the vaccine.

“We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine,” Walensky said in a statement. "As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated.”

Now that Walensky has given her approval, the U.S. will be able to begin distributing doses immediately. The Biden administration has already laid out its plan to roll out the vaccine for kids by working with pediatricians, children’s hospitals, school clinics, and other health care centers. 

Members of the CDC advisory committee expressed their strong support for vaccinating children in this age group during a meeting earlier in the day, emphasizing that the benefits of protecting kids from COVID-19 infections clearly outweighs the risks of side effects from the vaccine. Speaking directly to the public listening in on the video call, several members mentioned that they were eager to administer the vaccines to their own children and grandchildren.

“I think the data supports that we have one more vaccine that saves the lives of children,” said Sarah Long, professor of pediatrics at Drexel University College of Medicine. 

“We all have a responsibility to make this vaccine available to children and to their parents,” said Beth Bell, clinical professor of global health at the University of Washington. “I think this is a huge step forward for children and parents.”

Pfizer’s vaccine for children in this age group is a lower dose than the one being administered to adults. Pfizer says its COVID-19 vaccine is 90.7 percent effective at preventing symptomatic disease in kids ages five to 11. An analysis of Pfizer’s clinical trials of 2,268 participants, released by the FDA on Friday, also showed that none of the participants reported cases of severe disease or the COVID-19-related multi-inflammatory syndrome that has been seen in children.

Amy McKeever, 11/2/2021

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FDA authorizes Pfizer’s vaccine for emergency use in kids ages 5 to 11 ❯❯

The U.S. Food and Drug Administration has granted emergency use authorization to Pfizer’s low dose COVID-19 vaccine for kids ages five to 11. The FDA’s announcement is a critical step in the process to begin rolling out the shots.

“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA commissioner Janet Woodcock said in the announcement. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

Next, the U.S. Centers for Disease Control and Prevention will weigh in on who should receive the vaccine during a meeting scheduled for next week. Once the CDC makes its recommendation, the U.S. is prepared to begin distributing doses immediately. Last week, the Biden administration announced its plan to roll out the vaccine for kids by working with pediatricians, children’s hospitals, school clinics, and other health care centers.  

An FDA advisory committee had recommended emergency use authorization of the vaccine during a meeting held earlier this week. The New York Times reports that members of the FDA committee questioned whether the jabs are necessary for all children in the age group or if it should be limited to those with underlying conditions who are more at risk of severe COVID-19. However, they ultimately voted to authorize the vaccine because of their concern for the nearly two million children in that age group who have been infected.

Pfizer says its COVID-19 vaccine is 90.7 percent effective at preventing symptomatic disease in kids ages five to 11. An analysis of Pfizer’s clinical trials of 2,268 participants, released by the FDA on Friday, also showed that none of the participants reported cases of severe disease or the COVID-19-related multi-inflammatory syndrome that has been seen in children.

Amy McKeever, 10/29/2021

FDA panel recommends Pfizer vaccine for kids ages 5 to 11 ❯❯

U.S. regulators are inching closer to authorizing Pfizer’s COVID-19 vaccine for emergency use in children ages five to 11. On October 26 an FDA advisory committee voted to recommend emergency use authorization, and the head of the FDA is expected to issue a ruling in the coming days. Before the shots can begin to roll out, the CDC will weigh in on the matter in a meeting next week. 

The FDA panel’s vote in favor of the recommendation was near-unanimous, with one abstention. However, the New York Times reports that some committee members questioned whether all children in the age group need to be vaccinated and suggested authorizing shots only for those with underlying conditions that made them more susceptible to severe COVID-19. However, they concluded that the benefits outweigh the risks given the nearly two million children who have been infected so far.

The news comes a few days after the FDA released Pfizer’s analysis of its clinical trials of 2,268 participants showing that the vaccine is 90.7 percent effective at preventing symptomatic disease in kids in this age group. The analysis also showed that none of the participants reported cases of severe disease or the COVID-19-related multi-inflammatory syndrome that has been seen in children.

The company had previously announced that its analysis shows the vaccine is safe and elicits “robust” neutralizing antibodies. The vaccine follows a two-dose regimen of 10 milligram doses—a third of the dosage that is given to adults. 

The White House has announced its plans to roll out the vaccines to children by working with more than 25,000 pediatricians and other primary care sites, children’s hospitals, pharmacies, school clinics, and more.

Amy McKeever, 10/26/2021

Where cases are growing and declining in the U.S.
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Pfizer says its vaccine is 90.7 percent effective in kids ages 5 to 11 ❯❯

U.S. regulators are inching closer to authorizing Pfizer’s COVID-19 vaccine for emergency use in children ages five to 11.  On October 22 the FDA released Pfizer’s analysis of its clinical trials of 2,268 participants showing that the vaccine is 90.7 percent effective at preventing symptomatic disease in kids in this age group. The analysis also showed that none of the participants reported cases of severe disease or the COVID-19-related multi-inflammatory syndrome that has been seen in children.

The company had previously announced that its analysis shows the vaccine is safe and elicits “robust” neutralizing antibodies. The vaccine follows a two-dose regimen of 10 milligram doses—a third of the dosage that is given to adults.

A key FDA advisory committee will discuss Pfizer's data on October 26, with a final ruling to come in the following days or weeks. The White House has announced its plans to roll out the vaccines by working with more than 25,000 pediatricians and other primary care sites, children’s hospitals, pharmacies, school clinics, and more.

Amy McKeever, 10/22/2021

Read more of our coverage on the coronavirus pandemic here.

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