FDA Approves Pfizer Boosters for Those Aged 16-17

The U.S. Food and Drug Administration on Thursday approved the emergency use of the Pfizer coronavirus booster shot for Americans aged 16 and 17.

The move comes as the Delta variant is fueling surges in infections and hospitalizations in some pockets of the country and the highly contagious Omicron variant starts to spread across the United States.

"Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19," Acting FDA Commissioner Dr. Janet Woodcock said in an agency news release.

Extra protection ahead of the holidays

"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. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19," Woodcock adds.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said expanding the availability of booster shots makes sense.

"The Pfizer-BioNTech COVID-19 vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks," he noted in the agency news release. "Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group. A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups."

What's next?

The U.S. Centers for Disease Control and Prevention is expected to promptly endorse the FDA's approval, although no meeting of its vaccine advisory committee has been scheduled at this point, The New York Times reports.

Pfizer first sought the approval for using the boosters in this age group at the end of November, and it becomes the first booster shot approved for Americans this young.

Booster shots of the Pfizer and Moderna vaccines for everyone 18 and older were first authorized on Nov. 19 by U.S. health officials. All adults who'd received the single-dose Johnson & Johnson vaccine were already eligible for a booster.

An effort to keep Americans calm about Omicron

The latest move to expand booster availability comes as President Joe Biden tries to keep Americans calm about Omicron. Shortly after it emerged in South Africa, he called the new variant "a cause for concern, not a cause for panic."

Echoing that concern, the CDC then strengthened its recommendations on boosters, urging all Americans aged 18 and older to get the extra dose for the best protection.

"Today, CDC is strengthening its recommendation on booster doses for individuals who are 18 years and older. Everyone ages 18 and older should get a booster shot either when they are 6 months after their initial Pfizer or Moderna series or 2 months after their initial J&J vaccine," CDC Director Dr. Rochelle Walensky said Nov. 29 in an agency statement.

As "scientists in the United States and around the world are urgently examining vaccine effectiveness related to this [Omicron] variant, 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, because strong immunity will likely prevent serious illness," Walensky adds.

The Omicron variant has now spread to 21 U.S. states, as vaccine makers are still trying to determine whether their current shots will work as well against the new variant, or whether modified vaccines will be needed to fight it.

Those that are fully vaccinated, may be able to start doing some things that they had stopped doing because of the pandemic, but should still take extra precautions.

Preventing COVID

In addition to getting vaccinated, the FDA recommends the following tips to prevent yourself from developing COVID:

Wash your hands often with plain soap and water. The CDC recommends washing your hands often with soap and water for at least 20 seconds, especially after you have been in a public place, or after blowing your nose, coughing, or sneezing. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol. Learn more about safely using hand sanitizer.
Cover your mouth and nose with a cloth face covering or non-surgical mask when around others. Find more information about how to select, wear, and clean your mask.
Follow CDC guidance on large gatherings, social distancing and mask wearing, based on if you are fully vaccinated or not.

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