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March 25, 2022

CDC Approves Pfizer’s COVID Booster for Ages 12 to 17

CDC Approves Pfizer’s COVID Booster for Ages 12 to 17

The Centers for Disease Control and Prevention signed off on booster shots of the Pfizer-BioNTech Covid-19 vaccine for children and teens ages 12 to 17-years old. The decision quickly followed a move by the U.S. Food and Drug Administration (FDA) to amend the emergency use authorization (EUA) for the vaccine, clearing it for young people in this age group if it’s been at least five months since their second shot. 

“It is critical that we protect our children and teens from COVID-19 infection and the complications of severe disease. Today, I endorsed ACIP’s vote to expand eligibility and strengthen our recommendations for booster doses. We now recommend that all adolescents aged 12-17 years should receive a booster shot 5 months after their primary series.," said CDC director, Rochelle P. Walensky, MD, MPH in a January 5 news release. "This booster dose will provide optimized protection against COVID-19 and the Omicron variant. I encourage all parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations.”

The Pfizer vaccine booster’s protective health benefits in younger teens far outweigh possible risks, according to the FDA. But just like in adults, its efficacy has declined over time in this age group.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants. In particular, the Omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

In addition to extending the range of people eligible for a COVID booster, regulatory officials also shortened the waiting period for the additional shot by one month. Now, everyone ages 12 and up who received the Pfizer vaccine is eligible for a booster five months after their second shot. All adults who got the Moderna vaccine are also eligible for a booster five months after their second jab. Keep in mind, adults who got the J&J shot can still receive a booster two months later. 

The FDA took one more step to broaden use of the Pfizer vaccine, recommending that immunocompromised children ages 5 to 11 get a third dose of the vaccine 28 days after their second dose as part of their primary series.

Experts are pushing for boosters
Across the board, U.S. health officials are taking a stronger stance on boosters, advising all those who are fully vaccinated to get a COVID-19 booster shot as soon as they are eligible.

The moves come amid a widespread uptick in new coronavirus cases and the swift rise of the Omicron variant, which is now the dominant strain in the U.S. The fact that this variant has more worrisome mutations than any others initially raised alarms. Scientists are still working to understand just how much more contagious Omicron is and whether it is better at evading the immune system than other variants.

The CDC urges all those eligible to get fully vaccinated and boosted, advising this is the best way people can protect themselves from severe disease, hospitalization, and death; help slow the spread of COVID-19; and reduce that odds that new variants will emerge.

As of January 6, 62.4 percent of the U.S. population is fully vaccinated, 74 percent have gotten at least one dose of a COVID vaccine and 35.3 percent of people who are fully vaccinated have gotten a booster.

What recent data shows
The effectiveness of existing COVID vaccines has declined since mid-summer as more time had passed since people got their shots and highly contagious Delta variant emerged.

A November study published in Science found that the effectiveness of Pfizer’s vaccine dropped from 86 percent in February to 43 percent in October. Similarly, Moderna’s efficacy against symptomatic COVID-19 fell from 89 percent to 58 percent and Johnson & Johnson’s efficacy fell from 86 to 13 percent.

On November 9, Pfizer also submitted more recent findings from its Phase 3 trial to the FDA. The trial, which involved more than 10,000 people aged 16 or older who received a booster vaccine or a placebo, took place while the Delta variant accounted for nearly all new COVID-19 cases. All of the participants were fully vaccinated against COVID-19 and had received their shots 11 months earlier, on average.

The trial found that the group who got the booster had a 95.6 percent reduction in symptomatic COVID-19 over an average 2.5-month monitoring period. Some 109 people developed a symptomatic case of COVID-19 in the non-boosted group, compared to only five of the people in the booster group. The results held true regardless of age, sex, ethnicity, and participants’ other disease conditions, and no new safety concerns were reported.

A separate study conducted by Israeli researchers came to similar conclusions. The study, which was published on October 29 in The Lancet, examined the safety and efficacy of the Pfizer booster among 1.1 million fully vaccinated people. Compared to the placebo group, far fewer people experienced COVID-19-related admission to hospital, severe disease, or COVID-19-related death if they got a third dose of the vaccine. The third dose was 93 percent effective in preventing hospitalization, 92 percent effective in preventing severe disease, and 81 percent effective in preventing death from COVID-19.

Now, scientists in South Africa are testing existing COVID-19 vaccines against Omicron. Their early findings suggest the variant has “robust ability” to evade them—though not entirely.

But Pfizer and BioNTech also have early data, which shows that while the initial two doses of its mRNA vaccine was "significantly less effective” at protecting against Omicron, a booster shot was able to effectively neutralize it in lab tests.

Experts agree that being fully vaccinated and boosted is the best way to help slow the spread of the coronavirus, defend against the current surge in new cases and help turn the tide of the pandemic.

“Vaccination is our best defense against COVID-19, including the circulating variants,” said Dr. Marks in a January 7 news release. “We encourage everyone to get vaccinated—it’s never too late to get your COVID-19 vaccine or booster.”

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