The Centers for Disease Control and Prevention reinforced federal regulators’ decision earlier this week to authorize Pfizer booster doses for healthy people ages 12-15, a move that comes amid growing concerns that federal regulators are shutting out vaccine experts from decision-making.
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The CDC’s Advisory Committee on Immunization Practices voted 13-1 to recommend administering Pfizer booster doses to otherwise healthy adolescents ages 12-17 just hours before CDC Director Rochelle Walensky gave her final approval. The FDA authorized booster shots for 12- to 15-year-olds Monday and for 16- and 17-year-olds last month without convening its committee of vaccine experts, making Wednesday’s the latest authorization in a succession of green lights for extra doses meant to slow down the spread of the highly contagious omicron variant.
“The FDA experts are right in being hesitant to authorize boosters in young people,” said Dr. Marty Makary, a professor at Johns Hopkins University School of Medicine and outspoken critic of the Biden administration’s push for boosters in healthy young people. “We’re in a real political quagmire. We’ve got a rogue FDA bypassing the normal process of convening experts and putting authorization before them for a vote before authorizations are issued.”
In mid-November 2021, the FDA authorized booster shots for all adults, whereas before the boosters were only recommended for people at high risk of getting sick through their jobs or due to underlying health problems. About a week later, the CDC announced that all adults should get booster shots, an upgrade from the recommendation for adults over 50 to get extra doses. Then last month, the FDA authorized Pfizer booster shots for people 16 and 17 years old for the first time. All of these changes were made without first publicly convening panels of vaccine experts. The CDC maintained Wednesday, though, that agency leadership was not purposely sidestepping expert input in favor of expedited shots in arms.
“As the vaccine landscape continues to evolve, there will be modifications made by FDA to [Emergency Use Authorizations]. … There will be times when the CDC director approves these changes based on a data review by [CDC experts]. These approvals do not deflect from the critical role ACIP plays in advising the director on important issues and questions related to the COVID vaccination program,” said Dr. Amanda Cohn, chief medical officer of the National Center for Immunizations and Respiratory Diseases.
Dissenting opinions on offering boosters to adolescents are based on scientific findings of the nonzero risk of experiencing myocarditis and pericarditis, two types of heart inflammation that have been mostly detected in young men. For instance, the lone “no” vote came from Dr. Helen Talbot of Vanderbilt University, who told fellow panelists that she did not vote to recommend the boosters because she doesn’t “think it’s fair for a 12- to 17-year-old who has been vaccinated to risk myocarditis again for an unknown benefit.”
Though instances of the inflammatory conditions are rare, the long-term effects on young men post-vaccination, such as tissue scarring in the heart, are still unknown.
“Most cases are mild, and the vast majority of people with myocarditis will be fine. But most is not all,” Makary told the Washington Examiner. “[Giving boosters to teenagers] is not 100% benign. So we should be using this tool if there’s a clear-cut clinical benefit. As of now, that has not been demonstrated.”
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Two Israeli studies show that while the risk of contracting a heart inflammation condition is still low overall, it is a risk nonetheless and is highest within 21 days of getting vaccinated with the Pfizer shots, primarily after the second dose. Another study using the Israeli government’s own tracking data found that males of all ages had myocarditis occur at 0.64 cases per 100,000 people after the first dose and 3.83 cases per 100,000 after the second dose. The incidence increased to 1.34 and 15.07 per 100,000 after the first and second doses, respectively, for young men ages 16-19.
Wednesday’s recommendation clears the way for millions of teenagers to get boosters immediately, as at least five months have passed since the FDA authorized vaccines for that age range.
