FDA, CDC panel approve expanding Pfizer COVID-19 booster to kids 12-15

Update (Jan. 5, 2022): An advisory panel to the Centers for Disease Control and Prevention (CDC) voted Wednesday to approve a Food and Drug Administration (FDA) decision regarding the Pfizer COVID-19 vaccine booster in kids. That decision, in part, allowed for kids aged 12-15 to get boosted. The CDC panel also said teens should get the booster as soon as five months after their last shot. The video above shows the panel’s debate and vote.

The chief safety question when considering boosters for kids is a rare type of heart inflammation called myocarditis. The side effect is seen mostly in younger men and teen boys who get either the Pfizer or Moderna vaccines. The vast majority of cases are mild and they seem to peak in older teens. On Wednesday, the panel voted that a booster was safe for younger teens.

CDC Director Rochelle Walensky will weigh the panel’s advice before making a final decision.

Original Story (Jan. 3, 2022): The Food and Drug Administration (FDA) announced Monday it has adjusted its emergency use authorization for the Pfizer COVID-19 vaccine to allow more kids to get booster doses. The move can be seen as a response to an alarming increase in child hospitalizations related to the virus. The increase is believed to be one of the effects of the surging Omicron variant.

In the seven-day period from Dec. 21 to Dec. 27, 334 American children went to the hospital. That was a 58% increase compared to the previous week, compared to a more modest 19% increase in the general population. To address this increase, the FDA is:

• Expanding eligibility for the Pfizer booster to kids 12-15 years old.
• Shortening the time between second and third doses of the Pfizer vaccine from at least 6 months apart to at least 5 months apart.
• Allowing for a third primary series dose for certain immunocompromised children ages 5-11.

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19,” Acting FDA Commission Janet Woodcock said in a news release.

The FDA decision to expand booster eligibility to younger kids comes a month after health officials in South Africa released data on the effectiveness of the Pfizer vaccine against the Omicron variant. The data found the vaccine was only 33% effective against COVID-19 infection.

“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,” FDA vaccine chief Dr. Peter Marks said in the release. “In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines.”

As for the shortening of the period between second and third doses, the FDA said data from Israel found “no new safety concerns” in kids 12-15 who got their booster five months after their second dose. The same result was found in all age groups who got their booster after five months.

Monday’s announcement is not the final step in expanding Pfizer booster eligibility among kids. The Centers for Disease Control and Prevention must now decide on the matter. CDC Director Rochelle Walensky is expected to rule later this week.