FDA paves way for COVID-19 vaccine in 12- to 15-year-olds

The Food and Drug Administration (FDA) late yesterday expanded the emergency authorization of the Pfizer COVID-19 vaccine to include 12- to 15-year-olds, paving the way for vaccinating a proportion of school-age children before the fall.

"Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations," said Acting FDA Commissioner Janet Woodcock, MD, in a press release.

The Pfizer vaccine had previously been approved for use in people ages 16 and up.

The FDA said approximately 1.5 million children ages 11 to 17 have been infected with COVID-19 in the United States from Mar 1, 2020, through Apr 30, 2021, according to data from the Centers for Disease Control and Prevention (CDC).

Tomorrow the CDC's Advisory Committee on Immunization Practices will hold an emergency meeting to vote on whether to recommend the shot for 12- to 15-year-olds. The 12 to 15 age group represents approximately 17 million children in the United States.

Hesitancy may play a role in success of vaccinating teens

The FDA's move has pushed schools and pediatricians to consider their potential role in vaccination campaigns, the New York Times reports. Many worry that parents will be more hesitant to vaccinate prepubescent or pubescent children.

Today during the US Senate Committee on Health, Education, Labor and Pensions hearing on the federal response to COVID-19, CDC Director Rochelle Walensky, MD, MPH, said "I recognize some parents want to see how it goes, but I am encouraging all children to be vaccinated. And I am also encouraging children to ask for the vaccine," Walensky said. She also said her 16-year-old son is vaccinated because he wanted a normal social life back.

But lawmakers from both sides of the aisle attacked Walensky, and said the CDC has been too strict and at times conflicted when it has come to advice about children and the pandemic.

Meanwhile, a new poll gives more insight into vaccine hesitancy among adults over the age of 18: Just 11% of American adults who remain unvaccinated say they definitely will get the shot, while 34% say they definitely won't, according to the latest poll from the Associated Press-NORC Center for Public Affairs Research.

The rest of poll respondents are split, with 27% saying they probably will get vaccinated and 27% who say they probably won't. Adults under 45, rural Americans, and Republicans are the most likely to say they will avoid vaccination.

Of those who say they will not get vaccinated, 55% say they refuse to do so because of vaccine side effects, and nearly 75% say they believe the vaccines were not properly tested.

Success in vaccinating older Americans

The CDC COVID Data Tracker shows 329,843,825 COVID-19 vaccine doses have been delivered in the US, and 261,599,381 doses have been administered, with 115,530,780 Americans fully vaccinated.

The US reported 36,231 new COVID-19 cases yesterday, and 399 deaths, according to the Johns Hopkins COVID-19 tracker. In total, the nation has tracked 32,756,428 COVID-19 cases, including 582,418 deaths.

Those over the age of 65 are most at risk for severe COVID-19, and new data from the CDC show early efforts to vaccinate this group have been mostly successful in the United States.

The CDC report shows that, during Dec 14, 2020, through Apr 10 of this year, a total of 42,736,710 (79.1%) older adults had initiated vaccination, or gotten at least one dose of COVID-19 vaccine.

Men were vaccinated at a higher rate than women, a difference not seen in vaccination with influenza and shingles vaccine, the authors said. Overall, the biggest difference between county-level vaccine rates was linked to socio-economic factors.

"On average, counties with low vaccination initiation rates (<50% of older adults having received at least 1 vaccine dose), compared with those with high rates (≥75%), had higher percentages of older adults without a computer, living in poverty, without Internet access, and living alone," the CDC wrote.

Other US developments

  • Novavax is unlikely to seek emergency use authorization for its COVID-19 vaccine until July at the earliest, the Washington Post reported yesterday. The filing has been delayed by manufacturing regulatory issues.

  • President Biden will speak with six governors today about innovative ways to get more people vaccinated, USA Today reports

  • The five states with the highest percentage of adults with at least one vaccine dose are Vermont, Massachusetts, Hawaii, Connecticut, and New Hampshire, according to CNN. The five states at the bottom Mississippi, Alabama, Louisiana, Wyoming, and Idaho.

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