FDA delays decision on COVID vaccine for children under 5

key takeaways

  • The FDA has postponed a meeting to review the safety and efficacy of Pfizer’s COVID-19 vaccine in children under 5.
  • Pfizer is collecting more data and hopes to submit it to the FDA for review within the next month or two.
  • While it was a necessary decision, it could still cause frustration and confusion for parents, experts say.

Parents of young children across the country have received some disappointing news recently. On February 11, 2022, the U.S. Food and Drug Administration (FDA) announced that it would postpone an advisory committee meeting scheduled for next week, when experts will choose whether to recommend Pfizer’s COVID-19 vaccine for children under 5 years of age. authorized.

Health experts and parents look forward to final recommendations on vaccinating young children and discussing their safety and effectiveness. But now the FDA says it will wait for data on the efficacy of Pfizer’s three-dose vaccine, rather than two, in children under 5 before deciding whether to approve the vaccine.

This age group is the only population for which Pfizer’s vaccine has not been authorized. (Moderna and Johnson & Johnson’s COVID-19 vaccines are already approved for use in people 18 and older. Both companies are still working on pediatric doses.)

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Why is it delayed?

According to reports, statistical news, Pfizer’s version of the vaccine for children under 5 was initially tested in a two-dose regimen. The amount of each dose is one-tenth of the adult dose.

However, Pfizer announced late last year that the antibody levels at both doses were insufficient to ward off the virus in a clinical trial in children aged 2 to 4 years. (Surprisingly, both doses did produce adequate responses in children aged 6 months to 23 months.) Now, a third dose can be added to the mix.

“The data we see [from Pfizer in advance of the advisory committee meeting] Made us realize that we need to look at the data from the third dose in the ongoing trials to be sure we can proceed with authorization,” Peter Marks, MD, director of the FDA’s Center for Biologics Research and Evaluation, explained in a briefing with reporters reason for the delay.

Concerns about COVID-19 and children have grown recently. While severe illness remains rare among children infected with COVID-19, Marks told reporters Friday that the recent surge in the Omicron variant has led to higher rates of hospitalizations in children than at any time during the pandemic.

What does Omicron look like in a child?

Pfizer announced in January 2022 that it had been requested by the FDA to seek emergency use authorization from the FDA for a two-dose regimen for children 6 months to 5 years of age. According to reports, usa today, the FDA requirement is unusual. Usually, the company decides when to file, not the other way around.

Marks explained to reporters why the agency urged Pfizer to seek two-dose authorization.

“Given the recent surge in Omicron and the significant increase in hospitalization rates for the youngest children to date during the pandemic, we believe it is our responsibility as public health agencies to act urgently and consider all options available, including requiring the The company provided us with preliminary data for two doses in the ongoing study,” Marks said.

But the data proved insufficient to warrant a review by the advisory committee.

“Assessing these initial data was useful for our review,” added Marks. “But at this time, we believe more information about the ongoing third-dose evaluation should be considered.”

what does this mean to you

In the coming months, as more data is collected, experts advise parents to rely on the tools they’ve been using throughout the pandemic: wearing masks and vaccinating eligible family members.

Will this decision make parents hesitate?

The delay was unexpected. Health care experts worry that delays in reviewing the vaccine for the youngest age group could reduce parental confidence, especially since it is already low.

According to January 2022 data from the Kaiser Family Foundation, only 31% of parents said they would vaccinate their children under 5 as soon as a vaccine became available. Twenty-nine percent said they would wait and see, 12 percent said they would only vaccinate children ages 5 and older when needed, and 26 percent said they would never vaccinate their children against COVID-19.

Health experts expect some parents to be more hesitant about injections. But others may be disappointed that a vaccine for this age group has not yet been authorized.

“A lot of parents have been anxiously waiting for months to get their children vaccinated. They think a vaccine is finally available,” Andrew Pavia, MD, director of pediatric infectious diseases at the University of Utah, told VigorTip.

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But rather than worrying that the delay will increase parental hesitation, Pavia is more concerned that “authorizing the first two doses without knowing the effectiveness of the third dose is more likely to undermine trust in the process.”

Many parents may find the news of the authorization delay confusing and disturbing, Julie Morita, MD, executive vice president of the Robert Wood Johnson Foundation, the largest private medical charity in the United States, told VigorTip. She advises parents of young children to start discussing vaccines with their doctors, trusted community health leaders and local health departments.

“Even before authorization, experts can discuss with you the review process for vaccines for all age groups, why it’s important to vaccinate your child once it is available, and any specific concerns you have about your child,” Morita added.

The information in this article is current as of the date listed, which means that you may have updated information as you read this article. For the latest updates on COVID-19, visit our Coronavirus news page.