FDA OKs updated COVID booster for kids as young as 6 months

Masked boy with bandaid

Albert Martine / iStock


The US Food and Drug Administration (FDA) today announced that it has authorized emergency use of both updated mRNA COVID-19 vaccine boosters in children as young as 6 months old—with a caveat excluding those who have already received three doses of the Pfizer-BioNTech vaccine.

The step comes ahead of a potential rise in COVID activity surrounding the holidays and amid large spikes in other respiratory viruses. The Centers for Disease Control and Prevention (CDC) still needs to sign off on the recommendation before the youngest kids can receive the new bivalent (two-strain) boosters.

Delay for youngsters who got full Pfizer series

FDA Commissioner Robert Califf, MD, said, "More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so—especially as we head into the holidays and winter months where more time will be spent indoors."

COVID vaccine uptake in the youngest age-group has lagged: Less than 5% of children ages 4 and younger have completed their primary series, according to CDC data.

In its announcement today, the FDA said children ages 6 months through 5 years who received the Moderna vaccine primary series can receive a single booster of the bivalent vaccine 2 months after completing the last dose.

Regarding the Pfizer vaccine, children ages 6 months through 4 years who have not yet started their three-dose series or have not yet received the third dose in the three-dose series can receive the updated Pfizer booster as their third dose. The FDA said as part of today's announcement that the monovalent (single-strain) vaccine is no longer authorized as the third dose of the three-dose series in the age-group.

However, young Pfizer recipients who have completed the primary three-dose series with the monovalent vaccine aren't currently eligible for the updated booster. The FDA said kids who have had three doses of the monovalent vaccine should still have protection against Omicron subvariants. It added that data to support giving the updated bivalent vaccine is expected in January. "The agency is committed to evaluating those data as quickly as possible," the FDA said.

Peter Marks, MD, who directs the FDA's Center for Biologics Evaluation and Research, said data suggest that the updated bivalent vaccines will provide increased protection against COVID.

"Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing," he said.

In other US developments:

  • The US House of Representatives today, as part of a $858 billion defense spending bill, rescinded the COVID vaccine mandate for the US military, according to CNN. The measure still needs to pass the Senate and be signed by President Joe Biden. Republican House members pressed for the repeal, and Democrat members included the provision to get the crucial bill passed.
  • Gov. Kate Brown yesterday extended Oregon's state of emergency because of the spread of respiratory viruses in children and the resulting strain on children's hospitals. The original order was announced on Nov 13. The order said conditions continue to deteriorate, with flu and COVID-19 activity now straining adult hospital capacity.

Plan to develop pandemic accord

Following a 3-day meeting in Geneva, countries that are part of the World Health Organization (WHO) agreed yesterday to develop a draft of a legally binding pandemic accord. The "zero draft" is rooted in the WHO Constitution and is designed to better protect the world against future pandemics.

Discussions about the pandemic accord began during a special session at the World Assembly, and an Intragovernmental Negotiating Body made up of 194 WHO member states has met three times since it was established in December 2021.

A smaller group with delegates from all six WHO regions—the INB Bureau—will develop the draft, which will be used when negotiations begin in February 2023.

Precious Matsoso, PharmD, INB Bureau co-chair who is from South Africa and has held WHO leadership positions, said the impact from the COVID-19 pandemic on lives, economies, and societies must never be forgotten. "The best chance we have, today, as a global community, to prevent a repeat of the past is to come together, in the spirit of solidarity, in a commitment to equity, and in the pursuit of health for all, and develop a global accord that safeguards societies from future pandemic threats."

In other global developments:

  • The FDA and the European Medicines Agency will hold a meeting with experts and stakeholders on Dec 15 to discuss new strategies for developing monoclonal antibodies in the face or rapidly evolving SARS-CoV-2 variants.
  • Following China's announcement yesterday of scaled-back COVID measures, Hong Kong health officials announced they were relaxing some isolation, testing, and quarantine rules, according to government announcements translated and posted by Avian Flu Diary, an infectious disease news blog. Social distancing requirements, however, remain in place at least through the end of December.

More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so—especially as we head into the holidays and winter months where more time will be spent indoors

Robert Califf, MD, FDA Commissioner

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