Pfizer Seeking COVID-19 Vaccine Approval for Children Under 5

Young children, specifically those under five years old, are the final group of those in the U.S. who are ineligible to receive a COVID-19 vaccine. But a new move by pharmaceutical company Pfizer could see (most of) this age group closer to being vaccinated against the virus. In an announcement made on Tuesday, Pfizer has lodged a request to the U.S. Food and Drug Administration (FDA) for the COVID-19 vaccine to be approved for use on children aged six months to four years of age.

The path to Pfizer’s new request has not been a conventional one. Normally, a company will independently submit a request for FDA approval, but in this rare instance, the FDA originally urged Pfizer to seek approval. This was a decision spurred on by the wave of omicron cases, which is currently the most dominant variant in the United States. “The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

The FDA announced that Pfizer’s request will be discussed during a virtual meeting with its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 15. This event can be viewed by the public on the FDA’s livestream on YouTube. If the agency approves the request, the Centers for Disease Control and Prevention (CDC) will be the next body to weigh in. If all goes well, the vaccine could be available to young children by the end of February.

Until then, there are several precautions parents and carers can take to better safeguard their children against COVID-19, including the simple act of masking up. “In the meantime, the best way to protect children, including when they are at school or day care, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caretakers to get vaccinated or receive a booster dose when eligible,” said Acting FDA Commissioner Janet Woodcock, M.D. The commissioner also weighed in on what many concerned parents are thinking: We know COVID-19 vaccines are generally very safe for adults. But what about for young children? “Children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials,” said Dr. Woodcock in a statement. While children of this age group will follow the same two-dose series as other age groups, they will only be given a shot containing one-tenth of the regular dose given to adults. (It’s not unusual for different age groups to receive different doses of vaccines because of how the immune system develops with age.)

In October 2021, the FDA authorized the Pfizer COVID-19 vaccine for use in children aged 5 to 11 years of age. Approximately one third of U.S. children in this age group were vaccinated against the virus between November 3–December 19, 2021. During the clinical trials in the lead up to the approval, the vaccine was administered to more than 3,000 children in this age group. There were no severe reactions reported—the adverse reactions recorded were mild to moderate. (Minor symptoms after a vaccination can be common signs that the inoculation is doing its job!) To further prioritize the safety of children, these adverse reactions were meticulously reported to various vaccine-safety surveillance systems including the Vaccine Adverse Event Reporting System (VAERS) and v-safe.

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