Pfizer seeks FDA approval for vaccine for kids 5 and younger

The shots, if approved by the FDA and CDC, could be available by March
Posted at 6:07 PM, Feb 02, 2022
and last updated 2022-02-07 14:18:57-05

(WXMI) — A COVID-19 vaccine for kids ages 5 and under could be available as early as next month. Pfizer submitted their data for that age group to the U.S. Food & Drug Administration (FDA) on Wednesday with hopes the agency will extend emergency-use authorizations to the nation’s youngest citizens.

There are an estimated 19 million children 5 and under in the U.S. and they are the last group still left to be considered by the FDA and Centers for Disease Control and Prevention (CDC). If both federal agencies sign off, the shots could be available by March.

“I think this is absolutely huge,” said Dr. Rosemary Olivero, a pediatric infectious disease specialist with Spectrum Health. “Omicron is still a pretty large threat in the United States, and children really are bearing the brunt of COVID-19 infections and, even in many areas, hospitalizations.”

The vaccine authorization for kids ages 5 to 11 took about four weeks to complete.

The shot itself is about one tenth the dosage of the vaccine adults received. Initial data submitted by Pfizer showed the new vaccine worked extremely well — as good as it did in adults — for kids ages 6 months to 2 years old. However, the efficacy was not as robust for kids ages 2 to 4 years old. Federal regulators still urged Pfizer to submit their data, saying the vaccine is still safe and some protection is better than none.

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“We know very well in the infectious disease and immunology world that your antibody response that you get from a lab does not necessarily equate to your likelihood to get a severe infection. It’s just one way of looking at that,” said Dr. Olivero. “We take it seriously but it’s also not the full picture. Any immune response, even if it doesn’t meet the antibody cutoff, is far superior to no antibodies to protect you against COVID-19.”

But health experts are still fighting hesitation among the public. A survey conducted by the Kaiser Family Foundation, released Tuesday, shows only three in ten parents of kids 5 and under plan to vaccinate their children.

“I think it is a very common misconception that, after we get through this surge, COVID will be over, so 'Why would I vaccinate my kid?'” said Dr. Olivero. “COVID is indeed endemic now, meaning that it’s going to be part of our normal, circulating respiratory viruses year in, year out.”

Once the FDA approves the data, it will be sent to the CDC, which will decide if all kids in that age group should receive the shot right away, or if it should be reserved for at-risk youth for the time being. If approved by the CDC, the shots will be available at your pediatrician’s office or at retail pharmacies currently offering vaccinations.

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