A ten year old child high fives Pharmacist Colleen Teevan after he received the Pfizer-BioNTech Covid-19 Vaccine for kids
FDA Panel Approves Pfizer COVID Vaccine For Children Age 5 To 11 Photo by Joseph Prezioso/ AFP via Getty Images

Pfizer Inc. and BioNTech are now in the process of acquiring regulatory approval of its COVID-19 vaccine for children 6 months to 5 years old. Clinical trials for the vaccine began last year for this age group with an approved decision expected to be announced this month.

According to Reuters, Pfizer began submitting data for emergency use authorization on Tuesday, despite not being able to meet a key immune response target for children aged 2 to 4 years old. However, clinical trials found that two 3-microgram doses were seen to be effective in children below the age of 2 years.

The results of these studies have prompted Pfizer to dive into the possibilities of a third 3-microgram dose two months after the last administered jab. From there, the FDA has pushed Pfizer to proceed with their 2-dose data submissions so the approval process can start rolling.

The US Food and Drug Administration said an outside committee of expert advisers will convene on Feb.15 to discuss the emergency use authorization. Should the approval go forward, the US Center for Disease Control and Prevention will need to sign off on how the doses will be implemented. Meanwhile, Pfizer and BioNTech said, for now, they are seeking FDA approval for the authorization of the first two dozes of the planned 3-dose administration.

The data on the third dose will soon follow after completing their submissions to the FDA on the first two doses in the coming days.

On the other hand, Merck former executive director of medical affairs for vaccines, John Grabenstein said US regulators should consider the vaccine as a 2-dose course rather than seeing this as a first two-dose course of a planned 3-dose regimen. "I just can't believe that they would authorize getting started without knowing what the third dose would do,” he added.

While the FDA has approved the vaccine for emergency use in children aged 5 to 11 years old, as well as for teenagers between 12 to 17 years old, many parents are still in the grey whether to allow their younger children to get vaccinated.

As it is, only 22% of children between the age of 5 to 11 years have been fully vaccinated in the US since the campaign started in November, with Sweden recently deciding against recommending COVID-19 vaccines for this age group.

A student receives a dose of the Pfizer/BioNTech vaccine
A student receives a dose of the Pfizer/BioNTech vaccine at the Covid-19 Vaccine Hub Porta di Roma, as part of vaccinations for students about to get their diploma, on June 1, 2021 in Rome, Italy. According the Italian government, just over 19 percent of Italians are fully vaccinated, with 37 percent having received a first dose, on par with the European average. Photo by Antonio Masiello/Getty Images

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