Published 18:52 IST, September 20th 2021
COVID-19: Pfizer working on vaccine for kids aged 5-11; plans for regulatory approval soon
In a major step towards inoculating youngsters, Pfizer on Monday mentioned that their vaccine showed great results when tested on children aged 5 to 11.
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In a major step towards inoculating youngsters, COVID vaccine maker Pfizer on Monday mentioned that their vaccine showed great results when tested on children aged 5 to 11. The company said that it would further work towards the US authorisations on the same. The vaccine made by Pfizer and its German partner BioNTech is already available for anyone aged 12 and older.
Efficiency of Pfizer on elementary kids
As the world moves on towards continuation and reopening of schools and classes, Pfizer has maintained that it would work towards approving its vaccine which showed great results when tested on children of all age groups. The vaccine already has authorisation for anyone above 12 and is further gaining traction in the age group between 5 - 11 with its improved results. To check efficiency, Pfizer said that it studied the lower dose in 2,268 kindergartners and elementary school-aged kids and tested a third of the amount that's currently registered in each vaccine shot. Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what's the right dose and that it works safely in younger kids.
Today with @BioNTech_Group, we are proud to announce positive topline results from the pivotal trial of our #COVID19 vaccine in children 5-11 years of age. https://t.co/a1mSEgxNHQ pic.twitter.com/9xGfYEzFuy
— Pfizer Inc. (@pfizer) September 20, 2021
'I think we really hit the sweet spot': Pfizer VP on efficient inoculation
In a report by AP, Pfizer Senior VP Dr Bill Gruber said, "Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults." The Pfizer VP while assuring the safety of the dosage mentioned that similar or fewer temporary side effects were witnessed among younger generations. These included sore arms, fever or achiness. Gruber said the company aimed to apply to the Food and Drug Administration (FDA) by the end of the month for emergency use in this age group, followed shortly afterwards with applications to European and British regulators. "I feel a great sense of urgency in making the vaccine available to children under 12," Gruber appended.
We look forward to sharing these data with regulatory authorities and submitting them for peer-reviewed publication. pic.twitter.com/iFq6m8nlsJ
— Pfizer Inc. (@pfizer) September 20, 2021
FDA says, 'Pfizer study not extensive'
FDA chief Dr Peter Marks had previously told the AP that once Pfizer turned over its study, the FDA would evaluate the data hopefully in a matter of weeks to decide if the shots are safe and effective enough for younger kids or not. The FDA required what is called an "immune" bridging study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults.
Contradicting with the fact that Pfizer carried out a press release and not a scientific publication, the FDA maintained that the study was not large enough to detect any extreme case of side effects. The FDA remarked that the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer's Gruber had attested that once the vaccine got authorized for younger children, they'll be carefully monitored for rare risks just like everyone else.
(With inputs from AP)
Image: AP/Shutterstock/Representative Image
18:52 IST, September 20th 2021