Pfizer Asks U.S. Regulators To Stop COVID-19 Shots For Children 5-11. to approve
Pfizer on Thursday asked the U.S. government to approve the use of its COVID-19 vaccine in children ages 5-11 – and if regulators agree, the shots could start within a few weeks.
Many parents and paediatricians are calling for the protection of children under the age of 12, today’s age limit for the vaccine from Pfizer and its German partner BioNTech. Not only can teens get seriously ill at times, but keeping them in school can be a challenge as the coronavirus is still raging in poorly vaccinated communities.
Pfizer announced in a tweet that it had officially submitted its application to the Food and Drug Administration.
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It is now up to the FDA to determine if there is enough evidence that the shots are safe and work just as well in younger children as they do in teenagers and adults. An independent panel of experts will publicly debate the evidence on October 26th.
One big change: Pfizer says its research shows the younger children should be given a third of the dose everyone else is now given. After their second dose, 5-11 year olds developed antibody levels to fight viruses that were as strong as adolescents and young adults with a normal strength vaccination.
While children are less at risk of serious illness or death than the elderly, COVID-19 sometimes kills children, and cases in teenagers have skyrocketed as the extra-contagious Delta variant has swept across the country
“I am very happy to be helping other children get the vaccine,” said Sebastian Prybol, 8, from Raleigh, North Carolina. He’s enrolled in Pfizer’s study at Duke University and doesn’t yet know whether he received the vaccine or the sham vaccine.
“We want to make sure it is completely safe for her,” said Sebastian’s mother, Britni Prybol. But she said she would be “overjoyed” when the FDA approves the vaccine.
Pfizer looked at the lower dose in 2,268 volunteers, ages 5-11, and said there were no serious side effects. The study isn’t big enough to find extremely rare side effects, such as heart inflammation, which sometimes occurs after the second dose of the normal strength vaccine, especially in young men.
If the FDA approves the use of the child-sized doses in an emergency, there is one more hurdle before vaccinations can begin in this age group. Advisors to the Centers for Disease Control and Prevention will decide whether vaccinations are recommended for adolescents and the CDC will make a final decision.
To avoid dosing mix-ups, Pfizer plans to ship vials specially marked for pediatric use with the lower dose.
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Reference: time.com
