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Pfizer to Ask FDA to Allow 3rd COVID Shot for Healthy 5- to 11-Year-Olds, Based on Study of 140 Kids|Vaccine "Adverse Effects" News|Community Discussion|MPN Community

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Pfizer to Ask FDA to Allow 3rd COVID Shot for Healthy 5- to 11-Year-Olds, Based on Study of 140 Kids
Pfizer and BioNTech today said they plan to apply for Emergency Use Authorization of a COVID-19 booster dose for healthy 5- to 11-year-olds based on results of a small study that has not been published or analyzed by independent experts.
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Pfizer and BioNTech today said they plan to apply for Emergency Use Authorization (EUA) of a COVID-19 booster dose for healthy 5- to 11-year-olds based on results of a small study that has not been published or analyzed by independent experts. 

The companies also plan to request authorization from the European Medicines Agency and other regulatory agencies around the world as soon as possible.

Pfizer said in a press release the third dose of its vaccine produced significant protection against the Omicron variant in children 5 to 11 in a small Phase 2/3 clinical trial. 

The study was based on data from only 140 children 5 through 11 years old who received a booster dose six months after the second dose of Pfizer-BioNTech’s COVID vaccine as part of the primary series. 

A closer look at 30 children showed a 36-fold increase in virus-fighting antibodies — levels high enough to fight the Omicron variant, ABC News reported

Pfizer claimed the third dose was “well tolerated with no new safety signals observed.”

Although Pfizer said more than 10,000 children under the age of 12 have participated in clinical trials investigating Pfizer’s COVID vaccine, only 140 were selected for the study forming the basis for the company’s EUA request. 

Commenting on the news, Dr. Brian Hooker said, “The clinical trial used to support the notion of a COVID-19 booster for 5- to 11-year-olds is entirely inadequate to make any such recommendation.”

Hooker, chief science advisor at Children’s Health Defense (CHD), added:

“This small-scale, limited-time trial contains only 140 patients, which is not sufficiently sized to assess vaccine adverse events at all, especially rarer injuries such as the devastating medical maladies sustained by Maddie de Garay — an adolescent injured in the original Pfizer clinical trial.” 

Hooker said he was also concerned there are “no data on the prevention of COVID-19 infection, only neutralizing antibody titers, which are not necessarily predictive of transmission and severity of the disease.” 

Dr. Liz Mumper, a pediatrician, said, “Once again, Pfizer does science by press release.” Mumper said the rise in antibody titers is just one small piece of the story of kids and COVID.

“The more important issue is that, on the basis of careful risk-versus-benefit analysis, healthy children do not need a COVID vaccine,” Mumper said, because many kids already had COVID and developed robust and durable antibodies.

 

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