Pfizer asks FDA to approve vaccine for kids 5-11

(Pixabay)

One day after several Scandinavian nations announced a halt to the Moderna mRNA vaccine for younger people, Pfizer asked the Food and Drug Administration for emergency authorization to administer its mRNA vaccine to children ages 5 to 11.

The chief concern about the Moderna shot is the increased risk of heart inflammation, or myocarditis. And that was a stated reason, among other adverse effects, behind an FDA panel’s 16-2 vote last month against recommending Pfizer booster shots for those from ages 16 to 65.

In fact, Moderna CEO Stephane Bancel told Bloomberg News in a report Wednesday that data indicate the risk of myocarditis is similar between the Pfizer and Moderna vaccine. (He insisted, though, that the risk of contracting myocarditis from COVID-19 is much greater than contracting it from the vaccine).

On Thursday, Finland joined Denmark and Sweden in pausing the Moderna COVID-19 shots to men under the age of 30 due to the risk of heart inflammation.

The Pfizer-BioNTech vaccine is approved for people age 16 and older, and has an emergency use authorization for people ages 12 to 15.

Last month, a poll found nearly half of likely American voters are not confident that the COVID-19 vaccines are necessary and appropriate for children ages 5-12. Only 42.2% say they are confident that young children should get the shots, according to the Trafalgar Group survey. Conducted Sept. 17 to 19, it found 66.8% of Republicans and 54.7% of independents are not confident.

WND reported Wednesday three Pfizer scientists were captured on hidden camera in the latest Project Veritas investigation acknowledging that natural immunity is superior to the company’s vaccine. Pfizer scientist Rahul Khanke said employees are “bred and taught” to insist that the “vaccine is safer than actually getting COVID.” He said “we cannot talk about this” in public.

Expert panel to debate safety
The Associated Press reported Thursday that if the FDA approves, reduced-dose shots of the Pfizer vaccine for young children could begin within weeks. Currently, the age cutoff for COVID-19 vaccinations is 12.

An independent expert panel commissioned by the FDA will publicly debate the safety and efficacy evidence on Oct. 26.

Critics of administering the vaccine to children, including Dr. Marty Makary of Johns Hopkins University, argue the risk of death and hospitalization from COVID-19 is statistically zero. The count of COVID deaths after 18 months is 520, according to the American Academy of Pediatrics, which is considerably lower than the annual count for the seasonal flu.

And studies also have shown that transmission of COVID-19 by children is extremely low. Advocates argue that cases among children have increased amid the delta variant surge. However, a study in Australia found that while the delta wave has seen a fivefold increase in outbreaks in schools and childcare in the country, most children have mild or no symptoms. And transmissions at schools is low, with household transmissions of much greater concern. The findings were consistent with other studies overseas.

Late Thursday afternoon, Florida’s Department of Health issued a statement rebutting a claim by the state’s agriculture commissioner. The health department said, contrary to the commissioner’s claim, there is “no evidence that schools are high risk locations of spread.”

“A study supported by CDC and completed by the State Epidemiologist, alongside the State Surgeon General and other top experts at the Department of Health, found that fewer than 1% of students had school-related COVID-19,” the department said.

Pfizer said its study found no serious side effects in the lower dose in 2,268 volunteers ages 5 to 11. However, the study isn’t large enough to detect relatively rare side effects such as heart inflammation. Vaccines historically have required five to 10 years of rigorous clinical trials of various demographic groups to gain approval.

On Thursday, Makary cited a new study from Israel finding myocarditis was seen in 11 per 100,000 males 16-29 after vaccination. The study underscores the importance of recognizing natural immunity, he said.

Moderna, meanwhile, has asked the FDA for permission to use its vaccine in 12- to 17-year-olds. It’s also studying its shots in elementary school children.

Both Pfizer and Moderna also are studying even younger children, down to 6 months. They anticipate results later this year.

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