US Chief Medical Advisor Anthony Fauci has said children under five years will likely need three shots of the experimental COVID-19 vaccine in a Thursday interview with the non-profit group Blue Star Families.
Mr Fauci expressed his hope that the US Food and Drug Administration (FDA) will approve the Pfizer-BioNTech vaccine, the only COVID-19 vaccine approved for children aged five to 11, for children under five next month.
“My hope is that it’s going to be within the next month or so and not much later than that, but I can’t guarantee that,” he said.
“I can’t outguess the FDA. I’m going to have to leave that to them.”
Mr Fauci, who has been linked to the development of COVID-19, or the Chinese Communist Party (CCP) virus at a lab in Wuhan, later told CNBC that he is not involved with the FDA’s vaccine approval process.
“I did not at all mean to imply that the authorization would come within a month. I meant that we do not know. . .I am not involved in that decision,” he stated.
Meanwhile, the World Health Organization (WHO) has said there is no evidence to suggest that healthy children and young adults require COVID-19 booster shots.
Centres for Disease Control and Prevention (CDC) Director Dr Rochelle Walensky has also stated that there is no evidence showing the Omicron variant causes more severe illness in children than earlier CCP virus strains.
Pfizer-BioNTech is currently conducting two COVID-19 vaccine trials. One involves children between six months to two years of age, while the other trial is on children between two and four years.
According to CNBC’s report, the initial two vaccine doses did not induce a sufficient immune response in children two to four years old.
“[D]ose and regimen for children six months to 24 months worked well, but it turned out the other group from 24 months to 4 years did not yet reach the level of non-inferiority, so the studies are continued,” Mr Fauci said.
Pfizer announced in December 2021 that it expects to submit the three-dose vaccine trial data to the FDA within the first half of this year if it is successful. The company also said it did not identify any safety concerns with the doses administered to the young subjects.
The children in the trials received three microgram doses, while adults currently receive 30-microgram doses.
On January 3 this year, the FDA extended its Emergency Use Authorization (EUA) for Pfizer boosters in 12 to 15-year-olds.
“As previously reported by The Defender, the push to authorize COVID vaccines for younger children could be tied to the fact that vaccine makers benefit from legal protections for childhood vaccines,” wrote Michael Nevradakis from The Defender.
“Under the National Childhood Vaccine Injury Act of 1986, when CDC’s Advisory Committee for Immunization Practices places a vaccine on the mandatory childhood vaccine schedule, vaccine makers are shielded from liability for injury claims. . .However, as long as its COVID vaccine for children remains under EUA, Pfizer will also benefit from liability protections provided under the Public Readiness and Emergency Preparedness Act — so either way, the vaccine maker won’t be held accountable if its product harms young children.”
Meanwhile, Sweden has decided that the vaccine does not benefit children between 5 to 11. Norway will make the jabs optional for children within this age bracket, and Denmark will revise its vaccination policy for children.
“[W]ith the knowledge we have today, with a low risk for serious disease for kids, we don’t see any clear benefit with vaccinating them,” said Sweden Health Agency official Britta Bjorkholm.
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