SAWT BEIRUT INTERNATIONAL

| 3 October 2022, Monday |

US considers authorization of first COVID-19 vaccine for children under 5

After Pfizer Inc and BioNTech SE launched the regulatory licensing procedure on Tuesday, US authorities are reviewing the first COVID-19 vaccination for children under the age of five, the only age group not currently eligible for the doses.

A decision might be made as soon as this month.

The companies stated that they began submitting data for an emergency use authorization despite failing to meet a key target in a clinical trial of 2- to 4-year-olds. According to the researchers, they are submitting the data at the request of the US Food and Drug Administration in order to address an urgent public health need in the age group.

The introduction of a vaccination for younger children might relieve the stress of parents who have had to deal with quarantines and the closure of pre-schools and childcare centers.

“Having a safe and effective vaccination available for children this age is a priority,” said interim FDA Commissioner Janet Woodcock. She stated that the agency requested the application due to the recent Omicron increase.

The FDA announced on Feb. 15 that an independent group of expert advisors will meet to discuss the authorisation. If that is approved, the US Centers for Disease Control and Prevention must also approve how the immunizations will be administered following a meeting of its own advisors. Those sessions have often occurred within a week or so following FDA determinations.

The pharmaceutical firms have stated that they are requesting FDA approval for the first two doses of a proposed three-dose regimen.

“If two doses are permitted, parents will be able to begin a COVID-19 immunization series for their children while awaiting potential permission of a third dosage,” stated Pfizer CEO Albert Bourla.

According to him, three doses of the vaccine are expected to be required “to obtain high levels of protection against existing and possible future variations.”

The businesses anticipate completing data submission to the FDA in the coming days, with data on the third dosage to follow.

Pfizer and BioNTech are studying a 3-microgram dosage of the vaccine in the age group, compared to a 10-microgram dose in children aged 5 to 11, and 30 micrograms in those aged 12 and older.

Should the FDA approve the vaccine, the businesses anticipate to have an abundant supply of the 3-microgram doses.

EVIDENCE OF CLINICAL BENEFIT?

The change might cut the time it takes for this age group to get immunized by months. If a third dose is finally approved, many youngsters may have already began the program. Pfizer is presently evaluating two doses separated by three weeks, followed by a third dosage at least eight weeks later.

The change might cut the time it takes for this age group to get immunized by months. If a third dose is finally approved, many youngsters may have already began the program. Pfizer is presently evaluating two doses separated by three weeks, followed by a third dosage at least eight weeks later.

Pfizer said in December that it will modify its clinical study to test a three-dose version of the vaccine since the lower dose produced an immunological response in two to four-year-olds that was inferior than the response assessed in individuals aged 16 to 25. The immunization elicited an immunological response comparable to that of 16- to 25-year-olds in children aged six to 24 months.

Former Merck executive director of medical affairs for vaccines John Grabenstein says authorities should assess the vaccine as a two-dose course rather than the first two doses of a planned three-dose regimen.

“I cannot recall any instance in which the FDA made a regulatory determination without knowing the data from the end of the study,” Grabenstein added. “I just can’t believe they’d approve starting without knowing what the third dose would do.”

However, John Moore, a Weill Cornell Medical College professor of microbiology and immunology, said the approach “seems like an innovative solution to a genuine problem, and there are no safety consequences, which would normally be a dealbreaker.”

The vaccine is already licensed for emergency use in children as young as five years old in the United States. It has complete adult approval.

The FDA has also approved a third booster dosage of the Pfizer/BioNTech injection for adults and children over the age of 12. It approved a two-dose vaccination for youngsters aged five to eleven.

It’s uncertain how many parents will choose to vaccinate their children in their early childhood.

Vaccination of children has been sluggish in the United States, with just around 22 percent of children aged five to eleven receiving two doses since the campaign to immunize that age group began in November.

    Source:
  • Reuters