Pfizer Inc says it plans to have data from its early childhood clinical trials available by the end of the month and will submit it to the U.S. Food and Drug Administration (FDA) for approval shortly after.
Frank D’Amelio, the company’s CFO and executive vice president of global supply, provided an update on the timeline during a speech at the Morgan Stanley Annual Global Healthcare Conference on Tuesday.
“We expect to have safety and immunogenicity data for children between the ages of five and 11 by the end of September,” he said on the website. webcast.
“And then we’d expect to file that with the FDA in early October for a possible… [emergency use authorization].’
Currently, the Pfizer vaccine, made with German partner BioNTech, is only approved for children ages 12 and older in both the US and the European Union.
Parents and doctors have debated whether or not to vaccinate children as they account for 0.1 percent of all Covid deaths in the US
Speaking at the Morgan Stanley Annual Global Healthcare Conference (above) on Tuesday, Pfizer CFO Frank D’Amelio said the company expects to have data from its clinical trial on children ages 5-11 by the end of September and will seek FDA approval. apply in October
Parents are split 50/50 on whether or not to vaccinate their children as children make up 0.1% of all Covid deaths in the US Pictured: Dr. Erin Biro Holds Her Son As He Gets An Injection In Pfizer Covid Vaccine Trial
Pfizer has enrolled approximately 4,500 younger children at nearly 100 clinical trial sites in 26 US states, Finland, Poland and Spain.
According to clinicaltrials.gov, the study works the same way it does with older children and adults.
About half of the group aged five to 11 will receive two doses 21 days apart and the other half will receive placebo injections.
The team will test the vaccine-generated safety and tolerability of the immune response by drawing blood before dose 1 and six months after dose 2.
If the vaccine is proven to be safe and effective, the study will be unblinded after six months, meaning those who received the placebo will be allowed to receive the vaccine.
Trials for children aged six months to four years have since progressed to phase III, and researchers are still collecting data.
D’Amelio also provided an update on the timeline for this age group, saying that the emergency authorization application should be completed in early November.
“We would expect similar data for children ages six months to five years… I’ll call it submitting the data for the five- to 11-year-olds in the weeks after that,” he said.
‘We expect to archive’ [for emergency use authorization for ages five to 11] early October. The six months before the five-year-old we hope to file will submit similar data. I’ll call it the original submission in a month or so shortly after.’
Children are often the last group tested in clinical trials because they are not just small adults.
Their bodies and immune systems behave differently, meaning they may have different treatment needs.
In addition, children may require different doses or needle sizes depending on their height, weight and age. Therefore, most children are not vaccinated until safety in the adult population is well documented.
In fact, Pfizer announced that it has chosen lower doses for COVID-19 vaccine studies in children than it does for teens and adults.
Those 12 years and older will receive two doses of 30 micrograms (μg) of the vaccine,
However, children between the ages of five and 11 are given 10 g doses and children aged six months to four years receive three g doses.
Vaccines have been proven to be highly effective in adults and teens, but many parents are not enthusiastic about vaccinating their children.
In April 2021 opinion poll, conducted by the Kaiser Family Foundation, parents were asked whether they would have their child vaccinated once a COVID-19 vaccine is approved and available for their child’s age group.
Three in ten parents – 29 percent – of children under 18 said they would have their child vaccinated ‘immediately’ while 15 percent said they only plan to vaccinate their children if the school requires it and 19 percent said their child certainly won’t be vaccinated.
A July 2021 surveyMott Children’s Hospital National Poll on Children’s Health at Michigan Medicine last month found that 39 percent of parents said their children had already received a coronavirus shot.
But 40 percent of parents also said it was ‘unlikely’ that their children would be vaccinated.”
More than five million children have been infected with COVID-19 since the start of the pandemic, according to the American Academy of Pediatrics.
However, most pediatric cases are not serious and virus-related childhood deaths are rare, with pediatric deaths accounting for just 0.1 percent of all COVID-19 deaths.