- Pfizer CFO Frank D’Amelio speaks at the Morgan Stanley Annual Global Healthcare Conference on Tuesday
- He said the company expects to receive data from its clinical trial on children ages 5-11 by the end of September and will file for FDA approval in October.
- D’Amelio said he expects the data for people aged six months to four years to be sent to the FDA for approval by November.
- Currently, the shot is only approved for use in the US and Europe in people 12 years of age and older.
- 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
Pfizer Inc. says it plans to make data from its clinical trials among young children available by the end of the month and will file for approval with the US Food and Drug Administration (FDA) shortly thereafter.
Frank D’Amelio, the company’s CFO and executive vice president of global supplies, gave an update on the timeline while speaking at the Morgan Stanley Annual Global Healthcare Conference on Tuesday.
“We expect to have safety and immunogenicity data for five to eleven-year-olds by the end of September,” he said. webcast.
‘And then we’d expect to potentially file with the FDA in early October [emergency use authorization].’
Currently, the Pfizer vaccine, made with German partner BioNTech, is approved only for children 12 years of age and older in both the US and the European Union.
Parents and doctors are debating whether or not to vaccinate children, as they account for 0.1 percent of all COVID deaths in the US.
Pfizer’s CFO Frank D’Amelio spoke at the Morgan Stanley Annual Global Healthcare Conference on Tuesday (above) and said the company is seeking data from its clinical trial on children ages 5-11 by the end of September. and will file for FDA approval. October
Parents are split 50/50 on whether to vaccinate their children as children make up 0.1% of all Covid deaths in the US Image: Dr Erin Biro holds her son as he gets a shot at the Pfizer COVID vaccine trial
Pfizer has enrolled about 4,500 young children at nearly 100 clinical trial sites in 26 US states, Finland, Poland and Spain.
According to clinicaltrials.gov, the study works in the same way as it did in older children and adults.
About half of people aged five to 11 years will be given two doses spaced 21 days apart and the other half will be given a placebo shot.
The team will test the safety, tolerability immune response generated by the vaccine by drawing blood before dose 1 and six months after dose 2.
If the vaccine proves to be safe and effective, the trial will be blinded at a six-month follow-up, meaning those receiving the placebo will be allowed to receive the vaccination.
Trials for children aged six months to four years have 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 filing for emergency use authorization should happen in early November.
‘We would expect similar data for children between the ages of six months and five years … I would call it in the weeks immediately following the filing of data for children aged five-11 years,’ she said.
‘We hope to file’ [for emergency use authorization for ages five to 11] beginning of October. We expect to file similar data in six months for a five-year-old, I would call it a month immediately following the original filing.’
Children are often the last group to be tested during clinical trials because they are not the only young adults.
Their bodies and immune systems behave differently, which means they may require different treatments.
In addition, children may require different doses or needle sizes depending on their height, weight, and age – which is why most children are given only after there is a well-documented understanding of safety in the adult population. Vaccine is given.
In fact, Pfizer announced that it has selected a lower dose for COVID-19 vaccine trials in children than in adolescents and adults.
People 12 years of age and older get two 30 microgram (μg) doses of the vaccine,
However, children aged five to 11 years will be given a 10 microgram dose and children between six months and four years will be given a three microgram dose.
Vaccines have proven to be highly effective in adults and adolescents, but many parents are not enthusiastic about vaccinating their children.
in April 2021 voteRun by the Kaiser Family Foundation, parents were asked whether they would vaccinate their child once a COVID-19 vaccine was authorized and available for their child’s age group.
Three in 10 parents – 29 percent – said they would get their child vaccinated ‘immediately’, while those under 18 said 15 percent said they only plan to vaccinate their children if the school requires it and 19 percent said their child will definitely not be vaccinated.
1 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 have already received a coronavirus shot.
However, 40 percent of parents also said that it is ‘unlikely’ that their children will be vaccinated.
According to the American Academy of Pediatrics, more than five million children have been infected with COVID-19 since the pandemic began.
However, most pediatric cases are not serious and virus-related deaths in children are rare, accounting for just 0.1 percent of all COVID-19 deaths.