Pfizer and BioNTech plan to seek approval soon for their COVID-19 vaccine in children ages five to 11.
Dr Özlem Türeci, chief physician of BioNTech, told German news site Der Spiegel that the companies will soon release the results of their research in children under 12 and seek approval of the injection for emergency use from the US Food and Drug Administration. . Drug Administration (FDA) and other agencies.
“In the coming weeks, we will present the results of our study in the five-to-11-year-olds worldwide to authorities and apply for vaccine approval for this age group,” said Türeci.
She added that the vaccine formula is the same as that for adolescents and adults, but the dose is smaller.
Currently, the Pfizer vaccine 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
Pfizer and BioNTech plan to seek approval for their COVID-19 vaccine in children ages five to 11 in the coming weeks. Pictured: A Pfizer COVID-19 vial at a mobile clinic in East Los Angeles, July 2021
Dr Özlem Türeci, chief physician at BioNTech, said the vaccine is the same as the vaccine approved for adolescents and adults, but at a smaller dose. Pictured: Marisol Gerardo, 9, is held by her mother while receiving the second dose of Pfizer vaccine during a clinical trial at Duke Health in Durham, North Carolina, April 2021
A few hours after the new ones from Pfizer and BioNTech, the FDA said the clinical trial data submitted by vaccine manufacturers should include a monitoring period of at least two months after the last dose to ensure safety.
“Children are not small adults — and issues that could be addressed in pediatric vaccine studies could include the need for different doses or different strength formulas of vaccines already used for adults,” FDA Acting Commissioner Dr Janet Woodcock said in a joint statement. with dr. Peter Marks, director of the Center for Evaluation and Research of Biologics.
About 4,500 younger children are enrolled at nearly 100 clinical trial sites in 26 US states, Finland, Poland and Spain.
According to clinicaltrials.gov, the trial will work 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 from six months to four years old are still in their early stages and will be expanded once the researchers can determine its safety.
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 an April 2021 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.