The German company BioNTech announced that it will request in the coming weeks the approval by the European pharmaceutical authorities of its coronavirus vaccine for use in children of between 5 and 11 years.
“We are already preparing the production,” confirmed BioNTech co-founder Özlem Türeci, who specified that “in the coming weeks the results of the studies on children from five to eleven years of the world will be presented to the authorities and approval will be requested of the vaccine for this age group, here in Europe. “
The first German children under the age of 12 will be able to be vaccinated with the BioNTech brand in mid October and it is estimated that it will soon be distributed to the rest of the world.
The vaccine has been developed jointly with the American pharmaceutical giant Pfizer and as Türeci explained in statements to the magazine Der Spiegel is “less dosed”.
“Over the next few weeks we will present the results of our trial in children aged five to 11 years with regulators from all over the world and we will request the approval of the vaccine in this age group, also here in Europe”, stated the BioNTech directive.
The results of the study are already available and as anticipated “are good, everything is going according to plan”, so that “they should only be processed by the approval authorities.”
By the end of this year it is projected to have the data from the study on the youngest children, from six months, with which all age ranges could end covered by the vaccine in 2022.
Also BioNTech founder Ugur Sahin urged doing everything possible to convince undecided people to get vaccinated in the coming weeks. “We must do what we can to mobilize as many people as possible in these two months,” Sahin said.
FDA expects to approve children’s vaccine by early 2022
To all this, the United States Food and Drug Administration (FDA) let it transpire that emergency authorization for COVID-19 vaccines in children under 12 could arrive in the middle of next winter, so it is estimated that it will be early next year.
The agency also hopes to move rapidly toward full approval of the vaccine for this age group later. A sticking point for some families who continue to doubt is that the vaccines currently in use are administered under authorization for emergency use and have not received full approval from the FDA.
Full approval, if it comes quickly after the emergency round, could ease that parental concern.
Both Moderna and Pfizer-BioNTech launched trials of their Covid-19 vaccines for children under 12 years of age in March and the results are expected to be known in the coming months. Then FDA officials will need time to review applications from drug companies.
The control agency needs four to six months of safety tracking data for children under 12 years of age, while only requiring two months of follow-up data for adult clinical trials.
Pfizer and Moderna have already applied for a full license for their vaccine for adults over 18 years of age, and according to the FDA, granting full approval to adults is the agency’s top priority.
As reported NBC News, Pfizer said in a statement that the results of its clinical trials in children ages 5 to 11 will be released during this month of September, and then you could request an emergency use authorization. “Data for children ages 2 to 5 could come soon after,” the company said, estimating that results for children ages 6 months to 2 years could be released between October and November.
Buddy Creech, one of the principal investigators for the Moderna KidCOVE clinical trials, which includes children up to 6 months, predicted a pediatric data release similar to Pfizer’s.
“I can’t imagine, except maybe for kids ages 6 to 11, that we’re going to have too much data before the end of fall,” said Creech, also an expert in pediatric infectious diseases and director of the Vanderbilt vaccine, a research program at the Vanderbilt. Vanderbilt University Medical Center in Nashville, Tennessee.