BioNTech’s Covid-19 vaccine, jointly developed with Pfizer, should be available to 12- to 15-year-olds in Europe from June, the chief executive of the German company has said.
Uğur Şahin said BioNTech had submitted its application for emergency approval of vaccines for this age group in the US at the start of April, and next Wednesday would be ready to submit the application for approval by the European Medicines Agency.
The Pfizer/BioNTech vaccine is already approved in the US and the EU for those 16 years of age and older. Vaccinating children is seen as a crucial next step towards herd immunity and ending the pandemic.
The prospect of getting older children inoculated before the next school year starts would also relieve the strain on parents who are juggling the demands of homeschooling while keeping up with jobs.
At the end of last month, BioNTech and its US partner, Pfizer, reported that approval studies had shown a high antibody response from the vaccine among 12 to 15-year-olds. Participants tolerated the vaccine well and it offered them a 100% protection against the virus.
The companies are also testing the vaccine on babies and children aged six months to five years old.
Quick Guide
How does the Pfizer/BioNTech Covid-19 vaccine work?
The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.
In the case of an mRNA vaccine, the virus’s mRNA is injected into the muscle, and our own cells then read it and synthesise the viral protein. The immune system reacts to these proteins – which can’t by themselves cause disease – just as if they’d been carried in on the whole virus. This generates a protective response that, studies suggest, lasts for some time.
The two first Covid-19 vaccines to announce phase 3 three trial results were mRNA-based. They were first off the blocks because, as soon as the genetic code of Sars-CoV-2 was known – it was published by the Chinese in January 2020 – companies that had been working on this technology were able to start producing the virus’s mRNA. Making conventional vaccines takes much longer.
Adam Finn, professor of paediatrics at the Bristol Children’s Vaccine Centre, University of Bristol
“In July we can expect to have results for five to 12-year-olds, and in September for younger children. The evaluation takes around four to six weeks,” Şahin told Der Spiegel in an interview. “If everything goes well, as long as the data has been analysed by then, we’ll be able to submit an application for the approval of the vaccine for all children in these age groups in a variety of countries.”
Şahin said he expected Europe to have achieved herd immunity by July, or August at the latest. But he also stressed that Europe was only safe as long as the rest of the world had the virus under control. The efficacy of the BioNTech/Pfizer vaccine had so far been tested on a total of 30 variants, including the Indian variant B1617, and the results were positive in every case, he said.
He said that everyone who had been fully vaccinated would need a third booster shot, about nine to 12 months after the first. After that, a single annual top-up would be required.
The BioNTech/Pfizer shot is based on novel mRNA technology and was the first Covid-19 jab to be approved in the west late last year.
This content first appear on the guardian