Race for approval: is the vaccine for children coming soon?


Status: 10.09.2021 2:11 p.m.

The pharmaceutical company BioNTech will soon apply for the use of its corona vaccine for younger children – in a lower dose. Production is already being prepared.

If BioNTech co-founder and medical director Özlem Türeci has its way, the first children under the age of twelve in Germany could be vaccinated with the BioNTech agent as early as mid-October. Türeci told the “Spiegel”: “In the coming weeks we will present the results of our study on the five to eleven year old to the authorities worldwide and apply for approval of the vaccine for this age group, also here in Europe.” The vaccine is the same, but the dose is lower. “We are already preparing the production,” says Türeci.

The corresponding study results are therefore available and would only have to be prepared for the approval authorities. “It looks good, everything is going according to plan,” confirmed Türeci’s husband, BioNTech co-founder and boss Ugur Sahin. This means that approval could come a little faster than expected. The head of the National Association of Statutory Health Insurance Physicians, Andreas Gassen, had recently forecast a vaccine for children under the age of twelve at the end of the year. But BioNTech’s plans go further anyway: by the end of the year, the study data on younger children from six months onwards would also be expected.

Billions in sales beckon

In the race for the fastest approval of the vaccine for children between five and eleven, the pharmaceutical company Moderna is also in the running. Clinical trials are currently ongoing in the US for both the Pfizer / BioNTech and Moderna vaccines. Previously, there had been delays because the FDA had requested more children than study participants at both BioNTech and Moderna.

Children would be vaccinated in late fall or early winter, immunologist and advisor to US President Joe Biden, Anthony Fauci, told NBC. It could take a little longer for younger children because the age groups from two to five and from six months to two years are checked separately. Competitor Johnson & Johnson is also working on a vaccine, but is a few weeks behind.

Billions in sales from vaccination doses

For pharmaceutical companies, the extension of the approval would mean the prospect of further sales in the billions. Analysts estimate that BioNTech and Moderna have already concluded supply contracts with a volume of more than 60 billion dollars for the years 2021 and 2022. They would include the two doses originally required, but the calculation also included potential so-called booster vaccinations.

For the year 2023, experts again expect around 6.6 billion dollars in sales for BioNTech; Moderna is forecasting sales of 7.6 billion, mostly through booster vaccinations. These estimates do not include the additional income from the now expanded population group.



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