KEY POINTS

  • Pfizer's COVID-19 vaccine could be available to babies by September
  • The vaccine trial includes participants as young as six months old
  • Pfizer and BioNTech plan to submit their request for approval by September

BioNTech, the German company that partnered with Pfizer to develop a COVID-19 vaccine, revealed the shots could be available for babies by September.

BioNTech Chief Executive Ugur Sahin told German magazine Spiegel that researchers are expecting the results by September from trials of the Pfizer/BioNTech vaccine given to babies as young as 6 months old.

“In July, the first results could be available for the 5-to-12-year-olds, in September for the younger children,” Sahin told Spiegel, according to Aljazeera.

“If all goes well, as soon as the data is evaluated, we will be able to submit the application for approval of the vaccine for all children in the respective age group in different countries,” he added.

The BioNTech chief executive also noted that evaluating the data would take between four to six weeks.

Dr. Yvonne Maldonado, professor of pediatrics, epidemiology and population health at Stanford University, enrolled her children in the Pfizer vaccine trial. Her son Soren, who is 7-months-old, is the youngest participant in Stanford Hospital’s Pfizer vaccine trial.

“Children under 18 make up 85 million people in [the] U.S. — about 20% of the population. Getting them vaccinated is a major contribution to reducing transmission of virus,” she told ABC News.

“So far, because this vaccine has been tested in a lot of teenagers and so many adults and it was shown [to be] very safe, we felt pretty comfortable to participate,” she added.

At the start of April, BioNTech and Pfizer submitted their application to U.S. regulators to request emergency-use approval for a COVID-19 vaccine for adolescents aged 12 to 15. Both companies are preparing to submit their application for approval to the European Medicines Agency on May 5.

In late March, Pfizer revealed that approval studies of its vaccine showed a high antibody response among 12-

to 15-year-olds and offered trial participants 100% protection against the virus.

The Pfizer coronavirus vaccine is already approved for use for people ages 16 and older in the U.S. and EU.

On Tuesday, Pfizer CEO Albert Bourla revealed that both companies expect their experimental oral drug treatment for COVID-19 to be available by the end of this year. The antiviral therapy will prevent the virus from reproducing in the lungs, nose and throat.

Pfizer vaccines being prepared for injection at the Christine E. Lynn Rehabilitation Center in Miami, Florida on April 15, 2021
Pfizer vaccines being prepared for injection at the Christine E. Lynn Rehabilitation Center in Miami, Florida on April 15, 2021 AFP / CHANDAN KHANNA