Trials Show Comirnaty Safe for Children 5 to 11

21.09.2021 - Phase 2/3 clinical trials with the Pfizer/BioNTech Covid-19 vaccine Comirnaty have shown that it is safe, well tolerated and produces robust neutralizing antibody responses in children aged 5 to 11 years, the companies said on Sept. 20. The vaccine partners now plan to submit the data to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies around the world “as soon as possible.”

Children participating in the tests were given a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants receiving 10 µg doses were said to be comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses.

The positive results could pave the way for the shot to be rolled out in the US for this age group before the end of October, reports said, although the findings have not yet been peer-reviewed or published in a scientific journal. Results from the American-German duo’s tests with children under five are expected later this year, around the same time results from Moderna’s vaccine trials in children under 12 are expected.

Although children generally have a much lower risk of Covid-19, even from the Delta variant, since July pediatric cases have risen by about 240% in the US, indicating the public health need for vaccination,” said Pfizer CEO Albert Bourla.  According to the American Academy of Pediatrics, children now account for more than one in five new cases. More have been admitted to hospitals and intensive care units in the past few weeks than at any other time in the pandemic.

US press reports said the reopening of schools has fueled the surge of late, especially in Southern states where fewer adults have been vaccinated, and wearing masks is discouraged by state governors. In Mississippi, nearly 6,000 students tested positive for Covid in one week, and more than 30,000 students, teachers and staff had to be quarantined

The Pfizer/BioNTech announcement came at the start of a week in which the FDA is due to decide whether to greenlight Covid booster shots for all age groups. The health agency’s advisory panel on Sept. 18 declined to recommend a third dose of the Comirnaty vaccine for anyone other than people over 65 and the immunocompromised, while at the same time suggesting that workers with occupational exposure to the virus could be included.

Author: Dede Williams, Freelance Journalist