Teens Fully Protected by Pfizer’s COVID-19 Vaccine, Company Says

Adolescents aged 12 to 15 were fully protected against symptomatic COVID-19 after being vaccinated with the Pfizer / BioNTech mRNA vaccine in a small Phase III clinical trial, Pfizer reported in a press release Wednesday.

The company also said the vaccine was well tolerated in the age group, causing only the standard side effects seen in people aged 16 to 25. The vaccine is already authorized for people aged 16 and over.

The vaccine was found to be more effective in stimulating defensive immune responses in adolescents aged 12 to 15 than in the 16 to 25 age group, producing even higher levels of antibodies capable of neutralizing SARS-CoV-2. In a neutralizing antibody measure, young people vaccinated in the new trial had geometric mean titers (GMT) of 1,239.5, compared to GMTs of 705.1 previously seen in people aged 16 to 25, Pfizer noted. .

The trial involved 2,260 adolescents aged 12 to 15, of whom 1,131 were vaccinated and 1,129 received a placebo. There were 18 symptomatic COVID-19 cases in the trial, all of them in the placebo group. In today’s press release, the company trumpeted that the vaccine has demonstrated “100% effectiveness.” However, the trial was not primarily designed to assess efficacy. This was primarily to assess relative immune responses, so more data is needed to fully assess efficacy. Additionally, Pfizer and BioNTech only published key trial results, not the full trial data, which has not been peer reviewed.

Last year, a Phase III trial involving more than 46,000 people found the vaccine to be 95% effective in preventing symptomatic COVID-19 in adults.

The robust immune responses and the protection demonstrated in the new trial in adolescents are positive signs. Pfizer and BioNTech now plan to submit the data to the United States Food and Drug Administration, as well as regulatory agencies in the European Union, to expand the use of the vaccine to adolescents.

“We share the urgency to expand the authorization of our vaccine for use in younger populations and are encouraged by the data from clinical trials in adolescents aged 12 to 15,” said Albert Bourla, CEO from Pfizer, in the press release. “We plan to submit this data to the FDA as a proposed amendment to our emergency use authorization in the coming weeks and to other regulators around the world, in the hope of starting to vaccinate this age group before the start of the next school year. “

Last week, the companies announced the start of testing of safety and immune responses in infants and children aged 6 months to 11 years. The trial divides children into three groups: 6 months to 2 years old, 2 to 5 years old, and 5 to 11 years old. The first doses were given to children in the 5 to 11 age group last week, and the companies plan to launch the 2 to 5 year old group next week.