A recent clinical trial demonstrated the Pfizer-BioNTech COVID-19 vaccine elicits "100 percent efficacy and robust antibody responses" in adolescents from 12 to 15 years old, according to an announcement from the pharmaceutical company.
The announcement was made on Wednesday via a company press release and the findings are not to be published or peer-reviewed yet. Nevertheless, if the results hold strong, they could open the door to extending vaccination to this age group and younger.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year,” Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said in a statement.
The results come from a Phase 3 trial in 2,260 adolescents aged 12 to 15 in the US. During the clinical trial, 18 people in the placebo group developed COVID-19, while no one in the vaccinated group caught the infection. The blood tests also revealed promising results, showing the vaccines sparks a strong immune response, even more so than those recorded earlier in people aged 16 to 25 years old.
Pfizer also said that they've just dosed the first participants in a clinical study assessing their COVID-19 vaccine on three younger age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. The results will be released in due course.
So far, there has been a multitude of clinical trials testing the different COVID-19 vaccines in adults - most of which have been very promising. However, certain groups of people (such as adolescents) were not included in the initial round of clinical trials, meaning there was not enough hard data to guide vaccine decisions. Now, a bunch of studies is broadening the data available. For instance, a study released last week that found the Pfizer/BioNTech and Moderna COVID-19 vaccines are safe and highly effective during pregnancy
Experts commenting on the news said the announcement holds a lot of promise, but the findings need further confirmation since they were only revealed in a short press release, not a peer-reviewed study.
“As with most such press releases, details are scanty, making it hard to comment confidently on the validity of the claims made. It would be very helpful to see the full details in one or more peer-reviewed papers,” said Dr Peter English, Retired Consultant in Communicable Disease Control and past Chair of the BMA Public Health Medicine Committee.
“When the full, peer-reviewed papers appear – or when regulators receive the data directly from the companies – it will open up the way to extending vaccination to this age group (and likely to the younger age group referred to in the press release). It will be important to do this to achieve herd immunity,” added Dr English.
