The first long-term study of Pfizer’s Covid-19 vaccine is out — and the results show that the shot is 100% effective against the coronavirus in those 12 to 15 years of age, it was announced on Monday.
Officials from Pfizer and BioNTech announced that their Covid-19 inoculation was 100% effective in preventing infections in adolescents in this age bracket, as seen from the results up to four months after administration of the second shot.
The results, from the Phase 3 trials of the Pfizer product, using a total of 2,228 subjects, will be used in the Pharma giant’s application to the US Food and Drug Administration for an extension of their Covid-19 vaccine authorization for that age cohort.
Ugur Sahin, the CEO and co-founder of BioNTech, the German partner of Pfizer in the creation of the vaccine, said in a statement today “These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a Covid- 19 vaccine in individuals 12 to 15 years of age.”
Covid-19 vaccine 100% effective, safe for young teens
He added that “The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our Covid-19 vaccine across adolescent and adult populations.”
This Phase 3 trial data showed no serious safety concerns whatsoever even six months after the teens’ second dose of the vaccine.
Albert Bourla, the Thessaloniki-born Pfizer chairman and CEO, said in the statement that this additional data “provide further confidence in our vaccine’s safety and effectiveness profile in adolescents. This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed.”
The United States has distributed the vaccine to this age cohort since May of 2021, when the FDA extended the emergency use authorization for the vaccine to younger teens. This was the first vaccine in the world to receive to be fully authorized for all those who are 16 years of age and older.
Pfizer and BioNTech officials say that they will also use the results of the study to pursue the shot’s approval in other countries where it has already been granted emergency use authorization.
As part of this Phase 3 trial, subjects experienced a total of 30 Covid infections — but all of them occurred in those who had received a placebo shot.
Moreover, the efficacy of the inoculation did not vary between race and ethnic groups, gender, or even the presence of underlying conditions, including obesity, according to Pfizer and BioNTech.
Vaccine for 5-11 year olds also shows “robust” antibody response
In September, Pfizer officials stated that the company’s Covid-19 vaccine for children from 5 to 11 years old was not only safe but showed what they call a “robust” antibody response, according to a statement.
At a time when the Delta variant of the virus continued to surge around the globe, and unvaccinated young children returned to school in person, the pharmaceuticals giant stated that a Phase 2/3 trial demonstrated that its coronavirus vaccine was not only safe but also sparked a “robust” antibody response in children from the age of 5 to 11.
Although the data was brand-new and had not yet been peer-reviewed, the results came as extraordinarily welcome news as this age cohort returned to school at a time when the Delta variant continues its march across the globe, causing spikes in hospitalizations and deaths around the world.
The vaccine has been distributed to children in that age bracket for several weeks now, beginning on November 2, 2021.