Pfizer COVID-19 vaccine safe, efficacious for adolescents
Apr 03 2021
It did not list the side effects for the younger group, but the adult trial's side effects generally were mild to moderate and included injection-site pain, headaches, fever and fatigue.
Clinical trials of the Pfizer/BioNTech's COVID-19 vaccine showed that it has a 100 percent efficacy in adolescents and is well-tolerated in minors between the ages of 12 and 15, paving the way for distribution, the companies announced.
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.
The Pfizer/BioNTech two-shot vaccine is already authorised for use in people as young as 16.
The vaccine has also been found to be 100 per cent effective against severe diseases, as defined by the CDC, and 95.3 per cent effective against severe cases of Covid-19 as defined by the FDA.
He said the effectiveness against the South African variant was "especially noteworthy", since it showed the vaccine is likely to offer effective protection in real-world settings where several different coronavirus variants could be circulating.
All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Those comparisons to the older population are important, because researchers are building off of the knowledge they gained in the adult trials.
Since then, it has been used in millions of adults in more than 65 countries.
The shot was also 100% effective in preventing illness among trial participants in South Africa, where a new variant called B1351 is dominant, although that rate was derived from a relatively small number of nine infections observed there, which were all in the placebo group, Pfizer said.
The trial data "provide the first clinical results that a vaccine can effectively protect against now circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population", BioNTech Chief Executive Ugur Sahin said in a statement.
BioNTech CEO Ugur Sahin added: "We are longing for a normal life", he said in a statement. "The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 United Kingdom variant".
Pfizer also said the vaccine produced a "robust" antibody response in children, exceeding those recorded earlier in young participants.
A separate Phase 1/2/3 study of the Pfizer/BioNTech vaccine in children ages 6 months to 11 years launched last week, when the first children ages 5 to 11 received a shot. The company aims to enroll 4,644 children in the trial and expects results by the end of 2021.
AstraZeneca in December removed children from a mid-to-late stage trial of its COVID-19 vaccine in Britain. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said those younger children may have to wait until the first quarter of 2022, reported CNN.