Pfizer and BioNTech asked the FDA to approve their vaccine for children ages 12 to 15 because it gave 100% protection against the virus in the age group that was studied.
A health worker prepares a vaccine at a private school. The photo was taken by RoDRIGO BUENDIA.
The images are from the same source.
The companies pointed to the results of their trial, which found zero cases of Covid-19 among fully vaccineed children when tested seven days to four months after receiving the second Pfizer/BioNTech dose.
The vaccine is currently available for the age group, as well as children ages 5 to 11, under an FDA emergency use authorization, which requires the vaccine's benefits to outweigh its "known and potential risks."
The data from the trial will be filed with the European Medicines Agencies and medical authorities in other countries.
The shot was approved by the FDA in August.
The companies will be able to continue making the vaccine after the Covid-19 outbreak is over.
The Pfizer/BioNTech shot is the only Covid-19 vaccine approved for people under 18.
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The Pfizer/BioNtech Covid-19 shot was found to be effective in preventing hospitalizations in people ages 12 to 18 when the delta variant was the dominant strain of the coronaviruses.
The vaccine against the omicron variant of the coronaviruses has been effective, but health officials are concerned about a drop in effectiveness. Discovery Health, a South African private health insurance administrator, released findings Tuesday from a real-world study that showed the Pfizer/BioNTech Covid-19 vaccine was 70% effective at preventing Covid-19-related hospitalizations and 33% effective at preventing infections. The data analyzed 211,000 Covid-19 tests and found that 42% of them were from adults who had received two Pfizer shots. The director of the National Institute of Allergy and Infectious Diseases said during a White House press briefing that Covid-19 booster shots from Pfizer/BioNTech or Moderna offer substantial protection against hospitalization from the omicron variant.
After adjusting for vaccination status, the data from Discovery Health showed a 29% dip in hospitalizations compared to the alpha variant.
