“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” acting FDA commissioner Dr. Janet Woodstock said in a statement on Monday. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
“The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population,” the press release states.
The decision opens up the vaccine to a new segment of the population after inoculations were previously allowed only down to the age of 16. It also comes at a time when all US states have worked through their vaccine priority groups and made shots available to everyone 16 and older.
Pfizer in late March released data on a clinical trial involving 2,260 participants ages 12-15. The efficacy rate was 100%, as none of the participants who received the vaccine contracted Covid-19. Among those who were given placebo shots, 18 contracted Covid-19.
Mild side effects were more common after the second jab than the first and included tiredness, headache, chills, muscle pain, fever and joint pain, the FDA said. The side effects in the 12-15 group were similar to those in trial participants 16 and older.
CDC data showed that as of April 30, there had been about 1.5 million US Covid-19 cases among children ages 11-17. Children typically suffer more minor symptoms than adults. While 11- to 17-year-olds account for about 4.5% of overall infections, children ages 0-17 make up less than 0.1% of Covid-19 deaths.
A CDC advisory committee is expected to vote on Wednesday whether to recommend use of the Pfizer-BioNTech vaccine in children ages 12-17, as approved by the FDA. Once that recommendation is made, President Joe Biden’s administration plans to quickly distribute the shots to the new age group through pharmacies, family doctors and pediatricians.
Moderna’s Covid-19 vaccine also could become available to children later this year. Regulators are awaiting results on the company’s clinical trial for 12- to 17-year-olds. The vaccine is currently available to Americans 18 and older.
The other Covid-19 vaccine approved for use by adults in the US, made by Johnson & Johnson, has a trial pending for 16- and 17-year-olds.
The Biden administration plans to start vaccinating children under 12 by early next year.
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