US government approves Pfizer’s COVID-19 vaccine for children in 12-15 age group
The US Health Body has assured that the known and potential benefits of the Pfizer vaccine in individuals of 12 years of age or above have outweighed the known and potential risks and have supported the vaccine's use on them.
The United States Food and Drug Administration on May 10, 2021, gave the emergency use approval to Pfizer-BioNTech Covid-19 vaccine for the children in the 12-15 age group. The US government aims at setting up shots for many before the beginning of the next school year.
Janet Woodcock, the FDA Commissioner while commenting on the latest approval stated that the FDA's expansion of the emergency use authorization for the Pfizer vaccine to include the teenagers of the 12-15 age group is a significant step in the fight against the Coronavirus pandemic.
BREAKING: Today, with @BioNTech_Group, we announced @US_FDA expanded the Emergency Use Authorization of our #COVID19 vaccine to adolescents 12 to 15 years of age. Learn more: https://t.co/7C2YfXK868 pic.twitter.com/c69qUmRRzU— Pfizer Inc. (@pfizer) May 10, 2021
The US FDA determined that Pfizer's COVID-19 vaccine has met the statutory criteria to amend the Emergency Use Approval. The US Health Body further added that the known and potential benefits of this vaccine in individuals of 12 years of age or above have outweighed the known and potential risks and have supported the vaccine's use on them.
US FDA assures rigorous and thorough review of data before approval:
The US FDA Commissioner while making an announcement stated that the step allows for a younger population to be protected from the pandemic which also brings the US closer to returning to a sense of normalcy and ending the pandemic.
She added that the parents and guardians can be assured that the health agency undertook a thorough and rigorous review of all the available data of Pfizer, as it has with all of the other COVID-19 vaccine emergency use authorizations.
Crucial step for lessening the public health burden:
The Director of the Centre for Biologics and Evaluation and Research of FDA, Peter Marks said the vaccine authorization for the younger population is a significant step for lessening the immense public health burden which was caused by the pandemic.
He added that with science guiding the decision-making process and evaluation, US FDA assures the public and the medical community that the available data has met the rigorous standards for supporting the emergency use of Pfizer's vaccine on teenagers.
Results of Pfizer vaccine study on US teenage volunteers:
In late March 2021, Pfizer had released the preliminary results from a COVID-19 vaccine study of 2,260 volunteers between the age of 12-15. The results showed that there were no cases of Coronavirus among the fully vaccinated adolescents compared with the 18 among those given the dummy shots. The company informed that the vaccinated kids had side effects similar to young adults.
The major and most common side effects observed in the adolescent clinical trial participants were pain at the injection site, headache, tiredness, muscle pain, chills, fever, and joint pains. They typically lasted for 1-3 days.
However, it has been warned that the Pfizer vaccine must not be given to anyone with a known history of severe allergic infection.
The vaccine is also determined to be 91% more effective in preventing the symptomatic COVID-19 infection at least 6 months after the second dose.
Other vaccines in US seeking approval for vaccination of teenagers:
Pfizer was not the only company in the US that has been seeking to lower the age limit for its vaccine. Results are also likely to come by the middle of 2021 from a US study of the Moderna vaccine in 12 to 17 years old.
However, in a sign that the findings were promising, the US FDA has already allowed both Pfizer and Moderna to begin the US studies in children 11 years and younger, while also working their way to as young as 6 months old.
Pfizer Vaccine in the US:
More than 131 billion doses of Pfizer COVID-19 vaccine have already been administered in the United States. The demand for vaccines among adults has dramatically slowed in recent weeks.
The US officials hope that vaccinating teens of the country will further help in reducing the virus caseload and will allow schools to reopen with minimal disruptions.
The US Government has ordered at least 300 million doses of the Pfizer vaccine by the end of July 2021, which is enough to protect 150 million people.