The emergency use of Pfizer- BioNTech Covid-19 vaccine in adolescents aged 12-15 has been authorized by the US Food and Drug Administration (FDA) on Monday for the prevention of Covid-19 vaccine caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
FDA said in a news released posted on its website on Monday, Xinhua reported that FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met all the legal criteria to amend the emergency use authorization (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.
Safe And Effective For Adolescents
According to a safety data uploaded by FDA, 2,260 participants aged 12 through 15 years old participated in an ongoing randomized, placebo-controlled clinical trial in the US, which found that out of 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo and more than half if the participants were followed for the safety for at least two months after taking the second dose of the vaccine.
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
Minor Side Effects Can Be Expected After First Dose
There are some common side effects that were seen in the adolescents’ participants in the clinical trial that typically lasted from 1 to 3 days. The side effects that were seen in them at the injection site were tiredness, chills, muscle pain, fever and joint pain.
However, there were exceptions of the pain at the injection site like more adolescents showed these vaccine side effects after the second dose than after the first dose while the other side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older.
While some individuals experienced the side effects of following any vaccination, note FDA, while on the other hand not every individual’s experience will be the same and there are also some who may not even experience any side effects at all.
Shot Not Meant For People With History Of Severe Allergic Reaction
The FDA stressed that the Pfizer-BioNTech Covid-19 Vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis to any component of the vaccine. Pfizer Inc was issued the EUA amendment for the Pfizer-BioNTech Covid-19 Vaccine. However, the issuance of an EUA is not an FDA approval (licensure) of a vaccine.
The news release said the EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of Covid-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance or to protect public health or safety.