FDA permits emergency use of Pfizer-BioNTech vaccine on adolescents

The US Food and Drug Administration (FDA) has authorized the emergency use of Covid-19 vaccine developed by Pfizer-BioNTech on adolescents aged between 12-15 years of age. The agency claims that the vaccine has met the statutory criteria for its EUA (emergency use authorization), while its known potential benefits on individuals 12 years of age and older outweighs its potential risks.

According to data presented by the FDA, around 2,260 individuals aged between 12 to 15 years enrolled in an randomized, placebo-controlled clinical trial in the US. Out of these, nearly 1,131 participants were subjected to the vaccine while 1,129 were given a saline placebo. Over half of the participants were monitored for safety for at least two months following being subjected to a second dose.

Commonly reported side effects in participants during the clinical trial were pain at the injection site, headache, tiredness, chills, fever, muscle pain, and joint pain, which typically lasted for only 1-3 days. With the exception of pain at the injection site, adolescents reported these side effects followed by a second jab.

The FDA noted that some individuals might experience side effects following COVID-19 vaccination, however, not every individual's experience will be same with some not experiencing side effects at all. The agency also advised that the Pfizer-BioNTech Covid-19 vaccine should not be given to individuals with a known history of severe allergic reaction, including anaphylaxis to any component of the vaccine.

Reports claim that the EUA will be effective until declaration that circumstances exist justifying the authorization of the drug’s emergency use for treatment and prevention of Covid-19. The authorizations can be revoked or revised if it is determined that the EUA no longer abides by the statutory requirements for issuance or for the protection of public health and safety.

Source Credit: https://www.business-standard.com/article/current-affairs/fda-allows-emergency-use-of-pfizer-biontech-vax-in-adolescents-aged-12-15-121051100094_1.html