US Authorises Pfizer’s COVID-19 ‘Booster’ Vaccine for 12-15-Year-Old Adolescents
16:03 GMT 03.01.2022 (Updated: 16:10 GMT 03.01.2022)
WASHINGTON (Sputnik) - The US Food and Drug Administration (FDA) announced on Monday that it has issued an emergency use authorisation (EUA) for Pfizer-BioNTech’s booster vaccine against the novel coronavirus for 12- to 15-year-old adolescents.
“On January 3, 2022, having concluded that revising this EUA is appropriate to protect the public health …, FDA is reissuing the December 16, 2021 letter of authorization in its entirety with revisions incorporated to amend the EUA for COMIRNATY (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to: (i) authorize the use of the vaccine as a single booster dose in individuals 12 through 15 years of age,” FDA said in a letter to Pfizer.
The FDA also said it has shortened the period of time, after which both, adolescents and adults, can get a Pfizer booster shot - from six to five months after they received the second vaccine dose.
In addition, the FDA said it has authorised booster vaccine shots for immunocompromised children in the 5-11 age group, according to the letter.
The Centers for Disease Control and Prevention (CDC) is expected to hold its Advisory Committee meeting later this week to vote on the changes endorsed now by the FDA.
Over the past seven-day period, US health authorities reported 2.14 million new COVID-19 infections with an average per day count reaching nearly 320,000 amid the growing prevalence of the Omicron variant. Health experts have said the coronavirus Omicron variant cases are mild and the instances of hospitalisation are significantly less than the Delta variant.