The U.S. Meals and Drug Administration is getting ready to approve the Pfizer / BioNTech Covid vaccine for teenagers 12-15 years outdated by early subsequent week, the New York Occasions reported Monday, citing federal officers aware of the plans Company are acquainted.
Approval is eagerly awaited after drug producers introduced in March that the vaccine had been discovered secure, efficient in a scientific trial in 12-15 yr olds and produced strong antibody responses.
In response to a Reuters request for remark, the FDA responded that its assessment of the extension of the approval for emergency use of the vaccine would proceed with out offering additional particulars.
The vaccine has already been permitted in the US for folks aged 16 and over.
Pfizer declined to touch upon the New York Occasions report.
The director of the US Facilities for Illness Management (CDC) Rochelle Walensky mentioned in early April that the vaccine might be permitted by mid-Might.
If approval is granted for these 12-15 yr olds, the CDC’s Vaccination Advisory Board will possible meet the next day to assessment scientific trial knowledge and make suggestions to be used of the vaccine in adolescents, the report mentioned.
Getting the vaccine permitted would enhance the nation’s vaccination marketing campaign and assist allay dad and mom’ fears about defending their youngsters from Covid-19.
Moderna and Johnson & Johnson are additionally testing their vaccines in 12 to 18 yr olds. Information from Moderna’s examine is predicted to be accessible quickly.
Pfizer and Moderna have additionally began research with even youthful youngsters, ages six months to eleven. Each firms have introduced that they may be capable to vaccinate youngsters below the age of 11 as early as the start of 2022.