The US Federal Drug Administration, on September 22, amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Comirnaty vaccine so that a single booster dose may be given to the elderly and at-risk individuals, six months after the completion of the usual two doses.
The FDA’s authorization applies only to the Comirnaty, which is also the only FDA-approved COVID-19 vaccine to date for those aged 16 and older.
So who is recommended to take the booster dose?
- Individuals older than 65 years of age
- Individuals older than 18 who are at a higher risk of severe COVID-19
- Individuals older than 18 whose line of work exposes them more to the virus risking serious complications
Those with compromised immunity, 12 years and older, were already advised a three-shot regimen since August 12.
Also, those who wanted to get a booster shot have been receiving them at the pharmacies regardless of the federal guidance. Altogether, over 20 lakh (2 million) people are reported to have taken the third shot already.
How did the FDA come to this decision?
The ‘Vaccines and Related Biological Products Advisory Committee -VRBPAC’ met recently to discuss the pros and cons.
Safety trials in over 300 participants aged 18 – 55, and 12 participants aged 65 and older, were monitored for over two months, and the findings were studied.
As to the side effects, the swollen lymph nodes in the underarm were more frequent after the third dose.
But the antibody response against the coronavirus one month after taking a booster shot was better than that after the usual two doses.
Based on the findings, the FDA said that a booster dose of Pfizer-BioNTech COVID-19 Vaccine may effectively prevent COVID-19 and the potential benefits outweigh the known and potential risks in the sections of people it has now recommended the dose to.