TAIPEI (Taiwan News) — Taiwan’s Food and Drug Administration (FDA) on Monday (Aug. 1) announced that the Pfizer-BioNTech vaccine for COVID-19 has been granted emergency use for children ages 6 months to 4.
An advisory committee convened on July 29 gave a green light to the vaccine, which will be given to eligible children in three doses, 0.2 ml each. A 21-day period is required between the first two shots, while individuals must wait for another eight weeks for a third jab, said FDA.
The neutralizing antibodies generated by the Pfizer vaccine in the age group were found no less potent than the levels seen in clinical trials for teens and adults, according to FDA. No additional safety concerns were raised compared to other age groups.
Irritability, loss of appetite, pain or swelling where the shot was given, and fever are the most common side effects for infants aged 6 months to 2 years old. For those 2 to 4, pain or redness where the shot was given, fatigue, fever, and headache are mostly reported, the agency said.
No cases of myocarditis or pericarditis, sometimes associated with mRNA vaccination, or deaths have been reported in the trials, it added.
Moderna vaccine doses for children ages 6 months to 5 years old have been rolled out in Taiwan since July 21.