Taiwan’s Food and Drug Administration (FDA) announced Monday that it has granted emergency use authorization (EUA) to the Pfizer-BioNTech (BNT) COVID-19 vaccine for children aged between 6 months and 4 years old.
An expert panel was convened on July 29 to review the EUA request submitted by the biotechnology company for its COVID-19 vaccine for young children, according to an FDA release.
Considering the ongoing COVID-19 situation in Taiwan, the FDA explained that infants and young children are encouraged to be vaccinated for protection against the disease and to reduce the risk of severe illness and death.
Based on results of the Phase 1/2/3 clinical trials conducted on children 6 months to under 5 years of age, the Pfizer-BNT vaccine showed a robust neutralizing antibody response consistent with that of adolescents and adults, the FDA said.
No cases of myocarditis, pericarditis or death were reported during the clinical trials, it said.
Common adverse reactions
The most common adverse reactions in children aged between 6 months and under 2 years old who received a dose of the vaccine during clinical trial included decreased appetite, injection site pain/redness/swelling, and fever, according to the FDA.
Meanwhile, for children aged 2 to under 5 years old, the common adverse reactions included injection site pain/redness, fatigue, fever and headache.
The Pfizer-BNT COVID-19 vaccine for children aged between 6 months and 4 years old will be administered in three 0.2 milliliter doses, each containing 3 micrograms of mRNA, with a minimum interval of 21 days for the first two doses and after that, a period of at least eight weeks before getting a third shot.
Taiwan began offering the Moderna COVID-19 vaccine to children aged 6-11 on May 2 and started the rollout of the Pfizer-BNT COVID-19 vaccine for children aged 5-11 on May 25.
Deal to procure 1.9 million doses
On Monday, the Central Epidemic Command Center (CECC) announced that Taiwan had signed a deal to purchase 1.9 million doses of the Pfizer-BNT COVID-19 vaccine for children under 5.
CECC head Victor Wang (???) said the Advisory Committee on Immunization Practices under the Ministry of Health and Welfare would convene an expert meeting as soon as possible for discussions on issues related to the vaccine’s administration as well as delivery timeline.
Meanwhile, CECC official Chou Jih-haw (???) said the rollout of the Pfizer-BNT vaccine could only be arranged when a delivery schedule was confirmed with the manufacturer.
Source : Focus Taiwan News Channel