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進入《TAIPEI TIMES》FDA authorizes vaccine for children
Vials labelled “VACCINE Coronavirus COVID-19” and a syringe lie in front of a Moderna logo on Dec. 11 last year. Photo: Reuters
LOW RISK: A clinical trial found the chance of children aged six to 11 having a bad reaction to the Moderna vaccine was about the same as for adults, the FDA said
By Lee I-chia / Staff reporter
The Food and Drug Administration （FDA） yesterday issued emergency use authorization for the Moderna COVID-19 vaccine for children aged six to 11.
Specialists attended a meeting at the FDA yesterday morning to review the safety and effectiveness of Moderna’s Spikevax vaccine on children aged six to 11, FDA Director Wu Shou-mei （吳秀梅） said.
They agreed that the vaccine is suitable for children in that age category as their primary series of vaccines, she said, adding that each dosage should be 0.25ml, or only half the adult dose, and the two doses should be administered at least 28 days apart.
According to a phase 2/3 clinical trial of Spikevax, the neutralizing antibodies and immunogenicity induced by the vaccine were not inferior to those recorded in young people aged 18 to 25 or in the adult group, the FDA said.
A slightly higher percentage of children had a post-vaccination fever than in the adult group, but their chance of having an adverse reaction to the vaccine were about the same as adults’, it said, adding that most reactions were mild and temporary.
The most common adverse reactions children had in the clinical trial were fatigue; headache; muscle soreness and pain; chills; nausea; vomiting; swelling and tenderness near the armpit; fever; and pain, swelling and redness at the injection site, which is similar to adults, the FDA said.
It said that it would continue to monitor the safety warnings of COVID-19 vaccinations from around the world, analyze immunization reports and implement safety monitoring mechanisms.
Minister of Health and Welfare Chen Shih-chung （陳時中）, who heads the Central Epidemic Command Center, said whether the vaccine would be offered to children would be discussed at the next Advisory Committee on Immunization Practices （ACIP） meeting on Wednesday.
If the committee recommends that children get vaccinated, the center would begin with administrative measures, such as surveying parents about their intentions and having them sign consent forms, he said.
There are about 1.2 million children aged six to 11 in Taiwan, but how many would get vaccinated is difficult to estimate, as the child vaccination rate in the US is only about 30 percent, Chen said.
Asked if the center would consider offering a fourth dose of vaccines to adults, as some US experts have said that immunity from the booster dose is waning, Chen said that it would also be discussed at the ACIP meeting.
About 134,000 doses of vaccines were administered on Saturday, bringing the nation’s first, second and booster dose vaccination rates to 84.12 percent, 79.33 percent and 54.89 percent respectively, he said.
新聞來源：TAIPEI TIMES
