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Adolescents in the 12 to 15 age-group in the United States now become eligible to take the Pfizer-BioNTech Covid-19 vaccine, after it received the regulatory go-ahead.
The US Food and Drug Administration (FDA) said it had expanded the emergency use authorisation (EUA) on the Pfizer-BioNTech Covid-19 to include adolescents 12 through 15 years of age. This involved amending the EUA originally issued early December for administration in individuals 16 years of age and older. The mRNA vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older, the regulator said.
The other mRNA vaccine, from American biotech company Moderna is also undertaking vaccine trials on a similar age group. In fact, both companies are also looking at the sub-12 age group, upto 6 months.
Janet Woodcock, acting FDA Commissioner said, the emergency approval to protect a younger population against Covid-19 brought them “closer to returning to a sense of normalcy and to ending the pandemic.” From March 1, 2020 through April 30, 2021, approximately 1.5 million Covid-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder Covid-19 disease course as compared to adults, the regulator said.
The FDA has determined that the Pfizer-BioNTech Covid-19 vaccine met the criteria to amend the EUA, and the known and potential benefits of this vaccine in the target age-group outweighed the known and potential risks, supporting the vaccine’s use in this population, it said. “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Safety Data
The FDA said that their safety data on the said age-group included 2,260 participants aged 12 through 15 years enrolled in an ongoing randomised, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose, it said.
The most commonly reported side effects in the adolescent clinical trial participants, which lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, the FDA said, alerting vaccinators and recipients to the same. The Pfizer-BioNTech Covid-19 vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis—to any component of the vaccine, it added.
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