Pfizer and BioNTech said on Tuesday they were seeking emergency authorization from U.S. health regulators to use their Covid vaccines for children older than 6 months and younger than 5.
If the U.S. Food and Drug Administration (FDA) approves the two-injection regimen, it will be the first Covid vaccine available for this age group in the United States.
The companies said Tuesday that they began filing formal applications “at the request of the FDA,” a process that the agency appears to want to speed up.
In a tweet shortly after the announcement, the FDA said it would meet in two weeks, on February 15, to consider the request.
“Providing a safe and effective vaccine for children in this age group is the agency’s top priority,” said FDA interim chief Janet Woodcock, who added that “in light of the recent surge in Omicron,” the FDA requested an application for the vaccine.
Pfizer Chief Executive Albert Bourla said in a statement that the companies are seeking to authorize just two doses of the vaccine, but believe a third dose is needed “to achieve full control of current and potential future variants.” High level of protection”.
“If two doses are authorized, parents will have the opportunity to start a Covid-19 vaccine series for their children while awaiting the potential authorization of a third dose,” he added.
To limit side effects in this younger group, Pfizer has opted to significantly reduce the dose of its vaccine, opting for just 3 micrograms per injection, compared with 30 micrograms for those over 12 and 10 micrograms for those 5 to 11 years old.
The company’s researchers concluded last fall that a low dose of the vaccine protected children under two but not those two to five, and announced in December that they would add a third dose to the trial. vaccine.
Data from the three-dose regimen “is expected to be submitted to the FDA in the coming months to support a potential expansion,” Pfizer and BioNTech said in the statement.
If the FDA authorizes emergency use of the vaccine, an advisory committee from the Centers for Disease Control and Prevention (CDC) will meet to decide whether to recommend the vaccine.
There are about 23 million children under the age of five in the United States, and two years after the pandemic began, many parents can’t wait to get their young children vaccinated against the coronavirus.
The Pfizer-BioNTech vaccine was approved three months ago for emergency use in children aged 5 to 11, but absorption has been relatively slow.
According to the Centers for Disease Control and Prevention (CDC), only 30 percent of people in this age group have received at least one dose of the vaccine, and about 22 percent are fully vaccinated.
Young children are less likely to get seriously ill from Covid-19, but some still end up in hospital with the virus.
Complete News Source : Hindustan Times
