Pfizer and BioNTech are seeking US approval for the Covid-19 vaccine for kids
Key Takeaways:
- On Tuesday, Pfizer and BioNTech announced that they seek emergency approval from US health regulators to use their Covid vaccine in children aged six months to five years.
- The FDA announced in a tweet shortly after the announcement that it will hold a meeting to consider the request in two weeks, on February 15.
- According to the Centers for Disease Control and Prevention, only 30% of those in that age group have received at least one dose, and only about 22% are fully vaccinated (CDC).
Pfizer and BioNTech declared on Tuesday that they are seeking emergency approval from US health regulators for using their Covid vaccine in kids aged six months to 5 years.
If the Food and Drug Administration (FDA) authorizes the two-shot regimen, it will be the first Covid vaccine available in the United States for this age group.
On Tuesday, the companies said that they began submitting their formal application "in response to a request" from the FDA, which appears to want to move the process along quickly.
The FDA announced in a tweet shortly after the announcement that it will hold a meeting in two weeks, on February 15, to consider the request.
"Having an effective and safe vaccine accessible for children in this age group is a primary concern for the agency," interim FDA head Janet Woodcock said, adding that the application was requested "in light of the recent Omicron surge."
The companies are requesting approval for only two doses of their vaccine. Still, they believe a third will be required "to achieve high levels of protection against present and prospective future variants," according to Pfizer CEO Albert Bourla.
"If two doses are authorized, parents will be able to begin a Covid-19 immunization series for their children while waiting for a third dose," he added.
Pfizer chose to significantly reduce the dosage of its vaccine for this young age group, opting for only 3 micrograms per jab vs. 30 for all those over 12 years old and 10 for ages five to 11.
Last fall, the company's researchers concluded that low dosage of the vaccine offered protection in kids up to 2 years old but not in those older two to five, and they announced in December that they would add a third dose to their trials.
Pfizer and BioNTech stated in a statement that data on the three-dose regimen is "predicted in the coming months and would be submitted to the FDA to support a potential expansion" of this initial request.
Suppose the FDA approves the vaccine for emergency use. In that case, the Centers for Disease Control and Prevention (CDC) will convene an advisory committee to decide whether or not to recommend its use.
- Minors have a slower adoption rate -
In the United States, there are approximately 23 million children under the age of five, and 2 years after the pandemic started, many parents are eager to vaccinate their young kids against the coronavirus.
The Pfizer-BioNTech vaccine was authorized for emergency use in children aged five to eleven months ago, but uptake has been slow.
As per the CDC and Prevention, only 30% of those in that age category have received at least one dose, and only about 22% are fully vaccinated (CDC).
Although young children are less likely to become seriously ill due to Covid-19, the virus still causes some to be hospitalized.
As the Omicron strain spread rapidly, the number of new pediatric Covid hospitalizations in the United States reached an all-time high in December.
In young children with Covid, some cases of the life-threatening illness MIS-C (a multi-system inflammatory syndrome in children) have been reported.
As per the Centers for Disease Control and Prevention, about 400 children aged four and under have died in the US due to Covid-19 since the outbreak began.