by Melissa Koenig at Daily Mail
- Pfizer-BioNTech has asked the Food and Drug Administration to authorize the use of its COVID vaccine for kids between six months and four years old
- The company submitted data showing that its vaccine is safe and generated a strong immune response in young children
- It is recommending two doses, given three weeks apart for children ages six months to four years that would be 3 micrograms each
- The FDA will now consider that request, and review the applicable data
- Its advisory group is already set to meet on June 15 to offer guidance on pediatric doses and if they recommend it, it could be cleared within days
- The Centers for Disease Control and Prevention, though, would still have to sign off on it
Pfizer-BioNTech announced on Wednesday it has asked the Food and Drug Administration to authorize the use of its COVID-19 vaccine for young children between the ages of just six months and four years.
That age group is the only one not yet eligible for the COVID vaccines, and Pfizer is recommending two doses, given three weeks apart for children in that age group. Those shots would be just three micrograms each – one-tenth the dose given to adults.
Pfizer’s move comes as COVID cases are once again on the rise and follows a similar one from its rival, Moderna, submitted in late April for COVID vaccines for children under the age of six – though COVID cases remain mild in young children.
The FDA will now consider both requests, NBC News reports, and will review the applicable data. It could grant the emergency authorization later this month.
Its advisory group, the Vaccines and Related Biological Products Advisory Committee, is already scheduled to meet on June 15 to offer guidance on pediatric doses – and if the group recommends the use of the vaccine on the young children, the FDA could clear the way for doses within a few days.
But the Centers for Disease Control and Prevention would still need to sign off on the doses before they could be administered.
In a statement to ABC News, FDA officials confirmed they have received Pfizer’s request for an Emergency Use Authorization for children under four.
‘We recognize parents are anxious to have their young children vaccinated against COVID-19, and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible, using a science-based approach,’ they said…
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