(Washington DC) – U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for its two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years of age while it awaiting data on the three-dose regimen, aiming to clear it, a person familiar with the matter told The Associated Press in late February.
The company’s filing is expected to be submitted as early as Tuesday.
Preliminary Pfizer data has shown that the vaccine – given to young children at a dose one-tenth the dose for adults – is safe and induces an immune response. But last year Pfizer announced a two-dose injection that had been shown to be less effective at preventing COVID-19 in children aged 2-5, and regulators encouraged the company to add a third dose to the study. in the belief that another dose would boost the vaccine. effective as a booster dose in adults.
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Now, the Food and Drug Administration is pushing the company to submit a two-dose data-driven application for approval in February and then return for additional authorization when data becomes available. data from the third dose study, scheduled for March. , a person familiar with the matter said. The two-step authorization process could mean young children could be vaccinated up to a month earlier than previously estimated, assuming the FDA and Centers for Disease Control and Prevention give the shots the green light. .
Read more: My baby hasn’t been vaccinated yet and I’m mostly keeping him together
The person spoke on condition of anonymity to discuss sensitive legal issues. This person reported that the reduced efficacy of the two-dose vaccine was not unexpected for the occurrence of The Omicron variant is highly infectious of COVID-19. Allowing young children to get two doses of the vaccine earlier will eventually speed things up when they can get the stronger protection expected from the third dose.
That should be good news for parents with young children, the last remaining age group without approval for a COVID-19 shot.
Young children are much less likely to develop serious complications or die from COVID-19 than adults, but the incidence in this age group has increased in the national context. spike in cases from the Omicron . variant. Most cases and deaths occur in older people, especially those who have not been vaccinated.
Accelerating the licensing of children’s vaccines against COVID-19 has been a priority for more than a year for the Biden administration, which believes it is essential to reopening and maintaining schools and care centers. children open the door – and to free the parents who are shouldering the responsibility of taking care of the children. back to the workforce.
Vaccines for children 5-12 years old was approved by U.S. regulators in November, although reception of the shots was slower than expected by U.S. officials.
Pfizer’s main series is made three weeks apart. A third dose for young children is being studied for use at least two months after the second dose.
News of the previous regulatory review was first reported by The Washington Post.
