U.S. regulators are urging drugmaker Pfizer to apply for an emergency authorization for a two-dose regimen of the COVID-19 vaccine for children 6 months to 5 years of age pending data on the course. three doses, aimed at clearing the way for injections like Soon after in late February, a person familiar with the matter told The Associated Press on Monday.
The company’s application is expected to be submitted on Tuesday at the earliest.
Preliminary Pfizer data has shown 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.
Now, the Food and Drug Administration is pushing the company to submit a two-dose data-driven application for potential approval in February, and then return to apply for additional authorization once it is available. data from the third dose study, scheduled for March, said a person familiar with the matter. 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. .
The person spoke on condition of anonymity to discuss sensitive legal issues. The person said that the reduced effectiveness of the two-dose vaccine was not unexpected given the emergence of a highly infectious omicron variant 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 the age group has increased amid the number of cases from the omicron variant. nationwide increased dramatically. Most cases and deaths occur in older people, especially those who have not been vaccinated.
Accelerating the release of vaccines for children against COVID-19 has been a priority for more than a year for the Biden administration, which has argued it is essential to reopening and keeping schools and centers Daycare is open – and to free up parents who are responsible for childcare back to the workforce.
Vaccines for children ages 5-12 were approved by U.S. regulators in November, although vaccination has been 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.
https://www.nbcchicago.com/news/national-international/us-urges-pfizer-to-apply-for-under-5-covid-shots-ap-source/2744772/ US urges Pfizer to register COVID scans for children under 5: AP source