Finally there is news about COVID-19 vaccines for children under 5 years old

(Washington DC) — U.S. regulators urge drug maker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children aged 6 months to 5 years pending data on a cure with three doses, aiming to clear the way for shooting as soon as the end of February, a person familiar with the case told The Associated Press.

The company’s application is expected to be filed Tuesday.

Early Pfizer data showed that the vaccine — given to younger children at one-tenth the strength of the injection for adults — is safe and triggers an immune response. But last year, Pfizer announced that the two-dose injection was found to be less effective at preventing COVID-19 in children ages 2-5, and regulators encouraged the company to add a third dose to the study. in the belief that a different dose would enhance the effectiveness of the vaccine. effectiveness just like booster doses in adults.
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Now the Food and Drug Administration is urging the company to file its application based on the data from two doses for potential approval in February and then return for additional authorization once it has the data from the third dose study, expected in March, said the person familiar with the matter. The two-step authorization process could mean that young children could be vaccinated more than a month earlier than earlier estimates, assuming the FDA and the Centers for Disease Control and Prevention give the green light.

Read more: ​My kids can’t be vaccinated yet and I barely keep it together

The person spoke on condition of anonymity to discuss sensitive regulatory issues. The person said the reduced effectiveness of the two-dose vaccine was not unexpected given the emergence of the highly transmissible Omicron variant of COVID-19. If young children were vaccinated earlier with a two-dose injection, this would eventually speed up when they could get the expected stronger protection from a third dose.

That would be welcome news for parents of young children, the last remaining age group without approval for COVID-19 injections.

Young children are much less likely than adults to develop serious complications or die from COVID-19, but the number of cases among the age group has risen amid the nationwide peak in cases of the Omicron variant. Most cases and deaths occur in the elderly, especially in unvaccinated people.

Speeding up the approval of pediatric vaccines against COVID-19 has been a priority for more than a year by the Biden administration, which believes they are critical to reopening and keeping schools and daycare centers open – and to freeing up of parents in charge of childcare duties to return to the labor market.

Vaccines for children ages 5-12 were approved by US regulators in November, although shot absorption is slower than US officials had hoped.

Pfizer’s primary series is administered three weeks apart. The third dose for young children is tested for administration at least two months after the second dose.

News of the earlier regulatory review was first reported by The Washington Post.

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