Health
AP Source: US Requests Pfizer to Apply for COVID Shots Under 5
US regulatory agencies are asking pharmaceutical company Pfizer to apply for an emergency permit for a double-dose regimen of the COVID-19 vaccine for children aged 6 months to 5 years.
Washington-US regulators are asking pharmaceutical company Pfizer to apply for an emergency permit for a double-dose regimen of the COVID-19 vaccine for children aged 6 months to 5 years. Shot told the Associated Press on Monday in late February, a person familiar with the matter.
The company’s application was scheduled to be submitted on Tuesday.
Early Pfizer data show that the vaccine, which is given to young children at one-tenth the strength of an adult injection, is safe and produces an immune response. But last year, Pfizer announced that double-dose shots proved less effective in preventing COVID-19 in children aged 2 to 5 years, and regulators said another dose was a vaccine booster. The effect is very similar to what the dose does for adults.
Currently, the Food and Drug Administration may submit an application based on the double dose data as it may be approved in February, and will return to additional approval once the data for the third dose study are available. I am urging the company. In March, someone familiar with the matter said. The two-step approval process could mean that infants could be vaccinated more than a month earlier than previously estimated, assuming the FDA and the Centers for Disease Control and Prevention approve shots.
The person spoke anonymously and discussed sensitive regulatory issues. He said the decline in efficacy of the double-dose vaccine was not unexpected given the emergence of highly contagious epidemic variants of COVID-19. Allowing young children to be vaccinated with two doses early will ultimately accelerate when the stronger protection expected from the third dose can be obtained.
This is welcome news for toddler parents, the last age group to remain without COVID-19 shot approval.
Infants are much less likely to develop more serious complications or die from COVID-19 than adults, but with the nationwide surge in cases of the Omicron variant, the incidence of disease in the age group is high. It is rising. Most cases and deaths occur among the elderly, especially those who have not been vaccinated.
Speed up pediatric approval vaccination Opposition to COVID-19 has been a priority for the Biden administration for over a year and is important for reopening and maintaining open schools and day care centers and for freeing parents responsible for childcare to return to the workforce. I think it is.
The vaccine for children aged 5-12 years was approved by US regulators in November, but shot capture was slower than US authorities expected.
Pfizer’s primary series is given at 3-week intervals. The third dose for infants is being considered at least 2 months after the second dose.
News of previous regulatory reviews was first reported by The Washington Post.
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