FDA Authorizes Pfizer Covid-19 Booster Dose For Children Between 5-11yrs

The US Food and Drug Administration has granted emergency use authorization for the booster dose of Pfizer/BioNTech’s Covid-19 vaccine for children aged between 5 to 11 years, at least five months after completion of the primary vaccines.

The vaccine maker had requested for this emergency use authorization at the end of April, quoting company data that a third vaccine raised Omicron-fighting antibodies 36 times more in this age group.

FDA Commissioner Dr Rober Califf said on Tuesday, “While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease. The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19.”

In a statement, Pfizer said that 4,500 children between 5 to 11 years of age participated in the Pfizer/BioNTech Covid-19 vaccine trial and no new safety issues were observed.

Studies from the New York State Department of Health and the US Centers for Disease Control and Prevention found that the effectiveness of the Pfizer’s vaccine doses for children in this age group fell during the Omicron surge, from 68% to about 12% against infection. However, the two doses, which were administered continued to protect against severe cases or hospitalizations.

Public health officials in the US have asked citizens to stay up-to-date with their Covid-19 vaccinations, inclusive of all recommended booster doses, as it is still the best protection against Covid.

A recent analysis done by CNN of CDC data showed that for those people who were fully vaccinated and boosted in February, the risk of dying from Covid-19 was 20 times lower than it was for people who were not vaccinated.

The CDC’s Advisory Committee on Immunization Practices will meet on Thursday to discuss the Covid-19 vaccine boosters. Though the agenda for the meeting has not been decided, the Federal Register said that a note has scheduled.

Vaccine company Moderna has also requested FDA authorization for a second Covid-19 booster shot for everyone 18 and older, but a decision has yet to be made regarding that request.

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