Pfizer asks FDA for emergency approval of COVID-19 vaccine for kids under 5
two-dose shot was less effective at preventing COVID-19 in kids ages 2-5. Researchers analyzed a subset of youngsters in the study a month after their second dose to see if the little kids developed levels of virus-fighting antibodies that were similar to teens and young adults who get the regular shots.
The very low-dose shots appeared to work in youngsters under age 2, who produced similar antibody levels. But the immune response in 2 to 4-year-olds was lower than the study required.Rather than trying a higher-dose shot for the preschoolers, regulators encouraged Pfizer-BioNTech to add a third dose to the study on the belief that another dose would boost the vaccine's effectiveness much like booster doses do in adults.But in the meantime, the U.S.
Food and Drug Administration (FDA) pushed the company to submit its application based on the two-dose data for potential approval in February, and then to return for additional authorization once it has the data from the third dose study.
Data from the third dose study isn’t expected until March, the Associated Press reported, citing a person familiar with the matter.The person said the decreased effectiveness of the two-dose vaccine was not unexpected given the emergence of the highly transmissible omicron variant of COVID-19.
United States
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India
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