Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children under 5, the company announced Monday. Pfizer plans to present the data to US regulators later this week, in a further step toward allowing younger children to receive the vaccines.
The news comes after months of anxious waiting by parents desperate to vaccinate their infants, toddlers and preschoolers, especially as COVID-19 cases rise again. The 18 million children under the age of 5 are the only group in the United States still unable to be vaccinated against COVID-19.
The Food and Drug Administration (FDA for its acronym in English) has begun to review the data of the Moderna pharmaceutical company, which hopes to start offering two doses for children in the summer.
Pfizer has had a harder time finding its focus. His goal is to give children an even lower dose – just a tenth of the amount adults receive – but during his trial he found that two injections didn’t seem like enough for preschoolers. So the researchers gave a third injection to more than 1,600 children — ages 6 months to 4 years — during the winter surge of the omicron variant.
In a press release, Pfizer and its partner BioNTech said the additional injection worked, raising the children’s antibody levels enough to meet the FDA’s criteria for emergency use of the vaccine without safety concerns.
Preliminary data suggests the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned that the estimate is based on only 10 cases diagnosed among study participants at the end of the study. of April. Study guidelines state that at least 21 cases are needed to formally determine efficacy, and Pfizer promised an update as soon as more data becomes available.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.