Pfizer and BioNTech announced Wednesday that they have submitted their request for an emergency use authorization for their Covid-19 vaccine in children ages 6 months to 5 years.
The data included over 1,700 children who had received their 3rd dose of the vaccine. These children were all vaccinated during the same time period when the new variant dominated.
Results of the clinical trial have been released. It appears the vaccine is safe and that it produced a strong immune response.
The study was conducted on a sample size of 50 people, which is considered to be small and does not represent a real-world scenario.
The findings are consistent with those from the United States and other countries and suggest that the three-dose schedule is immunogenic and acceptable for older adults, the companies said.
The results from the first mid-trial phase suggest that the vaccine has an efficacy of about 80 percent, according to results from a mid-trial analysis of data collected so far.
The companies identified 10 symptomatic cases at least 7 days after the third dose.
The efficacy will only be considered final when at least 21 symptomatic cases have been observed in the vaccine group and are then compared with the number of symptomatic cases in the placebo group.
This youngest age group has smaller vaccines than other age groups.
The two most common vaccines given to people 12 and older are the MMR vaccine and the flu vaccine. Children 5 to 12 get the MMR and the flu vaccine.
Both of those groups are eligible for booster doses.
The first two doses were given three weeks apart, and the third dose was given at least two months after the second dose.
At the beginning of February, the US Food and Drug Administration asked the vaccine manufacturers to file an Emergency Use Authorization based on the two-dose data but then postponed a meeting of the advisory board so the third-dose data could be considered.
The FDA will convene its Vaccines and Related Biological Products Advisory Committee on June 14 to discuss Moderna’s request for a Covid-19 vaccine for people ages 6 through 17.
On June 15, the committee will discuss the request from Moderna and Pfizer for vaccines for younger children.
Moderna submitted its vaccine data for children 6 months through 5 years to the FDA in late April.