Three doses of Pfizer’s pediatric Covid-19 vaccine are safe and show a strong immune response in children aged six months to 5 years, according to vaccine makers Pfizer and BioNTech. The laboratories said, on Monday (23), that they will finish sending the test data to the Food and Drug Administration (FDA), a US agency similar to Anvisa, this week.
The phase 2/3 study included 1,678 children who received the third dose during the period when the Omicron variant predominated.
According to the tests, antibody levels identified one month after the third dose showed that the vaccine produced an immune response similar to two doses in young people aged 16 to 25, the companies said in a press release. The data has not yet been peer-reviewed or published.
Preliminary results of the study showed 80.3% vaccine efficacy against symptomatic Covid-19 in this younger age group. The companies identified 10 symptomatic cases at least seven days after the third dose. However, the effectiveness rate will not be determined until at least 21 symptomatic cases are found in the vaccine group and then compared to the number of symptomatic cases in the placebo group, which did not receive the immunizer.
The companies said that three doses of the infant formulation for this younger age group were “well tolerated” and no new safety signals were identified.
“These first-line safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally, with the hope of making this vaccine available to younger children as soon as possible, subject to regulatory authorization,” said the report. Pfizer chairman and CEO Albert Bourla in a statement.
The dosage of vaccines for this younger age group is lower than that used in more advanced age groups. People aged 12 years and older receive two doses of a 30 microgram vaccine and children aged 5 to 12 years receive two doses of a 10 microgram vaccine. Both age groups are suitable for booster doses.
For children aged 6 months to 5 years, the Pfizer vaccine is three doses of 3 micrograms. The two initial doses were given three weeks apart and the third dose was given at least two months after the second dose.
Children under 5 are the only age group not yet eligible for Covid-19 vaccination. Vaccine for this age group was delayed when results from a two-dose series of Pfizer vaccine did not provide the expected level of protection. The companies said they would change the test to add a third dose.
In February, the FDA asked companies to submit an emergency use authorization application based on the two-dose data, but postponed a meeting of the agency’s vaccine advisory board so that the third-dose data could be considered.
The FDA’s Vaccines and Related Biologicals Advisory Committee has meetings scheduled for June 8, 21, and 22 to discuss emergency use authorization updates that may make younger children eligible for vaccination with either Moderna or Pfizer vaccines.
Moderna submitted its vaccine data for children ages 6 months to 5 years old to the FDA in late April. Moderna’s submission is based on two 25 microgram doses given 28 days apart.
Source: CNN Brasil
