The pharmaceutical companies Pfizer and BioNTech announced that their three 3-microgram dose vaccines are 80.3 percent effective in children six months to five years of age against COVID-19.
The trial included 1,678 children who received a third vaccine dose during the period when the Omicron coronavirus variant dominated. The companies found that the vaccine produced a similar immune response one month after being administered compared to two doses in 16-25-year-old.
The companies said "the vaccine was found to elicit a strong immune response "with a “favorable safety profile similar to placebo”. Despite the results, the companies warned that the trial was not big enough to estimate protection against the disease, and the preliminary estimate could be adjusted with more data collected.
“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “These topline 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 quickly as possible, subject to regulatory authorization.”
Pfizer and BioNTech identified 10 symptomatic cases at least seven days after the third dose. The trial protocol specifies a formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose.
“We are preparing the relevant documents and expect to complete the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks,” Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech said in a statement.
Pfizer also said its vaccine was safe, with a similar safety profile as placebo shots. If authorized, this vaccine would be three shots of 3 micrograms each. Each dose is one-tenth the adult dose.
The vaccine for this age group had been delayed when the results of a two-dose series of the Pfizer/BioNTech vaccine didn't provide the expected level of protection.
“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” said Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech. “We are preparing the relevant documents and expect to complete the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”
Moderna submitted its vaccine data for children 6 months through 5 years of age to the FDA in late April.
Moderna's submission consists of two 25-microgram doses given 28 days apart. Moderna is also studying a third shot for young children.
The FDA said Monday that it will convene its Vaccines and Related Biological Products Advisory Committee on June 14 to discuss Moderna's COVID-19 Emergency Use Authorization (EUA) request for people ages six years through 17. The committee said it would discuss Moderna and Pfizer's EUA requests for vaccines for younger children on June 15.
