Health experts are expecting the Food and Drug Administration (FDA) to soon authorize both the Pfizer and Moderna vaccine.
After the FDA authorizes the vaccines, then the Centers for Disease Control and Prevention (CDC) will weigh in their recommendations.
The FDA said the data Pfizer submitted suggested that three doses of the Pfizer vaccine are more effective than just getting two doses.
“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.”
The agency said that out of the 1,415 children who received three doses of the vaccine during the clinical trial, only a few got sick, but nothing serious.
“Given the uncertainty of the COVID-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19-associated morbidity and mortality in this age group,” the FDA said.
The agency also said that based on topline data, three doses of the Pfizer-BioNTech COVID-19 Vaccine met all immunobridging criteria required for Emergency Use Authorization. The third 3-µg dose was well tolerated among 1,678 children under 5 years of age with a safety profile similar to the placebo. The vaccine efficacy of 80.3 percent was observed in the descriptive analysis of three doses during a time when Omicron was the predominant variant.
“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.”
Michelle Corson, Program Manager/Public Relations officer at the Kern County Public Health Services Department, said vaccination is a child’s best protection against serious illness or long-term effects caused by COVID-19.
“Before authorization or approval for use, scientists conducted clinical trials and presented their findings to the U.S Food and Drug Administration. FDA has determined that both the Pfizer-BioNTech and Moderna COVID-19 vaccines are safe and effective and have authorized them for use in children 6 months of age and up,” said Corson.
Corson said ongoing safety monitoring shows that COVID-19 vaccination continues to be safe for children and that the benefits of COVID-19 vaccination outweigh the known and potential risks.
“We encourage parents to talk to their child’s pediatrician, and to learn more about vaccine safety in children by visiting the CDC website,” said Corson.
She also said Public Health continues to make COVID-19 vaccines available to the community through various partnerships and mobile vaccination events throughout the County. Many pediatric healthcare providers offer COVID-19 vaccines.
“Our canvassing team continues to visit neighborhoods to inform families of upcoming vaccination events and to answer any questions,” said Corson. “Our COVID-19 Vaccination Map identifies locations where the COVID-19 vaccine is available throughout the community. It is important for community organizations to share resources, like those provided by the state here as they are trusted messengers.”