On Monday, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Pfizer COVID vaccine to be administered in children ages between 12 and 15.
This FDA’s decision will help the schools to fully reopen in the fall – one of the goals of both the Trump and Biden administrations.
Dr. Janet Woodcock, the acting FDA Commissioner, called the approval “a significant step in “returning to a sense of normalcy.”
She said, “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
However, the Pfizer COVID vaccine in adolescents is not yet a done deal.
The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will take a call on Wednesday whether to recommend the use of the vaccine in this age group.
After that decision, CDC Director Dr. Rochelle Walensky will decide whether to go ahead with the vaccine in that age group.
In December, the FDA granted EUA that allowed the Pfizer coronavirus vaccine to be given to people aged 16 and above.
Meanwhile, the company is conducting clinical trials of its vaccine in younger children and expecting to apply for EUA in September.
Last week, President Joe Biden announced a new strategy for expanding vaccinations, including vaccinating 12-to-15-year-olds was a key component, according to Medscape Medical News.
He said the administration was ready to ship the vaccine directly to pharmacies and pediatricians to speed up the vaccination rate in adolescents.
In March, Dr. Anthony Fauci, the nation’s top infectious disease expert told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. We ultimately would like to get and have to get children into that mix.”
In late March, Pfizer submitted data to the FDA showing that its COVID vaccine was 100% effective at preventing COVID-19 infection in children aged between 12 and 15 in clinical trials.
Dr. Albert Bourla, Pfizer CEO, tweeted that “today brings very encouraging news for families and adolescents across the United States.”
“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world,” he added. “In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts.” The article was published on Medscape.
