The Pfizer vaccine may not be available for children until November
WASHINGTON (AP) — Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of COVID-19…
Washington (AFP) – Pfizer has submitted research to the US Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children, but the vaccines may not be available until November.
On Tuesday, the company said it had provided health regulators with data from a recent study of a vaccine for children ages 5 to 11. Officials previously said they would submit a request to the Food and Drug Administration to allow its use in the coming weeks.
Once the company submits its application, US regulators and public health officials will review the evidence and consult with their advisory committees at public meetings to determine if the shots are safe and effective enough to recommend their use.
The process could mean that the footage may not be available until Thanksgiving approaches, according to a person familiar with the process but not authorized to discuss it publicly. But it’s possible, depending on how quickly the FDA works, that the shots could become available as early as November, the person said.
The drugmaker and its partner, Germany’s BioNTech, say they expect to request authorization for emergency use of the vaccine in children aged 5 to 11 “in the coming weeks.” The companies also plan to submit the data to the European Medicines Agency and other regulators.
Pfizer’s double-shot vaccine is currently available to those 12 years of age or older. An estimated 100 million people in the United States have been fully vaccinated, according to the Centers for Disease Control and Prevention.
Pfizer has tested a lower dose of the injection in children. The drug company said last week that researchers found that the vaccine developed levels of antibodies to fight the coronavirus in children that were just as strong as those in teens and young adults who get regular doses of strength.
Earlier this month, the head of the Food and Drug Administration, Dr. Peter Marks, told the Associated Press that once Pfizer turns over the results of its study, his agency will evaluate the data “hopefully within weeks” to determine if the shots are safe and effective enough for children. the youngest.
Pfizer’s updated schedule was first reported by the Wall Street Journal.
The US company, Moderna, which makes other vaccines, is studying its shots on children of primary school age. Results are expected later in the year.
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