Pfizer vaccine for children may not be available until November
Pfizer has submitted research to the United States Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children, but injections may not be available until November.
The company said Tuesday it provided health regulators with data from a recent study of its vaccine in children aged 5 to 11. Officials had previously said they would file an application with the FDA to authorize the use in the coming weeks.
Once the company files its application, U.S. regulators and public health officials will review the evidence and consult with their advisory committees in public meetings to determine whether the injections are safe and effective enough to recommend their use.
This process can mean that plans may not be available until Thanksgiving, according to someone familiar with the process but not authorized to discuss it publicly. But it’s possible that, depending on how quickly the FDA acts, the shots will be available earlier in November, the person said.
The drugmaker and its partner, Germany’s BioNTech, say they expect to seek authorization for emergency use of their vaccine in children aged 5 to 11 “in the coming weeks.” The companies also plan to submit data to the European Medicines Agency and other regulators.
The two-shot Pfizer vaccine is currently available for ages 12 and older. An estimated 100 million people in the United States have been fully vaccinated with it, according to the Centers for Disease Control and Prevention.
Pfizer has tested lower dose injections in children. The drugmaker said last week that researchers found the vaccine developed levels of coronavirus antibodies in children that were just as strong as those found in adolescents and young adults receiving regular doses.
Earlier this month, FDA chief Dr Peter Marks told the AP that once Pfizer submits the results of its study, his agency will assess the data “hopefully within a few weeks. ? To decide if the injections are safe and effective enough for younger children.
Pfizer’s updated calendar was first published by the Wall Street Journal.
Another US vaccine maker, Moderna, is also studying its vaccines in school-aged children. The results are expected later this year.