Days after the FDA approved J&J’s COVID vaccine for emergency use, the company announced plans to test the vaccine on newborns, despite the vaccine’s risks and strong evidence that COVID poses virtually no risk to healthy children.
On Friday, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization for Johnson & Johnson’s (J&J) COVID vaccine, paving the way for the one-shot vaccine to be administered beginning this week.
The Centers for Disease Control and Prevention (CDC) also recommended the vaccine for people 18 and older. On Sunday, J&J revealed plans to test its one-shot vaccine on infants, including newborns, pregnant women and the immunocompromised. The expanded clinical trials were laid out in the company’s application for emergency use approval and in briefing materials provided to the FDA and discussed briefly during the meeting.
According to the New York Times, the plan for expanded clinical trials met the approval of Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the FDA’s advisory committee that reviewed the company’s vaccine data.
When Levy saw the outlines of the planned trials, he said: “They did not get into a lot of detail about it but did make it clear they will be pursuing pediatric and maternal coronavirus immunization studies.”