Following Pause of Johnson & Johnson COVID-19 Vaccine, Experts Continue Monitoring for Safety
Although the CDC and FDA have lifted the pause on Johnson & Johnson’s COVID-19 vaccine, Humphreys said the vaccine now comes with a warning label, and ongoing safety reviews will be paramount to ensure its continued safety.
In an interview with Pharmacy Times, Sophia Humphreys, PharmD, MHA, said the 10-day pause of Johnson and Johnson’s COVID-19 vaccine was a busy time filled with data collection and panel review to ensure the vaccine’s safety.
The 10-day pause was instituted by the FDA and CDC following concerns about the rare condition cerebral venous sinus thrombosis (CVST) seen in a few patients following administration of Johnson & Johnson’s COVID-19 vaccine, in addition to thrombocytopenia. Although CVST is typically treated with heparin, Humphreys said the addition of thrombocytopenia makes this treatment more complicated, and thus makes these safety concerns more serious.
Although the occurrence of this adverse event is rare—thus far affecting just 15 vaccine recipients out of almost 8 million—Humphreys said it was important that the CDC and FDA verify the vaccine’s safety. A panel of CDC advisors voted to lift the pause on April 23, although the FDA has added a warning label regarding CVST, especially in women between 18 and 49 years of age.