J&J Provides Update on COVID-19 VaccineBy
Johnson & Johnson (J&J) has provided an update regarding a pause of use of its COVID-19 vaccine.
Earlier this week (as reported on April 15, 2021), the US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) paused use of J&J’s COVID-19 vaccine in order to review data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine. The six reported cases were out of more than 6.8 million doses of the vaccine that had been administered in the US as of April 12, 2021.
The CDC Advisory Committee on Immunization Practices (ACIP) convened on April 14, 2021 to consider reports of an extremely rare disorder involving blood clots in combination with low platelets observed in a small number of individuals following vaccination with the vaccine. The FDA will review that analysis as it also investigates these cases. Until that process is complete, the agencies are recommending a pause in the use of the vaccine out of an abundance of caution. In addition, J&J has been reviewing these cases with European health authorities. The company made the decision to proactively delay the rollout of its COVID-19 vaccine in Europe and pause vaccinations in all of its COVID-19 vaccine clinical trials while guidance is updated for investigators and participants.
“We strongly support awareness of the signs and symptoms of this extremely rare event to ensure the correct diagnosis, appropriate treatment and expedited reporting by health care professionals,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J, in an April 14, 2021 statement. “We continue to believe in the positive benefit-risk profile of our vaccine. We value the consideration of the Advisory Committee, and we will continue to collaborate with medical experts and global health authorities, including the CDC, the US Food and Drug Administration, [the] European Medicines Agency, and the World Health Organization, as we work toward continuing vaccinations to end the global pandemic.”
The pause is not considered to have an impact on the US government’s vaccination plans.
“[The J&J] vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” said Jeff Zients, White House COVID-19 Response Coordinator, in an April 13, 2021 statement, “Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week […] This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day and meet the President’s goal of 200 million shots by his 100th day in office.”
Source: Johnson & Johnson, (statement on vaccine), Johnson & Johnson (statement on committee meeting), the US Food and Drug Administration, and the White House