If this side effect occurs in one in a million people, you’re going to not see that in the preapproval process. “When this trial was done, the Johnson & Johnson trial in the United States, it involved about 18,000 U.S., 44,000 people worldwide. “In many ways this should be reassuring to people, in some ways,” Offit said in an interview on CNN. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, said recommending the pause is a sign the vaccine monitor systems are working and that the agencies discovered and took action on a “very, very rare side effect postapproval.” (Photo By Tom Williams/CQ-Roll Call, Inc via Getty Images)ĭr. Rishell of Cleveland Park receives the Johnson & Johnson COVID-19 vaccine from Heidi Johnson in Washington, D.C. “However, we expect it to be a matter of days,” Woodcock said. She said how long the recommended pause lasts depends on what the agencies learn in the next few days. In the press conference, Acting FDA Commissioner Janet Woodcock said the CDC’s Advisory Committee on Immunization Practices will meet on April 14 to further review these cases and assess their potential significance. “his was taken rapidly in order to honor our commitment to the American public, to ensure that any safety signal that came up during this vaccine rollout was fully addressed in a transparent manner.” “So one needs to make sure that providers are aware that if they see people who have low blood platelets, or if they see people who have blood clots, they need to inquire about a history of recent vaccination and then act accordingly in the diagnosis and management of those individuals,” Marks said. The six women suffered from a combination of a type of blood clot called cerebral venous sinus thrombosis, or CVST, and low levels of blood platelets, a condition known as thrombocytopenia.Įven though the cases are so few and very rare, Marks said the agencies acted quickly because the usual treatment for blood clots - an anticoagulant drug called heparin - “can actually cause tremendous harm or the outcome can be fatal.” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a separate April 13 press conference at the White House. “There have been no red flag signals” from the Pfizer/BioNTech and Moderna vaccines, said Dr. The recommended pause only involves the Johnson & Johnson vaccine, which uses a different type of vaccine technology than the other two vaccines that have been authorized in the United States and administered in much greater numbers. One died and one remains in critical condition, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a n April 13 press conference. In six cases there have been reports of “a rare and severe type of blood clot” in those who received the J&J vaccine, prompting the Food and Drug Administration and Centers for Disease Control and Prevention to recommend “a pause in the use” of the J&J vaccine “out of an abundance of caution.”Īll six cases involved women ages 18 to 48 and their symptoms - which included severe headache, abdominal pain, leg pain or shortness of breath - occurred six to 13 days after they received the J&J vaccine, the agencies said in a joint statement. So far, nearly 200 million doses of COVID-19 vaccines have been administered in the U.S., including 7.2 million doses of the Johnson & Johnson vaccine. As of April 7, 2022, the CDC and FDA had confirmed 60 cases, including nine deaths, among more than 18.6 million J&J vaccines administered. The FDA’s decision was based on an evaluation of the rare risk of TTS and the availability of other vaccines that haven’t shown a risk for the condition. Update, May 6, 2022: On May 5, the FDA limited authorized use of the J&J vaccine to adults who either couldn’t get one of the other authorized or approved COVID-19 vaccines because of medical or access reasons, or only wanted a J&J vaccine for protection against the disease. For more information, please see our guide to the J&J vaccine. The CDC endorsed the recommendation the same day. 16, a committee advising the Centers for Disease Control and Prevention voted to recommend the Pfizer/BioNTech and Moderna vaccines over the J&J vaccine because of the risk of a rare but serious blood clotting disorder coupled with low platelets.
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