Use of Johnson & Johnson’s COVID-19 vaccine should be resumed in the United States as specified under its emergency use authorization by the U.S. Food and Drug Administration, advisers to the U.S. Centers for Disease Control and Prevention recommended on Friday.
The panel last week called for more data about a possible link to rare blood clots in the brain before deciding how and whether to end a “pause” in administration of J&J vaccines called for by the CDC and the Food and Drug Administration.
The decision by CDC’s advisory panel has global implications since J&J’s immunization is seen as an important tool for poorer countries and less accessible populations, given that it only requires one dose and can be stored at normal refrigerator temperatures, making it relatively easy to transport.
Some panel members argued an extension of the pause could signal to the world that the vaccine had major safety issues. There have been six reported cases of rare brain blood clots accompanied by low platelets in the blood out of nearly 8 million doses administered in the United States. U.S. officials last week said a handful more possible cases were under review.
State health officials on Thursday said the CDC was investigating two more possible cases, probing the death of an Oregon woman in her 50s and the hospitalization a Texas woman with symptoms similar to those found in the clot cases – both of whom had received J&J’s shot. Officials have not linked the cases to the vaccine.
The United States has ordered enough doses of vaccines from Pfizer/BioNTech and Moderna to cover all U.S. adults, but many senior regulators, including U.S. infectious disease chief Anthony Fauci, have signaled they hope to resume use of the J&J vaccine.
CDC Director Dr. Rochelle Walensky said Thursday she was hopeful for a quick decision on J&J’s vaccine, especially as EU regulators backed the shot this week, and added U.S. advisers on Friday would review data as well as the agency’s risk/benefit analysis.
“I will look toward their guidance. I believe its really important to make a swift decision,” she told NBC News’ “Today” program on Thursday, adding that she expected U.S. guidance to be issued soon after Friday’s meeting.
The European Medicines Agency on Tuesday recommended adding a warning about unusual blood clots with low blood platelet counts to the vaccine’s product label, saying that benefits of the shot outweighed the risks. The drugmaker has said it would resume rolling in the region.
U.S. National Institutes of Health Director Dr. Francis Collins told ABC News’ “Good Morning America” program on Friday the Europeans’ decision to move ahead while adding a warning was “encouraging.”
He added possible clots are “one in a million kind of risk” while “this vaccine can save lives” in the fight against a pandemic, which has already claimed more than 3.2 million lives globally, including at least 570,674 in the United States.
J&J has faced several setbacks since its shot gained U.S. emergency authorization in February, first drawing scrutiny over its halting process to scale up production of the vaccine, and then over rare cases of clots in a handful of vaccine recipients. FDA inspectors this week cited serious cleanliness and medical safety issues at an Emergent BioSolutions plant making the J&J vaccine.
European regulators said the blood clots in patients who received the J&J vaccine bear close resemblance to 169 cases in Europe reported with the AstraZeneca Plc vaccine.
U.S. officials said a key reason for their pause was to communicate the risk to doctors on how to recognize the side effects and treat them, saying patients with clot-related symptoms following the J&J vaccine should not be given heparin, a blood thinner widely used to treat clotting disorders.
“This is a treatable condition if you recognize it right away,” Collins told ABC.
