J&J COVID-19 vaccine 'pause' reviewed, U.S. officials hope to resume shots

[April 23, 2021]  By Manas Mishra

(Reuters) - Advisers to the U.S. Centers for Disease Control and Prevention will meet again on Friday to consider whether to it is safe to resume injections of Johnson & Johnson's COVID-19 vaccine, as senior U.S. health officials prepare for a green light.

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 had argued that an extension of the pause could send a message 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.

The United States has ordered enough doses of vaccines from Pfizer Inc/BioNTech and Moderna Inc 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 she was hopeful for a quick decision on J&J's vaccine, especially as EU regulators acted this week, adding that U.S. advisers meeting 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.

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/File Photo

The European Medicines Agency on Tuesday recommended adding a warning about unusual blood clots with low blood platelet count 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.

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. Earlier this week, FDA inspectors blasted the cleanliness and medical safety of an Emergent BioSolutions plant making the J&J vaccine in a report released on Wednesday.

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.

FDA and CDC officials said a key reason for the pause was to communicate the risk to doctors on how to recognize the side effects and treat them.

Patients who exhibit clot-related symptoms after receiving the J&J vaccine should not be given heparin, a blood thinner widely used to treat clotting disorders.

(Reporting by Manas Mishra in Bengaluru; additional reporting by Susan Heavey in Washington; editing by Peter Henderson, William Maclean)

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