Sunday, July 4, 2021

Johnson & Johnson’s COVID-19 vaccine, on pause for more than a week, is nearing another green light


With few additional cases of rare and serious blood clots seen over the last several days, health officials in the United States are expected to recommend the resumption of Johnson & Johnson’s COVID-19 vaccine rollout.

Resumption of the shot will likely come with a warning about the unusual side effect which has stricken roughly one in every million of those who have received the vaccine, The New York Times reports.

A working group of experts assembled by the Centers for Disease Control and Prevention will review data today and make their recommendation to the FDA. 

When the group met last Wednesday, it reported six cases and one death among the 7.2 million recipients of the vaccine. At the time, the group decided to extend the pause of the shot to gather more data.

RELATED: CDC vaccine experts punt on Johnson & Johnson COVID-19 vaccine guidance, extending the pause

Since then, only a few additional cases have been reported. The FDA declined to divulge how many to the New York Times.

“We’ve now received more cases, but it isn’t an avalanche,” FDA acting director Janet Woodcock said on Thursday. “We’re not seeing a big surge, which is a great relief.”

When the FDA ordered the pause on April 13, Woodcock said she expected it to last a “matter of days” while the FDA and CDC investigated.  

RELATED: Feds call halt to Johnson & Johnson COVID-19 vaccine rollout after ‘extremely rare’ blood clot cases 

This week, the CDC reported two additional cases. On Tuesday, a woman in Oregon who had received the J&J vaccine before the pause died after developing a blood clot. On Wednesday, a female recipient in Texas was hospitalized with a blood clot.

All eight of the cases reported in the U.S. are women.

Meanwhile, across the Atlantic, the European Medicines Agency this week concluded that a link between the vaccine and rare blood clotting cases was possible but that the benefits of the shot outweighed the risks. 

RELATED: Johnson & Johnson sees ‘very viable path forward’ for its COVID-19 vaccine despite safety, manufacturing setbacks

Johnson & Johnson had delayed its rollout of the shot in Europe while the U.S. investigated. But after the EMA ruling, the company resumed shipments to the continent.

Some European countries are limiting its use. France, for example, will restrict it to those older than 55. Italy will allow it only for those over age 60. The company is committed to provide 55 million doses to Europe by the end of June.

RELATED: FDA orders shutdown at Emergent’s troubled plant 2 weeks after handing J&J the keys

Even if vaccinations resume in the U.S., supply remains an uncertainty. Last week, the FDA ordered a temporary halt to the production of drug substance at an Emergent BioSolutions plant in Baltimore. Just two weeks earlier, the FDA had turned COVID-19 vaccine manufacturing at the plant over to J&J.

For its part, J&J has pledged to deliver 100 million doses to the U.S. during the first half of the year.



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