US Halts Use Of J&J COVID Vaccine After 6 Cases Of Deadly Rare Blood Clots Identified
In a shocking report that could have dramatic implications for the US vaccine rollout, federal public health authorities in the US have decided to stop administering COVID jabs developed by Johnson & Johnson, and are asking states to do the same. The reason? Authorities have identified six cases of rare and life-threatening blood clots, at least one of which resulted in death.
According to the NYT, which broke the news, all six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition, the officials said.
The FDA published its own advisory shortly after the NYT broke the news.
The FDA is holding a press briefing at 1000ET to share more details about its call for an immediate pause to all JNJ vaccines.
All federal facilities will halt use of the jab immediately, and the states are expected to follow suit by ordering jabs to be suspended at their vaccination site. Regardless, we imagine most Americans would refuse a JNJ jab now that reports of the blood clots, which also were found to be associated with AstraZeneca vaccines by authorities in Europe.
Federal health agencies on Tuesday will call for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination, officials briefed on the decision said.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition, the officials said.
Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.
While the move is framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.
The FDA and CDC will jointly examine any potential link between the vaccines and the blood clots. The decision to halt the rollout could “”substantially complicate” the country’s vaccination trajectory, and already, markets are looking shakey.
Scientists with the Food and Drug Administration and C.D.C. will jointly examine possible links between the vaccine and the disorder and determine whether the F.D.A. should continue to authorize use of the vaccine for all adults or limit the authorization. An emergency meeting of the C.D.C.’s outside advisory committee has been scheduled for Wednesday, officials said.
An F.D.A. spokeswoman declined to comment.
The move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy. Regulators in Europe and elsewhere are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca and Oxford University researchers. That concern has driven up some resistance to all vaccines, even though the AstraZeneca version has not been approved for use in the United States.
Supply disruptions at a US factory in Baltimore coincidentally led to a dramatic reduction in supply of Johnson & Johnson vaccines on the market, leading to shortages that prompted a brief slowdown in the US vaccine rollout. Nearly 7 million people have received the JNJ jab so far in the US, and roughly 9 million more doses have been shipped. Fortunately, most of the vaccines distributed so far in the US were manufactured by Moderna and Pfizer-BioNTech. Still, the Biden Administration had been counting on using hundreds of thousands of JNJ doses per week. And what’s more, the jab – which had the advantage of being doled out in a single dose, as opposed to multiple doses for Pfizer and Moderna – was supposed to play an important role in helping Europe catch up to the US and UK.
As for how this might set back the Biden Administration’s push to vaccinate the US, “it’s unclear.” In the US alone, 300K to 600K people a year develop blood clots, according to CDC data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous thrombosis, is extremely rare. What’s more, it’s the same disorder linked to jabs produced by AstraZeneca in Europe.
Out of 34M people who received the vaccine in Britain, the European Union and three other countries, only 222 experienced blood clots, and in those cases, the clotting was linked with low levels of platelets. The majority of these cases occurred within the first 14 days following vaccination, mostly in women under 60 years of age.
Like AstraZeneca, JNJ uses the adenovirus platform for its jabs, which, as it happens, was the reason Australia cited when it announced Tuesday overnight that it wouldn’t purchase the JNJ jabs for domestic use.
Tue, 04/13/2021 – 07:10