Johnson & Johnson said it would delay the planned deployment of its Covid-19 vaccine in Europe after U.S. health agencies called for a hiatus on use of the vaccine in the United States while they investigate several incidents blood clots.
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were examining six reported U.S. cases of “rare and serious” blood clots in people who received the J&J vaccine. The people were all women aged 18 to 48, who developed symptoms six to 13 days after vaccination.
J&J said it continues to work closely with experts and regulators to assess the data. “We are aware that thromboembolic events, including those with thrombocytopenia, have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine, ”he said.
The company’s shares were down 2.5% on Tuesday.
J&J also said he was proactively cutting his planned deployment in Europe, which was due to start this week. The European Medicines Agency reiterated on Tuesday that it was examining a number of cases of blood clots in people who have received the J&J vaccination, with a view to deciding whether “regulatory action may be necessary”. He has so far said there is no evidence of a causal link.
Almost 7 million doses of the J&J jab have been administered in the United States. Federal vaccine distribution sites will stop using the vaccine, and individual states will likely follow suit. New York Health Commissioner Howard Zucker said in a statement Tuesday morning that the state will follow the federal recommendation and suspend the use of jabs “immediately” while the vaccine is evaluated.
Anyone who already has an appointment for the J&J vaccine in the state’s mass vaccination states would receive the Pfizer vaccine instead, Zucker said.
The CDC said it would review the cases at a meeting of its advisory committee on immunization practices on Wednesday, while the FDA is also investigating the significance of blood clots.
“Until this process is complete, we recommend a pause in the use of this vaccine as a matter of great caution,” the agencies said, adding that it was important for health organizations to understand and properly plan treatment for. the particular blood type. clot.
J&J vaccine is the only one shot vaccine authorized use in the United States, the Pfizer and Moderna vaccines each require two doses. Its approval in February was seen as a boon to efforts to speed up the rollout of the vaccine.
However, the vaccine has encountered obstacles since then, including manufacturing issues at one of its supplier’s factories which ruined a lot. Use of the J&J jab had also been discontinued at a handful of vaccination sites in several states after reports of adverse events.
The call to suspend vaccine rollout over fears of blood clots follows similar issues with the Oxford / AstraZeneca jab, which have been studied by the EMA. Last week, the EMA concluded that very rare cases of unusual blood clots should be listed as a side effect of the AstraZeneca vaccine.
Both vaccines are adenovirus vaccines. The Pfizer and Moderna plans use messenger RNA technology.
Eric Kremer, adenovirus expert at the Institute of Molecular Genetics in Montpellier, said that while the side effect was “extremely rare”, J&J cases did not look “encouraging”.
Cody Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital and a member of the FDA Immunization Advisory Committee, said: “It is not completely surprising that there appears to be some association with blood clots. because the AstraZeneca vaccine also used an adenovirus.
Outside the United States, South Africa has vaccinated just under 300,000 health workers with the J&J vaccine since February.
Pretoria has ordered 31 million doses of J&J for its mass deployment. Local South African media reported on Tuesday that health experts were considering a hiatus on local use of the J&J vaccine in light of US and European inquiries. The South African Department of Health did not immediately respond to a request for comment.
Norwegian authorities, who are to decide whether to extend their AstraZeneca vaccine suspension on Thursday, said they would announce their response to the J&J jab at the same time.
Steinar Madsen, medical director of the Norwegian Medicines Agency, told national broadcaster NRK of the US decision: “This is a dramatic step, but there are cases which are similar to what we have seen in Europe with AstraZeneca. and it is obvious that this needs to be looked at more closely.
The CDC and the FDA said the symptoms found in the six women – cerebral venous sinus thrombosis with low blood platelet counts – may require treatment different from typical blood clots and that blood thinning medications “may be dangerous.”
The White House insisted the hiatus would not prevent it from achieving its goal of overseeing 200 million vaccinations during the first 100 days of the Biden administration.
“This announcement will not have a significant impact on our vaccination plan: the Johnson & Johnson vaccine represents less than 5% of gunfire recorded in the United States to date”, Jeff Zients, President Covid coordinator . -19 task force, said in a statement.
“Based on the President’s actions earlier this year, the United States has secured enough doses of Pfizer and Moderna for 300 million Americans.”
Additional reporting by Donato Paolo Mancini in Rome, Richard Milne in Oslo and Joseph Cotterill in Johannesburg