ONE-IN-A-MILLION RISK
Johnson & Johnson Covid vaccine suspended by FDA and CDC after 6 out of almost 7 million had blood clots and one died
STATES across the US are halting the use of the Johnson & Johnson single-dose Covid vaccine following a recommendation by the FDA and CDC over blood clot concerns.
Federal health agencies have called for use of the vaccine to be paused immediately today so that rare cases of blood clots can be investigated "out of an abundance of caution";.
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It comes after six recipients of the jab - out of almost seven million in the US - developed a rare disorder involving blood clots within about two weeks of vaccinations, with one dying and another in a critical condition.
The women, aged 18 to 48, presented symptoms between six and 13 days after receiving the Janssen jab.
Arkansas, Kentucky, Florida, New York, Michigan and Mississippi are among states that have decided to pause the use of the J&J jab following the recommendation.
Speaking at a press conference this morning, Janet Woodcock, Acting FDA Commissioner, said: "This morning, the FDA and CDC announced that out of an abundance of caution, we are recommending a pause in the use of the Johnson & Johnson Covid-19 vaccine, due to reports of six cases of a rare and severe type of blood clot following vaccination administration.
"We're recommending this pause while we work together to fully understand these events and also so we can get information out to healthcare providers and vaccine recipients."
She stressed that the cases are "extremely rare".
Dr Peter Marks, director of FDC Center for Biologics Evaluation and Research said the handful of cases being investigated involved a blood clot called cerebral venous sinus thrombosis, seen alongside low levels of blood platelets.
If those suffering from this rare type of blood clot are given the standard treatments, it can "actually cause tremendous harm, or the outcome can be fatal", Dr Marks added.
"So one needs to make sure that providers are aware that if they see people who have low blood platelets or, if they see people who have blood clots, they need to inquire about a history of recent vaccination, and then act accordingly in the diagnosis and management of those individuals," he said.
"This was taken rapidly in order to honor our commitment to the American public to ensure that any safety signal that came up during this vaccine rollout was addressed in a transparent manner."
Dr Marks said there is no association with the oral contraceptive pill in this cases.
Anne Schuchtat, Principal Deputy Director said the risk for those who had the J&J jab more than a month ago "is very low at this time".
"For people who recently got the vaccine, if in the last couple weeks, they should be aware to look for any symptoms," she added.
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"If you've received the vaccine and developed severe headaches, abdominal pain, leg pain or shortness of breath, you should contact your healthcare provider and seek medical treatment."
She reiterated that these symptoms are different form the flu-like ones some people experience after a Covid vaccine.
The pause is expected to last "a matter of days", Dr Woodcock said, adding that the time frame will depend on what is learnt over the coming day.
On Wednesday, the CDC will convene at a meeting of the Advisory Committee on Immunization Practices to further review cases and assess their potential significance.
The FDA will then review that analysis as it also investigates the reported incidents.
"Until that process is complete, we are recommending this pause," the FDA added.
"This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."
The White House has said that the pause will not significantly impact its vaccine rollout.
The US military has also decided to pause the distribution of the vaccine.
Press secretary John Kirby said: "The safety of our force and their families is a top priority for the the Department."
Dr Marks has said the pause is a recommendation, not mandatory.
"We're not going to stop that provider from administering the vaccine because it could be right, in many cases, that benefit risk will be beneficial overall to that individual in the large majority of cases," he added.
'PROACTIVELY DELAY ROLLOUT'
Johnson & Johnson has confirmed it has made the decision to "proactively delay the rollout" of its vaccine in Europe following the recommendation to pause its use in the US.
A statement from the company said: "The safety and well-being of the people who use our products is our number one priority.
"We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our Covid-19 vaccine.
"Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
"In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe."
The company has reassured that it will "continue to work closely with medical experts and health regulators", adding that it "strongly supports the open communication of this information to healthcare professionals and the public".
Almost seven million people in the US have so far received the Johnson & Johnson shot according to data from the Centers for Disease Control and Prevention.
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Scientists with the Food and Drug Administration and Centers for Disease Control will examine possible links between the vaccine and the rare cases.
It will determine whether the FDA should continue to authorize use of the vaccine for all adults or limit it.
Meanwhile, a man in New Jersey has been hospitalized with Covid, just five weeks after being receiving a single shot of the Johnson & Johnson jab.
Francisco Cosme, 52, had his one-dose vaccine on March 6 and continued to wear a mask and social distance, reports
Just a few weeks later, however, on April 1, Cosme tested positive for Covid and later became hospitalized after his condition worsened.
He remains in a critical condition at John F. Kennedy Medical Center, where he is also being treated for pneumonia.
It comes after Europe’s drug regulator the European Medicines Agency (EMA) launched a safety review into the jab after one person died from a blood clot after receiving the vaccine.
The Janssen jab is currently not in use in the UK, but could be by the summer.
At the end of February, the Food & Drug Administration granted emergency approval for Johnson & Johnson's Covid vaccine in the US.
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