The FDA stops utilizing Johnson & Johnson Covid’s vaccine on account of uncommon blood clotting issues in six girls
Johnson & Johnson COVID-19 vial and box at a vaccination site. Despite a small number of people who have experienced side effects, including blood clots, doses of the Johnson & Johnson vaccine are being given across the state of Florida.
Paul Hennessy | LightRocket | Getty Images
The Food and Drug Administration said Tuesday it is calling on states to temporarily stop using Johnson & Johnson’s Covid-19 vaccine “out of caution” after six women in the US developed a rare bleeding disorder.
“Right now, these adverse events seem extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “The safety of COVID-19 vaccines is a top priority for the federal government and we take all reports of health problems following COVID-19 vaccination very seriously.”
A White House spokesman referred CNBC to HHS when asked for comment.
All six cases occurred in women between the ages of 18 and 48, with symptoms developing six to 13 days after receiving the shot. Doctors usually treat these types of blood clots with heparin, but health officials determined that it could be dangerous in this case and recommended a different treatment.
J&J said in a statement that “no clear causal link” was found between the blood clots and the vaccine, adding that it is working closely with regulators to evaluate the data.
People who receive the vaccine and “develop severe headache, abdominal pain, leg pain, or shortness of breath” within three weeks of vaccination should see their doctor, “according to the FDA and CDC.
J & J’s shares were down more than 3% on the Tuesday leading up to trading.
The CDC will hold a meeting of the Advisory Committee on Vaccination Practices on Wednesday to further study the cases, federal health officials said on Tuesday. The FDA is also investigating the cases.
J & J’s Covid-19 vaccine, like the Pfizer and Moderna shots, received emergency approval from the FDA to begin distributing the doses in the U.S. An EEA grants conditional release based on two months of safety data until another filing for full approval is required, which normally requires at least six months of data.
When J&J submitted its Covid vaccine data to the FDA in February, no specific concerns were identified with the analysis by age, race and comorbidities, according to the agency. The FDA said at the time that the most common side effects were headache and fatigue, followed by muscle pain, nausea, and fever.
The New York Times reported the news first.
It is unclear how the hiatus will affect J & J’s goal of shipping 100 million cans to the US by the end of May. The company was already plagued by manufacturing problems after a facility operated by Emergent BioSolutions ruined 15 million doses of the vaccine.
Last week, the European Medicines Agency said it had identified a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems. AstraZeneca has not received approval for use in the United States
Emer Cooke, executive director of the European Medicines Agency, said in a televised news conference last week that unusual blood clotting with low platelets would be added to the AstraZeneca vaccine product information as a “very rare” side effect, along with a number of other possible ones Side effects.
Both J&J and AstraZeneca use adenovirus, a common type of virus that typically causes mild cold symptoms, to develop their Covid-19 vaccines.
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