The Food and Drug Administration on Tuesday called 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 aged 18 to 48 years, 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.
According to the news, first reported by the New York Times, J & J’s shares fell 2.4% on the Tuesday leading up to trading.
The CDC will convene 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 vaccine, like Pfizer and Moderna’s vaccine, received emergency approval from the FDA to begin distribution of doses in the United States. An EEA grants conditional clearance based on two months of safety data pending another filing for full approval, which typically takes at least six months of files.
J&J submitted its Covid vaccine data to the FDA in February. At the time of the analysis for age, race and comorbidities, no specific concerns were identified, 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.
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.
Dr. Kavita Patel told CNBC on Tuesday she believes the FDA’s recommendation is likely to have lasting effects on the nation’s efforts to fight the pandemic.
“This is a devastating blow to these J&J vaccination efforts in the US,” said Patel, a family doctor in Washington, DC, in an interview on CNBC’s “Squawk Box”. Patel said the supply of Pfizer and Moderna’s two-shot vaccines will not be able to quickly meet the demand caused by the J&J hiatus. This will delay US vaccination efforts, she added.
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.
Isaac Bogoch, an infectious disease specialist who served on multiple drug data and safety monitoring panels, noted that J&J and AstraZeneca use the same platform for their vaccines. The J&J and AstraZeneca vaccines both use an adenovirus, a common type of virus that typically causes mild cold symptoms.
“Obviously we don’t have all the information and we need to learn more about the mechanism and risk factors,” he told CNBC. “But of course we can’t sweep potential adverse events under the rug and it needs to be investigated thoroughly.”