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April 15, 2021: -On Tuesday, the Food and Drug Administration asked states to temporarily pause using Johnson & Johnson’s Covid-19 vaccine “out of an abundance of caution” after six women in the U.S. developed a blood-clot disorder that left one woman dead, and left another in critical condition. “Right now, these adverse events are seen to be extremely rare,” the FDA said with the Canter’s for Disease Control and Prevention. “COVID-19 vaccine safety is the first priority for the federal government, and we take all reports of health problems follows COVID-19 vaccination very seriously.”
Jeffrey Zients, President Joe Biden’s Covid czar, said the halt would not have a “significant impact” on the administration’s goal to administer 200 million Covid doses within Biden’s first 100 days in office. He said J&J’s vaccine makes up lower than 5% of the recorded shots in arms in the U.S. to date.
J&J said that “no clear causal relationship” is identified between the blood clots and the vaccine and says it is working closely with regulators to assess the data.
People who receive the vaccine and “develop a serious headache, abdominal pain, leg pain, or breath shortage within three weeks after vaccination should contact their health care provider,” the FDA and CDC said.
On Wednesday, the CDC will conduct a meeting of the Advisory Committee on Immunization Practices to further review the cases, federal health regulators said on Tuesday. The FDA is also investigating the claims.
In February, J&J submitted its Covid vaccine data to the FDA, and no specific concerns were identified at the time while analysed by age, race, and comorbidities, according to the agency. The FDA said the most common were headache and fatigue, later follows by muscle pains, nausea, and fever.
It’s unclear how the pause will affect J&J’s goal to deliver 100 million doses to the U.S. by May end. The company has been plagued by manufacturing issues after a plant run by Emergent BioSolutions ruined 15 million doses of the vaccine.
Dr. Kavita Patel, a former federal health official, told CNBC she believes the FDA’s recommendation will have long-lasting impacts on the nation’s efforts to combat the pandemic.
Patel said the supply of the two-shot vaccines from Pfizer and Moderna wouldn’t be able to make up the demand created by the J&J pause quickly. This will delay U.S. vaccination efforts, she added.
Last week, Europe’s medicines regulator said it found a possible link between the coronavirus vaccine developed by AstraZeneca and the University of Oxford and rare blood-clotting issues. AstraZeneca has not received authorization for use in the U.S.
