Posted: Tuesday, April 13, 2021. 3:32 pm CST.
By Aaron Humes: Six reported cases of a “rare and severe” type of blood clot among persons vaccinated with the Johnson and Johnson one-shot COVID-19 vaccine have resulted in its rollout being paused in the U.S., CNN reports.
The halt was ordered by the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) after more than 6.8 million doses had been administered. All of the victims were women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, per a CDC/FDA joint statement.
The bodies are to meet separately to review the CDC Advisory Committee on Immunization Practices (ACIP) and recommended the pause “out of an abundance of caution.” Johnson said in its own statement that it has decided to delay European rollout of its vaccine.
Adverse events connected to the vaccine include severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination, though even these, the company said, “appear to be extremely rare.”
Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine at Grady Health System, pointed to the type of vaccine – both Johnson and Oxford-AstraZeneca’s vaccines are adenovirus vector vaccine types. The two other Covid-19 vaccines authorized for emergency use in the United States — Pfizer’s and Moderna’s — are mRNA vaccines, which are a different type. The O-AZ vaccine faces its own issues in Europe and elsewhere.
Dr. del Rio said that he still recommends people to get vaccinated against Covid-19.
The new announcement from the FDA and CDC means all federal health channels — mass vaccination sites, community health centers and the like — that were previously administering the Johnson & Johnson vaccine will immediately stop for the time being, according to a federal health official.
The agencies are recommending that states do the same, but it will be up to the individual states to make that decision because they are given a separate allocation of doses.
The pause happened because this type of blood clot is not listed on the list of potential adverse side effects that were part of the emergency use authorization for Johnson. While officials are stressing it is rare, they want health care providers to have time to understand what potential side effects are and how to best treat them.
The CDC and FDA came to a decision late Monday night, a federal health official said.
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