CDC and FDA in a joint statement on Tuesday recommended a pause in the use of Johnson & Johnson's (J&J's) single-dose Covid-19 vaccine after six people who received the vaccine developed a rare and severe type of blood clot called cerebral venous sinus thrombosis (CVST).
According to STAT News, the blood clotting cases are similar to ones reported after use of AstraZeneca's Covid-19 vaccine, which FDA has not yet authorized, and an adverse event reported during J&J's Covid-19 vaccine clinical trial in the United States, which led to the trial's temporary pause.
CDC and FDA recommend pause in use of J&J's Covid-19 vaccine
As of Monday, more than 6.8 million Americans have received J&J's vaccine, according to CDC data. Among the recipients of J&J's vaccine, six women between the ages of 18 and 48 developed CVST, and symptoms occurred six to 13 days after their vaccinations, Peter Marks, the director of FDA's Center for Biologics Evaluation and Research, and Anne Schuchat, CDC's principal deputy director, said in the statement. All of the cases of CVST were "seen in combination with low levels of blood platelets," a condition called thrombocytopenia, Marks and Schuchat said.
According to the New York Times, one woman who developed CVST after receiving J&J's vaccine has died, and a second women in Nebraska is in critical condition.
Marks and Schuchat said cases of CVST among recipients of J&J's vaccine "appear to be extremely rare," but they're "recommending a pause in the use of this vaccine out of an abundance of caution" as CDC and FDA scientists examine the potential link between the vaccine and CVST.
Their statement added, "This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."
According to the Times, the federal government is expected to follow the recommendation and suspend use of J&J's vaccine at all federally run vaccination sites—which federal officials said will serve "as a strong signal" to states to take the same action.
Marks and Schuchat said CDC on Wednesday will convene a special meeting of the Advisory Committee on Immunization Practices (ACIP), which is a panel of outside experts that advises CDC on vaccines, to assess the potential significance of the CVST cases, while FDA continues to investigate. Once they've completed their review, CDC and FDA will determine whether FDA should limit the vaccine's authorization, the Times reports.
According to CNN, European health authorities are similarly investigating cases of blood clotting among people who received J&J's vaccine. The European Medicines Agency has reported "four serious cases of unusual blood clots" after people received J&J's vaccine, but it hasn't yet determined whether there's a causal relationship between the vaccine and blood clots.
In a statement Tuesday, Johnson & Johnson said, "We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine."
How the pause may affect America's coronavirus epidemic
According to the Times, the pause in use of J&J's vaccine "could complicate the nation's vaccination efforts."
For example, New York City Council member Mark Levine (D) in a tweet wrote that the city's vaccination campaign relies on J&J's vaccine to inoculate the homebound, reach small private doctors' offices, and supply vaccine doses to mobile vaccination vans.
However, Jeff Zients, the Biden administration's Covid-19 response coordinator, suggested the pause "will not have a significant impact on our vaccination plan," adding that "Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date."
The news about J&J's vaccine comes as the United States is racing to vaccinate Americans to prevent coronavirus cases and to stop the emerging variants of the virus, which appear to be more transmissible and potentially more deadly than earlier versions of the virus.
According to data compiled by the Times, the United States' average daily number of newly reported coronavirus cases over the past week was 69,030—up by 6% compared with the average from two weeks ago.
The Times' data showed that, as of Tuesday morning, the rates of newly reported coronavirus cases were "staying high" in Washington, D.C and 27 states that have reported a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alaska, Colorado, Connecticut, Delaware, Florida, Idaho, Illinois, Indiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Hampshire, North Carolina, North Dakota, Ohio, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Vermont, Virginia, West Virginia, and Wisconsin.
In addition, the rate of newly reported coronavirus cases was "going up" as of Tuesday morning in four states—Oklahoma, Oregon, Nevada, and Washington—that had been seeing comparatively lower case rates. Meanwhile, the rate of newly reported coronavirus cases was "going down" Iowa, New Jersey, New York, and Rhode Island, which have had comparatively higher case rates, the Times reports.
Similarly, hospitalizations Covid-19 hospitalizations are rising again. According to data from the Times, 43,735 Americans with Covid-19 were hospitalized for treatment on Tuesday morning—up by 10% compared with the average from two weeks ago. Even as coronavirus cases and hospitalizations climb throughout the country, the number of newly reported deaths linked to the coronavirus has continued to decline. According to data compiled by the Times, 476 new deaths were linked to the coronavirus on Wednesday, down 27% compared with the average from two weeks ago (Weiland et al., New York Times, 4/13; Allassan, Axios, 4/13; Branswell, STAT News, 4/13; McGinley/Johnson, Washington Post, 4/13; Cohen, CNN, 4/13; West/Ansari, Wall Street Journal, 4/12; New York Times, 4/13; Rummler, Axios, 4/13).