UPDATE: The FDA and CDC will 'call for an immediate pause in use of Johnson & Johnson's single-dose coronavirus vaccine'

The New York Times is reporting this morning that the “FDA & CDC to call for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the US developed a rare disorder involving blood clots within about two weeks of vaccination”:

NYT: FDA & CDC to call for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the US developed a rare disorder involving blood clots within about two weeks of vaccination https://t.co/CqodtaBXfN

— Jesse Rodriguez (@JesseRodriguez) April 13, 2021

According to the report, “six women developed rare blood clots” after receiving the vaccination:

Breaking News: The U.S. will seek to pause Johnson & Johnson’s coronavirus vaccine after six women developed rare blood clots, officials briefed on the decision said.https://t.co/9cnE2E0Ehn

— The New York Times (@nytimes) April 13, 2021

Around 7 million doses of the vaccine have already been given. So, is this the right move?

Important breaking news

US govt calling for a pause of the J&J vaccine after a small number of people develop a very rare blood clot.

While unfortunate, its the right step.

Central to vaccination success is ensuring people have confidence they are safehttps://t.co/pnyNnbvHjm

— Ashish K. Jha, MD, MPH (@ashishkjha) April 13, 2021

Or just a “massive mistake”?

I repeat: 7 million doses of J&J. Just 6 clotting instances. This is such a massive mistake. https://t.co/5YkErYzlBG

— Jessica Hullinger (@JessHullinger) April 13, 2021

There has to be more to this, right? A decision like this has long-term ramifications as people will now likely always question this vaccine’s safety despite what the FDA and CDC say:

Millions of J&J shots given out. 6 cases of blood clots. Even if it was 1 million shots given out, that’d be 0.000006%. This is an interesting decision that could have huge ramifications for vaccine rollout in the US. https://t.co/se0zHvAbjW

— Herb Scribner (@HerbScribner) April 13, 2021

As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare

— U.S. FDA (@US_FDA) April 13, 2021

Treatment of this specific type of blood clot is different from the treatment that might typically be administered.

— U.S. FDA (@US_FDA) April 13, 2021

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

— U.S. FDA (@US_FDA) April 13, 2021

Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.

— U.S. FDA (@US_FDA) April 13, 2021

Please join us via YouTube for an audio press conference at 10 a.m. EDT. We will keep the public updated as we learn more. https://t.co/fWguuQzhMR

— U.S. FDA (@US_FDA) April 13, 2021

#COVID19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.

— U.S. FDA (@US_FDA) April 13, 2021

UPDATE 2

Response from Johnson & Johnson:

J&J Statement

“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.”

(h/t @ericMstrauss) pic.twitter.com/a6e5zBWRY5

— Karen Travers (@karentravers) April 13, 2021

Editor’s note: This post has been updated.

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