US Gets Dose Of Europe’s Vaccine Woes, As J&J Shot Paused

Risk sentiment took a hit early Tuesday when US health officials called for an immediate halt to Johnson & Johnson’s COVID vaccine, a potential setback for the Biden administration’s speedy effort to inoculate Americans in time to turbocharge a summer economic boom.

The “pause” (as it was billed) came after a half-dozen people who received the single-dose shot developed a blood cot disorder around two weeks after being vaccinated. One person died, and another was hospitalized in critical condition. All of the six recipients were women between 18 and 48.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC said, adding that,

As of April 12, 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the US. CDC and FDA are reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. 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. 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.

Exceptionally rare though this is, the news certainly won’t do much to embolden anyone reluctant to receive a vaccine or otherwise win over any hearts and minds among those who long ago decided against being vaccinated.

Comparisons to the controversial AstraZeneca vaccine are inevitable and, in the absence of an all-clear from federal agencies, it’s possible the J&J vaccine could suffer the same fate as Astra’s shot — namely, scientists and doctors could begin to debate whether its use should be limited to specific demographics.

Thankfully, most of America’s vaccine supply is comprised of the Pfizer and Moderna shots, neither of which are the subject of any known serious safety issues. Still, as The New York Times wrote Tuesday, “the move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy.” The Biden administration, the Times noted, “had still been counting on using hundreds of thousands of doses every week.”

I’m not a doctor and, unlike so many folks writing daily for public consumption, I’ve never implicitly masqueraded as one over the past year. But, from a common sense perspective, it seems reasonable to suggest that if this type of clot is, as the FDA and CDC called it, “rare” and requires “different” treatment from what would “typically be administered,” doctors probably aren’t prepared for it and will need additional information to ensure they can respond. “Usually… heparin is used to treat blood clots [but] in this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” officials said.

As the Times went on to say Tuesday, “government experts are concerned that an immune system response triggered by the vaccine was the cause.”

This isn’t the first time the issue has come up. A few days ago, European regulators said they were evaluating similar cases. Australia says it won’t buy J&J’s vaccine because it’s based on the same platform as the Astra shot. “[It’s] an adenovirus vaccine,” a spokesman told The Guardian Australia. “The government does not intend to purchase any further adenovirus vaccines at this time.”

The Pfizer-BioNTech and Moderna shots are based on different technology.

“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” J&J said, in a statement.

The FDA went on to reiterate that COVID vaccine safety “is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”

Full FDA statement

SILVER SPRING, Md.April 13, 2021 /PRNewswire/ — The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

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. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. 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.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.