Use of J&J Vaccine Halted in U.S. for Review of Blood Clot Side Effects

The J&J vaccine is being hit with a double whammy these days – new investigations of blood clots possibly related to the vaccine in the United States and critical supply problems. Even if U.S. officials quickly end the temporary halt on those vaccinations to investigate adverse effects, short supply of the product likely will continue in the near term. Here is more information.

WASHINGTON, DC – Pharmacists are getting a lot of requests for the one-dose Johnson & Johnson COVID-19 vaccine, but concerns about side effects and slowed down shipments are likely to make it difficult to meet demand in the near future.

In a press release, the Food and Drug Administration and national Centers for Disease Control and Prevention announced a pause in the use of this vaccine out of an “abundance of caution,” according to a press release.

https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine

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

“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,” the agencies state.

As of April 12, more than 6.8 million doses of the Johnson & Johnson vaccine from Janssen have been administered in the United States. Public health officials are reviewing data on six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.

The CDC and FDA explain that, in these cases, cerebral venous sinus thrombosis (CVST) was seen in combination with thrombocytopenia. Their statement points out that all six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

The agencies also emphasize that treatment of CVST is different from the treatment that might typically be administered, such as use of heparin, which they say could be dangerous in this situation.

“Right now, these adverse events appear to be extremely rare,” according to the statement attributed to Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, MD, Principal Deputy Director of the CDC.

Pharmacists and other healthcare professionals are urged to watch out for 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. They should be advised to contact their health care provider and the adverse event should be reported to the FDA.

Even before the temporary halt, production capacity was an issue. J&J is working closely with the Food and Drug Administration to resolve the issues holding up authorization of an additional facility in Baltimore, explained Jeff Zients, the White House’s COVID-19 response coordinator.

Once that authorization is received, the company expects to start shipping 8 million doses per week towards the end of April, Zients added. And, despite the holdup, J&J is expected to meet its commitment to deliver around 100 million shots by the end of May. The single-dose shot was granted emergency use authorization by the FDA in late February.

“They’re not in the weekly cadence, regular cadence that Moderna and Pfizer have both achieved,” Zients said at a briefing April 9. “When you talk about the doses being down significantly week to week, I think it’s important to remember that a week or two ago, Johnson & Johnson actually delivered 11 million doses all at once. That we got into the market immediately. This past week, it was closer to, I think it was just under two million doses, so that’s the decrease that you talked about, and that’s the fluctuation that we expect until they are able to get through the FDA process and open the additional plant.”

Zients cautioned that supply will remain lower until the new facility is open and approved, adding, “We’re optimistic that once they have the FDA authorization that there’ll be able to deliver, as they’ve told us, at that eight million per week cadence.”

Other than that, COVID-19 vaccine supply remains good, according to the White House, which reported that, the week of the press conference, more than 28 million doses went out to states, tribes, and territories, and through the federal channels. Zients said that was more than enough supply to maintain and increase the current seven day average of 3 million shots per day.

“In fact, over the past three weeks, we’ve allocated almost 90 million doses of Pfizer, Moderna, and Johnson & Johnson vaccine to states, tribes, and through the federal channels, he said, adding that both Pfizer and Moderna are on track to meet their commitment of each delivering a total of 200 million doses by the end of May.