How Johnson & Johnson pause will impact clinical trials in Michiana

SOUTH BEND, Ind. --- All eyes are on the FDA and CDC as the U.S. waits for more information about next steps in the Johnson & Johnson vaccine rollout. The organizations recommended the pause of vaccine doses after six cases of rare and severe blood clots were confirmed.

South Bend Clinic is one of about 100 clinical trial sites around the world for the drugmaker.

“It was brand news to me and quite a surprise and disappointment as well, but I hope it turns out to be coincidental and not actually to do with the vaccine,” South Bend Clinic Principal Investigator Dr. Jim Harris said.

Dr. Harris oversees the clinical vaccine trials at South Bend Clinic and said the announcement came as such a surprise because nothing similar to these cases happened in the clinical trials on the inside, let alone publicly.

None of the six cases of blood clots were identified in local residents, according to Harris.

Harris said all local participants have received their doses. Johnson & Johnson announced guidance for clinical trial sites, issuing the following statement, saying in part:

“We are committed to providing transparent updates throughout the clinical development process of our vaccine, in compliance with regulatory standards and our own high ethical and scientific principles. With the recommendation from CDC and FDA, Janssen has decided to voluntarily pause vaccinations in all Janssen clinical trials. Investigator Calls will be organized over the 24-48 hours to provide further guidance for the respective trials.”

“My impression is that because the doses have been given already, it’s going to be very important to continue to follow those patients and see what happens to them down the road,” Harris said. “The attendance study is to follow patients for up to two years, so I think that when there’s a development like this, it makes it even more important to follow them over time and see what other things can happen with vaccines.”

Six out of upwards of 7,000,000 people is a small number, but we do know that these cases appear to be in women aged 18 to 50. Harris said this brings into question whether there could be a certain group at-risk.

“Should we continue to use this vaccine going forward or not, should we defer to the other vaccines because they may or may not be safer at this point,” Harris said. “So I think the best thing to do is not panic, but respect the fact that we’ve put a hold on the vaccine for now and wait for further information about it.”

The White House announced that the pause will not have a significant impact on overall vaccine rollout. With less than one week until President Biden’s new deadline for all U.S. adults to be eligible for a vaccine, a White House official said Johnson & Johnson makes up less than 5% of recorded shots in arms.

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