ROCHESTER, N.Y. (WROC) — Rochester Regional Health infectious disease expert Dr. Ed Walsh held a media briefing Tuesday in regards to the new report on the pausing of the Johnson & Johnson COVID-19 vaccine.
Monroe County and New York state have suspended use of the Johnson & Johnson vaccine until further notice, following reports of potentially dangerous blood clots from the CDC and FDA.
Dr. Walsh, who led the Pfizer study at RRH said the Johnson & Johnson vaccine is on pause for use until it’s lifted by the CDC and FDA. He said the federal authorities would continue to meet and provide guidance as determinations are made.
Acting FDA commissioner Dr. Janet Woodcock said Tuesday: “We expect it to be a matter of days for this pause.”
Full briefing with Dr. Walsh
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating unusual clots in six women that occurred 6 to 13 days after vaccination. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48.
The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca. Dr. Walsh said these blood clot reports have not occurred with the mRNA vaccines like Pfizer and Moderna.
More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.
“These are rare events, and the numbers look like they are in the one in one million — for every million person vaccinated, there’s one event like this — but unfortunately it can result in death,” Dr. Walsh said. “They are very rare events, so it’s hard to assess the risk-benefit for an individual patient. This seems to be more common in people under 50, there seems to be a predominance in women. So is it possible that there’s little or no risk in people above 50? These are things we need to figure out as we move forward.”
Dr. Walsh said, statistically, there is more of a chance from dying from COVID-19 than dying from a blood clot cause by a Johnson & Johnson vaccine.
“Clearly the risk of dying from COVID far exceeds one of these one in a million events, but it raises concerns for all individuals, and that’s understandable,” Dr. Walsh said.
Dr. Walsh said this J&J pause will likely lead people to become more concerned about receiving a COVID-19 vaccine.
“I think we anticipated, at least among ourselves, that anytime a new vaccine is developed, the clinical trials are done in rather select populations, in that it’s not always everyone,” Dr. Walsh said. “The studies, although large, if you consider 50,000 people large, are not large enough to identify smaller risks like one in a million — which is never done for any vaccine or therapeutic. So once these vaccines or drugs are rolled out to millions and millions of people of keeping track of these rare events. It’s not uncommon to be in this position, it’s something that has happened before and will undoubtedly happen again with new medications as they come out.”
Dr. Walsh said it’s important to monitor common symptoms for blood clot linked to this report, including headaches, stomachaches, and abdominal pain.
“We don’t quite understand why this has happened. We don’t understand the mechanism completely. What we do have information on is what it looks like and some information on treatment which might also be useful,” Dr. Walsh said. “I think the only thing you can say is that people who have been recently vaccinated, in the last three or four weeks, should pay attention and not trivialize a stomachache, headache, or abdominal pain.”
Dr. Walsh reiterated the pandemic wages on, and the virus is here to stay — he just said the choice is up to the individual: Either get vaccinated, or get the virus.
Check back with News 8 WROC as we will continue to update this developing story.