Dr. Mendoza on J&J pause: One in a million side effect, people should still get vaccinated

Coronavirus

ROCHESTER, N.Y. (WROC) — Monroe County Public Health Commissioner Dr. Michael Mendoza says the use of the Johnson & Johnson vaccine is suspended in the county until further notice, following reports of potentially dangerous blood clots.

Despite Tuesday’s development on the J&J shot, the health commissioner said these instances of reported blood clots are extremely rare, and that Monroe County residents should continue the process of getting vaccinated as soon as possible.

“It is important to note that nearly 7 million doses of the J&J vaccine have been administered in the United States — 7 million,” Dr. Mendoza said. “And of that nearly 7 million, six women have developed a rare disorder involving blood clots within two weeks of getting the shot, and unfortunately one woman has passed away.

“While any loss of life or serious illness is concerning, we have to remember that this has occurred in an extraordinarily minute percentage of people who have received the vaccine thus far,” Dr. Mendoza said. “So we are pausing our use of the J&J vaccine out of an extreme abundance of caution. There is a good possibility these women may have developed the blood clots even without the vaccine — we just don’t know, but that’s why it’s prudent to review what happened.”

The health commissioner said the vaccine pause is a sign that “the system is working.” He said it gives time to evaluate more fully and transparently to make sure everyone has all the information to stay safe.

“This should not be viewed as a reason to not get vaccinated,” Dr. Mendoza said. “The risk of serious illness or death from COVID-19 is much higher than the risk of serious illness or death from getting the vaccine.”

The health commissioner described the blood clots as a “one in a million side effect” and said it is not a reason to panic.

“We often toss that term around, but this was literally a one in a million side effect,” Dr. Mendoza said. “Now, obviously it’s very serious, and we want to know more about it, but I do want to remind people that association doesn’t equal causation. Right now we have an association that we need to understand. We need to see if in fact the vaccine was the cause of these side effects, but we don’t yet know that.

“I don’t think we need to panic,” Dr. Mendoza said. “Those who got the vaccine more than three weeks ago have nothing to worry about. We are advising anyone who has gotten the vaccine within the last three weeks to pay attention to your symptoms as you normally would. If you have unusual head pain, leg pain, abdominal pain, or shortness of breath, we would then encourage you to contact your health care provider, but other than that, anyone who has gotten the vaccine more than three weeks ago need not worry.”

The health commissioner said the leftover Johnson & Johnson vaccines will be stored until further notice, but he said the county’s most recent shipment were supplies of Pfizer and Moderna anyways.

“If we are going to get past this pandemic and return to a sense of normalcy, we have to get vaccinated today,” Dr. Mendoza said. “The longer we let this virus spread, the more time we give it to mutate and grow. Even if you are young and you are not concerned about the impact of COVID-19, you may be allowing it to mutate and grow, and therefore impacting the rest of our community.

“You have the power to do something,” Dr. Mendoza said. “Vaccines are by far the best tool we have for stopping this pandemic in its tracks as quickly as we can. So please if you have not already done so, schedule an appointment today to receive the Pfizer or Moderna vaccines — both of which are safe and widely available to 16-years-or-old in our community.”

Full briefing with Dr. Mendoza

In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said it was investigating clots in six women in the days after vaccination, in combination with reduced platelet counts.

More than 6.8 million doses of the J&J vaccine have been administered in the U.S. U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.

Dr. Janet Woodcock, the FDA’s acting commissioner, said Tuesday: “We expect it to be a matter of days for this pause.”

New York Health Commissioner Dr. Howard Zucker announced the state is pausing use of the Johnson & Johnson vaccine statewide, immediately.

“Today the CDC and FDA issued a statement recommending a pause in the use of the Johnson & Johnson vaccine out of an abundance of caution. New York State will follow the CDC and FDA recommendation and pause the use of the Johnson & Johnson vaccine statewide immediately today while these health and safety agencies evaluate next steps. All appointments for Johnson & Johnson vaccines today at New York State mass vaccination sites will be honored with the Pfizer vaccine.

As the CDC and FDA have said, any adverse events related to the Johnson & Johnson vaccine ‘appear to be extremely rare’ and, ‘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.’

I am in constant contact with the federal government and we will update New Yorkers as more information becomes available.”

A statement from Wegmans officials Tuesday morning:

“Following the recommendations of the CDC and FDA, Wegmans has canceled all Johnson & Johnson vaccine appointments, including those scheduled for today’s clinic at the Wegmans Conference Center. We will pause use of the Johnson & Johnson vaccine while the CDC and FDA further investigate the issue.”

Local colleges, including SUNY Brockport, St. John Fisher College, and Nazareth College announced similar pauses on their vaccination clinics Tuesday morning.

Check back with News 8 WROC as we will continue to update this developing story.

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