Effects of J&J vaccine halt not felt in Monongalia County

Coronavirus

MORGANTOWN, W.Va. – News of the federal government halting the use of the Johnson & Johnson COVID-19 vaccine did not give the Greater Monongalia County Covid-19 Vaccine Clinic any concern about its supply chain.

“Fortunately, we hadn’t started using any of the J&J in the community,” Todd Karpinski said.

Karpinski

Karpinski is the chief pharmacy officer at WVU Medicine, which is part of a coalition that helps to run the county’s vaccine clinic. He said there was hope they could receive some J&J vials eventually, but they weren’t holding their breath.

We were hoping that in the next couple of weeks we could start getting supply of the J&J. As you know, the storage requirements are less harsh in terms of freezer temps, so we wanted to start using it in some of our clinics, but we had no definitive time frame for getting vials here.

Todd Karpinski – Chief Pharmacy Officer, WVU Medicine

What the vaccine clinic has had were Pfizer and Moderna vaccines, which Karpinski said have been highly effective and safe.

“From a supply chain standpoint and being able to offer vaccine to folks in Monongalia Co., it affects us zero,” he said. “We still have plenty of Pfizer vaccine with our coalition with the health department and Mon Health. We have plenty of open dates to schedule a vaccine over the next two weeks, so from a supply chain standpoint it doesn’t affect us at all.”

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FILE – In this March 6, 2021, file photo, boxes stand next vials of Johnson & Johnson COVID-19 vaccine in the pharmacy of National Jewish Hospital for distribution in east Denver. U.S. health officials are weighing next steps as they investigate unusual blood clots in a small number of people given the vaccine — a one-dose shot that many countries hoped would help speed protection against the pandemic. (AP Photo/David Zalubowski, File)

However, from a societal standpoint, Karpinski said, there could be a negative impact.

That impact will likely come in the form of vaccine hesitancy among those who have not been inoculated. That’s because anytime a potential adverse drug event happens, it gives people pause about whether they should get vaccinated, he said.

Many may ask if that’s the case, then why was the halt necessary?

Dr. Diane Gross, an epidemiologist at the Monongalia County Health Department (MCHD) said this is standard practice with all new drugs, not just the COVID-19 vaccines.

Gross

She said the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are being “especially diligent” with these vaccines to ensure that they are as safe as possible.

Out of an abundance of caution, the FDA and the CDC have asked that people stop giving that vaccine for now, while an expert panel convenes to review the data to see if we think these events in these six individuals were related to the vaccine that they got.

Dr. Diane Gross – Epidemiologist, MCHD

While you never want to halt usage of a lifesaving drug, this temporary stoppage indicates the federal government has been closely monitoring the vaccine distribution, Gross said.

Karpinski agreed.

“Diane is absolutely correct,” he said. “I think if nothing else, we can consider this a very good thing in that we have a lot of eyes on the vaccine and the impact it is having from the CDC, the ACIP, the FDA so that these things are being identified very early.”

Food and Drug Administration building is shown Thursday, Dec. 10, 2020 in Silver Spring, Md. A U.S. government advisory panel convened on Thursday to decide whether to endorse mass use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans. (AP Photo/Manuel Balce Ceneta)

The relevant federal agencies will meet Wednesday, April 14, to review the data. What it indicates so far is that six people suffered blood clots out of nearly 6.8 million people who received the J&J inoculation in the U.S.

Karpinski said the federal government could continue distribution only 24 hours after its meeting, only time will tell. What he does know for certain is that these kinds of unknowns are to be expected.

“When drugs are studied, these drugs are studied in 30,000-40,000 patients and then they were released for emergency use,” he said.

That means when millions of people, an exponentially greater population than the trial, start using the vaccine it was likely that something like this halt could occur.

But Karpinski is hopeful. That the six cases, including one fatality, are just outliers and not indicative of a greater problem.

“I can say in this is these instances of clots in these six females could be potentially unrelated to the vaccine,” he said. “There were some other issues that were noted, some conditions that those six individuals have that could have also have led to some clotting issues.”

MCHD, where Gross is employed

For her part, Gross said the initial data isn’t promising for J&J.

“A quick look tells us 2-15 cases of this type of blood clot occur per one million people per year,” she said. “And so this is six out six million, is that just that normal amount? I think probably not because it was six people two weeks after getting that vaccine. If it were six million in the population it would be more randomly dispersed across time. But those are the kinds of things that you have to look at.”

Regardless of her own preliminary concerns, Gross also said only time will tell if the federal government approves the vaccine.

In the meantime, she and Karpinski want people to take advantage of the Pfizer and Moderna vaccines, which have been used by tens of millions of Americans and have proven to be safe and effective.

“The fact that this happened and that it’s been caught early and that it’s being investigated extremely early is a really good thing that the federal government has a lot of eyes on this to make sure that people are kept safe, so I would say we all wait and see what the results are from the hearing today,” Karpinski said. “And then we will see what happens with the J&J vaccine as we go forward. But, Pfizer and Moderna still are given to millions and millions of people across the US, no significant events like this being reported, so very safe vaccines.”

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