University of Iowa hospitals expert takes questions on J&J concerns

Dr. Pat Winokur is the executive dean of the UI’s Carver College of Medicine and principal investigator for the UI portion of the Pfizer/BioNTech COVID-19 vaccine trials. photo courtesy UIHC

Tuesday’s emergent pause on U.S. use of the single-shot Johnson & Johnson COVID vaccine alarmed many Americans — including some of the tens of thousands of Iowans already vaccinated with one-dose product.

But University of Iowa Carver College of Medicine Executive Dean Patricia Winokur, on the front lines of Iowa’s role in researching and developing COVID vaccine, is encouraging Iowans to have patience as investigators analyze more data around rare blood clotting that’s affected six of more than 6.8 million Americans who received the J&J vaccine.

Winokur also urged the public not to jump to conclusions about other COVID vaccines.

“This is actually what should happen,” Winokur said Tuesday, noting rare events happen with many drugs, but scientists can’t catch them until a product is widely distributed.

“And so the fact that we caught this is actually telling us that our system is working.”

Q: Should people who already got the J&J vaccine be worried?

A: Stressing the rarity of the clotting concerns — less than one in a million — Winokur said UI Health Care is sending letters to those who received the J&J vaccine, notifying them of concerns and advising they watch for headaches, severe abdominal pain, shortness of breath, and leg swelling — all symptoms of blood clots.

“Typically what we have seen in the six cases is that the events have happened within about a week to three weeks after the vaccine. So that’s the time frame that is most important for people to watch.“

Q: Are these concerns and this pause a result of the speed at which the vaccines were developed?

A: “Though this vaccine was evaluated quickly, and approved quickly, we would not have seen this type of event in any vaccine that was produced under slow circumstances,” Winokur said, noting regulators were able to catch the rare reactions because so many doses went out.

“As you get out into large numbers of people that have received this drug, or vaccine, we start to see these rare events.”

Q: Do you think this will create more vaccine-hesitancy?

A: “I think it will cause some people to be more distrustful,” Winokur said.

Q: How could that distrust, and losing the option of the J&J vaccine in the immediate term, affect the nation’s pursuit of herd immunity?

A: “It slows us down a little bit,” she said. “Any dose of vaccine we have, we want to use, we want to get it out as fast as possible. But remember, we are ramping up the production of the Pfizer and Moderna (vaccines.) … So that’s the good news.”

Plus, Winokur said, more vaccines are in development — like an option from Novavax, for which UIHC is a trial site.

“If we’re lucky, maybe Novavax will have good data too.”

Q: What do researchers think is behind the clotting?

A: “My guess is this is going to be something that’s more of an autoimmune type process. What I can’t tell you exactly is what triggered the body to respond with making antibodies to the platelets. But that’s the physiology of it. It looks like the body has made some type of antibody that’s recognizing a compound the platelets made.”

Q: Is this similar to clotting that’s been reported in association with the COVID vaccine from AstraZeneca, which is not approved in the U.S.

A: “This syndrome does look to be very similar to the cases that they’ve seen in Europe with the AstraZeneca vaccine,” Winokur said, adding regulators and researchers likely will look into connections and similarities as they investigate the J&J concerns.

Q: Why do women seem to be more affected by the J&J-associated clotting?

A: Although research is ongoing, Winokur said there are possibilities.

“Women have estrogen, and estrogen is a pro-coagulant to some extent,” she said, adding, “Some of these women were on oral contraceptives … Also, we know that women sometimes are more predisposed to autoimmune disorders, in general. So that’s something that we will be looking at.”

Q: Do any of these concerns seem to affect the J&J vaccine’s efficacy against COVID-19?

A: “No. The good news is that this was a very effective vaccine that did induce antibodies to the spike protein, which is what we think is protective for COVID-19. And so these people will still have very good immune responses that are protective.”

Q: Do you think the J&J vaccine is forever gone? Or could it resume being used eventually?

A: “I think we don’t have enough data yet … We’ve only seen what’s been released into the press, and we need the real, raw data, and we need some of those experts to weigh in.”

Q: What is the threshold for incidents pausing use of a vaccine? Could the Pfizer and Moderna options face a similar fate?

A: “This is the question of risk-benefit,” Winokur said. “We have a pandemic. We know people are dying … So that’s the risk-benefit ratio that you have to evaluate.”

As for the Pfizer and Moderna vaccines, she said, “We have a lot more experience.”

“And this is an unusual enough syndrome that I think we would have had reports by now. And we haven’t. So I think that’s a really important point that needs to be considered. We have hundreds of millions of doses of Pfizer and Moderna that have been delivered and used around the world. And we haven’t seen this clotting disorder in those hundreds of millions of people.”

Vanessa Miller covers higher education for The Gazette.

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