University of Iowa medical expert takes questions on J & J vaccine concerns

Tuesday’s pause on the use of the single-shot Johnson & Johnson COVID-19 vaccine alarmed many Americans, including some of the thousands of Iowans already vaccinated with the one-dose brand.

But University of Iowa Carver College of Medicine Executive Dean Patricia Winokur, on the front lines of Iowa’s role in researching and developing a COVID -19 vaccine, is encouraging Iowans to have patience as investigators analyze more data about rare blood clotting that has affected six of more than 6.8 million Americans who have received the Johnson & Johnson vaccine.

Winokur also urged the public not to jump to conclusions about the other COVID-19 vaccine brands — Moderna and Pfizer-BioNTech.

“This is actually what should happen,” Winokur said, 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 in a short time.

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

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,” she said.

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-19 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 Johnson & Johnson 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.”

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