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UW virologist: Any new vaccine warrants ‘very careful observation’ for rare side effects

A sign at a West Seattle vaccine clinic. (MyNorthwest photo)

After six reported cases of blood clots out of 6.8 million administered doses, use of the Johnson & Johnson vaccine has been paused in Washington state, and across the United States. Dr. Keith Jerome, director of the UW Virology Lab, says this matches standard procedure.

There’s ‘still time’ to slow the spread of COVID-19, prevent fourth wave

“This is a pause, so we don’t know how this is going to end up,” Jerome said. “But, yeah, it is standard when we have a brand new vaccine of any type, there’s a lot of very careful observation for rare side effects.”

“So these vaccines get tested initially in a small group of people, and if they show any problems, they pretty much end at that point,” he explained. “And then the final clinical trial that we do before they go out to the public usually has tens of thousands of folks. So the vaccine trials had typically about 30,000 people in each of them for approval. What that means is that the really rare side effects, the one in a million sorts of things, you can’t see in those. And so that’s why we very carefully follow up people after they get the vaccine or other therapeutics to try and understand these rare things.”

Jerome noted that this case is a very small number of people, but it’s a potentially serious complication.

“The policy is to try to look at the data and make sure that there’s a real linkage here, and then if it is something real, figure out what’s the pathway forward,” he said. “And is it something where the benefits outweigh the risks? Are there groups that we can identify who just shouldn’t get this vaccine, and so forth? Or it could be that the vaccine will just not be used going forward. But my guess is that it will be some sort of middle ground.”

In terms of the vaccination effort, Dr. Jerome does think we’re starting to see the impacts of it already.

“Just in terms of, again, we made a conscious decision to protect our citizens who were at the highest risk of severe disease and death and that’s particularly the oldest folks among us. So I think that’s proven to be a pretty good decision and that’s paying off in many fewer deaths,” he said. “Doesn’t mean that younger people can’t have severe disease — some end up in the hospital, and some unfortunately have died. If we look at the population level numbers though, they are better in that regard.”

Compared to other countries, Dr. Jerome says the United States is doing a good job in the vaccination rollout. He’s spoken to colleagues in other places that are personally a little jealous, he says, because they haven’t been able to get their vaccine yet.

“We need to do that first,” Jerome said about focusing on vaccinations nationwide. “But then I think we do need to look overseas and start to think about how we can actually help, or encourage, or provide advice because that could come back to bite us. That is, as you said, where the virus evolves. Every time it infects a new person, it has a chance to evolve into something that’s potentially more dangerous. And so the faster we can get those other countries sort of up to snuff as well, the less chance that something will come back around that, for example, our vaccines are less effective at preventing.”

What to expect as Washington vaccine eligibility opens Thursday

As of April 15, everyone age 16 or older is now eligible for the COVID-19 vaccine in Washington. So when’s the all clear?

“Well, certainly so called ‘vax day’ doesn’t mean that we’re all clear because obviously everybody hasn’t gotten the vaccine,” Jerome replied. “One thing we’re going to have to deal with in this country, and it will be interesting to see, is how many people ultimately choose to not get the vaccine or just sort of keep putting it off because they’re scared or because they’ve heard about this this rare side effect with the Johnson & Johnson vaccine.”

“If that number is too high, it will mean that we’ll continue to have some cases around the U.S.,” he added. “So I don’t think we’re out of the woods. We’re certainly not out of the woods yet. As I said, for a long time, I still keep looking at summertime as a time when life kind of gets back to something that looks much much more normal, and I’m still optimistic that that’s going to be the case.”

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