A vaccine front-runner hits the brakes
AstraZeneca yesterday paused the late-stage trials for its coronavirus vaccine because of a suspected adverse reaction in a participant. Now it will investigate whether the vaccine caused the illness, which several people familiar with the situation said was transverse myelitis — an inflammation of the spinal cord that is often prompted by viral infections.
This is the second time that AstraZeneca, which is developing its vaccine with the University of Oxford, has put its trials on hold. Another participant developed symptoms of transverse myelitis, researchers reported in July, but it was later attributed to an “unrelated neurological illness.”
AstraZeneca’s vaccine has garnered attention as one of the most promising and advanced candidates. To understand what the pause may mean in the race for a vaccine, we spoke with our colleague Katherine Wu, a science reporter. Our conversation has been lightly edited and condensed.
What does pausing the vaccine trials mean?
AstraZeneca is not giving the vaccine to any more people until they can determine whether the person’s sickness was directly linked to the vaccine.
How is AstraZeneca’s vaccine different from the other coronavirus vaccines in development?
AstraZeneca’s vaccine is based on what’s called a viral vector. You want to produce an immune response to the coronavirus, but instead of using the coronavirus itself, they use what’s called an adenovirus that they took from a chimpanzee.
This is meant to be a modified virus that they have genetically altered to be harmless to humans, but they’ve also modified it to express some genes from the coronavirus. The idea is that this virus is like a chauffeur that can bring coronavirus genes into the body and then will allow the body to mount a response to the products of those coronavirus genes, but the body will not be infected with the coronavirus.
What happens now with the trial?
The U.S. vaccine trials were not in full swing yet. AstraZeneca was planning to enroll 30,000 people at 80 sites. They’ve enrolled at only 62 sites, so this may mess up their timeline.
AstraZeneca has previously said they were hoping to roll something out early next year. That could still be possible. It really depends on what other data emerges from the Phase 3 trials. But if this hold takes awhile to investigate, it could be longer than that.
It is also possible that if they notice more of these adverse events or if the event is bad enough, the trial could be stopped. In that case the researchers have to be pretty sure they are seeing something that resulted from the vaccine. That’s a big question mark right now. We don’t know whether this person was in the placebo group or the vaccine group.
How long could the investigation take?
That is totally unclear at this point. AstraZeneca released statements yesterday saying they were going to expedite the process as much as possible so that their plans for the Phase 3 trial weren’t going to be derailed.
But obviously the most important thing here is to make sure that the participant is safe and being followed up on. They’ve made it sound as if they’re not going to cut corners.
How should people think about this pause?
One of the most important things is that people should not be worried. I see this as an optimistic development. If the researchers notice an adverse effect, the right thing to do is to pause the trial and figure out what’s going on.
The other upshot is that if adverse events happen and they have a relationship to any of the vaccine candidates, this is what Phase 3 trials are for. This is why it’s so important to see the data through and to really monitor these patients. We wouldn’t know that this is happening if we were rushing through these trials, so this is science working as it should.
New York City dining is moving back indoors
Gov. Andrew Cuomo said the city’s indoor dining ban would be lifted on Sept. 30, with occupancy capped at 25 percent of capacity. That will ease one of the country’s last outright bans, which has decimated the city’s enormous restaurant industry.
New York City has maintained a test positivity rate of about 1 percent for the last several weeks, indicating that the virus is largely under control. If rates stay low, the cap at restaurants will expand to 50 percent of capacity.
Restaurants will also be required to measure the temperatures of all guests, take contact information for at least one member of every party, keep tables six feet apart and require masks whenever guests are not seated at a table.
During the lengthy ban, some 10,000 restaurants opened for outdoor dining under an expansive city program, though many have struggled to make ends meet. Eater reports that more than 1,000 bars and restaurants have closed since the pandemic began, and about 163,000 restaurant and bar workers were unemployed as of the end of July
Beginning on Monday, Britain will ban most gatherings of more than six people, including at pubs, restaurants and cafes, to quell a recent surge in cases. Restaurants will also now be required to take customers’ personal details for contact-tracing purposes.
In Ireland, a photo of an older man having a solitary meal in a pub started a conversation about coronavirus regulations and life’s simple pleasures.
What else we’re following
What you’re doing
My partner and I created “planetarium nights,” where a few days leading up to them, we research different topics like black holes, constellations and Mars exploration. Then we present the topics to each other, complete with fun lighting, themed drinks and space-esque music!
— Paige Hamm, Norfolk, Va.
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