“We’ll never have perfect data, and there will always be uncertainty,” said Grace Lee, a professor at Stanford University and chair of the advisory panel’s COVID-19 Vaccine Safety Technical Subgroup, when the group met on Wednesday. “It’s really, for me, about getting better risk estimates.”
Committee members agreed to reconvene once they’ve had more time to gather and assess data about who might be most at risk of complications, and how that compares to the risk of catching and spreading covid.
All six of the cases reported after the vaccine became widely available occurred in women; one additional case—a man—was reported during clinical trials. All patients were between 18 and 48, and several were treated with the blood thinner heparin, which is typically used for clots but worsened the condition of these patients. The symptoms appear very similar to ones associated with AstraZeneca’s covid vaccine, which many European countries have limited or even stopped using. The active components of both are delivered to cells by adenoviruses that have been modified so that they can’t replicate.
But because there are other treatments available that use totally different methods, experts say that it is sensible to hold to see if more information becomes available. The Johnson & Johnson vaccine counts for only 7.5 million of America’s 195 million shots delivered; Pfizer-BioNTech and Moderna, which use mRNA rather than adenoviruses, are responsible for the rest.
“We’ll never have perfect data, and there will always be uncertainty. It’s really, for me, about getting better risk estimates.”
“The risks and benefits of continuing to administer the J&J vaccine can’t be looked at in isolation,” says Seema Shah, a bioethicist at Lurie Children’s Hospital in Chicago. “If people have alternatives, at least while the FDA is figuring things out, it makes sense to steer people in the direction of those alternatives.”
Resumption of Johnson & Johnson shots may not mean that it becomes available to everybody, however. Safety of vaccines is important because they’re given to healthy people, rather than treating people who are already sick, and successfully figuring out which groups might see the most benefit—or most harm—could mean US regulators give tiered recommendations. Several EU countries, for instance, have said the AstraZeneca vaccine should be given to older people at higher risk of complications from covid, rather than younger people who might be at higher risk of vaccine complications.
“At the end of the day, the critical issue is if I’m a 30 year old woman and I get this vaccine, how much will that increase my risk of this bad thing?” says Arthur Reingold, chair of California’s covid-19 Scientific Safety Review Workgroup and a former member of the CDC’s vaccine advisory panel.
A more complicated question is what data the committee will review to make a final decision.
No comprehensive data
Information may be limited because the issue was caught quickly, and because the Johnson & Johnson vaccine is so far only being deployed in the US (the company said it was delaying delivery to European Union countries.) But making a determination may also prove difficult because America’s medical data is highly fragmented.
Without a national healthcare system, there’s no comprehensive way to assess risks and benefits for different groups who have received the vaccine. There is no routine federal capability to connect patient data with vaccine records. Instead, regulators hope clinicians will hear about the pause and proactively report cases they hadn’t previously connected to vaccinations.
“It might stimulate some clinician to say, ‘Oh my God, Mrs. Jones had that three weeks ago,’” says Reingold. In addition, he says, “there’s still quite a few people who have gotten a dose within the last two weeks, and some of them could develop this rare side effect.”
The voluntary system may seem archaic, but that is how the six cases under review came to the attention of the authorities. They were reported to the CDC through an online database called the Vaccine Adverse Events Reporting System, or VAERS. It is an open website for medics, patients, and caregivers to notify the government about potential vaccine side effects.
Because the system is so open, and requires opt-in participation, it’s impossible to calculate exact risks using VAERS data. Epidemiologists generally think of it as a place to look for hypotheses that tie vaccines to side effects, rather than a source that can be used to confirm their suspicions.
The Frost nails its uncanny, disconcerting vibe in its first few shots. Vast icy mountains, a makeshift camp of military-style tents, a group of people huddled around a fire, barking dogs. It’s familiar stuff, yet weird enough to plant a growing seed of dread. There’s something wrong here.
Welcome to the unsettling world of AI moviemaking. The Frost is a 12-minute movie from Detroit-based video creation company Waymark in which every shot is generated by an image-making AI. It’s one of the most impressive—and bizarre—examples yet of this strange new genre. Read the full story, and take an exclusive look at the movie.
—Will Douglas Heaven
Microplastics are everywhere. What does that mean for our immune systems?
Microplastics are pretty much everywhere you look. These tiny pieces of plastic pollution, less than five millimeters across, have been found in human blood, breast milk, and placentas. They’re even in our drinking water and the air we breathe.
Given their ubiquity, it’s worth considering what we know about microplastics. What are they doing to us?
The short answer is: we don’t really know. But scientists have begun to build a picture of their potential effects from early studies in animals and clumps of cells, and new research suggests that they could affect not only the health of our body tissues, but our immune systems more generally. Read the full story.
Here, bits of plastic can end up collecting various types of bacteria, which cling to their surfaces. Seabirds that ingest them not only end up with a stomach full of plastic—which can end up starving them—but also get introduced to types of bacteria that they wouldn’t encounter otherwise. It seems to disturb their gut microbiomes.
There are similar concerns for humans. These tiny bits of plastic, floating and flying all over the world, could act as a “Trojan horse,” introducing harmful drug-resistant bacteria and their genes, as some researchers put it.
It’s a deeply unsettling thought. As research plows on, hopefully we’ll learn not only what microplastics are doing to us, but how we might tackle the problem.
Read more from Tech Review’s archive
It is too simplistic to say we should ban all plastic. But we could do with revolutionizing the way we recycle it, as my colleague Casey Crownhart pointed out in an article published last year.
We can use sewage to track the rise of antimicrobial-resistant bacteria, as I wrote in a previous edition of the Checkup. At this point, we need all the help we can get …
… which is partly why scientists are also exploring the possibility of using tiny viruses to treat drug-resistant bacterial infections. Phages were discovered around 100 years ago and are due a comeback!
Our immune systems are incredibly complicated. And sex matters: there are important differences between the immune systems of men and women, as Sandeep Ravindran wrote in this feature, which ran in our magazine issue on gender.
Artists are often the first to experiment with new technology. But the immediate future of generative video is being shaped by the advertising industry.Waymark made The Frost to explore how generative AI could be built into its products. The company makes video creation tools for businesses looking for a fast and cheap way to make commercials. Waymark is one of several startups, alongside firms such as Softcube and Vedia AI, that offer bespoke video ads for clients with just a few clicks.
Waymark’s current tech, launched at the start of the year, pulls together several different AI techniques, including large language models, image recognition, and speech synthesis, to generate a video ad on the fly. Waymark also drew on its large data set of non-AI-generated commercials created for previous customers. “We have hundreds of thousands of videos,” says CEO Alex Persky-Stern. “We’ve pulled the best of those and trained it on what a good video looks like.”
To use Waymark’s tool, which it offers as part of a tiered subscription service starting at $25 a month, users supply the web address or social media accounts for their business, and it goes off and gathers all the text and images it can find. It then uses that data to generate a commercial, using OpenAI’s GPT-3 to write a script that is read aloud by a synthesized voice over selected images that highlight the business. A slick minute-long commercial can be generated in seconds. Users can edit the result if they wish, tweaking the script, editing images, choosing a different voice, and so on. Waymark says that more than 100,000 people have used its tool so far.
The trouble is that not every business has a website or images to draw from, says Parker. “An accountant or a therapist might have no assets at all,” he says.
Waymark’s next idea is to use generative AI to create images and video for businesses that don’t yet have any—or don’t want to use the ones they have. “That’s the thrust behind making The Frost,” says Parker. “Create a world, a vibe.”
The Frost has a vibe, for sure. But it is also janky. “It’s not a perfect medium yet by any means,” says Rubin. “It was a bit of a struggle to get certain things from DALL-E, like emotional responses in faces. But at other times, it delighted us. We’d be like, ‘Oh my God, this is magic happening before our eyes.’”
This hit-and-miss process will improve as the technology gets better. DALL-E 2, which Waymark used to make The Frost, was released just a year ago. Video generation tools that generate short clips have only been around for a few months.
The most revolutionary aspect of the technology is being able to generate new shots whenever you want them, says Rubin: “With 15 minutes of trial and error, you get that shot you wanted that fits perfectly into a sequence.” He remembers cutting the film together and needing particular shots, like a close-up of a boot on a mountainside. With DALL-E, he could just call it up. “It’s mind-blowing,” he says. “That’s when it started to be a real eye-opening experience as a filmmaker.”
