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Why is it so hard to review the Johnson & Johnson vaccine? Data.

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Why is it so hard to review the Johnson & Johnson vaccine? Data.


“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.

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The Blue Technology Barometer 2022/23

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The Blue Technology Barometer 2022/23


Overall ranking

Pillars

Comparative

The overall rankings tab shows the performance of the examined
economies relative to each other and aggregates scores generated
across the following four pillars: ocean environment, marine activity,
technology innovation, and policy and regulation.

This pillar ranks each country according to its levels of
marine water contamination, its plastic recycling efforts, the
CO2 emissions of its marine activities (relative to the size
of its economy), and the recent change of total emissions.

This pillar ranks each country on the sustainability of its
marine activities, including shipping, fishing, and protected
areas.

This pillar ranks each country on its contribution to ocean
sustainable technology research and development, including
expenditure, patents, and startups.

This pillar ranks each country on its stance on ocean
sustainability-related policy and regulation, including
national-level policies, taxes, fees, and subsidies, and the
implementation of international marine law.

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Experts

MIT Technology Review Insights would like to thank the following
individuals for their time, perspective, and insights:

  • Valérie Amant, Director of Communications, The SeaCleaners
  • Charlotte de Fontaubert, Global Lead for the Blue Economy, World Bank Group
  • Ian Falconer, Founder, Fishy Filaments
  • Ben Fitzgerald, Managing Director, CoreMarine
  • Melissa Garvey, Global Director of Ocean Protection, The Nature Conservancy
  • Michael Hadfield, Emeritus Professor, Principal Investigator, Kewalo Marine Laboratory, University of Hawaii
    at Mānoa
  • Takeshi Kawano, Executive Director, Japan Agency for Marine-Earth Science and Technology
  • Kathryn Matthews, Chief Scientist, Oceana
  • Alex Rogers, Science Director, REV Ocean
  • Ovais Sarmad, Deputy Executive Secretary, United Nations Framework Convention on Climate Change
  • Thierry Senechal, Managing Director, Finance for Impact
  • Jyotika Virmani, Executive Director, Schmidt Ocean Institute
  • Lucy Woodall, Associate Professor of Marine Biology, University of Oxford, and Principal Scientist at Nekton
Back

About

Methodology: The Blue Technology Barometer 2022/23

Now in its second year, the Blue Technology Barometer assesses and ranks how each of the world’s largest
maritime economies promotes and develops blue (marine-centered) technologies that help reverse the impact of
climate change on ocean ecosystems, and how they leverage ocean-based resources to reduce greenhouse gases and
other effects of climate change.

To build the index, MIT Technology Review Insights compiled 20 quantitative and qualitative data indicators
for 66 countries and territories with coastlines and maritime economies. This included analysis of select
datasets and primary research interviews with global blue technology innovators, policymakers, and
international ocean sustainability organizations. Through trend analysis, research, and a consultative
peer-review process with several subject matter experts, weighting assumptions were assigned to determine the
relative importance of each indicator’s influence on a country’s blue technology leadership.

These indicators measure how each country or territory’s economic and maritime industries have affected its
marine environment and how quickly they have developed and deployed technologies that help improve ocean
health outcomes. Policy and regulatory adherence factors were considered, particularly the observance of
international treaties on fishing and marine protection laws.

The indicators are organized into four pillars, which evaluate metrics around a sustainability theme. Each
indicator is scored from 1 to 10 (10 being the best performance) and is weighted for its contribution to its
respective pillar. Each pillar is weighted to determine its importance in the overall score. As these research
efforts center on countries developing blue technology to promote ocean health, the technology pillar is
ranked highest, at 50% of the overall score.

The four pillars of the Blue Technology Barometer are:

Carbon emissions resulting from maritime activities and their relative growth. Metrics in this pillar also
assess each country’s efforts to mitigate ocean pollution and enhance ocean ecosystem health.

Efforts to promote sustainable fishing activities and increase and maintain marine protected areas.

Progress in fostering the development of sustainable ocean technologies across several relevant fields:

  • Clean innovation scores from MIT Technology Review Insights’ Green Future Index 2022.
  • A tally of maritime-relevant patents and technology startups.
  • An assessment of each economy’s use of technologies and tech-enabled processes that facilitate ocean
    sustainability.

Commitment to signing and enforcing international treaties to promote ocean sustainability and enforce
sustainable fishing.

About Us

MIT Technology Review was founded at the Massachusetts Institute of Technology in 1899. MIT Technology Review
Insights is the custom publishing division of MIT Technology Review. We conduct qualitative and quantitative
research and analysis worldwide and publish a wide variety of content, including articles, reports,
infographics, videos, and podcasts.

If you have any comments or queries, please
get in touch.

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What Shanghai protesters want and fear

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What Shanghai protesters want and fear


You may have seen that nearly three years after the pandemic started, protests have erupted across the country. In Beijing, Shanghai, Urumqi, Guangzhou, Wuhan, Chengdu, and more cities and towns, hundreds of people have taken to the streets to mourn the lives lost in an apartment fire in Urumqi and to demand that the government roll back its strict pandemic policies, which many blame for trapping those who died. 

It’s remarkable. It’s likely the largest grassroots protest in China in decades, and it’s happening at a time when the Chinese government is better than ever at monitoring and suppressing dissent.

Videos of these protests have been shared in real time on social media—on both Chinese and American platforms, even though the latter are technically blocked in the country—and they have quickly become international front-page news. However, discussions among foreigners have too often reduced the protests to the most sensational clips, particularly ones in which protesters directly criticize President Xi Jinping or the ruling party.

The reality is more complicated. As in any spontaneous protest, different people want different things. Some only want to abolish the zero-covid policies, while others have made direct calls for freedom of speech or a change of leadership. 

I talked to two Shanghai residents who attended the protests to understand what they experienced firsthand, why they went, and what’s making them anxious about the thought of going again. Both have requested we use only their surnames, to avoid political retribution.

Zhang, who went to the first protest in Shanghai after midnight on Saturday, told me he was motivated by a desire to let people know his discontent. “Not everyone can silently suffer from your actions,” he told me, referring to government officials. “No. People’s lives have been really rough, and you should reflect on yourself.”

In the hour that he was there, Zhang said, protesters were mostly chanting slogans that stayed close to opposing zero-covid policies—like the now-famous line “Say no to covid tests, yes to food. No to lockdowns, yes to freedom,” which came from a protest by one Chinese citizen, Peng Lifa, right before China’s heavily guarded party congress meeting last month. 

While Peng hasn’t been seen in public since, his slogans have been heard and seen everywhere in China over the past week. Relaxing China’s strict pandemic control measures, which often don’t reflect a scientific understanding of the virus, is the most essential—and most agreed-upon—demand. 

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Biotech labs are using AI inspired by DALL-E to invent new drugs

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Biotech labs are using AI inspired by DALL-E to invent new drugs


Today, two labs separately announced programs that use diffusion models to generate designs for novel proteins with more precision than ever before. Generate Biomedicines, a Boston-based startup, revealed a program called Chroma, which the company describes as the “DALL-E 2 of biology.”

At the same time, a team at the University of Washington led by biologist David Baker has built a similar program called RoseTTAFold Diffusion. In a preprint paper posted online today, Baker and his colleagues show that their model can generate precise designs for novel proteins that can then be brought to life in the lab. “We’re generating proteins with really no similarity to existing ones,” says Brian Trippe, one of the co-developers of RoseTTAFold.

These protein generators can be directed to produce designs for proteins with specific properties, such as shape or size or function. In effect, this makes it possible to come up with new proteins to do particular jobs on demand. Researchers hope that this will eventually lead to the development of new and more effective drugs. “We can discover in minutes what took evolution millions of years,” says Gevorg Grigoryan, CEO of Generate Biomedicines.

“What is notable about this work is the generation of proteins according to desired constraints,” says Ava Amini, a biophysicist at Microsoft Research in Cambridge, Massachusetts. 

Symmetrical protein structures generated by Chroma

GENERATE BIOMEDICINES

Proteins are the fundamental building blocks of living systems. In animals, they digest food, contract muscles, detect light, drive the immune system, and so much more. When people get sick, proteins play a part. 

Proteins are thus prime targets for drugs. And many of today’s newest drugs are protein based themselves. “Nature uses proteins for essentially everything,” says Grigoryan. “The promise that offers for therapeutic interventions is really immense.”

But drug designers currently have to draw on an ingredient list made up of natural proteins. The goal of protein generation is to extend that list with a nearly infinite pool of computer-designed ones.

Computational techniques for designing proteins are not new. But previous approaches have been slow and not great at designing large proteins or protein complexes—molecular machines made up of multiple proteins coupled together. And such proteins are often crucial for treating diseases.  

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