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May. 17, 2021 11:06AM EST
Sanofi, GSK COVID vaccine shows strong immune response in phase 2 trials
Sanofi and GSK announcedthis morning their COVID-19 vaccine candidate demonstrated a strong immune response in adults in a phase 2 clinical trial.
Why it matters: Sanofi and GSK say their recombinant protein-based vaccine candidate could ultimately serve as a universal COVID-19 vaccine booster, able to boost immunity regardless of the vaccination first received.
- It could also ultimately help ease the ongoing global supply needs for vaccines.
Details: Sanofi and GSK said the vaccine triggered an antibody response in 95% to 100% of all the trial participants, ages 18 to 95, who got the vaccine.
- The companies also observed a "high immune response after a single dose in patients" who previously recovered from COVID-19, which shows the vaccine has strong booster potential.
- It's a promising development after the companies had to delay their vaccine in December to improve immune response in older adults. Still, it's also important to point out this is a phase 2 clinical trial, a relatively small study with 722 volunteers in the U.S. and Honduras.
A global Phase 3 trial with more than 35,000 participants from various countries is expected to start in the coming weeks to test the efficacy of two vaccine formulations against variants, officials said.
- In parallel, the companies also plan to conduct booster studies.
- Should the candidate prove successful in clearing Phase 3 testing and other regulatory hurdles, officials said a vaccine could be approved by the end of 2021.
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May. 28, 2021 01:48PM EST
Biden's push for fiber revives a Google dream
President Biden's plan to boost broadband across the country could also be a boon to Google's internet ambitions.
Why it matters: Biden wants to invest billions in building "future-proof" networks to connect all Americans, using a technology that Google previously struggled to deploy widely.
What's happening: Biden's plan emphasizes building fiber and steering funding to community-owned networks to ensure widespread connectivity and increase competition. That generally aligns with Google Fiber's new approach of partnering with cities willing to do the bulk of the infrastructure work.
The big picture: Fiber-optic lines deliver broadband to residential homes at gigabit speeds — much higher than the current federal definition of broadband, 25 Mbps download/ 3 Mbps upload.
- Fiber installed directly to homes could close the digital divide in a more lasting way than technologies that aren't capable of the same speeds, but building fiber networks through rural terrain and sparsely populated areas is very expensive.
Catch up quick: In 2010,Google announced plans to build a 1-gigabit-per-second fiber network in trial locations, but in 2016 "paused" expansion to new cities.
What went wrong: Google quickly learned that building a fiber network can be a long and costly process.
- A big issue for the company was the bureaucratic slog of attaching their equipment to poles, which in some cases involved working with competitors to gain access.
What they're saying: "One of the things we've learned is building infrastructure is long, slow, extraordinarily expensive, and fundamentally different than writing code for a new Google product," John Burchett, Google Fiber head of policy, comms, and community affairs, told Axios. "We may have started this process with a little bit of naïveté about how quickly we could impact the world."
The pivot: Google Fiber, which is available in 16 cities, said in July that West Des Moines, Iowa, would be the first new city it enters.
- The city is building an open-access conduit network for use by multiple internet service providers, and Google Fiber will be the first tenant on the network.
- "This is all part of us looking for ways to move faster in an economically sustainable model," Burchett told Axios. "And hopefully show the industry that there is a way for new entrants in this market to compete."
By the numbers: A 2017 study from Paul de Sa, then the chief of the FCC's Office of Strategic Planning and Policy Analysis, found that it would cost $80 billion to subsidize a fiber network that would reach the 22 million locations that lacked high-speed internet access using 2015 data.
Cities that want to build their own networks could see funding from the Biden administration's infrastructure proposal.
- The White House points to studies that argue that community-run networks offer lower prices to consumers and that some of the fastest networks in the country are municipal-run or in cities partnering with providers to offer internet service.
- Google Fiber sees the administration's interest in city-run networks as a way for it to expand the West Des Moines model to other cities — with Google or another provider as a partner.
- "I think it's an opportunity for Google Fiber, but more importantly it's an opportunity for communities to figure out how best to meet their broadband needs, because we all can agree what we've got now isn't working," Burchett said.
Yes, but: Republicans on the Hill are opposed to city-run networks, which they argue can be poorly managed, and they worry the focus on fiber could lead to upgrading existing service rather than connecting Americans who lack any options.
Ting Internet, a fiber provider in 13 cities, said it works with cities that need broadband, but often builds and operates the networks itself.
- "There's not one model that will work for every place," Ting senior vice president Jill Szuchmacher, a Google Fiber alum, told Axios. "Some of our builds, we've built the network ourselves and operated it. Others, we've partnered with cities where they've they owned the network, or they build a network. It really will take creativity."
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Jun. 22, 2021 11:05PM EST
New memos show how top FDA officials thought slim evidence was enough for Alzheimer drug approval
FDA statisticians did not believe experimental Alzheimer's treatment Aduhelm proved that it could slow down the cognitive disease, but the top brass at the agency thought there was enough evidence to approve the drug anyway, according to internal documents released by the FDA today.
Why it matters: Outside experts almost unanimously voted down the drug, and the scientific community has blasted the FDA's approval of Aduhelm. But FDA leaders repeatedly cited "the urgent and unmet medical need" for Alzheimer's treatments.
The big picture: The conditional approval of Aduhelm is based on the theory "brain amyloid plaques" are major contributors to Alzheimer's, and therefore reducing those plaques will fight the disease. That theory is controversial and unproven.
- Memos from top FDA neurology officials and Peter Stein, director of FDA's Office of New Drugs, highlighted how Aduhelm reduced amyloid plaques in one of the main clinical trials, and that marker "is reasonably likely to predict clinical benefit."
- However, as Zach Brennan of Endpoints News pointed out, FDA officials are contradicting their own agency's 2018 guidance on Alzheimer's drug development, which says "there is unfortunately at present no sufficiently reliable evidence that any observed treatment effect on such biomarker measures," like lowering amyloid levels, "would be reasonably likely to predict clinical benefit."
- In a meeting this past April, five top FDA officials thought Aduhelm met the criteria for "accelerated approval," an option that FDA leaders told its outside expert panel was not up for consideration.
- Sylva Collins, the FDA's director of the Office of Biostatistics, "dissented on the approach, stating her belief that there is insufficient evidence to support accelerated approval or any other type of approval," according to one of the memos.
The bottom line: The FDA's decision to approve a drug that has not proven to work and has side effects like brain bleeds — and on a theory that goes against the agency's own guidance for evaluating Alzheimer's drugs — will have lasting financial and scientific repercussions.
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Jul. 03, 2021 11:00AM EST
The world's population growth is slowing, and that's OK
Population growth is continuing to slow in the U.S. and China — the world’s top two economies — but that’s not necessarily a bad thing.
Why it matters: While population trends can be difficult to change, there is unlikely to be a “point of no return" where they can't be reversed — if government leaders proactively address the foundational causes, like the burdens and costs of child care or fears of immigration.
- Population growth impacts economic growth because it can increase innovation, workers, and goods produced and consumed.
By the numbers: The United Nations projects that the world population will grow to 9.7 billion people in 30 years, from about 7.7 billion as of 2019.
- More than half of that growth will be concentrated in nine countries, including the U.S.
- Over the same time period, China will be one of 55 countries or areas where population is expected to decline by at least 1%.
- Globally, the number of young people entering their reproductive years now is larger than their parents’ generation — so even if the global level of fertility were to fall immediately to around two children per woman, births would still exceed deaths for several decades, according to the U.N.
Yes, but: “We focus way too much on the percent growth like quarterly GDP,” American Enterprise Institute adjunct fellow Lyman Stone tells Axios. “We should think about what people want. What level of immigration people want. What age would people like to die.”
- The U.S. is currently failing to achieve the average social preference across all three demographic trackers — immigration, life expectancy, and fertility are all trending down.
- “When pretty normal desires are not being fulfilled, that’s an indicator that society has a problem," Stone says.
Americans still want multiple children, but they’re worried about child care costs, their own student debt, a lack of family leave policies, and a pause in their careers.
- These concerns are also limiting family growth in China — on top of a severe gender imbalance caused by the country’s one-child policy and male child favoritism.
While Beijing has relaxed restrictions on the number of children families can now have in China, the new policy seeks more to bolster its workforce than to promote population. That’s because at the same time, the Chinese Communist Party is also raising the country’s retirement age, eliminating a key source of child care for Chinese families.
- In the U.S., President Biden’s plan to start sending monthly payments to families with children is seen as a way to recognize the young as a societal good, not private responsibility.
The big picture: Population is a measure of how many options people have for business partners, customers and romantic relationships — the numbers for which are all likely to improve with a larger society, says Stone.
- What also matters more than absolute population growth is the age distribution of population, especially for economic growth.
- “If you have a lot of young people and relatively fewer older adults, you basically get the distribution China had in 1990, which will guarantee a [large] labor force for economic growth,” says Emma Zang, assistant professor of sociology at Yale University.
- There’s no consensus on how many people the planet can support, since there’s no guarantee that populations will grow as projected or that people will consume food and energy in the same wasteful ways as they have.
The bottom line: If countries want population growth to pick up, leaders must first fix the underlying causes for a slowdown.
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