90% of China’s Sinovac employees, families took coronavirus vaccine: CEO

About 90% of Sinovac Biotech Ltd employees and their families have taken an experimental coronavirus vaccine developed by the Chinese firm under the country’s emergency use program, its chief executive said on Sunday.

The extent of inoculations under the emergency program, which China launched in July but has released few details about, points to how actively it is using experimental vaccines in the hopes of protecting essential workers against a potential COVID-19 resurgence, even as trials are still underway.

The program is intended for specific groups, including medical staffers and those who work at food markets and in the transportation and service sectors.

Sinovac, whose CoronaVac is in Phase 3 clinical trials and has been included in the emergency scheme, offered the candidate vaccine to approximately 2,000 to 3,000 employees and their families on a voluntary basis, CEO Yin Weidong told Reuters.

“As a vaccine developer and manufacturer, a new outbreak could directly impact our vaccine production,” Yin said on the sidelines of an international trade fair in Beijing, explaining why his company was included in the emergency program.

Data gathered from the program could offer evidence of the vaccine’s safety, but such data, which is not part of the registered clinical trial protocols, will not be used as main materials that regulators review in judging whether to approve the vaccine for commercial use, Yin said.

He said those who chose to be inoculated, including his wife and parents, had been informed of the potential side effects prior to taking the shot, and that its vaccine completing only early and mid-stage trials.

Yin, who also took the shot, said doctors asked about their health conditions before the vaccination, and the occurrence rate of adverse reaction among those vaccinated has been “very low”.

Side effects after taking CoronaVac include fatigue, fever and pain, with mostly mild symptoms, according to results of a mid-stage trial sponsored by Sinovac, involving 600 participants and published last month ahead of peer review. bit.ly/2GwIz9b

No vaccine has passed final, large-scale trials to prove it is effective and safe enough to protect people against the virus that has led to over 870,000 deaths globally.

https://www.reuters.com/article/us-health-coronavirus-vaccine-sinovac-ex/exclusive-90-of-chinas-sinovac-employees-families-took-coronavirus-vaccine-says-ceo-idUSKBN25X0BG

Baxter cut to Hold from Buy by Argus

https://finviz.com/quote.ashx?t=BAX

Pandemic Pushes Technology Revolution of the Roaring 2020s

In my August 12 newsletter, I discussed the technological innovations that drove the prosperity of the 1920s. Then I discussed the ones that are likely to do the same during the current decade:

“The awesome range of futuristic ‘BRAIN’ technological innovations includes biotechnology, robotics and automation, artificial intelligence, and nanotechnology. There are also significant innovations underway in 3-D manufacturing, electric vehicles [EVs], battery storage, blockchain, and quantum computing.”

In my 2018 book, Predicting the Markets, I observed:

“In the past, technology disrupted animal and manual labor. It sped up activities that were too slow when done by horses, such as pulling a plow or a stagecoach. It automated activities that required lots of workers. Assembly lines required fewer workers and increased their productivity. It allowed for a greater division of labor, but the focus was on brawn. Today’s ‘Great Disruption,’ as I like to call it, is increasingly about technology doing what the brain can do, but faster and with greater focus.”

The future is always coming, of course. However, the future is already here to a large extent. Consider the following awesome technologies that are just starting to proliferate in ways that should boost productivity and prosperity:

(1) Home-based work, education, and entertainment. The pandemic has transformed the way many people work, pursue an education, and get entertained. They can do all these activities from home because of technologies that allow them to carry on their lives over the Internet. When the pandemic is finally over, many people may go back to their old normal routines. Employers, however, may tell their employees to continue to work from home or closer to home in the suburbs. Reducing or eliminating commutes to work certainly increases productivity. It also cuts the costs of urban office space.

A recent study by the National Bureau of Economic Research compared employee behavior over two eight-week periods before and after shelter-in-place mandates were implemented. Looking at email and meeting metadata, the group calculated that the workday lasted 48.5 minutes longer, the number of meetings increased about 13%, and people sent an average of 1.4 more emails per day to their colleagues.

(2) Telemedicine. Telemedicine allows patients to visit with clinicians remotely using virtual technology. Innovative uses of telemedicine are increasing with advances in telehealth platforms and remote patient-monitoring technology. New mobile health apps and wearable monitoring devices help track a patient’s vitals, provide alerts about needed care, and help patients access their physician. Over the last few months, millions of people have relied on video or telephone calls to talk to their doctors.

During the coronavirus pandemic, the Centers for Medicare and Medicaid Services (CMS) has taken unprecedented action to expand telehealth for Medicare beneficiaries. On March 13, 2020, President Trump made an emergency declaration under the Stafford Act and the National Emergencies Act empowering CMS to issue waivers to Medicare program requirements to support healthcare providers and patients during the pandemic. One of the first actions CMS took under that authority was to expand Medicare telehealth on March 17, 2020, allowing all beneficiaries to receive telehealth in any location, including their homes.

Before the public health emergency, approximately 13,000 beneficiaries in fee-for-service Medicare received telemedicine in a week. In the last week of April, nearly 1.7 million did so. In total, over 9 million beneficiaries have received a telehealth service during the public health emergency, mid-March through mid-June, according to a July 15 HealthAffairs blog post.

(3) 6G. An August 21 article in SingularityHub, titled “6G Will Be 100 Times Faster Than 5G—and Now There’s a Chip for It,” reports the following:

“Though 5G—a next-generation speed upgrade to wireless networks—is scarcely up and running (and still nonexistent in many places) researchers are already working on what comes next. It lacks an official name, but they’re calling it 6G for the sake of simplicity (and hey, it’s tradition). 6G promises to be up to 100 times faster than 5G—fast enough to download 142 hours of Netflix in a second—but researchers are still trying to figure out exactly how to make such ultra-speedy connections happen.”

However, this technology probably won’t be available for prime time until 2030. For now, we’ll have to settle for 5G. The pandemic has slowed the rollout of 5G at the same time as it has increased the demand for the technology to facilitate working remotely by boosting data transmission speeds. Nevertheless, the rollout should continue during the second half of this year into 2021. When it becomes truly accessible, it promises to be more than 30 times faster than the average 4G download speed and to revolutionize self-driving cars, augmented reality, and the Internet of Things.

(4) Robotics, automation, and 3D manufacturing. The August 18 issue of National Geographic featured an article titled “The robot revolution has arrived.” The COVID-19 pandemic has significantly boosted the interest in having robots do more of what humans did before the health crisis. In many instances, it is simply the medically wise alternative to using infection-prone humans. The article reports:

“Already, in 2020, robots take inventory and clean floors in Walmart. They shelve goods and fetch them for mailing in warehouses. They cut lettuce and pick apples and even raspberries. They help autistic children socialize and stroke victims regain the use of their limbs. They patrol borders and, in the case of Israel’s Harop drone, attack targets they deem hostile.”

The pandemic disrupted global supply chains. One likely outcome is that manufacturers will increasingly explore ways to work with suppliers closer to home. Instead of just-in-time inventories, companies will be looking for ways to have just-in-case inventories available in the event of future supply disruptions. They are increasingly using 3D printers to produce parts on demand to the exact specification and in the exact numbers required—reducing wait time and safeguarding against external disruptions.

Robots, automation, and 3D printers are revolutionizing manufacturing. An August 21 article in engineering.com reports:

“Mighty Buildings claims to increase the efficiency and reduce the waste in building modern homes. Drawing from foundations in robotics, manufacturing and sustainability, Mighty Buildings’ goal is no less than the reimagination of the construction sector. The company uses a combination of 3D printing and prefab techniques to automate up to 80 percent of the building process for greater productivity. … According to the Oakland, Calif.-based startup, they can build a 350-square-foot studio unit in under 24 hours while using 95 percent fewer labor hours at twice the speed of traditional manufacturing methods.”

If one of the consequences of the pandemic is de-urbanization, there will be more suburbanites who will need to buy one or more cars to get around their small towns. The August 7 Forbes reports:

“A mass shift to single-occupancy vehicles is occurring nationwide according to new research from Cornell University, which poses a major traffic and pollution problem in many cities. The solution, according to today’s most influential automakers, is to accelerate the development of electric, driverless cars programmed by artificial intelligence.”

Volkswagen AG pledged more than a fifth of its vehicles will be electric by 2025, while investing 44 billion euros ($52 billion) on autonomous driving and “mobility services” by 2023.

By the end of the 2020s, autonomous drones carrying passengers and cargo could be as ubiquitous as in the old television cartoon The Jetsons. EHang, a Chinese company, reportedly is ahead of the pack with its autonomous aerial vehicle, or AAV. A user can summon an EHang drone using an app. The drone lands at a predetermined spot near the requested pick-up location. It can carry up to two passengers with a combined weight of under 440 pounds and travel up to 32 kilometers (22 miles) on a single charge.

(5) Batteries. The outlook for EVs and drones depends largely on progress made in increasing the capacity and service lives of large batteries while reducing their weight, as Jackie and I have often discussed in the past. The future may belong to solid-state batteries, which reportedly could be available by 2025. That’s the same year that the world’s biggest automakers plan to launch an array of new electric models.

Dr. Ed Yardeni

http://blog.yardeni.com/2020/09/the-future-is-coming-technology.html

Chance for a Covid-19 vaccine approval this fall — if it’s done right

There is growing concern that the Food and Drug Administration, under political pressure, could approve a Covid-19 vaccine before it has robust safety and efficacy data.

The consequences of such a decision could be significant, particularly if the vaccine is ultimately shown to be less effective than early data suggest. But an approval before the completion of large, Phase 3 trials does not have to be problematic. Experts aren’t ruling out the possibility that a vaccine could be cleared this fall if it is very effective.

“There are mechanisms by which products that have a good amount of data can be made available in a controlled way,” said Natalie Dean, an assistant professor of biostatistics at the University of Florida who specializes in vaccine study design.

But Dean also sees risks. 

“If you make a decision based on promising but not convincing data, and then you discontinue your randomization,” she said, “you discontinue your evidence-generating process. You can never go backward. You can never go back and generate your evidence.”

Here is how a fast approval might play out, if all goes well — and some warning signs that a science-based process is not being followed.

The FDA has laid out clear criteria for the full approval of a vaccine: It should reduce the rate of symptomatic Covid-19 disease by 50%. Equally important is that the data should suggest it’s highly unlikely that the vaccine could possibly be less than 30% effective. Any vaccine less  effective than that would be useless.

The agency also said that there should be safety data of a year or more for at least 3,000 patients. There’s no way to shorten that timeframe, and it is one of the reasons experts believe the FDA could grant a Covid-19 vaccine an emergency use authorization, rather than full approval. 

It’s also possible that the studies could be ended early based on an interim analysis of data. 

These early looks are handled by a data and safety monitoring board, or DSMB, that reviews the data from a study regularly to make sure that patients are not being endangered by side effects from the vaccine and that it’s still ethical to give a placebo. 

“At the end of the day, if things are done according to the tradition, the DSMB looks at the data intermittently and makes one of four determinations,” explained Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, which is working with Moderna and AstraZeneca on vaccine trials.

A study can be stopped because a vaccine is clearly effective; it can be stopped because  clinicians are seeing troubling side effects. The DSMB can recommend changes to a study. Or, as usually happens, it can do nothing.

“It’s up to the DSMB, in their judgment, to balance the safety issue, the efficacy issue, and the duration of the trial issue,” Fauci said. “And that’s the reason why they’re an independent group. They are not the company because obviously the company is going to want to get their product approved as quickly as possible.”

But there are also pre-set rules as to when a trial can be stopped. “The earlier you stop it, the higher the bar,” Fauci said.

Technically, the final decision about what to do rests with the companies that are developing the vaccines, Fauci said. But, he added, “it would be unusual for the company to do something completely dissociated from or at odds with the DSMB.”

How could these interim analyses play out? Each of the Phase 3 trials is enrolling at least 30,000 volunteers. It’s expected that the trials could need about 150 cases of Covid-19 to tell whether or not the vaccine is preventing disease. 

But the more effective a vaccine is, the more likely it is that the trial could be stopped at an interim analysis based on fewer cases. Because the studies are so big, this could happen very fast. Pfizer, which is conducting its study with partner BioNTech but not with NIAID, has said its first interim analysis will occur when 32 patients have developed Covid-19. That could happen as early as this month.

Is it likely the trial will be stopped that early? Probably only if the vaccine is extremely effective, with only a handful of patients in the vaccine group getting sick. 

Steven Nissen, a cardiologist at the Cleveland Clinic, thinks the trial shouldn’t be stopped so quickly, even if the DSMB has that option based on the efficacy data. He once ran a study of an obesity drug that was stopped — yielding unclear results — because the company funding the study improperly released an interim analysis.

“If I were designing this trial, and I knew you had to have full safety information, what is the value of the interim, exactly?” Nissen asked. “How do you help society with an interim if you can’t stop because you don’t know about safety?”

And if the DSMB thinks that it is ethical to keep patients on placebo, experts are firm that the results of these analyses should not be made public. 

“If you release an interim analysis that didn’t cross the threshold but the groups have started to diverge, chaos can [ensue],” said Dean. “People don’t know what to do with that information. And I don’t think people can use that information responsibly.” 

Side effects, she said, might be more apparent early on than many people expect, because with vaccines they usually occur within weeks of the administration of the shot. But she, too, hopes the DSMBs on these studies have the wherewithal not to rush.

“This is not a disease where you have to wait a decade to accrue the information you need,” Dean said. “You’d have to wait another month, or another week, and when you think about how long the rollout is going to take, that’s not going to be long.”

Luciana Borio, a former acting chief scientist at the FDA, said that in a public health emergency, “it may be reasonable” to deploy vaccines before all requirements for licensure have been met. She added:  “It would be completely unreasonable and wrong to prematurely deploy them before you have randomized controlled clinical trials and clear data that the vaccine is safe and effective.”

And, she said, the decisions must be based on science, and made by staff at the FDA, with input from its advisory committees. The design of the studies, she said, should be made public before results are released.

“I hope we see these decisions driven by the appropriate group of experts in a transparent fashion in our advisory committees, and not from the podium at the White House or in a phone call from the White House to the commissioner,” Borio said.

Experts see a chance for a Covid-19 vaccine approval this fall — if it’s done right

Amazon.com Bans Foreign Plant Sales to U.S. Amid Global Seed Mystery

Amazon.com Inc. is barring foreign sales of seeds into the U.S. after thousands of suspicious packets, many postmarked from China, arrived at households around the world this summer.

The move by Amazon comes as the mystery seeds led U.S. officials to raise alarms about the ease with which seed sales can occur on e-commerce sites, creating potential threats to U.S. agriculture.

Amazon informed foreign sellers that, effective Sept. 3, it would no longer allow the import of plant or seed products, according to an email viewed by The Wall Street Journal. The email said some overseas sellers would have their offers removed from Amazon the same day.

Amazon also updated its public rulebook to reflect the new policy, saying that importing seeds into the U.S., or the sale of seeds within the U.S. by non-U.S. residents, is prohibited.

On Saturday, a merchant based in East Asia who sells Chinese seeds to Amazon customers in the U.S. said that his product had been removed by Amazon.

In its email to foreign seed sellers informing them of its new policy, Amazon said the action was “part of our ongoing efforts to protect our customers and enhance the customer experience.”

A spokesperson for the company said Saturday in a statement: “Moving forward, we are only permitting the sale of seeds by sellers who are based in the U.S.” Sellers who don’t follow the company’s guidelines will be subject to action, including potential removal of their account, the spokesperson said.

The policy change comes as multiple agencies, including the U.S. Agriculture Department, U.S. Department of Homeland Security’s Customs and Border Protection, U.S. Postal Service and state departments of agriculture, are investigating the mysterious seed shipments.

In recent months, thousands of people around the U.S. received in the mail seeds they didn’t order. Most were postmarked from China, and the shipments were often marked as jewelry, toys or other goods. Canada and the U.K. have been among other countries experiencing the same phenomenon.

U.S. agriculture officials have said they are working with officials in China to determine who is sending the seed packages and to stop future shipments. China’s Foreign Ministry said in July that mailing labels on the seed packages were forged and that China had asked the U.S. to send packages for investigation.

The USDA says it has worked with e-commerce companies for years to ensure they include information about USDA regulations on their sites and to remove sellers that illegally shipped agricultural material, including seeds. Since the mysterious mailings, however, the USDA says it has ramped up this work.

“E-commerce has presented us with a unique challenge,” Osama El-Lissy, a deputy administrator for the USDA’s Animal and Plant Health Inspection Service, said in an interview on Wednesday. “These sellers must meet the U.S.’s regulatory requirements.”

Agriculture officials have been concerned the seeds could introduce invasive species, weeds, pests or diseases that might harm U.S. agriculture. On Wednesday, Mr. El-Lissy said the USDA had received nearly 20,000 reports from seed recipients and collected some 9,000 packages. The USDA has so far assessed more than 2,500 of those packages, he said.

Mr. El-Lissy said the USDA has identified several seeds of noxious weeds, called dodder and water spinach. The agency has also found diseases known to occur in China, called pospiviroid and spindle tuber viroid, in seeds, as well as a few pests of significance: an immature wasp and a larval seed beetle.

As it collects the seed packages, sent to people across all 50 states, the USDA has been routing them to botanists, who are examining the seeds to determine their species and whether any are on a federal list of noxious weeds, which are potentially harmful. Seeds may then be sent to a Maryland laboratory for DNA testing to determine whether they carry pathogens that can cause plant diseases.

Mr. El-Lissy said the findings to date haven’t sparked significant concern, or necessitated the enactment of a federal emergency-response plan. Still, he said, the USDA is very concerned about the potential that one or more of the seed packages could contain a threat to U.S. agriculture. The agency can take steps to increase pest surveillance and prepare to respond quickly should it detect something in an agricultural region or the environment, Mr. El-Lissy said.

Authorities say the exact purpose of sending the unsolicited seed packages remains unclear but that a leading explanation is that they are part of a “brushing scam.” In these scams vendors selling through online retailers like Amazon pay “brushers” to place orders for their products, shipping packages with low-value or no contents to strangers. Brushers then pose as the buyers and post fake customer reviews to boost the vendor’s sales, sometimes posting the reviews to other products.

Amazon reiterated its view Saturday that seed deliveries linked to its site were genuine orders delayed due to Covid-19 and not incidents of brushing. The company has been investigating any connection the platform might have to the packages and whether brushing is involved.

In addition to being useful in brushing, seeds are also highly lucrative as a genuine e-commerce product, according to sellers based in China and elsewhere in Asia. High margins make the seed business attractive to foreign sellers, as a seed packet that costs $1.50 to buy from Chinese suppliers can retail for around $10 on Amazon, one seller said. Shipping fees are negligible on the ultralight packages.

Amazon’s removal of seed offers is to take place in stages, per the Sept. 3 email to foreign seed sellers. Foreign merchants who ship their seeds directly to U.S. customers will have their offers removed immediately. Those who rely on Amazon to fulfill their orders — and have inventory stored in Amazon warehouses — will have their offers removed starting Sept. 30, according to the email.

https://www.marketscreener.com/quote/stock/AMAZON-COM-INC-12864605/news/Amazon-com-Bans-Foreign-Plant-Sales-to-U-S-Amid-Global-Seed-Mystery-31235263/