×
China

US Intelligence Officials Say Chinese Government Is Collecting Americans' DNA (cbsnews.com) 95

schwit1 shares a report from CBS News: The largest biotech firm in the world wasted no time in offering to build and run COVID testing labs in Washington, contacting its governor right after the first major COVID outbreak in the U.S. occurred there. The Chinese company, the BGI Group, made the same offer to at least five other states, including New York and California, 60 Minutes has learned. This, along with other COVID testing offers by BGI, so worried Bill Evanina, then the country's top counterintelligence officer, that he authorized a rare public warning. "Foreign powers can collect, store and exploit biometric information from COVID tests" declared the notice. Evanina believes the Chinese are trying to collect Americans' DNA to win a race to control the world's biodata. Jon Wertheim speaks to Evanina and others for an investigation into how personal data, particularly biodata, has become a precious commodity and in the wrong hands, poses threats to national security and the economy.
Government

Joe Biden Promotes 'Science Advisor' to US Cabinet-Level Position (apnews.com) 146

"President-elect Joe Biden announced Friday that he has chosen a pioneer in mapping the human genome — the so-called 'book of life' — to be his chief science adviser," reports the Associated Press, "and is elevating the top science job to a Cabinet position." Biden nominated Eric Lander, founding director of the Broad Institute of MIT and Harvard, who was the lead author of the first paper announcing the details of the human genome, as director of Office of Science and Technology Policy and adviser on science. He is the first life scientist to have that job. His predecessor is a meteorologist.

Saying "science will always be at the forefront of my administration," Biden said he is boosting the science advisor post to Cabinet level, a first in White House history.... "Elevating (the science adviser) role to member in the President's Cabinet clearly signals the administration's intent to involve scientific expertise in every policy discussion," said Sudip Parikh, chief executive officer of the American Association for the Advancement of Science, the world's largest general scientific society.

Biotech

Theranos Destroyed Crucial Subpoenaed SQL Blood Test Database, Can't Unlock Backups (theregister.com) 148

An anonymous reader quotes a report from The Register: Failed blood-testing unicorn Theranos trashed vital incriminating evidence of its fraud, prosecutors said on Monday. The imploded startup's extensive testing data over three years, including its accuracy and failure rate, was "stored on a specially-developed SQL database called the Laboratory Information System (LIS)," according to a filing [PDF] in the fraud case against Theranos's one-time CEO Elizabeth Holmes and COO Sunny Balwani. The database "even flagged blood test results that might require immediate medical attention, and communicated this to the patient's physician," we're told.

Theranos claimed to have perfected technology that would allow industry standard blood tests to be run at great speed and with just a drop of blood, revolutionizing the health industry, and causing the business to be valued at $10bn. The reality, however, was that for one set of tests, the failure rate was 51.3 per cent. What does that mean? Prosecutors explain: "In other words, Theranos's TT3 blood test results were so inaccurate, it was essentially a coin toss whether the patient was getting the right result. The data was devastating."

So devastating that the database was subpoenaed by a grand jury digging into fraud claims against Holmes and Balwani. But when investigators turned to take a copy of the database, guess what? From the filing: "On or about August 31, 2018 -- three months after a federal grand jury issued a subpoena requesting a working copy of this database -- the LIS was destroyed. The government has never been provided with the complete records contained in the LIS, nor been given the tools, which were available within the database, to search for such critical evidence as all Theranos blood tests with validation errors. The data disappeared."

Science

The First Pig-to-Human Organ Transplants Could Happen This Year (medium.com) 88

Every day in the United States, 17 people die waiting for a lifesaving organ transplant. To address this crisis, one biotech company is turning to an unlikely source: pigs. Maryland-based United Therapeutics says it plans to begin transplanting organs from genetically modified pigs into people as soon as this year. From a report: "We're right on that cusp. We're looking to get into humans within the next year or two," said David Ayares, PhD, in an exclusive interview with Future Human. Ayares is the chief scientific officer of Revivicor, a subsidiary of United Therapeutics that's developing the pigs. "We think we have the pig that is going to be what we bring forward into humans in 2021 or 2022." For decades, scientists have been hopeful that organs from other species could be used to replace faulty ones in humans, known as xenotransplantation. But animal organs trigger immediate and severe immune reactions when transplanted into humans.
Biotech

Can mRNA Biotechnology be Adapted to Improve Flu Vaccines and Fight Cancer? (reuters.com) 75

Reuters notes the "miraculous speed" of mRNA vaccines, while also calling it "a glimpse of what's possible if it can be applied post-pandemic to treat cancer or rare diseases."

The vaccine market alone is worth about $35 billion each year, and investors apparently believe mRNA companies will capture around two-third of that, leading market researcher Bernstein to evalaute the combined worth of mRNA companies at nearly $180 billion. The technology is the closest thing yet to making medicine digital. MRNA vaccines essentially inject genetic code that instructs a recipients' cells to construct a part of the virus. The body recognizes the produced protein as foreign and mounts a future immune response when exposed. Moderna and BioNTech's vaccines show the technology works fast. Vaccines typically take a decade to develop. They took less than a year...

The speed of mRNA therapeutics is a big advantage. For example, flu vaccines only reduce the risk of illness by up to 60% because makers must guess which strains will be prevalent each season. Sometimes they're wrong. Shaving months off means better guesses, and higher efficacy.

The bigger opportunity comes from the validation of the mRNA "platform". Instructing cells to produce desired proteins could lead to multiple advances. Perhaps they can instruct the body to more vigorously attack cancerous cells or repair damaged tissue. Producing missing proteins might fight inherited diseases...

Success against Covid-19 means these companies will be flush with cash from sales and attract partnerships and scientific talent. That should make 2021 a watershed.

Medicine

How the Bill and Melinda Gates Foundation Fought the Pandemic (fastcompany.com) 144

In a long article titled "Gates versus the Pandemic," Fast Company looks at the many mitigation efforts launched by the Bill & Melinda Gates Foundation.

- It's one of the largest funders of the World Health Organization.

- It's partnered with the governments of Norway and India, the World Economic Forum, and the research-charity Wellcome Trust to launch an important group called the Coalition for Epidemic Preparedness Innovations (CEPI).

And then Fast Company breaks down the specifics: - The Gates Foundation invested $52 million in a German mRNA startup named CureVac in 2015; a year later, it gave Massachusetts-based Moderna a $20 million grant to support its development of mRNA-based HIV therapeutics, which helped the company further its underlying platform that can also be used to make vaccines.

- The foundation made an initial equity investment of $55 million in BioNTech, another German startup working on mRNA technology, in 2019. (While the foundation typically makes grants, it sometimes invests in companies to negotiate terms that require a funded product be globally accessible and affordable.)

The goal of all of this spending, in part, was to encourage these companies to focus on mRNA vaccines for communicable illnesses. "If you're looking at where the money is," in medical funding, "it's in oncology and cancer immunotherapy," says Lynda Stuart, deputy director of vaccines and host-pathogen biology at the Gates Foundation. Without a push, companies working in the space "wouldn't necessarily gravitate to infectious disease vaccines."

As the virus was beginning to spread, the Gates Foundation encouraged its other vaccine development partners to turn to COVID-19.

- Researchers at Oxford University started work on a coronavirus vaccine made from a weakened, altered form of a chimpanzee cold virus, a platform that CEPI had supported for other vaccines such as MERS.

- Novavax, a biotech startup the foundation had previously funded, also entered the race to create a vaccine.

By October, more than 200 COVID-19 vaccines were in development, but only 11 had reached Phase III clinical trials (human efficacy tests, the last step before regulatory approval). Of those, four vaccine platforms — from Moderna, BioNTech, Novavax, and the University of Oxford — had received early backing from CEPI or the Gates Foundation. In November, BioNTech-Pfizer, Moderna, and Oxford-AstraZeneca all announced that their respective vaccines had proved highly effective in preliminary study results. On December 11, the FDA approved the BioNTech-Pfizer vaccine, which represents a huge victory for the Gates Foundation. (In addition, the foundation is funding contenders that are at an earlier stage of development, such as Icosavax's nanoparticle vaccine construct.)

"Without the efforts of the Bill & Melinda Gates Foundation, the Covid-19 crisis would almost certainly be worse," writes Fast Company. "But its extensive role raises questions about how much we rely on philanthropy."

Their article includes this quote from a Northeastern University law professor focused on intellectual property rights and universal access to treatments for HIV/AIDS and COVID-19. "A fundamental question is, Well, because you have the money, should you be able to control the architecture of global health?"

A former director of vaccine delivery at the Gates Foundation counters that "they add value in helping to design very effective programs."
Biotech

Boston Biotech Conference Led To 245,000 COVID-19 Cases Across US (cnn.com) 43

An anonymous reader quotes a report from CNN: A biotech conference in Boston last February that's already been flagged as a Covid-19 superspreading event led to at least 245,000 other cases across the US and Europe, a new genetic fingerprinting study shows. One single case seems to have been responsible for many of the other eventual cases, the team at the Broad Institute in Massachusetts reported. Their study finds two particular genetic fingerprints of viruses associated with the conference and then tracks those lineages across the US. One "was exported from Boston to at least 18 US states as well as to other countries, including Australia, Sweden, and Slovakia," the team, led by Bronwyn MacInnis, director of pathogen genomic surveillance at the Broad Institute, wrote in the journal Science.

One was especially bad. A virus carrying one mutation -- a small genetic change they've flagged as C2416T -- was apparently carried to the conference by a single person, and ended up infecting 245,000 people. A subset of the viral strain with a mutation known as G26233T ended up in 88,000 of these cases. "A single introduction had an outsize effect on subsequent transmission because it was amplified by superspreading in a highly mobile population very early in the outbreak, before many public health precautions were put in place," the team wrote. "While Massachusetts accounted for most early spread related to the conference, Florida accounted for the greatest proportion of cases overall," they added.

Biotech

Singapore Becomes First Country To Approve Lab-Grown Meat (cnn.com) 78

Singapore has granted San Francisco start-up Eat Just Inc. regulatory approval to sell its laboratory-grown chicken in the city-state -- the world's first government to allow the sale of cultured meat. CNN reports: The product, created from cultured chicken cells, has been approved as an ingredient in chicken bites following Singapore Food Agency (SFA) approval, Eat Just said Tuesday. Initially, the chicken bites will debut in a Singapore restaurant, with plans for wider expansion into dining and retail establishments in the country, Josh Tetrick, co-founder and CEO of Eat Just told CNN Business. The product will be priced at parity with premium chicken, he added.

The cultured meat is created in a bioreactor -- an apparatus in which a biological reaction or change takes place -- Eat Just said. It has a high protein content and is a rich source of minerals, according to the company, which plans to sell the product under the GOOD Meat brand. For now, with manufacturing hubs in Singapore and Northern California, the company only has approval to sell the meat in Singapore, but it hopes to expand sales of cultured meat -- including cultured beef -- into the US and Western Europe, Tetrick said.

Medicine

No One Who Got Moderna's Vaccine In Trial Developed Severe COVID-19 (sciencemag.org) 177

An anonymous reader quotes a report from Science Magazine: Continuing the spate of stunning news about COVID-19 vaccines, the biotech company Moderna announced the final results of the 30,000-person efficacy trial for its candidate in a press release today: Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago.

More impressive still, Moderna's candidate had 100% efficacy against severe disease. There were zero such COVID-19 cases among those vaccinated, but 30 in the placebo group. The company today plans to file a request for emergency use authorization (EUA) for its vaccine with the U.S. Food and Drug Administration (FDA), and is also seeking a similar green light from the European Medicines Agency. The data released today bolster an interim report from the company two weeks ago that only analyzed 95 total cases but produced similarly impressive efficacy. "I would still like to see all of the actual data, but what we've seen so far is absolutely remarkable," says Paul Offit, a vaccine researcher at the Children's Hospital of Philadelphia who is a member of an independent committee of vaccine experts that advises FDA.

United States

Experimental Antibody Treatment for Covid-19 Patients Wins 'Emergency Approval' in America (msn.com) 81

America's Food and Drug Administration granted emergency authorization Saturday to an experimental antibody treatment (for people already experiencing Covid-19), reports the Washington Post: The drug, made by Regeneron Pharmaceuticals, is designed to prevent infected people from developing severe illness. Instead of waiting for the body to develop its own protective immune response, the drug imitates the body's natural defenses. It is the second drug of this type — called a monoclonal antibody — to be cleared for treating covid-19. The FDA authorized Eli Lilly & Co.'s drug on Nov. 9.

Regeneron's drug is a cocktail of two monoclonal antibodies, called casirivimab and imdevimab. The FDA said in authorizing the cocktail that it may be effective in treating mild to moderate covid-19 in adults and children 12 or older, and is indicated for those at high risk of developing severe illness. Doctors hope the drugs will keep those patients from being hospitalized... Regeneron executives said on the company's earnings call in early November that they project having enough doses for 80,000 patients by the end of November, and 300,000 total doses by the end of January...

In a clinical trial, the Regeneron drug reduced hospitalizations or emergency room visits when given to people at high risk of developing severe disease. It was also shown to reduce the amount of virus in people's bodies... The safety and effectiveness of the drug will continue to be studied. It is not authorized for use in hospitalized patients... In a study published Oct. 28 in the New England Journal of Medicine, researchers said the Lilly cocktail lowered the risk of follow-up medical visits and reduced levels of virus in people with mild to moderate symptoms of covid-19.

The progress on monoclonal antibodies comes as pharmaceutical and biotech companies are racing to produce coronavirus vaccines... The antibody treatments can play an important role in making the disease less dangerous.

Medicine

Moderna Becomes Second Firm To Reveal Positive Results With Nearly 95% Protection In Trials (theguardian.com) 119

An anonymous reader quotes a report from The Guardian: More than 1 billion people could be immunized against coronavirus by the end of next year with shots from the first two companies to reveal positive results, after the latest vaccine was shown to be nearly 95% effective in trials. With the US's top infectious diseases official, Anthony Fauci, hailing "the light at the end of the tunnel", the US biotech firm Moderna announced impressive results for its mRNA vaccine on Monday, a week after interim results for a Pfizer/BioNTech vaccine showed 90% effectiveness.

The inclusion of high-risk and elderly people in the Moderna trial suggested the vaccine would protect those most vulnerable to the disease, said Peter Openshaw, a professor of experimental medicine at Imperial College London, who described the results as "tremendously exciting." Though it is more expensive, Moderna's vaccine could potentially provide a major advantage over Pfizer's, which requires ultracold freezing between -70C (-94F) and -80C from production facility to patient. Moderna said it had improved the shelf life and stability, meaning its vaccine can be stored for six months at -20C for shipping and long-term storage, and at standard refrigeration temperatures of 2C to 8C for 30 days. Moderna said it could potentially manufacture 1bn doses by the end of 2021, adding to a further 1.3bn from Pfizer/BioNTech in the same timeframe. Both vaccines require two doses and are due to be assessed by regulators in coming weeks.
Moderna is planning to apply to the FDA for emergency use authorization in the coming weeks. "The biotech company said it would have 20 million doses ready to ship in the U.S. before the end of 2020 and hoped to manufacture 500 million to 1 billion doses globally next year," reports The Guardian. It's not expected to be available outside the U.S. until next year.
Biotech

Researchers 3-D Print Biomedical Parts With Supersonic Speed (phys.org) 14

schwit1 shares a report from Phys.Org: Forget glue, screws, heat or other traditional bonding methods. A Cornell University-led collaboration has developed a 3-D printing technique that creates cellular metallic materials by smashing together powder particles at supersonic speed. This form of technology, known as "cold spray," results in mechanically robust, porous structures that are 40% stronger than similar materials made with conventional manufacturing processes. The structures' small size and porosity make them particularly well-suited for building biomedical components, like replacement joints.

The team's paper, "Solid-State Additive Manufacturing of Porous Ti-6Al-4V by Supersonic Impact," published Nov. 9 in Applied Materials Today. "If we make implants with these kind of porous structures, and we insert them in the body, the bone can grow inside these pores and make a biological fixation," Moridi said. "This helps reduce the likelihood of the implant loosening. And this is a big deal. There are lots of revision surgeries that patients have to go through to remove the implant just because it's loose and it causes a lot of pain." Moridi added: "We only focused on titanium alloys and biomedical applications, but the applicability of this process could be beyond that. Essentially, any metallic material that can endure plastic deformation could benefit from this process. And it opens up a lot of opportunities for larger-scale industrial applications, like construction, transportation and energy."

Businesses

McDonald's To Launch a Plant-Based Burger: The McPlant (usatoday.com) 113

According to USA Today, McDonald's has developed a new plant-based platform dubbed McPlant that will debut in markets around the world early next year. From the report: "McPlant is crafted exclusively for McDonald's, by McDonald's," Ian Borden, McDonald's international president, said at the investor meeting. "In the future, McPlant could extend across a line of plant-based products including burgers, chicken substitutes and breakfast sandwiches." The plant-based and chicken sandwich announcements were part of the company's new growth strategy called "Accelerating the Arches." The strategy includes a commitment to the core menu.

"There are other plant-based burgers out there, but the McPlant delivers our iconic taste in a sink-your-teeth-in (and wipe-your-mouth) kind of sandwich," McDonald's said in a blog post Monday. "It's made with a juicy, plant-based patty and served on a warm, sesame seed bun with all the classic toppings." Borden said some markets will test the burger next year. Whether or not the vegan-friendly burger will arrive in the U.S. and a potential timeline was not immediately known. "We are excited about the opportunity because we believe we have a proven, delicious-tasting product," Borden said. "When customers are ready for it, we will be ready for them."
Beyond Meat, a pioneer of plant-based meat substitutes, said it co-created the plant-based patty that will be part of the McPlant platform with McDonald's.
Biotech

Tesco, One of the World's Largest Supermarket Operators, Sets 300% Sales Target For Plant-Based Alternatives To Meat (theguardian.com) 126

An anonymous reader quotes a report from The Guardian: Tesco is to become the first UK retailer to set a sales target for plant-based alternatives to meat as it steps up efforts to offer shoppers more sustainable options. The UK's largest supermarket will on Tuesday commit to boosting sales of meat alternatives by 300% within five years, by 2025. Over the past year, demand for chilled meat-free foods -- the most popular line including burger, sausage and mince substitutes -- has increased by almost 50%, the retailer said. As a result, it is expanding into more categories and creating larger "centerpiece" dishes for two people as well as family-sized portions.

The target is part of a wider package of sustainability measures developed with its charity partner the World Wide Fund for Nature (WWF) to try to halve the environmental impact of the average UK shopping basket. Dave Lewis, who steps down as Tesco chief executive on Wednesday, said: "We know from tackling food waste that transparency and ambitious targets are the first steps towards becoming a more sustainable business." Among 11 new plant-based foods going on sale at Tesco this week are centerpiece dishes using the wheat protein favorite seitan as a meat substitute, including a beef-free joint and hunter's chicken-free traybake. Turkey-free crowns and vegan mince pies are launching in time for Christmas.

Medicine

Large Antibody Study Offers Hope For Virus Vaccine Efforts (apnews.com) 62

Antibodies that people make to fight the new coronavirus last for at least four months after diagnosis and do not fade quickly as some earlier reports suggested, scientists have found. From a report: Tuesday's report, from tests on more than 30,000 people in Iceland, is the most extensive work yet on the immune system's response to the virus over time, and is good news for efforts to develop vaccines. If a vaccine can spur production of long-lasting antibodies as natural infection seems to do, it gives hope that "immunity to this unpredictable and highly contagious virus may not be fleeting," scientists from Harvard University and the U.S. National Institutes of Health wrote in a commentary published with the study in the New England Journal of Medicine. One of the big mysteries of the pandemic is whether having had the coronavirus helps protect against future infection, and for how long. Some smaller studies previously suggested that antibodies may disappear quickly and that some people with few or no symptoms may not make many at all. The new study was done by Reykjavik-based deCODE Genetics, a subsidiary of the U.S. biotech company Amgen, with several hospitals, universities and health officials in Iceland. The country tested 15% of its population since late February, when its first COVID-19 cases were detected, giving a solid base for comparisons.
Medicine

Dozens of Scientists Around the World Are Giving Themselves DIY Coronavirus Vaccines (nypost.com) 143

schwit1 shares a report from the New York Post: As governments around the world scramble to approve a vaccine against the deadly coronavirus, an increasing number of scientists have started administering DIY vaccines to themselves and even their friends and family members. The methods, results, and claims have varied widely among the dozens of scientists around the world who have taken this unconventional route.

One such effort is by scientist Johnny Stine, who runs North Coast Biologics, a biotech company in Seattle. In June, Washington attorney general slapped Stine with a lawsuit for administering his DIY vaccine to San Juan Island Mayor Farhad Ghatan and around 30 people, charging them $400, the New York Times reported. Another vaccine effort going outside FDA approval is the Rapid Deployment Vaccine Collaborative, or RaDVaC, which has among its 23 collaborators Harvard geneticist George Church. Proponents have welcomed the idea of going outside the normal regulatory process, given the extraordinary circumstances of the pandemic. But critics say these DIY vaccines are not being put to the test of placebo-controlled studies and could have unforeseen negative consequences.

Medicine

Biogen Conference Likely Led To 20,000 COVID-19 Cases In Boston Area (bostonglobe.com) 35

schwit1 shares a report from The Boston Globe: A new study estimates the Biogen conference held at Boston's Marriott Long Wharf hotel in February played a far greater role in spreading the coronavirus than previously thought. The research team analyzed the genetic sequences of the virus that caused COVID-19 in the 772 patients, almost all from Essex, Middlesex, Norfolk, and Suffolk counties. By examining mutations in the genetic code that naturally occur as the virus makes copies of itself -- subtle changes that act like a passport stamp showing where the pathogen has been -- the sleuths identified more than 80 distinct SARS-CoV-2 genomes of viruses that infected the Boston area in the first five months of the year. Most of the viruses came from elsewhere in the United States and Western Europe, the scientists said. But one virus with a unique genetic signature had an outsize impact. Some 289 of the 772 patients, or more than a third, were infected with a virus traceable to the meeting held on Feb. 26-27 by Cambridge biotech Biogen.

In a remarkable sign of how the virus can spread unpredictably and take a disproportionate toll on society's most vulnerable members, the 289 conference-related cases included 122 people living in Boston-area homeless shelters and employees who work there, the study says. It's unclear what path the virus took to get there. By multiplying the proportion of conference-related viral genomes in each of the four counties by the total number of coronavirus infections in Essex, Middlesex, Norfolk, and Suffolk, the scientists estimate that 20,000 infections could be linked to the Marriott event. The study never mentions Biogen by name. It simply refers to an "international business conference held in Boston from February 26-27."
"We never would have knowingly put anyone at risk," it said in a statement. "When we learned a number of our colleagues were ill, we did not know the cause was COVID-19, but we immediately notified public health authorities and took steps to limit the spread."
Biotech

Ailing Scientist Hopes to Become the World's First Cyborg (ottawacitizen.com) 68

The Telegraph reports: Peter Scott-Morgan stands, wide-eyed and tearful. "Good. Grief." he says quietly. "I was unprepared for the emotion... It's quite extraordinary. It really is." Using an exoskeleton, Scott-Morgan is experiencing what it is like to stand for the first time in months after being diagnosed with motor neurone disease in 2017, the same incurable condition that killed scientist Stephen Hawking.

The remarkable step, however, is just the first in the 62-year-old's bold journey to control his disease by becoming the world's first, full-fledged cyborg. "Think of it as a science experiment," he laughs. "This is cyborg territory, and I intend to be a human guinea pig to see just how far we can turn science fiction into reality." Eventually, Scott-Morgan wants the exoskeleton to encase his upper body, giving him superhuman strength and the ability to tower above "flesh and blood" humans. A mind-reading computer will be plugged directly into his brain, expressing his thoughts almost instantly. Meanwhile, his paralyzed face will be replaced by a hyper-realistic avatar that will move in time with a speech synthesizer...

Scott-Morgan says he isn't deteriorating but becoming a new version of himself — one that will eventually pave the way for a breed of humans that can augment their capabilities using technology... Instead of answering a question by laboriously typing out individual letters using a gaze tracker, in a similar way to Hawking, he will rely on the AI to provide a full and instant response. Eventually, the machine will speak for itself using phrases it has learned from Scott-Morgan — crossing a controversial line in what it means to be human....

Someday, the scientist hopes he can exist completely outside his physical body, with his personality, traits and knowledge downloaded on to a machine.

Medicine

A New Lyme Disease Vaccine Is Showing Promise (iflscience.com) 31

An anonymous reader quotes a report from IFLScience: Promising results have come out of the only active clinical trial for a vaccine against Lyme disease. Valneva, a French biotech company, recently announced its first Phase 2 clinical trial has shown that its vaccine against Lyme disease is both safe and effective. The vaccine works by triggering the body's immune system to produce antibodies for the six common serotypes of the disease that are found in North America and Europe. It does this by introducing an isolated protein of the pathogen to the body, allowing the immune system to recognize and respond to the surface proteins found on the bacteria responsible for Lyme disease, Borrelia burgdorferi.

Over 570 healthy adults in the US and Europe were given one of two dose levels of the vaccine in three injections, while others were given a placebo as a control. Both groups that received the active dose were found to have produced a significant amount of antibodies against each of the six most prevalent Outer Surface Protein A serotypes of B. burgdorferi. [...] This new potential vaccine, known as VLA15, is currently the only active Lyme disease vaccine in clinical development. Back in 1998, the US Food and Drug Administration (FDA) approved a Lyme disease vaccine known as LYMErix. It was withdrawn from the market just three years later following doubts over its effectiveness and other contentions. Much of the controversy, however, was often said to have been kicked up by the anti-vaccination movement, which was growing in momentum at the time.

Medicine

COVID-19 Vaccines With 'Minor Side Effects' Could Still Be Pretty Bad (wired.com) 243

"The risk of nasty side effects in the Moderna and Oxford trials should be made clear now, before it ends up as fodder for the skeptics," argues Hilda Bastian, a former consumer health care advocate and a Ph.D. student at Bond University who studies evidence-based medicine. An anonymous reader shares an excerpt from her article via Wired: On Monday, vaccine researchers from Oxford University and the pharmaceutical company AstraZeneca announced results from a "Phase 1/2 trial," suggesting their product might be able to generate immunity without causing serious harm. Similar, but smaller-scale results, were posted just last week for another candidate vaccine produced by the biotech firm Moderna, in collaboration with the U.S. National Institutes of Health. [...] Back in May, a CNN report described the Oxford group as being "the most aggressive in painting the rosiest picture" of its product, so let's start with them. Just how rosy is the Oxford picture really? It's certainly true that this week's news shows the vaccine has the potential to provide protection from Covid-19. But there are flies in the ointment. After the first clinical trial for this vaccine began in April, for example, the researchers added new study arms in which people got acetaminophen every six hours for 24 hours after the injection. That's not featured in their marketing, of course, and I saw no discussion of this unusual step in media coverage in early summer. Newspapers only said the vaccine had been proven "safe with rhesus monkeys," and did not cause any adverse effects in those animal tests. It was a worrying signal though: How rough a ride were people having with this vaccine? Was the acetaminophen meant to keep down fever, headaches, malaise -- or all of the above?

The press release for Monday's publication of results from the Oxford vaccine trials described an increased frequency of "minor side effects" among participants. A look at the actual paper, though, reveals this to be a marketing spin that has since been parroted in media reports. Yes, mild reactions were far more common than worse ones. But moderate or severe harms -- defined as being bad enough to interfere with daily life or needing medical care -- were common, too. Around one-third of people vaccinated with the Covid-19 vaccine without acetaminophen experienced moderate or severe chills, fatigue, headache, malaise, and/or feverishness. Close to 10 percent had a fever of at least 100.4 degrees and just over one-fourth developed moderate or severe muscle aches. That's a lot, in a young and healthy group of people -- and the acetaminophen didn't help much for most of those problems. The paper's authors designated the vaccine as "acceptable" and "tolerated," but we don't yet know how acceptable this will be to most people.

There is another red flag. Clinical trials for other Covid-19 vaccines have placebo groups, where participants receive saline injections. Only one of the Oxford vaccine trials is taking this approach, however; the others instead compare the experimental treatment to an injected meningococcal vaccine. There can be good reasons to do this: Non-placebo injections may mimic telltale signs that you've received an active vaccine, such as a skin reaction, making the trial more truly "blind." But their use also opens the door to doubt-sowing claims that any harms of the new vaccine are getting buried among the harms already caused by the control-group, "old" vaccines.
What about the Moderna vaccine? "According to the press release from May, there were no serious adverse events for the people in that particular dosage group," reports Wired. "But last week's paper shows the full results: By the time they'd had two doses, every single one was showing signs of headaches, chills or fatigue; and for at least 80 percent this could have been enough to interfere with their normal activities. A participant who had a severe reaction to a particularly high dose has talked in detail about how bad it was: If reactions even half as bad as this were to be common for some of these vaccines, they will be hard sells once they reach the community -- and there could be a lot of people who are reluctant to get the second injection."

UPDATE 7/27/20: Slashdot interviewed Oxford Vaccine Trial participant Jennifer Riggins and asked what her reaction was to Wired's article. Riggins is an American technology journalist and marketer who's self-employed in London. Here's what she said:

"I think the article is a poorly written, poorly researched opinion piece. It says offering acetaminophen or paracetamol is unusual with vaccines. I'm a working mom with a three-year-old, and you are told to give them acetaminophen or paracetamol before all live vaccines as they can cause discomfort and fever for the first 24 to 48 hours.

"I'm actually surprised this article was in Wired that tends to be reputable. It seems to be written by a vaccine skeptic at best who knows little about them. This is a dangerous message because we most likely won't have a widely distributed vaccine til 2021 at earliest. Even longer if you consider, like the chicken pox vaccine, it needs a booster for efficacy. This flu season is going to be awful and then combined with this coronavirus. Add to that less kids are getting vaccinated or at least are delayed during the pandemic. Any antivaxxer message is incredibly dangerous. We won't be able to have herd immunity for Covid-19 by winter but we could for the flu which will save so many lives."

Slashdot Top Deals