The national news cycle may have largely moved on from coverage of the COVID-19 pandemic — despite, as of this writing, infections being on the rise and more than 300 deaths tallied daily from the disease. But that certainly doesn't diminish the unprecedented international response effort and warp speed development of effective vaccines. 

In The Messenger: Moderna, the Vaccine, and the Business Gamble That Changed the World, veteran Wall Street Journal reporter Peter Loftus takes readers through the harrowing days of 2020 as the virus raged across the globe and biotech startup Moderna raced to create a vaccine to halt the viral rampage. The excerpt below takes place in early 2021, as the company works to adapt its treatments to slow the surging Delta variant's spread.

Harvard Business Review Press

Reprinted by permission of Harvard Business Review Press. Excerpted from The Messenger: Moderna, the Vaccine, and the Business Gamble That Changed the World by Peter Loftus. Copyright 2022 Peter Loftus. All rights reserved.

Delta

Viruses of all types frequently change. They mutate as they jump from person to person. The coronavirus was no different. Throughout the pandemic, health officials tracked variants of the SARS CoV-2 virus first found in Wuhan, China, as those variants arose. None seemed a big concern, until one was flagged in the United Kingdom in December 2020, right as Moderna’s vaccine neared approval. This UK variant appeared to be as much as 70 percent more transmissible. It was given the name the Alpha variant.

Alpha reinforced the possibility that the virus could mutate enough to become resistant to vaccines and treatments that were designed to target the earlier, predominant strain. Or it could fizzle out. But variants would keep coming. Shortly after Alpha, researchers identified another variant circulating in South Africa. Beta.

In late December—just a few days after the United States authorized its vaccine — Moderna issued a statement that it was confident the vaccine would be effective at inducing the necessary immune response against variants. The original vaccine targeted the full length of the spike protein of the coronavirus, and the new variants appeared to have mutations in the spike protein that represented less than a 1 percent difference from the original.

“So, from what we’ve seen so far, the variants being described do not alter the ability of neutralizing antibodies elicited by vaccination to neutralize the virus,” Tal Zaks said during a virtual appearance at the all-important J.P. Morgan Healthcare Conference in January 2021. “My definition of when to get worried is either when we see real clinical data that suggest that people who’ve either been sick or have been immunized are now getting infected at significant rates with the new variants.”

Even if the vaccine proved less effective against a new variant, Moderna could use its mRNA technology to quickly tweak the design of its Covid-19 vaccine, to better target a variant of the virus, Zaks said. After all, the company and its federal health partners had already demonstrated the year before how quickly they could design, manufacture, and test a new vaccine.

Still, Moderna needed to run a series of tests to see if its original vaccine offered the same high level of protection against variants as it showed in the big Phase 3 clinical trial.

Moderna collaborated again with researchers from NIAID including Barney Graham and Kizzmekia Corbett. They analyzed blood samples taken from eight people who were vaccinated with Moderna’s shot in the Phase 1 trial back in early 2020. They essentially mixed these blood samples with the coronavirus variants, engineered so they copied the mutations of the variants but couldn’t replicate and pose a threat to lab researchers. Researchers then analyzed whether the vaccine-induced antibodies present in the human blood samples could effectively neutralize the virus variants.

The results were mixed. They suggested the vaccine worked as well against the UK Alpha variant as against the original strain of the coronavirus. That was good news. Even if the UK variant spread more easily than the original virus, Moderna’s vaccine could probably mute its effects.

But the Beta variant first identified in South Africa seemed to pose a problem. The vaccine-induced antibodies had a significantly reduced neutralization effect on this strain in the lab tests. “Oh shit,” Bancel said when Stephen Hoge showed him the data. It wouldn’t be the last time. Moderna’s leaders saw the data on a Friday in late January 2021 and spent the weekend discussing it. They hoped that a modified, variant- targeted vaccine wouldn’t be needed, and that Moderna’s original vaccine would suffice, even if it had a reduced neutralizing effect. But Moderna didn’t want to be caught flat-footed if a variant-specific booster was needed.

They decided by the next Monday it was time to take action. They would develop a new version of the vaccine, one that more closely matched the mutations seen in the strain that circulated in South Africa, and which could potentially be given as a booster shot to better protect people who had gotten the original vaccine.

“It really highlights the fact that we need to continue to stay vigilant,” Moderna’s president, Stephen Hoge, said. “This virus is evolving, it’s changing its stripes. And we need to keep testing the new variants, and make sure the vaccine works against them.”

Moderna repeated the steps it took a year earlier: it quickly designed a new variant vaccine and manufactured an initial batch for human testing, shipping it to NIAID in late February, a year to the day after it had shipped the original batch of the original vaccine. The new batch was called mRNA-1273.351, appending the “351” because researchers initially called the variant seen in South Africa “B.1.351.”

“Moderna is going to keep chasing the variants until the pandemic is under control,” Bancel said that day.

Moderna also developed other plans to test. It would try a third dose of its original vaccine, given several months after the second dose, to see if that booster shot would protect against variants. It would also develop a combined vaccine that targeted both the original strain and the Beta strain.

Once again, volunteers stepped up to test these various approaches. Neal Browning, the Microsoft engineer who was the second person to get Moderna’s vaccine, showed up once again to volunteer. In the intervening year, he had gotten married, in a small outdoor ceremony to minimize Covid risk. Now he received a third dose of the Moderna vaccine. He felt tenderness at the injection site and a low-grade fever and chills, but the symptoms went away after several hours. He continued to visit the research site to give blood samples to be analyzed for immune responses.

By early May, Moderna had some answers. It gave booster shots — either the original vaccine or the Beta variant – targeting vaccine — to people about six to eight months after they had been vaccinated with two doses of the original vaccine. The company found that in the new analysis, both types of booster shots increased neutralizing antibodies against the Beta variant. And they increased antibodies against a related variant that had been detected in Brazil. But the newer version of the vaccine that targeted Beta induced a stronger immune response against the Beta variant than the booster shot of Moderna’s original vaccine.

At the time, Moderna’s plan was to continue testing the different booster approaches, with an eye toward possibly getting government approval to sell the booster shot that specifically targeted the Beta variant. But it didn’t seem particularly urgent. The existing mass vaccination campaign was making good progress at the time.

Then, with the virus on the retreat in the United States, scientists discovered a new variant driving an alarming surge in India. This variant had already jumped to other countries, including the United States. Initially, it was code-named B.1.617.2. It was even more contagious than the Alpha variant and there were fears that it could evade vaccines. This was the Delta variant.

The previous winter the hope provided by vaccines was juxtaposed with the deadliest virus surge in the United States. Again, in early summer 2021, the lifting of mask mandates and reopening of public life was bringing great hope and a sense of relief. And again, this would be juxtaposed with public-health officials sounding the alarm about the Delta variant. It could become the dominant strain of the virus in the United States, they said. The best way to stop its spread, officials said, was to get more people vaccinated, with any of the three vaccines available.

By mid-June, about 55 percent of the US adult population was fully vaccinated, which was good but still left many people exposed to the new Delta variant that spread much more easily than earlier strains. And there were clear geographic vulnerabilities. The Northeast United States had higher vaccination rates than the national average, particularly in some New England states, like Vermont with its 62 percent vaccination rate. But in the South the numbers were much lower in states like Alabama, where only 30 percent were fully vaccinated.

The high proportions of unvaccinated people in those places would serve as a breeding ground for Delta. And the more the variant spread, the more it could mutate into more variants.

By late July, the effects of an ill-fated combination — stubbornly low vaccination rates in some regions, the winding down of masking and distancing, and a rapidly spreading Delta strain—were clearer. Infections, hospitalizations, and deaths were climbing again, especially in open states like Florida, which suffered one of the highest rates of Covid-19 hospitalizations, and low-vaccinated states.

Doctors and nurses who thought they had put the worst of the pandemic behind them were once again scrambling to treat severely ill Covid-19 patients in intensive-care units. By the end of August, the United States was averaging about fifteen hundred Covid-19 deaths a day, versus fewer than two hundred in early July. Nearly all of the patients who ended up in the ICU were unvaccinated.

Some vaccinated people were beginning to test positive for Covid-19, too — commonly called “breakthrough” cases—and a few progressed to severe cases. The vaccines, after all, weren’t 100 percent effective in the clinical trials, either. A small percentage of vaccinated people in the studies got sick with Covid. But it was becoming clear that the vaccines weren’t entirely blocking transmission of the virus or stopping asymptomatic infections, as initially hoped.

Vaccinated people were better protected than unvaccinated people, even when Delta took over. In states like Massachusetts, less than 1 percent of fully vaccinated people in the state had tested positive for Covid-19 by the fall of 2021. Other analysis showed that people who weren’t fully vaccinated were nearly five times more likely to get infected, ten times more likely to be hospitalized and eleven times more likely to die from Covid than fully vaccinated people.

But Delta reminded people, or made them understand for the first time, that the vaccines weren’t bullet-proof. New indoor mask mandates were imposed, including at schools, where educators just weeks earlier had been eager for the first normal back-to-school season in two years. No vaccine was yet authorized for children under twelve (both Moderna and Pfizer were studying that population), raising concerns that Delta would spread rapidly among them as they gathered in classrooms.

By the end of the summer, people wondered if the pandemic would ever end. Some started talking about the coronavirus as endemic, not a pandemic.

And a big slice of America was still saying “No thanks” to the vaccine.

Nike wants to make fitness apps accessible to more people with disabilities. The athletics gear maker has introduced adaptive workouts to the Nike Training Club app (available for Android and iOS) that you can perform whether or not you have a disability. The seven classes in this set target a wide range of movement and equipment, ranging from upper-body strength training with dumbbells to yoga.

A Nike athlete with limb loss, Amy Bream, leads all the classes. You'll also find guidance from an adaptive training-focused physical therapist. Training Club already offers an exercise program for expecting and recent mothers.

The company isn't alone in making these apps more accessible. Apple added Fitness+ workouts for pregnant people and seniors last year and has Apple Watch wheelchair workout tracking, for instance. Still, Nike's move is an important step that could bring exercise apps to a wider audience.  

A group of 411 TV showrunners, creators and writers sent letters to executives at streaming platforms and other major Hollywood companies to demand better protections for workers in anti-abortion states. "We have grave concerns about the lack of specific production protocols in place to protect those at work for Netflix in anti-abortion states," they wrote in a letter to Netflix. “It is unacceptable to ask any person to choose between their human rights and their employment.” 

Similar letters, which were first reported on by Variety, were addressed to the likes of Apple, Disney, Warner Bros. Discovery, NBC Universal, Paramount, Lionsgate, Amazon and AMC. The signatories include well-known creators, such as Issa Rae, Lilly Wachowski, Lena Waithe, Amy Schumer, Shonda Rhimes, Mindy Kaling, Ava DuVernay and Lena Dunham. They're demanding specific safety measures for people working on productions in states that have banned abortion after the US Supreme Court overturned Roe v. Wade last month.

The group has demanded that the companies respond with details on their abortion safety plans within 10 days. Among other things, the writers want information on abortion travel subsidies, medical care for pregnancy complications (including ectopic pregnancies) and legal protections for workers who uphold a studio's abortion policies or help someone else obtain an abortion. They also implored the companies to immediately halt “all political donations to anti-abortion candidates and political action committees."

A Bloomberg report this week noted that studios are spending billions on productions in states that have banned or restricted abortions, though many were already filming before the Supreme Court decision in late June. Georgia, for instance, offers generous tax credits to productions, which has helped the state become a TV and film powerhouse. Last week, a law came into effect in the state. It essentially banned most abortions after six weeks of pregnancy, which is before many people know whether they're pregnant.

Seventeen Republican attorneys general have urged Google not to limit the appearance of anti-abortion centers in search results. They made the demand a month after Democratic lawmakers asked the company to refrain from directing people who are looking up information on pregnancy terminations to such centers. The Republican AGs suggested that if Google obliges the request from the other side of the aisle, they may investigate the company and undertake legal action. "If you fail to resist this political pressure, we will act swiftly to protect American consumers from this dangerous axis of corporate and government power," they wrote in a letter to Google and Alphabet CEO Sundar Pichai.

Many of the so-called crisis pregnancy centers in question have religious affiliations, as the Associated Press notes. Some centers have been accused of providing misleading information about abortion and contraception. Following a leak of a draft opinion suggesting that the Supreme Court would overturn Roe v. Wade, a ruling that ensured the right to abortion nationwide (a move that the court took in late June), Democrats in the House and Senate introduced a bill that seeks to "crack down on false advertising that crisis pregnancy centers employ to dissuade patients from getting the reproductive care they need, including abortion care."

"Directing women towards fake clinics that traffic in misinformation and don't provide comprehensive health services is dangerous to women's health and undermines the integrity of Google's search results," the Democratic lawmakers wrote in their June 17th letter. They cited statistics indicating that a tenth of Google searches for terms like "abortion clinics near me" and "abortion pill" included results for anti-abortion centers.

The Republican AGs took issue with the Democrats' missive. They noted that crisis pregnancy centers often provide services like free ultrasounds, pregnancy tests, sexually transmitted disease testing and parenting classes. "These pregnancy centers serve women, no matter who they are or what they believe," they wrote. "These attacks threaten not only those affiliated with the centers, but also the mothers in desperate need of the assistance the centers provide."

The AGs noted Planned Parenthood has acknowledged that crisis pregnancy centers "have religious missions" and “are faith-based organizations that oppose abortion." They claimed ceding to the Democrats' request would "[reek] of religious discrimination."

They went on to state that if Google complies with "this inappropriate demand to bias your search results against crisis pregnancy centers," their offices would investigate the company for possible violations of antitrust and religious discrimination laws. The AGs would also "consider whether additional legislation — such as nondiscrimination rules under common carriage statutes — is necessary to protect consumers and markets." They gave Google 14 days to respond.

Engadget has contacted Google for comment. Google previously said it will delete abortion clinic visits from users' location histories. Meanwhile, YouTube today started removing videos with unsafe instructions on how to self-administer an abortion.

YouTube says it will remove content that offers instructions on unsafe abortion methods, as well as false claims about abortion safety. Such content violates the platform's medical misinformation policies. YouTube says it will start taking down those videos today and ramp up its efforts in the coming weeks.

Additionally, YouTube is adding an information panel under abortion-related videos and above associated search results. The panel includes context and information from local and global health authorities, the service said.

"Like all of our policies on health/medical topics, we rely on published guidance from health authorities," a tweet from the YouTube Insider Twitter account reads. "We prioritize connecting people to content from authoritative sources on health topics, and we continuously review our policies & products as real world events unfold."

YouTube is taking the step after the US Supreme Court overturned Roe v. Wade, a ruling that ensured the right to abortion in the country. Several states immediately moved to ban abortions after the court's decision in late June. 

The platform banned COVID-19 misinformation following the onset of the pandemic. By August 2021, it had taken down more than a million videos with dangerous COVID-19 misinformation. The following month, the platform banned content with vaccine misinformation.

Amazon has struck a deal to buy primary healthcare company One Medical for $3.9 billion. The provider offers in-person care at locations across the US, but perhaps of more interest to Amazon, it has digital and virtual care services. The companies said One Medical makes it easier for people to "schedule appointments, renew prescriptions, access up-to-date health records and advance health outcomes."

One Medical aims to "make quality care more affordable, accessible and enjoyable." It has 767,000 members, as CNBC notes, with 188 medical offices across 25 markets. The acquisition is subject to approval from One Medical shareholders and other closing conditions. One Medical CEO Amir Dan Rubin will remain at the helm after the deal is complete.

Amazon believes that "healthcare is high on the list of experiences that need reinvention," according to Neil Lindsay, senior vice president of Amazon Health Services. “We love inventing to make what should be easy easier and we want to be one of the companies that helps dramatically improve the healthcare experience over the next several years," Lindsay said in a statement. "Together with One Medical’s human-centered and technology-powered approach to healthcare, we believe we can and will help more people get better care, when and how they need it."

Over the last few years, Amazon has made a notable push into the healthcare market. It launched an app-based health service for its employees in 2019, which it later opened up to more companies. It also has a pharmacy service that delivers prescription drugs to Prime users within two days. The company opened Amazon Pharmacy two years after it bought online pharmacy PillPack. Last year, it announced a version of Alexa for healthcare providers.

Brain-computer interfaces have become a practical (if limited) reality in the US. Synchron says it has become the first in the country to implant a BCI in a human patient. Doctors in New York's Mount Sinai West implanted the company's Stentrode in the motor cortex of a participant in Synchron's COMMAND trial, which aims to gauge the usefulness and safety of BCIs for providing hands-free device control to people with severe paralysis. Ideally, technology like Stentrode will offer independence to people who want to email, text and otherwise handle digital tasks that others take for granted.

Surgeons installed the implant using an endovascular procedure that avoids the intrusiveness of open-brain surgery by going through the jugular vein. The operation went "extremely well" and let the patient return home 48 hours later, according to Synchron. An ongoing Australian trial has also proven successful so far, with four patients still safe a year after receiving their implants.

It may take a long time before doctors can offer Synchron's BCIs to patients. The company received FDA approval for human trials in July 2021, and it's still expanding the COMMAND trial as of this writing. Still, the US procedure represents a significant step toward greater autonomy for people with paralysis. It also represents a competitive victory — Elon Musk's Neuralink has yet to receive FDA permission for its own implant.

Earlier this summer, physicians at NYU Langone were able to successfully transplant pig hearts into two recently-deceased humans. The medical team performed the procedures on June 16 and July 6, using special pig hearts that were genetically modified to be more acceptable for transplantation into a human body. Both the bodies were donated by recently deceased individuals and were placed on ventilator support so the efficacy of the pig hearts could be measured more accurately.

The study arrives as the field of xenotransplantation — or the act of transferring organs from one species to another — is under increased scrutiny. The first person to undergo a pig heart transplant died earlier this year, of what scientists believe was an adverse reaction to a drug to prevent rejection. The heart also contained DNA associated with a pig virus. Since the incident, the medical community has called for more meaningful research on the subject, as well as better safety protocols. Meanwhile, the FDA is considering approval of clinical trials for pig heart transplantation in humans, the Wall Street Journalreported last month.

Both human subjects — a 72-year-old Navy veteran and a 64-year-old retired New York City teacher — were monitored for three days before being taken off life support. Neither heart needed any outside support and functioned normally, which researchers are seeing as a promising sign for future research. Despite the NYU experiment’s positive outcome, surgeons cautioned that much more research is needed before pig heart transplants can be a viable alternative for people with heart disease.

“This is not a one-and-done situation. This is going to be years of learning what’s important and what’s not important for this to work,” NYU’s Dr. Robert Montgomery told the Associated Press.

Owlet is giving tired parents new tools they can use to (hopefully) get little bit more sleep than what they're getting with a baby in the house. The company has launched the Owlet Cam 2, which uses AI and machine learning to decipher sounds from the nursery and determine whether the baby is truly crying. It sends parents notification through the Owlet Dream App when it detects sounds, motion or crying from the baby's room. The camera can also send parents video clips of sound and movement that they can watch on their phone anytime. 

The 1080p HD camera comes with the features its predecessor has, including 4x zoom, night vision, two-way talk and room temp reading. However, unlike the previous version that only comes in white, it's also available in Sleepy Sage, Dusty Rose and Bedtime Blue.

Owlet has also rolled out a new predictive sleep technology feature for its system that automatically tracks the baby's sleep and wake windows when used with the company's Dream Sock. As its name implies, it can predict when the baby might be ready for sleep and can let parents know through the Owlet app — it can even adjust the child's anticipated sleep window as they age. That way, parents can plan their own rest periods and other activities around the baby's sleep schedule.

Predictive sleep will be available to both new and existing Dream Sock users through a firmware update slated for release today. Those who don't have a Dream Sock can still take advantage of the feature, though, by manually adding sleep sessions through Owlet's app. 

The company originally sold its monitoring device as the Smart Sock, but it had to pull it from US shelves after getting a warning letter from the Food and Drug Administration (FDA). While the FDA did not identify any safety concerns, the agency argued that it should be classified as a medical device due to its heart rate and oxygen level monitoring features. Owlet stopped selling the sock in the US last year to pursue the authority to market those features as part of the device's offerings. But company made it available for purchase in the US again earlier this year under a new name: the Dream Sock.

The Owlet Dream Duo that bundles a set of socks with a second-gen cam is now available for $439, but those who already have socks can get the the second-gen cam alone for $159. In the US, buyers can purchase the devices from Owlet's website, as well as from retailers like Amazon, Target, Walmart and Best Buy.

In January, doctors at the University of Maryland School of Medicine made history by successfully transplanting a pig's heart into a human. The 57-year-old patient may have died two months later due to complications from the experimental procedure, but the case has inspired scientists throughout the medical field to call on the FDA to expand the scope and scale of human-porcine transplantation research. During a two-day conference in late June, policy advisors to the FDA and medical professionals discussed the future of xenotransplantation and "most attendees agreed that human trials are needed to help answer the most pressing research questions," according to Nature. 

We've been stuffing pig organs into sick people since the early 19th century, but the technology has made rapid strides in recent decades thanks in part to the advent of CRISPR technology and more potent immunosuppressives. In 2017, researchers created the first human-pig hybrid embryo as well as devised a solution to potential inter-species viral infections. As of January, 2022, were implanting genetically modified pig kidneys into brain-dead donor recipients with great success.

“Our goal is not to have a one-off, but to advance the field to help our patients,” Dr. Jayme Locke, lead surgeon of the kidney study and director of UAB’s Incompatible Kidney Transplant Program, told the NYT. “What a wonderful day it will be when I can walk into clinic and know I have a kidney for everyone waiting to see me.”

Humans have also conducted numerous experimental pig-organ transplants into primates like baboons. But in order to safely and consistently do it with humans, researchers will have to test the techniques on humans, Caroline Zeiss, a veterinary specialist at Yale School of Medicine, told Nature. For example, doctors found traces of porcine cytomegalovirus (PCMV) in the heart transplant patient who died earlier this year and believe that it may have played a role in his demise, but they won't know for sure without further tests that a primate model — ones that can't be replicated in primates.

Researchers are only looking at “small, focused” clinical trials with “appropriately selected patients,” Allan Kirk, a transplant surgeon at the Duke University School of Medicine, told Nature. Researchers will have to answer a number of fundamental questions before the technology can be widely utilized, as well as determine the right mix of breeding and genetic tinkering needed to ensure that recipients' bodies won't reject them.

And while the decisions made during last week's meeting may not have an immediate impact on the agency's current stance on xenotransplantation, changes are reportedly afoot. The WSJ spoke to a "person familiar with the matter" at the end of June who asserts the FDA is planning to launch pig-organ transplantation trials in an effort ease the shortage of transplantable human organs (*angrily shakes fist at seatbelts*). There's no word on when such trials would launch as they are being handled on a case-by-case basis, the source said.