After 38 years as the head of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci announced on Monday that he will be stepping down from his role in December. Appointed to the position in 1984 by then-president Ronald Reagan, Fauci has personally overseen the federal government’s response to some of the 20th century’s deadliest infectious diseases — from tuberculosis and COVID to SARS and MERS.

But, as he told The Guardian in 2020, “my career and my identity has really been defined by HIV.” The prevention and treatment of HIV has been a prioritized area of research for the NIAID since 1986, and one that Dr. Fauci has devoted much of his public service to. The current state of AIDS research and response in America is thanks in no small part to his continued efforts in the field.

The NIAID is one of 27 specialized institutes and centers that make up the National Institutes of Health (NIH), which in turn reports to the Department of Health and Human Services. The NIH overall serves as the federal government’s premiere health research program. The NIAID operates within that bureaucratic framework, conducting and supporting “basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases,” per its mission statement. That includes everything from working to mitigate effects of the annual influenza strain and alleviate asthma in urban youth to leading the development of an effective vaccine against COVID-19. The technology behind that vaccine is now being adapted for use against HIV and malaria as well.

Working at the forefront of immunoregulation research in the early 1980s, Fauci developed treatments for a class of otherwise-fatal inflammatory diseases including polyarteritis nodosa, granulomatosis with polyangiitis (formerly Wegener's granulomatosis) and lymphomatoid granulomatosis. The results of those studies helped lay the groundwork for today’s research by the NIAID’s Laboratory of Immunoregulation. That research includes cellular and molecular mechanisms of HIV immunopathogenesis and the treatment of immune-mediated diseases. Combining the institute’s nearly four decades of HIV/AIDS research with cutting edge genomic technology has brought us not one, but three potentially viable AIDS vaccines, all of which are currently in clinical trials.

“Finding an HIV vaccine has proven to be a daunting scientific challenge,” Dr. Fauci said in a March NIAID release. “With the success of safe and highly effective COVID-19 vaccines, we have an exciting opportunity to learn whether mRNA technology can achieve similar results against HIV infection.”

The active, hands-on approach we see in response to the AIDS epidemic today is a far cry from that of the Reagan administration at the start of the crisis in 1983, which initially met the issue with silence. That is, outside of the time Larry Speakes, Reagan's press secretary, called it “the gay plague.”

Fauci’s initial efforts during the AIDS epidemic did more harm than good. In 1983, he published The Acquired Immune Deficiency Syndrome: The Ever-Broadening Clinical Spectrum in which he warned of “the possibility that routine close contact, as within a family household, can spread the disease.” We know now that this is not at all how HIV works, but at the time — despite the study urging caution until more evidence was gathered — it set off a moral panic in the media. The study was subsequently picked up by right-wing organizations and used as a political cudgel blaming the LGBTQIA+ community for the disease.

Reagan himself didn’t publicly mention the crisis until 1985, three years after it was officially identified by the CDC (and, coincidentally, a month after he admitted his involvement in the Iran-Contra Scandal). Social stigma around the disease made funding for basic health research nearly impossible to acquire, and was exacerbated by Reagan’s repeated budget cuts to the NIH and CDC.

"The inadequate funding to date has seriously restricted our work and has presumably deepened the invasion of this disease into the American population," a CDC staffer wrote in an April, 1983 memo to then-Assistant Director, Dr. Walter Dowdle. "In addition, the time wasted pursuing money from Washington has cast an air of despair over AIDS workers throughout the country."

Even after his appointment as Chief Medical Officer — one who was determined to treat the AIDS crisis with its deserved gravity — Fauci faced pushback from the LGBTQIA+ community, who demanded greater action from the government in response to the crisis and sought to accelerate the glacial pace of drug trials at the time.

By 1990, the community’s patience had reached a breaking point, resulting in ACT UP’s (AIDS Coalition to Unleash Power) attempt to storm the NIH in protest. “One of the things that people in ACT UP said is that we are the people who are experiencing this novel disease, and we are the experts, not just the scientists and doctors,” Garance Ruta, executive director of GEN magazine and an ACT UP member at the protest, told The Washington Post in 2020.

“I was trying to get them into all the planning meetings for the clinical trials,” Fauci told WaPo, in response. “I felt very strongly that we needed to get them into the planning process because they weren’t always right, but they had very, very good input.”

Over the last 30 years, the NIH has helped lead development of numerous antiretroviral therapies. Azidothymidine (AZT), the first drug discovered to inhibit HIV’s replication without damaging cells, was initially developed by the NIH as an anti-cancer drug in the 1960s. Its use as an antiretroviral, approved by the FDA in 1987, helped to establish the AIDS Clinical Trials Group (ACTG), which further accelerated research into nucleoside reverse transcriptase inhibitors (NRTIs, the class of drug to which AZT belongs). NIAID-funded studies in the 1990s helped establish combination therapies, which combine multiple medications for a synergistic effect, and explored a newly-identified class of drug, non-nucleoside reverse transcriptase inhibitors or NNRTIs.

NIAID

Today, nearly three dozen antiretroviral drugs are available, many of them combined into fixed-dose tablets. In the 1990s, people living with AIDS would be expected to take up to 20 individual pills at set schedules throughout the day. The average lifespan for someone infected with the disease was roughly a year. Today, assuming you’re lucky enough to live in the developed world, AIDS has become a chronic condition to be controlled with a single daily pill. For the 20 million people living with AIDS but without access to modern treatment, it remains a death sentence.

The state of medical research technology has also evolved, even if the nation’s prevailing notions of fairness and equality haven't improved much in the intervening years since Reagan held power. Advances in laboratory standardization and automation have rapidly reduced development cycles and the occurrence of outlier results. The monotonous tasks that were once performed by lab assistants are now handled by robotic arms equipped with pipette arrays.

Disease prevention and diagnosis efforts have been augmented in recent years with artificial intelligence and machine learning algorithms. They’ve also found use in helping to stem the spread of HIV and improve access to both retrovirals and PReP with applications including, “ML with smartphone-collected and social media data to promote real-time HIV risk reduction, virtual reality tools to facilitate HIV serostatus disclosure, and chatbots for HIV education,” argue Drs. Julia Marcus and Whitney Sewell, of Harvard and UMass Amherst, respectively.

And just as Dr Fauci is, quite specifically, not retiring — “I want to use what I have learned as NIAID Director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats,” he noted in Monday’s announcement — the work of the NIAID is far from complete. Even as we slowly conquer existing scourges like COVID and HIV, re-emerging threats like Monkeypox (not to mention ancient killers like Polio) will continue to appear on our quickly warming planet.

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.

Watching TV with hearing aids is about to get a little easier for Amazon Fire TV Cube owners. The second generation of the Fire TV Cube will now support Audio Streaming for Hearing Aids (ASHA) for compatible Bluetooth-enabled Starkey hearing aids. While the ability to stream TV audio to hearing aids has been around for a while, it normally requires an additional third-party device. Not all smart TVs support Bluetooth, so many hard-of-hearing users are forced to connect their hearing aids to their smartphone or a special adapter. But Fire TV will now allow users to directly pair their hearing aids with the streaming box.

ASHA (which is a Google-led initiative) has been available for Bluetooth devices since 2020. Fire TV Cube will be the first streaming device in the US to support ASHA, but it’s a safe bet to say more platforms will be on board in the future.

In order to pair their hearing aids to their Fire TV Cube, users should select “Settings” from Fire TV’s home screen. Users should then select “Accessibility”, followed by “Hearing Aids” and follow the on-screen instructions to pair them.

One drawback to relying on Bluetooth is viewers must remain within a 10-feet distance to still pick up Fire TV’s signal. Amazon recommends that viewers connect over their hearing aids over a 5Ghz wifi network, within 10 feet and in line of sight to Fire TV Cubes. Viewers with 2.4GHz wifi can still connect to Fire TV, but should keep in mind that the strength of their signal will vary depending on spectrum congestion.

In the world of hearing aids, Eargo stands out for a few reasons. Not least because of its different approach, but also because of its rapid, annual release cycle. It’s all part of how Eargo operates more like a technology company instead of a stuffy medical-device provider. This year’s model? It’s number 6, and it’s not a huge leap from last year’s, but it’s still a notable one. One that pushes Eargo ever nearer to feature parity with the competition it seeks to outdo while maintaining its tiny, tiny form factor.

It’s that form factor that is both beneficial and binding. To be clear, “invisible in canal” (IIC) hearing aids are not unique to Eargo, but they do tend to come with tradeoffs such as no Bluetooth connectivity, reduced battery life and, of course, a lack of on-device controls (such as volume). To Eargo’s credit, it has found ways to sidestep most of these challenges with each new product, and this time it’s automatic profile switching – dubbed “Sound Adjust” — that gets crossed off the list of things that an Eargo can’t do.

First, a reminder of some of the things previous models could already do. Despite their size you can configure Eargos via the companion app. Initially, this was limited to placing them in the (Bluetooth-enabled) charging case, but newer models can be adjusted while wearing them thanks to the clever use of ultrasonic commands. You can also switch preset profiles using a gesture (double-tapping your tragus). All Eargos are also rechargeable with a charging case so you don’t need to fiddle with batteries.

More recently, since last year’s model, you’ve been able to customize the audio profile of the hearing aids to match your own unique hearing needs, which is perhaps the most significant update for most people. As a direct-to-customer product there’s usually no audiologist fitting these for you, so the app-based process goes a long way to eliminating that rather obvious negative and probably also does a good job of convincing fence-sitters that these are serious hearing aids and not fancy personal amplifiers (all Eargo products have been FDA approved hearing aids).

James Trew / Engadget

When it comes to testing out the new Sound Adjust feature it’s not quite as simple as monitoring the companion app and watching it update as a profile changes. Thanks to how the Eargos communicate with the app (via the aforementioned ultrasound) the phone needs to be very close to the hearing aids with the volume up (above 75 percent) for it to make changes. Of course, that’s just one way. Right now, there’s no real way for the buds themselves to communicate back to the app. So how do we know when the hearing aids change modes?

As a crude test I left the Eargos on the “Normal” preset and then simulated a noisy room by playing some restaurant sounds over a nearby speaker. I can’t be certain what changes the device made, but compared to the same test wearing the previous model (without Sound Adjust) the noise did seem less jarring. The sharp sound of cutlery against plate was more pronounced in the older model than it was in the Eargo 6.

There is another, perhaps more immediately observable difference this time around and that’s the noise reduction, which seems much improved. As before you can decide how much noise reduction to apply from three different settings (low to high) or disable it if you prefer. It’s not obvious how much this feature impacts the battery life. I was able to get a full day’s use out of them with it activated and room to spare, so I don’t see why you wouldn’t use it — it really does make the hearing experience more natural.

These new features definitely add some finesse to the whole experience. They're also more practical updates, too. There’s a new “mask mode” which, and I mean this optimistically, I hope doesn’t remain useful for much longer but it’s there nonetheless. Another practicality is that the Eargo 6 is rated IPX7 for water resistance: finally, you can take a shower with these things in. With water-resistant earbuds/headphones, stepping into the shower with them on is a novelty, but with a hearing device you want to put on forget about, not having to remove them for a shower just gives you one less thing to worry about.

All these new changes increase the viability of the Eargo 6 as a replacement for whatever legacy device you might be using currently. Or, if you sense you could benefit from hearing assistance but the thought of a trip to the audiologist or haggling with insurance has been putting you off, these are about as easy an option you can find.

James Trew / Engadget

I do wish they were a little more comfortable for extended use. In general, they are fine – even for all-day wearing. But some days, my ears can feel a little more blocked than others and when this happens, I can sense some fatigue after a couple of hours with the Eargo inside. This can be further aggravated by eating, which reminds you how connected many of the muscles in our jaw and ear are.

It would also be nice to know when the Eargo have reached their maximum or minimum volume. There are controls in the app for adjusting them together and separately (perfect for my unilateral hearing loss) but I never know when it’s at maximum, so I end up either over pressing the “+” sign to make sure I must be at max when some simple feedback could just solve the mystery. This is obviously a minor nitpick, though it can be useful for helping to get the balance right to avoid going so loud as to create feedback, which does occur at higher volumes (on most hearing aids).

As always, if these sound like they might be helpful to you, you can buy them directly from the Eargo website for $2,950 (financing is available). As to whether this could be covered by your insurance, that’s less clear/something you’ll need to confirm with your provider.

Jabra announced its Enhance Plus earbuds back in August, debuting a model that offers assistance to people with mild-to-moderate hearing loss. At the time, the company also announced that it would sell it directly to customers as a FDA-cleared self-fitting hearing aid. Later this month, Jabra will do just that. On February 25th, the company says you'll be able to purchase the Enhance Plus from select hearing care clinics for $799. 

The earbuds put "medical-grade hearing enhancement" inside a more approachable form factor that looks like a set of regular earbuds. Jabra says this device is also quite compact, 40 percent smaller than the company's Elite 7 Pro which are already very small. The Enhance Plus can be customized to fit the user's needs, including three speech filters and three listening modes. The earbuds not only help with in-person conversations but also offer the ability to take calls and listen to music — the core features of any set of earbuds. 

Four microphones work to reduce background clamor while improving the overall clarity of speech according to Jabra, so they're suitable for use in noisy settings. The company says you can expect up to 10 hours of battery life with an additional two full charges in the included case. The earbuds are also IP52 rated dust and water resistant and are equipped with on-board controls for basic functionality. 

Jabra says the Enhance Plus have FDA 510(k) clearance as a self-fitting hearing aid. This means that it will be available direct to consumers as an over-the-counter device inline with the agency's pending regulation that expands access to hearing assistance products by creating a new hearing aid category. Jabra isn't the only company with devices that fit the FDA designation for OTC products. Another example is Bose's SoundControl hearing aids, which have been available nationwide in the US for $850 since last summer. Those, however, look more like traditional hearing aids rather than earbuds. 

For now, state law may require a hearing test to make sure the Enhance Plus is right for you. If it is, the set will be available in grey and beige color options when it goes on sale later this month. 

Moderna has begun early-stage clinical trials of an HIV mRNA vaccine, the company announced this week. On Thursday, it administered the first doses of a shot it co-developed with the International AIDS Vaccine Initiative to volunteers at the George Washington University School of Medicine and Health Sciences.

Like the company’s COVID-19 vaccine, the new treatment uses messenger RNA to “trick” the human body into producing proteins that will trigger an immune response. Moderna hopes the shot will induce a specific class of white blood cells known as B-cells, which can then turn into broadly neutralizing antibodies. Those proteins are “widely considered to be the goal of HIV vaccination, and this is the first step in that process,” according to the company.

As part of the trial, Moderna plans to test both a primary vaccine and a booster shot. The Phase 1 trial will involve 56 healthy, HIV-negative adult participants. The company will give 48 of those individuals the mRNA vaccine. Thirty-two of that group will also receive the booster shot. To the final eight involved in the first trial, the company will only administer the booster shot. Moderna says it will then monitor the entire group for six months to gauge the safety of the vaccine. It also plans to examine the immune response the vaccine triggers at the molecular level to determine if it’s effective.

Messenger RNA technology could lead to treatments for a host of deadly diseases, including malaria, but a breakthrough against HIV would be particularly noteworthy. According to statistics from the US government, approximately 1.2 million Americans have the virus, which can lead to the deadly AIDS disease. While outcomes for HIV patients have improved significantly since the ‘90s thanks to the development of new treatments and medication, no HIV vaccine has successfully passed early clinical trials.

The FDA has issued an emergency authorization Pfizer's antiviral pill Paxlovid, making it the first oral method for treating mild to moderate cases of COVID-19. The treatment is meant for high-risk people 12 and older who could progress to a more serious COVID infection. The best part? The FDA says it could be available to use within a few days, making it another tool as we face the Omicron variant wave.

Paxlovid is available by prescription only, and it's meant to be taken within five days of first noticing COVID symptoms. According to Pfizer's tests, it can prevent hospitalization or death by 88 percent in high-risk patients. The treatment, which can be prescribed to both vaccinated and unvaccinated people, consists of 30 pills taken over five days. It includes the protein inhibitor nirmatrelvir and rotinavir, which keeps that inhibitor from breaking down in your body. Side effects include an impaired sense of taste, high blood pressure, diarrhea and muscle aches. 

“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19," Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

So far, the US has ordered enough pills to treat 10 million people, the New York Times reports. The company plans to deliver enough pills to cover 65,000 Americans within a week. And after that, production is expect to ramp up, with 150,000 courses delivered in January and 150,000 in February. It also won't be the only antiviral pill around: Merck's competing treatment is expected to be approved soon, and it'll likely be more readily available than Pfizer's. Merck's option is far less effective, though—tests show it can only prevent hospitalization or death by 30 percent. (Still, that's better than having no treatment.) 

The stress and uncertainty surrounding the COVID pandemic, along with misinformation about the life-saving vaccines developed in response have broken many a weak mind over the past two years, leading people to try everything from injecting themselves with bleach and inhaling nebulized hydrogen peroxide, to slugging down horse dewormer in misguided attempts to outwit modern medicine. Surprise, none of it actually works. What's worse is that this sort of behavior is nothing new. Quack homeopathic remedies have existed for centuries — curing the bubonic plague through blood letting, self-flagellation, or sitting in hot sewers to drive off the fever, for example — and supported by little more than anecdotal evidence.

In their latest book, Patient Zero: A Curious History of the World's Worst Diseases, Dr. Lydia Kang and Nate Pedersen delve into the fascinating histories of some of humanity's deadliest diseases and the society-preserving works of the scientists who the developed cures, vaccines and treatments to counter them. In the excerpt below, we take a look at the deployment of antibiotics and antitoxins in the fight against diphtheria, anthrax, and other deadly diseases.  

Workman Publishing

Excerpted from Patient Zero:A Curious History of the World's Worst Diseases by Lydia Kang, MD, and Nate Pedersen. Workman Publishing © 2021

Aside from putting barriers between us and plagues, the next primary approach to defeating them was to attack them directly, thanks to breakthroughs in science that created and discovered antibiotics and antitoxins. Some of these medicines aren’t simply employed against microorganisms like bacteria, but act as antifungals, antivirals, and antiparasitics as well. Today, there are more than a hundred types of medicines in this group. The World Health Organization (WHO) maintains a list of medicines deemed essential for a country’s healthcare system to best care for its citizenry, and a large chunk of those essential meds battle infectious diseases.

Some might assume that penicillin was the first definitive weapon discovered in our fight against pathogens, but there were several that preceded it and broke significant ground when they were discovered.

The Prussian-born Emil von Behring was a doctor and an assistant to the famed Robert Koch at the Institute for Hygiene in Berlin. In 1888, he developed a way to treat those suffering from diphtheria and tetanus. Not a disease familiar to many these days, diphtheria is prevented by a vaccine that is usually coupled with your routine tetanus shot. In the 1800s, diphtheria was a terrible killer that inflamed a victim’s heart, inflicted paralysis, and caused a suffocating membrane to cover the throat. In Spain, the disease was so rampant in 1613 it was nicknamed El Año de los Garrotillos, or “The Year of Strangulations.”

Much of the disease caused by diphtheria is driven by the toxin created by Corynebacterium diphtheriae. Von Behring infected rats, rabbits, and guinea pigs with weakened (attenuated) forms of it, then gathered their serum—the liquid fraction of their blood, minus the red and white blood cells. That light, honey-colored liquid, which contained antibodies to the diphtheria toxin, was then injected into another set of animals that were sickened with fully virulent diphtheria bacteria.

The newly infected animals given the serum didn’t die because they gained a passive form of protection against the toxin with the donated serum. In 1891, a child’s life was saved using this new method for the first time. The serum was produced in large quantities using animals like sheep and horses. At a time when 50,000 children died annually from diphtheria, it was a miraculous treatment.

Tetanus serum was created soon after, becoming a workable treatment by 1915. Today, antitoxins are used to treat botulism, diphtheria, and anthrax. The same principles of antitoxin treatment are utilized for antivenom therapy to remedy poisonous animal bites, including those from black widow spiders, scorpions, box jellyfish, and cobras. A treatment called passive antibody therapy, in which the serum of patients recovered from an infection is given to other sick patients (also called convalescent plasma therapy), may have been helpful during the COVID-19 pandemic, though data is still forthcoming. Antibodies against infections can not only treat diseases like toxic shock syndrome, but prevent infections during exposures, such as those for hepatitis A and B and botulism. But the antibodies themselves have been employed to treat more than just bites, stings, and infections. Intravenous immunoglobulins from pooled donors treat a variety of disorders, such as ITP (immune thrombocytopenia) and severe immune deficiency diseases.

Another antibody therapy—monoclonal antibodies—has been a game-changer in treatments over the last decade or so, the first one approved by the FDA in 1986. These specially designed antibodies are used to treat several types of cancers (melanoma, breast, and stomach, among many others) and autoimmune diseases (including Crohn’s disease, rheumatoid arthritis, and psoriasis). The antibodies themselves are Y-shaped proteins that bind to a specific protein. In doing so, they can elicit a whole range of effects: switching on or off immune system cascades, destroying cells, blocking or engaging cell activities. The antibodies only bind to a single antigen, hence “mono,” and are produced by clones of cells that churn out the antibodies in large amounts. Sometimes they can also be bound to radioactive particles, delivering radioactivity directly to a cancer cell. Others can be bound to a chemotherapy agent. Often, they work alone.

In the realm of cancer therapy, most of us have some understanding of chemotherapy. But the origin of the term chemotherapy itself actually came from the fight to treat infections, not cancer. At the turn of the twentieth century, antibiotics had yet to establish themselves as a cure for infections. That changed with a physician and scientist named Paul Ehrlich. He was born in 1854 in East Prussia (now Poland) where his father ran a lottery office. During his career, he took advantage of the burgeoning German dye industry to experiment on how cells looked stained with different chemicals. His love of color led to some notable idiosyncrasies, like carrying colored pencil stubs in his pockets. But Ehrlich’s work led to what would become the famous Ziehl-Neelsen acid-fast stain for tuberculosis. (Unfortunately, he also stained his very own TB bacteria from his sputum, though luckily survived the illness.) Later he collaborated with the aforementioned Emil von Behring, a Nobel Prize–winning physiologist, on serum therapy for tetanus and diphtheria.

But perhaps Ehrlich’s most notable discovery happened by accident as he sought a chemical cure to treat a specific disease—a “chemotherapy.” Specifically, he hoped to cure sleeping sickness, a disease caused by a microscopic parasite called Trypanosoma brucei. He had been working with a chemical called atoxyl (meaning “nontoxic”), ironically an arsenic compound. Ehrlich coined the term “magic bullet” related to his hope of finding that perfect chemical that would hopefully kill a very specific pathogen, the Trypanosoma parasite, and not the patient. He ended up testing nine hundred variations of the arsenic compounds on mice. None were particularly effective, but he revisited #606 because it seemed to have an effect on a newly discovered bacterium believed to cause syphilis. In 1910, the medicine called Salvarsan (sometimes simply called “606”) was proven to be effective—it killed the syphilis spirochete and left the guinea pigs, rabbits, and mice alive.

In the next few decades, new research would be applied to battle not just the pandemics of old, but daily infections that could upend people’s lives. A scratch or bite could kill if those Staphylococcus or Streptococcus infections spiraled out of control. A German scientist named Gerhard Domagk began working with a group of chemicals called azo dyes that had a characteristic double nitrogen bond. Azo dyes can color textiles, leather, and foods various shades of brilliant orange, red, and yellow. When an azo compound had a sulfonamide group attached (a nitrogen and sulfur link with two oxygen atoms double-bonded to the sulfur, should you need to impress friends at a party), they knew they’d found something special. The sulfonamide group inhibits a bacteria’s ability to make folate, a necessary B vitamin. Humans, on the other hand, can obtain folate through their diet. And so another magic bullet was born. The new compound seemed to work in mice infected with Streptococcus, otherwise known as strep.

Domagk used the new medicine, called KL 730 and later patented as Prontosil, on his own daughter Hildegard. Suffering from a severe strep infection, she received a shot of Prontosil and recovered, though the drug left a telltale dyed, reddish discoloration at the injection site.

“Sulfa” drugs would go on to be used in a variety of medicines, including antibiotics (trimethoprim and sulfamethoxazole, aka Bactrim), diabetes medicines (glyburide, a sulfonylurea), diuretics (furosemide, or Lasix), pain meds (celecoxib, or Celebrex), and are also used today to treat pneumonia, skin and soft tissue infections, and urinary tract infections, among others.

Domagk’s work won him the Nobel Prize in 1935. However, the Nazis, who disapproved of how the Nobel committee tried to help German pacifist Carl von Ossietzky, had their Gestapo arrest Domagk for accepting the prize and forced him to give it back. He was able to receive it later in 1947.

The Food and Drug Administration is moving closer to making more affordable over-the-counter (OTC) hearing aids a reality for millions of Americans with mild or moderate hearing loss. The agency issued a proposal to create a category of approved devices that people would be able to buy without a prescription, hearing exam or having to arrange a fitting with an audiologist.

"The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids," the FDA said. Around 15 percent of adult Americans (some 37.5 million) have hearing difficulties, according to the agency.

The FDA's goal is to make it easier for those who could benefit from hearing aids to actually get one — it says only a fifth of people who fall into that category use such a device. The agency is hoping to tackle some of the barriers people might encounter, including cost, ease of access, social stigma and state and federal regulations.

In 2017, the federal government passed the Over-the-Counter Hearing Aid Act with the aim of improving access to more affordable hearing aids. Hearing aids have only available with a prescription as the FDA classed them as Class I or II medical devices. President Joe Biden signed an executive order in July that, in part, instructed the Secretary of Health and Human Services to publish a proposed rule for OTC hearing aids within 120 days.

The proposal is now open to a 90-day public comment period. If and when the rule is finalized, it will come into effect 60 days after it's published in the federal register.

Several companies have already made moves to gain a foothold in the OTC hearing aid market. Earlier this year, Bose started selling its SoundControl hearing aids after gaining approval from the FDA, while Jabra unveiled its Enhance Plus earbuds a couple of months ago. Other companies are blending hardware and tech in hearing aids, including Bragi and Olive Union.

Apple, meanwhile, recently updated AirPods Pro with a feature that amplifies the volume of other people's voices in conversation while reducing ambient noise. The company is also said to be looking into ways of using AirPods as health devices.

A number of companies make "hearing enhancement" devices that look more like a set of earbuds than a piece of clinical tech. Nuheara has been a staple at CES with its IQbuds line and companies like Bose, Bragi, Olive and others have offered a mix of tech and hardware to assist with hearing loss. Even Apple plans to introduce a "Converstaion Boost" for its AirPods Pro. Since the FDA allows companies to sell directly to consumers with mild-to-moderate hearing loss without the need for a prescription, the list of options is constantly growing. Another company that's specifically equipped to blur the line between hearing aid and true wireless earbuds is Jabra, thanks to the auditory assistance expertise of its parent company GN. 

With the Jabra Enhance Plus, the company offers a more approachable device for people who may not need what all-day hearing aids offer just yet. Jabra describes these earbuds as "a miniaturized true wireless form factor" that's 50 percent smaller than its stellar Elite 75t model. Those are already some of the smallest buds I've tested, so reducing the size even further makes the Enhance Plus more comfortable and more discreet. Plus, a design that resembles earbuds rather than a traditional hearing aid helps reduce the stigma around wearing something that helps your hear better. 

Inside, four separate sound processing features work to improve audio quality. The Enhance Plus analyzes sound to keep things as natural as possible while also reducing noise for speech clarity. The earbuds also ensure feedback doesn't hinder amplification and they isolate sounds coming from in front of you. 

Jabra

In addition to providing hearing enhancement, the Jabra Enhance Plus can work just like a set of true wireless earbuds to play music and take calls. Similar to other earbuds, the Enhance Plus comes with multiple sizes of ear tips to help you find the best fit, on-board controls and water/dust resistance (IP52). Jabra says they'll last 10 hours on a charge with 30 hours total when you factor in the charging case. An app assists with setup and offers a degree of customization. 

Jabra plans to launch the Enhance Plus at "select hearing care clinics" in the US "towards the end of the year." A licensed professional will conduct a hearing test to make sure these earbuds are appropriate. There's no word on pricing just yet, but the company says it's applying for approval under the FDA's self-fitting category. If you're looking for more of a true hearing aid rather than these "enhancers," Jabra also offers the Enhance Pro. It carries the more traditional behind-the-ear hearing aid design along with a charging case. It's also pricey, starting at $1,800. 

If that's what you're after, the Bose SoundControl hearing aids went on sale in May in a handful of states. That device puts the company's audio expertise to use to help you hear better, and Bose said it was the first FDA-cleared hearing aids that could be sold directly to consumers. What's more, they're more affordable at $850, but they run on the typical zinc-air batteries for hearing aids rather than being rechargeable.