How Will the COVID Pills Change the Pandemic?

In March, 2020, researchers at Emory University published a paper about a molecule called NHC/EIDD-2801. At the time, there were no treatments available for the coronavirus. But NHC/EIDD-2801, the researchers wrote, possessed “potency against multiple coronaviruses,” and could become “an effective antiviral against SARS-CoV-2.” A few days later, Emory licensed the molecule to Ridgeback Biotherapeutics, a Miami-based biotechnology company which had previously developed a monoclonal antibody for Ebola.

Ridgeback partnered with the pharmaceutical giant Merck to accelerate its development.The Emory researchers named their drug molnupiravir, after Mjölnir—the hammer of Thor. It turns out that this was not hyperbole. Last month, Merck and Ridgeback announced that molnupiravir could reduce by half the chances that a person infected by the coronavirus would need to be hospitalized. The drug was so overwhelmingly effective that an independent committee asked the researchers to stop their Phase III trial early—it would have been unethical to continue giving participants placebos.

None of the nearly four hundred patients who received molnupiravir in the trial went on to die, and the drug had no major side effects. On November 4th, the U.K. became the first country to approve molnupiravir; many observers expect that an emergency-use authorization will come from the U.S. Food and Drug Administration in December.

Oral antivirals like molnupiravir could transform the treatment of COVID-19, and of the pandemic more generally. Currently, treatments aimed at fighting COVID—mainly monoclonal antibodies and antiviral drugs like remdesivir—are given through infusion or injection, usually in clinics or hospitals. By the time people manage to arrange a visit, they are often too sick to receive much benefit. Molnupiravir, however, is a little orange pill.

A person might wake up, feel unwell, get a rapid COVID test, and head to the pharmacy around the corner to pick up a pack. A full course, which needs to start within five days of the appearance of symptoms, consists of forty pills—four capsules taken twice a day, for five days. Merck is now testing whether molnupiravir can prevent not just hospitalization after infection but also infection after exposure.

If that’s the case, then the drug might be taken prophylactically—you could get a prescription when someone in your household tests positive, even if you haven’t.Molnupiravir is—and is likely to remain—effective against all the major coronavirus variants. In fact, at least in the lab, it works against any number of RNA viruses besides SARS-CoV-2, including Ebola, hepatitis C, R.S.V., and norovirus. Instead of targeting the coronavirus’s spike protein, as vaccine-generated antibodies do, molnupiravir attacks the virus’s basic replication machinery. The spike protein mutates over time, but the replication machinery is mostly set in stone, and compromising that would make it hard for the virus to evolve resistance.

Once it’s inside the body, molnupiravir breaks down into a molecule called NHC. As my colleague Matthew Hutson explained, in a piece about antiviral drugs published last year, NHC is similar to cytosine, one of the four “bases” from which viral RNA is constructed; when the coronavirus’s RNA begins to copy itself, it slips into cytosine’s spot, in a kind of “Freaky Friday” swap. The molecule evades the virus’s genetic proofreading mechanisms and wreaks havoc, pairing with other bases, introducing a bevy of errors, and ultimately crashing the system.

A drug that’s so good at messing with viral RNA has led some to ask whether it messes with human DNA, too. (Merck’s trial excluded pregnant and breast-feeding women, and women of childbearing age had to be on contraceptives.) This is a long-standing concern about antiviral drugs that introduce genomic errors. A recent study suggests that molnupiravir, taken at high doses and for extended periods, can, in fact, introduce mutations into DNA. But, as the biochemist Derek Lowe noted, in a blog post for Science, these findings probably don’t apply directly to the real-world use of molnupiravir in COVID patients. The study was conducted in cells, not live animals or humans.

The cells were exposed to the drug for more than a month; even at the highest doses, it caused fewer mutations than were created by a brief exposure to ultraviolet light. Meanwhile, Merck has run a battery of tests—both in the lab and in animal models—and found no evidence that molnupiravir causes problematic mutations at the dose and duration at which it will be prescribed.With winter approaching, America is entering another precarious moment in the pandemic. Coronavirus cases have spiked in many European countries—including some with higher vaccination rates than the U.S.—and some American hospitals are already starting to buckle under the weight of a new wave. Nearly fifty thousand Americans are currently hospitalized with COVID-19.

It seems like molnupiravir is arriving just when we need it.It isn’t the only antiviral COVID pill, either. A day after the U.K. authorized Merck’s drug, Pfizer announced that its antiviral, Paxlovid, was also staggeringly effective at preventing the progression of COVID-19 in high-risk patients. The drug, when taken within three days of the onset of symptoms, reduced the risk of hospitalization by nearly ninety per cent. Only three of the nearly four hundred people who took Paxlovid were hospitalized, and no one died; in the placebo group, there were twenty-seven hospitalizations and seven deaths. Paxlovid is administered along with another antiviral medication called ritonavir, which slows the rate at which the former drug is broken down by the body.

Like Merck, Pfizer is now examining whether Paxlovid can also be used to prevent infections after an exposure. Results are expected early in 2022. (It’s not yet known how much of a difference the drugs will make for vaccinated individuals suffering from breakthrough infections; Merck’s and Pfizer’s trials included only unvaccinated people with risk factors for severe disease, such as obesity, diabetes, or older age. Vaccinated individuals are already much less likely to be hospitalized or die of COVID-19.)

Living in an Age of ExtinctionPaxlovid interrupts the virus’s replication not by messing with its genetic code but by disrupting the way its proteins are constructed. When a virus gets into our cells, its RNA is translated into proteins, which do the virus’s dirty work. But the proteins are first built as long strings called polypeptides; an enzyme called protease then slices them into the fragments from which proteins are assembled.
If you can’t cut the plywood, you can’t build the table, and Paxlovid blunts the blade. Because they employ separate mechanisms to defeat the virus, Paxlovid and molnupiravir could, in theory, be taken together. Some viruses that lead to chronic infections, including H.I.V. and hepatitis C, are treated with drug cocktails to prevent them from evolving resistance against a single line of attack. This approach is less common with respiratory viruses, which don’t generally persist in the body for long periods.
But combination antiviral therapy against the coronavirus could be a subject of study in the coming months, especially among immunocompromised patients, in whom the virus often lingers, allowing it the time and opportunity to generate mutations.

Merck will be producing a lot of molnupiravir. John McGrath, the company’s senior vice-president of manufacturing, told me that Merck began bolstering its manufacturing capacity long before the Phase III trial confirmed how well the drug worked. Normally, a company assesses demand for a product, then brings plants online slowly. For molnupiravir, Merck has already set up seventeen plants in eight countries across three continents. It now has the capacity to produce ten million courses of treatment by the end of this year, and at least another twenty million next year.

It expects molnupiravir to generate five to seven billion dollars in revenue by the end of 2022.How much will all these pills soften the looming winter surge? As has been true throughout the pandemic, the answer depends on many factors beyond their effectiveness. The F.D.A. could authorize molnupiravir within weeks, and Paxlovid soon afterward. But medications only work if they make their way into the body. Timing is critical. The drugs should be taken immediately after symptoms start—ideally, within three to five days. Whether people can benefit from them depends partly on the public-health infrastructure where they live. In Europe, rapid at-home COVID tests are widely available.

Twenty months into the pandemic, this is not the case in much of the U.S., and many Americans also lack ready access to affordable testing labs that can process PCR results quickly.Consider one likely scenario. On Monday, a man feels tired but thinks little of it. On Tuesday, he wakes up with a headache and, in the afternoon, develops a fever. He schedules a COVID test for the following morning. Two days later, he receives an e-mail informing him that he has tested positive. By now, it’s Friday afternoon. He calls his doctor’s office; someone picks up and asks the on-call physician to write a prescription. The man rushes to the pharmacy to get the drug within the five-day symptom-to-pill window.

Envision how the week might have unfolded for someone who’s uninsured, elderly, isolated, homeless, or food insecure, or who doesn’t speak English. Taking full advantage of the new drugs will require vigilance, energy, and access.Antivirals could be especially valuable in places like Africa, where only six per cent of the population is fully vaccinated. As they did with the vaccines, wealthy countries, including the U.S. and the U.K., have already locked in huge contracts for the pills; still, Merck has taken steps to expand access to the developing world.

It recently granted royalty-free licenses to the Medicines Patent Pool, a U.N.-backed nonprofit, which will allow manufacturers to produce generic versions of the drug for more than a hundred low- and middle-income countries. (Pfizer has reached a similar agreement with the Patent Pool; the company also announced that it will forgo royalties for Paxlovid in low-income countries, both during and after the pandemic.) As a result, a full course of molnupiravir could cost as little as twenty dollars in developing countries, compared with around seven hundred in the U.S. “Our goal was to bring this product to high-, middle-, and low-income countries at fundamentally the same time,” Paul Schaper, Merck’s executive director of global pharmaceutical policy, told me.

More than fifty companies around the world have already contacted the Patent Pool to obtain a sublicense to produce the drug, and the Gates Foundation has pledged a hundred and twenty million dollars to support generic-drug makers. Charles Gore, the Patent Pool’s executive director, recently said that, “for large parts of the world that have not got good vaccine coverage, this is really a godsend.” Of course, the same challenges of testing and distribution will apply everywhere.

Last spring, as a doctor caring for COVID patients, I was often dismayed by how little we had to offer. We tried hydroxychloroquine, blood thinners, and various oxygen-delivery devices and ventilator maneuvers; mostly, we watched as patients got better or got worse on their own. In the evenings, as I walked the city’s deserted streets, I often asked myself what kinds of treatment I wished we had. The best thing, I thought, would be a pill that people could take at home, shortly after infection, to halt the cascade of biological processes that sends them to the hospital, the I.C.U., or worse.

We will soon have not one but two such treatments. Outside of the vaccines, the new antiviral drugs are the most important pharmacologic advance of the pandemic. As the coronavirus becomes endemic, we’ll need additional tools to treat the inevitable infections that will continue to strike both vaccinated and unvaccinated people. These drugs will do that, reducing the damage that the coronavirus can inflict and, possibly, cordoning off avenues through which it can spread. Still, insuring that they are meaningfully and equitably used will require strength in the areas in which the U.S. has struggled: early and accessible testing; communication and coördination across health-care providers; fighting misinformation and building trust in rapid scientific advances. Just as vaccines don’t help without shots in arms, antivirals can’t work without pills in people.

 

Source: https://www.newyorker.com/

More on the Coronavirus

COVID-19 Vaccines Not Linked To Pregnancy Loss; Mixing Vaccines May Confer Greater Protection

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

COVID-19 vaccines not linked with pregnancy loss

Two studies in major medical journals add to evidence that COVID-19 vaccines are safe before and during pregnancy. One study, published in The New England Journal of Medicine on Wednesday, tracked nearly 18,500 pregnant women in Norway, including about 4,500 who had miscarriages.

Researchers found no link between COVID-19 vaccines and risk of first-trimester miscarriage, regardless of whether the vaccines were from Moderna, Pfizer and BioNTech, or AstraZeneca. Overall, the women with miscarriages were 9% less likely to have been vaccinated, according to the researchers’ calculations.

In a separate study published on Thursday in The Lancet, researchers tracked 107 women who became pregnant while participating in trials of AstraZeneca’s vaccine in the UK, Brazil and South Africa. Seventy-two of the women had received the vaccine while the others got a placebo. AstraZeneca’s vaccine had no effect on the odds of safely carrying the pregnancy to term, the researchers reported.

“It is important that pregnant women are vaccinated since they have a higher risk of hospitalizations and COVID-19-complications, and their infants are at higher risk of being born too early,” the authors of the Norwegian study wrote. “Also, vaccination during pregnancy is likely to provide protection to the newborn infant against COVID-19 infection in the first months after birth.”

Vaccine combinations with different technologies may be best

Healthcare workers in France who got a first shot of AstraZeneca’s COVID-19 vaccine and then the Pfizer/BioNTech vaccine for their second shot showed stronger immune responses than those who had received two shots of the Pfizer vaccine, in a recent study. Combining different technologies is known to boost immune responses to other viruses, and the current study suggests it may be true for the coronavirus as well.

Both vaccines in the study deliver instructions that teach cells in the body to make a piece of protein that resembles the spike on the coronavirus and that triggers an immune response. But they do it in very different ways. Both protocols provided “safe and efficient” protection, said Vincent Legros of Universite de Lyon in France, coauthor of a report published on Thursday in Nature.

But combining the AstraZeneca shot with the Pfizer/BioNTech vaccine “conferred even better protection” than two doses of Pfizer’s shot, including against the Delta variant, Legros said. The two technologies combined induced an antibody response of better quality, with more neutralizing antibodies that could block the virus, and more cells that have been “trained” by the vaccine to have increased defense potential, he said.  Combination vaccination “is safe and may provide interesting options… for clinicians to prevent SARS-CoV-2 infection,” Legros concluded.

Cognitive problems seen in middle-aged COVID-19 survivors

A “substantial proportion” of middle-aged COVID-19 survivors with no previous dementia had cognitive problems more than half a year after diagnosis, researchers have found. They looked at 740 people who ranged in age from 38 to 59. About half were white, and 63% were female. On tests of thinking skills, 20% had trouble converting short-term memories to long-term memories, 18% had trouble processing information rapidly, and 16% had trouble with skills needed for planning, focusing attention, remembering instructions, and juggling multiple tasks.

The average time from diagnosis was 7.6 months. About one-in-four patients had been hospitalized, but most of them were not critically ill. “We can’t exactly say that the cognitive issues were lasting because we can’t determine when they began,” said Dr. Jacqueline Becker of the Icahn School of Medicine at Mount Sinai in New York City, who co-led the study published on Friday in JAMA Network Open. “But we can say that our cohort had higher than anticipated frequency of cognitive impairment” given that they were relatively young and healthy, Becker said.

Data support use of Pfizer vaccine in children and teens

The Pfizer/BioNTech COVID-19 vaccine showed 90.7% efficacy against the coronavirus in a trial of children ages 5 to 11, the U.S. drugmaker said on Friday in briefing documents submitted to the U.S. Food and Drug Administration but not formally published. The children were given two shots of a 10-microgram dose of the vaccine – a third of the strength given to people 12 and older.

The study was not primarily designed to measure efficacy against the virus. Instead, it compared the amount of neutralizing antibodies induced by the vaccine in the children to the response of recipients in their adult trial. Pfizer and BioNTech said the vaccine induced a robust immune response in the children. Outside advisers to the FDA are scheduled to meet on Tuesday to vote on whether to recommend authorization of the vaccine for that age group.

A separate study from Israel conducted while the Delta variant was prevalent and published on Wednesday in The New England Journal of Medicine, compared nearly 95,000 12- to -18-year-olds who had received Pfizer’s vaccine with an equal number of adolescents who had not been vaccinated. The results show the vaccine “was highly effective in the first few weeks after vaccination against both documented infection and symptomatic COVID-19 with the Delta variant” in this age group, the research team reported.

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Source: COVID-19 vaccines not linked to pregnancy loss; mixing vaccines may confer greater protection | Reuters

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Retrieved 2020-05-14. “Sexual and Reproductive Health and Rights, Maternal and Newborn Health & COVID-19”. http://www.unfpa.org. Retrieved 5 June 2020. “RCOG and RCM respond to UKOSS study of more than 400 pregnant women hospitalised with coronavirus”. Royal College of Obstetricians & Gynaecologists. 11 May 2020. Retrieved 2020-05-12. Knight M, Bunch K, Vousden N, Morris E, Simpson N, Gale C, et al. (June 2020). “Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study”. BMJ. 369: m2107. doi:10.1136/bmj.m2107. PMC7277610. PMID32513659. Rimmer MP, Al Wattar BH, et al. (UKARCOG Members) (August 2020). “Provision of obstetrics and gynaecology services during the COVID-19 pandemic: a survey of junior doctors in the UK National Health Service”. BJOG. 127 (9): 1123–1128. doi:10.1111/1471-0528.16313. PMC7283977. 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American Journal of Roentgenology. 215 (1): 87–93. doi:10.2214/AJR.20.23034. PMID32174129. Liang H, Acharya G (April 2020). “Novel corona virus disease (COVID-19) in pregnancy: What clinical recommendations to follow?”. Acta Obstetricia et Gynecologica Scandinavica. 99 (4): 439–442. doi:10.1111/aogs.13836. PMID32141062. S2CID212569131. Karami P, Naghavi M, Feyzi A, Aghamohammadi M, Novin MS, Mobaien A, et al. (April 2020). “WITHDRAWN: Mortality of a pregnant patient diagnosed with COVID-19: A case report with clinical, radiological, and histopathological findings”. Travel Medicine and Infectious Disease: 101665. doi:10.1016/j.tmaid.2020.101665. PMC7151464. PMID32283217. “Coronavirus (COVID-19) infection and pregnancy Version 7”. Royal College of Obstetricians & Gynaecologists. 9 April 2020. Retrieved 2020-04-14. Coronavirus (COVID-19) Infection in Pregnancy (PDF) (Report). RCOG. 24 July 2020. p. 49. 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Bat Viruses? Puppy Experiments? Fact-Checking Critics’ Latest Claims About Dr. Fauci.

Dr. Anthony Fauci is facing a storm of new conservative-led criticism that the National Institute of Allergy and Infectious Diseases — which he’s led for decades — funded everything from risky coronavirus research in China to unnecessary experiments on dogs; here, we break down the outrageous and not-so-outrageous new claims, and the evidence supporting them.

Key Facts

Claim: House Republicans claim a letter sent to them by the National Institutes of Health last week “confirmed” a 2018-2019 study in the Chinese city of Wuhan involved gain-of-function research, a contentious method of studying viruses by enhancing them — despite denials from Fauci that the NIH funded gain-of-function research in Wuhan.

Context: The NIH letter said mice unexpectedly “became sicker” during an experiment in Wuhan involving bat coronaviruses whose spike proteins were replaced — but it didn’t mention gain-of-function research, and Fauci and NIH Director Dr. Francis Collins argued last week the study didn’t meet the definition of gain-of-function, though several experts still told the New York Times and The Intercept this kind of research is risky.

Claim: Rep. James Comer (R-Ky.) told Fox News last week the NIH letter “proves all along that this virus was started in the Wuhan lab,” tying it to months of insinuations from Republicans that Covid-19 began after a virus leaked from a lab.

Context: These bat viruses “could not possibly have caused the COVID-19 pandemic” because they’re too genetically distinct, the NIH says, an argument seconded by many scientists and the EcoHealth Alliance, the nonprofit recipient of the Wuhan NIH grant.

Claim: Separately, in recent weeks, lawmakers like Rep. Nancy Mace (R-S.C.) have chastised NIAID for funding “barbaric and gruesome” experiments on dogs, including studies allegedly exposing dogs to insects, cutting their vocal cords or euthanizing them.

Context: NIAID defended its dog experiments in a statement: It said researchers need to follow federal guidelines on humane treatment of animals, and dogs are sometimes given vocal cordectomies “humanely under anesthesia” to cut down on hazardous noise.

Claim: News outlets and advocates have spread photos of beagles from Tunisia whose heads were put in mesh cages filled with flies, part of a parasitic disease study that initially cited NIH funding when it was published in PLOS Neglected Tropical Diseases.

Context: NIAID told Forbes it actually “did not support this specific research,” and PLOS spokesperson David Knutson says the journal is issuing a correction to clarify the study’s funding was “erroneously attributed to the US National Institutes of Health.”

Chief Critic

Fauci has served as the director of NIAID — part of the NIH — since 1984, but he earned mainstream fame after Covid-19 emerged, and his support for public health measures like mask-wearing and social distancing has driven criticism from conservatives. In recent months, he’s also clashed with Sen. Rand Paul (R-Ky.) over the NIH’s ties to bat virus research in Wuhan. Most notably, during an explosive July hearing, Paul accused Fauci of lying about whether this work involved gain-of-function methods, and Fauci insisted the NIH hasn’t funded gain-of-function research in Wuhan.

Key Background

Gain-of-function research is ill-defined, and opinions on the practice vary widely. Some scientists view it as a useful way of predicting viruses’ future trajectory, but critics warn modifying viruses could pose a biosafety risk. The NIH paused gain-of-function studies for certain viruses in 2014, and three years later, it reopened this research but added extra scrutiny for any experiments that could enhance pathogens’ effectiveness against humans. However, the Wuhan research — which studied various coronaviruses — wasn’t subject to these additional rules because the bat viruses under study weren’t known to infect people, the NIH claimed in last week’s letter to Republicans on the House Oversight Committee.

Surprising Fact

The NIH’s letter to Republicans also said EcoHealth Alliance was required to report any growth in disease for its experiment beyond a certain threshold, but it “failed to report this finding right away.” NIH’s leader Collins told the Washington Post the group “messed up here,” though its findings weren’t necessarily dire. But EcoHealth spokesperson Robert Kessler told Forbes it believes these claims were a “misconception about the grant’s reporting requirements,” saying the group reported the data in question to the NIH in 2018.

What We Don’t Know

Some of this acrimony is tied to uncertainty about the pandemic’s origin. Fauci and many experts think the virus most likely jumped from animals to humans naturally and argue there’s insufficient evidence to suggest the virus escaped from a laboratory, but other scientists say an accidental leak from a lab is still a plausible theory, and Fauci and the Biden administration say they haven’t ruled out this possibility yet.

Still, even if the virus leaked from a lab, the NIH says the viruses studied in the Wuhan lab with EcoHealth Alliance’s participation were “very far distant from SARS-CoV-2,” the virus linked to Covid-19. Likewise, Kessler said none of those viruses “bear a close enough resemblance to the virus that causes COVID-19 to have played any role in its emergence.” And in his July exchange with Fauci, Paul said he isn’t necessarily alleging the NIH’s research specifically caused Covid-19.

Tangent

Some conservative pundits tied their anger over NIH-funded dog research to broader complaints about Fauci, but dog experiments have been controversial for years. NIAID says its rules around animal testing aim to “ensure the smallest possible number of subjects and the greatest commitment to their welfare,” and argues this research is useful. One study blasted by activists used dogs as an “appropriate model” to test a vaccine for a brutal mosquito-borne parasite, NIAID told Forbes, and another study in Tunisia — which it said is separate from the experiment that placed dogs’ heads in cages — investigated a vaccine for a common parasite by letting dogs roam in an “enclosed open space” during sandfly season.

However, advocates cast this research as cruel and unnecessary. Justin Goodman from the White Coat Waste Project, an anti-animal experimentation group often critical of Fauci, told Forbes in a statement the group’s concerns are “not about photos in Tunisia — or any one beagle lab. It’s about Dr. Fauci’s widespread and long pattern of wasteful and punishing puppy abuse.”

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I am a breaking news reporter at Forbes. I previously covered local news for the Boston Guardian, and I graduated from Tufts University in 2019. You can contact me at jwalsh@forbes.com or on Twitter at @joewalshiv

Source: Bat Viruses? Puppy Experiments? Fact-Checking Critics’ Latest Claims About Dr. Fauci.

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Should Businesses Force Employees to Get Covid Vaccine? Advice From a Lawyer

With the Covid-19 vaccine rollout steadily gathering steam, and an overwhelming desire to get back to business, companies face a difficult choice: should they force employees to get vaccinated? And if not, how can they encourage workers to roll up their sleeves? Bloomberg Businessweek spoke to Kevin Troutman, a Houston-based lawyer who co-chairs the national healthcare practice of the law firm Fisher Phillips. This interview has been condensed.

Could an employer face some liability if its workers arent vaccinated?

Workers comp laws are the exclusive remedy for illnesses and injuries contracted in the workplace. But employers also have to be concerned about following OSHA guidance, and we expect that OSHA is going to be issuing some COVID-specific standards. They’re going to at least say, I think, make the vaccines available to your employees, and it will be a violation if then you fail to do it. You could be fined and penalized and, you know, OSHA can hand out some substantial fines. So it can be it can be pretty significant.

What should employers do then to encourage employees to take the vaccine?

One thing that is really important is to share reliable objective information with employees, to try to dispel any misunderstandings or misconceptions that are out there. Ideally, the information should come from local healthcare providers — maybe arrange for a doctor in the community to just come out and maybe talk to their employees, answer some questions and help employees to understand the issues better.

If leaders of the organization believe that vaccinations are the right thing to do, and they are out there explaining it, and providing reliable information, and even setting an example and saying, “Hey, I’m getting vaccinated,” I think those things will help get employees more comfortable with taking the vaccine.

What about offering incentives for getting vaccinated?

A lot of employers think, “Well, I’ll just offer some money and, and get people to take the vaccination, and it’s as simple as that.” Unfortunately, it’s not as simple as that. All medical information is supposed to be treated as confidential — you’re not supposed to get that information and then use disability-related information to discriminate against an employee.

The thinking has been that if an incentive is large enough, that might make some employees feel pressured to disclose medical information in order to qualify for the incentive. On January 7, the EEOC issued a proposed rule that you can only offer what they call a “de minimis incentive” — like a water bottle or a gift card of modest value, which we think is around $20 or $25. Those rules were put on hold as part of the transition in administration and then withdrawn, so right now the EEOC stance is in limbo.

Now, a lot of employers are saying, “we’ll pay you for your time to get vaccinated, and maybe allow two hours or something like that.” I think this is a good approach. The employer can say it’s not an incentive. If the EEOC disagreed, the next thing you do is say that’s not enough to be coercive.

What are the risks to requiring your employees to get vaccinated?

Well, if you’re able to work through the people who say they need an accommodation, because of disability or religion, then the risks are you’re going to have 20 to 40 percent of your workforce just very upset, very distracted and not as productive as they would be. Do you want to have to fire them? You probably could legally, but as a practical matter, do you want to fire that many employees?

Is that worse for your company than having 20 or 40 percent of your employees not vaccinated?

I think each company has to decide. It depends a little bit on what you do, and how much interaction do you have with the public. One place it would make a lot of sense to mandate vaccines would be health care, where you’ve got some responsibility for the health and safety not just of yourself and your employees, but of people who are placed in your care. But even in the healthcare industry, I’m not seeing a huge rush to mandate vaccines. They’re making it available. But they’re not mandating it, whereas they have required flu shots.

Have you seen any particular industries that are inclined to mandate vaccinations?

We did a flash survey among clients and people who maintain regular contact with us. We got about 700 responses, and the agricultural and food production industry was at the top of the list among our respondents as to who was expecting to mandate the vaccination. But that was still only about 18 percent of the group.

How might this conversation be different in, say, July or August?

I think the legal issues are going to stay largely the same unless we get more guidance on incentives. From a practical point of view, by mid summer, we should see that a lot more people have been vaccinated. And we’re also going to have more data and more information to tell us more about side effects, and effectiveness of the vaccination. And we may know more about the extent to which being vaccinated prevents a person from transmitting the virus.

All of which will enable us then to improve our messaging to our employees, about why the vaccine makes sense and the risks, or lack of risks, associated with it compared to the benefits. And that’s going to give businesses a better idea of what’s feasible and what they’re going to do.

By: Robb Mandelbaum

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Why Vaccinated People Are Getting ‘Breakthrough’ Infections

A wedding in Oklahoma leads to 15 vaccinated guests becoming infected with the coronavirus. Raucous Fourth of July celebrations disperse the virus from Provincetown, Mass., to dozens of places across the country, sometimes carried by fully vaccinated celebrants.

As the Delta variant surges across the nation, reports of infections in vaccinated people have become increasingly frequent — including, most recently, among at least six Texas Democrats, a White House aide and an aide to Speaker Nancy Pelosi.

The highly contagious variant, combined with a lagging vaccination campaign and the near absence of preventive restrictions, is fueling a rapid rise in cases in all states, and hospitalizations in nearly all of them. It now accounts for about 83 percent of infections diagnosed in the United States.

But as worrying as the trend may seem, breakthrough infections — those occurring in vaccinated people — are still relatively uncommon, experts said, and those that cause serious illness, hospitalization or death even more so. More than 97 percent of people hospitalized for Covid-19 are unvaccinated.

“The takeaway message remains, if you’re vaccinated, you are protected,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. “You are not going to end up with severe disease, hospitalization or death.”

Reports of breakthrough infections should not be taken to mean that the vaccines do not work, Dr. Anthony S. Fauci, the Biden administration’s top pandemic adviser, said on Thursday at a news briefing.

“By no means does that mean that you’re dealing with an unsuccessful vaccine,” he said. “The success of the vaccine is based on the prevention of illness.”

Still, vaccinated people can come down with infections, overwhelmingly asymptomatic or mild. That may come as a surprise to many vaccinated Americans, who often assume that they are completely shielded from the virus. And breakthrough infections raise the possibility, as yet unresolved, that vaccinated people may spread the virus to others.

Given the upwelling of virus across much of the country, some scientists say it is time for vaccinated people to consider wearing masks indoors and in crowded spaces like shopping malls or concert halls — a recommendation that goes beyond current guidelines from the Centers for Disease Control and Prevention, which recommends masking only for unvaccinated people.

The agency does not plan to change its guidelines unless there is a significant change in the science, said a federal official speaking on condition of anonymity because he was not authorized to speak on the matter.

The agency’s guidance already gives local leaders latitude to adjust their policies based on rates of transmission in their communities, he added. Citing the rise of the Delta variant, health officials in several California jurisdictions are already urging a return to indoor masking; Los Angeles County is requiring it.

“Seatbelts reduce risk, but we still need to drive carefully,” said Dr. Scott Dryden-Peterson, an infectious disease physician and epidemiologist at Brigham & Women’s Hospital in Boston. “We’re still trying to figure out what is ‘drive carefully’ in the Delta era, and what we should be doing.”

The uncertainty about Delta results in part from how it differs from previous versions of the coronavirus. Although its mode of transmission is the same — it is inhaled, usually in indoor spaces — Delta is thought to be about twice as contagious as the original virus.

Significantly, early evidence also suggests that people infected with the Delta variant may carry roughly a thousandfold more virus than those infected with the original virus. While that does not seem to mean that they get sicker, it does probably mean that they are more contagious and for longer.

Dose also matters: A vaccinated person exposed to a low dose of the coronavirus may never become infected, or not noticeably so. A vaccinated person exposed to extremely high viral loads of the Delta variant is more likely to find his or her immune defenses overwhelmed.

The problem grows worse as community transmission rates rise, because exposures in dose and number will increase. Vaccination rates in the country have stalled, with less than half of Americans fully immunized, giving the virus plenty of room to spread.

Unvaccinated people “are not, for the most part, taking precautions, and that’s what’s driving it for everybody,” said Dr. Eric J. Rubin, the editor in chief of the New England Journal of Medicine. “We’re all susceptible to whatever anyone’s behavior is in this epidemic.”

Dr. Gounder likened the amount of protection offered by the vaccines to a golf umbrella that keeps people dry in a rainstorm. “But if you’re out in a hurricane, you’re still going to get wet,” she said. “That’s kind of the situation that the Delta variant has created, where there’s still a lot of community spread.”

For the average vaccinated person, a breakthrough infection is likely to be inconsequential, causing few to no symptoms. But there is concern among scientists that a few vaccinated people who become infected may go on to develop long Covid, a poorly understood constellation of symptoms that persists after the active infection is resolved.

Much has been made of Delta’s ability to sidestep immune defenses. In fact, all of the existing vaccines seem able to prevent serious illness and death from the variant. In laboratory studies, Delta actually has proved to be a milder threat than Beta, the variant first identified in South Africa.

Whether a vaccinated person ever becomes infected may depend on how high antibodies spiked after vaccination, how potent those antibodies are against the variant, and whether the level of antibodies in the person’s blood has waned since immunization.

In any case, immune defenses primed by the vaccines should recognize the virus soon after infection and destroy it before significant damage occurs.

“That is what explains why people do get infected and why people don’t get seriously ill,” said Michel C. Nussenzweig, an immunologist at Rockefeller University in New York. “It’s nearly unavoidable, unless you’re going to give people very frequent boosters.”

There is limited evidence beyond anecdotal reports to indicate whether breakthrough infections with the Delta variant are more common or more likely to fan out to other people. The C.D.C. has recorded about 5,500 hospitalizations and deaths in vaccinated people, but it is not tracking milder breakthrough infections.

Additional data is emerging from the Covid-19 Sports and Society Workgroup, a coalition of professional sports leagues that is working closely with the C.D.C. Sports teams in the group are testing more than 10,000 people at least daily and sequencing all infections, according to Dr. Robby Sikka, a physician who worked with the N.B.A.’s Minnesota Timberwolves.

Breakthrough infections in the leagues seem to be more common with the Delta variant than with Alpha, the variant first identified in Britain, he said. As would be predicted, the vaccines cut down the severity and duration of illness significantly, with players returning less than two weeks after becoming infected, compared with nearly three weeks earlier in the pandemic.

But while they are infected, the players carry very high amounts of virus for seven to 10 days, compared with two or three days in those infected with Alpha, Dr. Sikka said. Infected players are required to quarantine, so the project has not been able to track whether they spread the virus to others — but it’s likely that they would, he added.

“If they’re put just willy-nilly back into society, I think you’re going to have spread from vaccinated individuals,” he added. “They don’t even recognize they have Covid because they think they’re vaccinated.”

Elyse Freitas was shocked to discover that 15 vaccinated people became infected at her wedding. Dr. Freitas, 34, a biologist at the University of Oklahoma, said she had been very cautious throughout the pandemic, and had already postponed her wedding once. But after much deliberation, she celebrated the wedding indoors on July 10.

Based on the symptoms, Dr. Freitas believes that the initial infection was at a bachelorette party two days before the wedding, when a dozen vaccinated people went unmasked to bars in downtown Oklahoma City; seven of them later tested positive. Eventually, 17 guests at the wedding became infected, nearly all with mild symptoms.

“In hindsight, I should have paid more attention to the vaccination rates in Oklahoma and the emergence of the Delta variant and adjusted my plans accordingly,” she said.

An outbreak in Provincetown, Mass., illustrates how quickly a cluster can grow, given the right conditions. During its famed Fourth of July celebrations, the small town hosted more than 60,000 unmasked revelers, dancing and mingling in crowded bars and house parties.

The crowds this year were much larger than usual, said Adam Hunt, 55, an advertising executive who has lived in Provincetown part time for about 20 years. But the bars and clubs didn’t open until they were allowed to, Mr. Hunt noted: “We thought we were doing the right thing. We thought we were OK.”

Mr. Hunt did not become infected with the virus, but several of his vaccinated friends who had flown in from places as far as Hawaii and Alabama tested positive after their return. In all, the cluster has grown to at least 256 cases — including 66 visitors from other states — about two-thirds in vaccinated people.

“I did not expect that people who were vaccinated would be becoming positive at the rate that they were,” said Steve Katsurinis, chair of the Provincetown Board of Health. Provincetown has moved swiftly to contain the outbreak, reinstating a mask advisory and stepping up testing. It is conducting 250 tests a day, compared with about eight a day before July 1, Mr. Katsurinis said.

Health officials should also help the public understand that vaccines are doing what they are supposed to — preventing people from getting seriously ill, said Kristen Panthagani, a geneticist at Baylor College of Medicine who runs a blog explaining complex scientific concepts.

“Vaccine efficacy isn’t 100 percent — it never is,” she said. “We shouldn’t expect Covid vaccines to be perfect, either. That’s too high an expectation.”

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Source: Why Vaccinated People Are Getting ‘Breakthrough’ Infections – The New York Times

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