Glenn Cohen

Enno Lenze, a German entrepreneur, journalist, and museum director, had what felt like another job looking for a vaccination, a hunt he had been on since December...Finally, an option came through. World Visitor, a Norwegian travel agency, offered a package that included flying to Moscow to get Sputnik V, the Russian vaccine. Lenze and 50 other Germans jumped at the chance and traveled there earlier this month for their first jabs...Traveling for treatments with either limited availability or cheaper options than ones’ home country is not new according to I. Glenn Cohen, a professor at Harvard Law School and director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. A thriving medical tourism market has existed for years. In the case of COVID-19 vaccines, as long as at-risk groups have first been protected, countries with surplus vaccines could use them to jumpstart travel, if it is done carefully. “What matters is where the net benefit goes,” he says. “It should benefit the poorest in the community and not just the rich.” While two-dose vaccinations might tempt countries to keep visitors for longer, since it takes time to build an immune response, most post-jab tourism activities should not be rushed. “I’d be a little concerned,” he says. “I hope these people aren’t going to markets and bazaars right away.”

About a dozen colleges have said they will require students to receive a Covid-19 vaccine before returning for in-person instruction this fall. The mandate from this small but growing number of schools inserts them into the increasingly politically charged debate over whether businesses and other institutions should be able to make inoculation a condition of participating in events in person. Here’s what we know about colleges and student Covid-19 vaccinations. ... Glenn Cohen, a professor at Harvard Law School, said some schools are likely getting tripped up by legal language requiring the federal government to inform people they have the right to refuse a vaccine approved under an emergency-use authorization. The three vaccines that have been approved by the Food and Drug Administration—manufactured by Pfizer Inc., Moderna Inc. and Johnson & Johnson — were only approved for emergency use.

A small but growing number of colleges will require students to receive a Covid-19 vaccine, saying it is the most assured way of returning to some semblance of pre-pandemic campus life. ... Glenn Cohen, a professor at Harvard Law School, said schools are likely getting tripped up by legal language requiring the federal government to inform people they have the right to refuse a vaccine approved under an emergency-use authorization.

One Saturday morning in late March, Milicia Praca and her roommate grabbed their passports and a bag of crisps and drove towards the border between Bosnia and Herzegovina (BiH) and the Republic of Serbia. They were keen to accomplish an important task – enter Serbia, pull up their sleeves, and get vaccinated against COVID-19... “In Europe, for a person to literally drive to another country, get a vaccine and return home or to their place of residency, strikes me as unethical tourism,” said Glenn Cohen, a professor at Harvard Law School, who has specialised in health law policy, biotechnology and bioethics. “It increases the risk of the spread of COVID-19 and you may be taking a vaccine from someone who is entitled to it under that country’s law. People are putting themselves and others at risk as vaccine tourists,” he said...Most European countries require people to show proof of residency, citizenship or share details about their national health insurance, to get vaccinated. Professor Cohen believes these legal requirements may discourage vulnerable communities, such as undocumented migrants, from trying to get a jab. “To tackle the pandemic, everybody should be eligible to get the vaccine in the region they live in,” he said.

U.S. colleges hoping for a return to normalcy next fall are weighing how far they should go in urging students to get the COVID-19 vaccine, including whether they should — or legally can — require it. Universities including Rutgers, Brown, Cornell and Northeastern recently told students they must get vaccinated before returning to campus next fall. They hope to achieve herd immunity on campus, which they say would allow them to loosen spacing restrictions in classrooms and dorms...Harvard Law professor Glenn Cohen, who teaches health law and bioethics, said there's no legal reason colleges wouldn't be allowed to require COVID-19 vaccinations. It makes no difference that the shots haven't been given full approval, he said, noting that many colleges already require students to take coronavirus tests that are approved under the same FDA emergency authorization. But there’s also no federal guidance explicitly permitting vaccination mandates. The biggest clashes could come in states taking a stance against vaccination requirements, he said.

An op-ed by Dorit R. Reiss, I. Glenn Cohen, and Carmel Shachar: Covid-19 vaccines offer a way out of the global crisis that has upended — and cut short — lives for more than a year. Three vaccines have now received emergency use authorization (EUA) from the FDA. One question that employers and universities must rapidly consider and act upon is whether to mandate that returning employees and students be vaccinated. Some employers are starting to require Covid-19 vaccines, and Rutgers University became the first university to mandate them for students and employees. One argument against mandates is that individuals cannot be required to get a vaccine that is being distributed under an EUA, as opposed to a full license, an argument made in a recent First Opinion. That would potentially delay Covid-19 vaccine mandates until the FDA approved the first vaccine under a biologics license application (BLA) — and so far the timing of that is unknown. Important nuances lead us to a very different conclusion: There are few to no legal barriers to employers or schools requiring vaccines being distributed under EUAs.

Oxford University and AstraZeneca announced Monday that their COVID-19 vaccine is 79% effective overall and 100% effective at preventing severe disease, according to preliminary results from U.S. clinical trials. The Biden administration said last week that it will send about 4 million doses of the vaccine to Canada and Mexico, but it’s holding on to several million more, even though the AstraZeneca vaccine is not yet authorized in the U.S. and the administration has already secured more than enough doses of COVID vaccine for everyone in the country... “In a world where COVID is running rampant across the world and not in the United States, unless we’re going to be a fortress nation that’s not going to let anybody travel here ever, you’re going to have variants emerge elsewhere in the world, in such a way that they pose a danger to the United States,” said Glenn Cohen, a professor of health law and bioethics at Harvard Law School. Both healthwise and economically. “If we’re living in a world where large parts of the world don’t get fully vaccinated until 2022 or 2023, those are people who can’t travel to our shores. There are people who will not be able to consume our goods. There are people who will be in situations of political instability and suffering, and there’s going to be major economic loss,” Cohen said.

A drop in your daily step count. A missed period. A loss of hearing. If it’s collected by a smartwatch or wearable, that health data isn’t protected the same way your medical records are. And as wearables like smartwatches and headphones sweep up an increasing amount of health data — flagging potential medical issues that could be used for ad targeting or to discriminate against someone — some lawmakers and researchers are calling for a reconsideration of the current approach. In a sign of the increasing urgency of the problem during the current virtual care boom, U.S. senators last month reintroduced a bill that would make it illegal for companies like Apple, Amazon, or Google to sell or share the data collected by wearables...Legal experts consider the move a step in the right direction, but caution that further action is needed to address the vast amounts of information being absorbed by health tech startups and technology giants alike. “We are on a collision course with how to regulate health data as all the different types of wearables and health tech explode,” said Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard. “HIPAA doesn’t extend to the world of health tech, and it should,” she added...Harvard law professor Glenn Cohen likens the situation to an iceberg, where the tip represents the data covered by HIPAA and the rest represents all the information that is not shielded by the law. Today, there is nothing stopping an employer or insurer from using that unprotected data to price its products or deny someone a job. “I like to remind people that the ‘P’ in HIPAA isn’t privacy,” Cohen said. “The law made sense when we were talking about health care information, not health information” more broadly.

What if we could instantly double COVID-19 vaccine availability in America? This is the tantalizing prospect raised by data collected while testing the double-dose regimen for the Moderna and Pfizer vaccines. As two Canadian researchers highlighted in a letter to the New England Journal of Medicine this month, both vaccines have been found to achieve 92 percent efficacy 14 days after a recipient has been given just one dose. The second dose, administered three to four weeks after the first, offers comparatively small gains by this measure: It boosts the Pfizer vaccine's efficacy to 95 percent, and the Moderna vaccine's to 94 percent, differences of just three and two points, respectively...I reached out to I. Glenn Cohen, a professor of health law and bioethics at Harvard University, and Holly Fernandez Lynch, an assistant professor of medical ethics at the University of Pennsylvania. Together they edited FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, which explores the FDA's function, successes, and failures...If the companies do apply for a change, Cohen said he would expect the FDA to move quickly enough to give an answer within the critical period of vaccine shortages this spring. "As agencies go, FDA is appropriately careful in their review of these matters," he said, "but given the amount of data experience they have with Pfizer and Moderna thus far, if provided appropriate data, I think they could probably make a determination of whether such a change was warranted fairly quickly."

As recently as 10 years ago, Jeannie Suk Gersen was still telling people that the area of law she specialized in—sexual assault and domestic violence—didn’t hold much interest for the general public. A quiet corner of the profession, she thought. Remembering that now, she laughs. “But, you know,” she adds, “every area of law does end up moving into focus. Because, in the end, law is really about every aspect of our lives.” Which is partly why Gersen, J.D. ’02, has always taken it so seriously. “Words don’t just describe things,” she explains. In the law, “words actually do things.” ... “Jeannie is intellectually fearless,” says Bemis professor of international law Jonathan Zittrain. That’s a common sentiment among her colleagues... “There are a lot of people who are afraid to say things in our business,” says Learned Hand professor of law Jack Goldsmith, “and she’s not afraid to say what she thinks.” ... “Her whole response to Title IX has been very, very striking—and I think completely correct,” says Beneficial professor of law Charles Fried, who was Gersen’s teacher before he was her colleague ... Says her former teacher, Loeb University Professor emeritus Laurence Tribe, “I was always impressed by how both meticulous and yet unconventional her insights were. She would often come at issues in a kind of perpendicular way. Rather than finding a point between A and B, she would say that maybe that axis is the wrong axis.” ... “She has one of those amazing brains,” says Williams professor of law I. Glenn Cohen, who worked on the Harvard Law Review with Gersen. “She was a year ahead of me in law school, and we all regarded her more like a faculty member, even back then. She just seemed to know everything.”

As Florida residents struggle to get appointments for COVID-19 vaccines, some are worried the already limited supply may be going to people who don't even live in the state...Under Florida's vaccine plan healthcare workers, long-term care workers and those 65 years and older who are at least part-time residents are eligible to get the vaccine. Data from the Florida Department of Health revealed more than 1.1 million people have been vaccinated in the state. Out of those 1.1 million people, 39,000 reside outside of Florida. It's a new trend being called "vaccine tourism," in which people from outside the state travel to Florida to get vaccinated...Harvard law professor Glenn Cohen, a medical tourism expert, said he wasn't shocked when he heard of vaccine tourism and he sees it growing. "Yeah, I think the best thing we could do would be assisting other countries to meet their rollout and to supply them with vaccines to meet the needs of their population so that we don't create this market where the wealthy and able-bodied can travel," said Cohen. "Unfortunately, we've ended up in a place where every country has its purchase order and every country is doing its own distribution. And that setup is part of what has set the preconditions for this instance of vaccine tourism."

With Pfizer and its partner BioNTech on the cusp of an authorized COVID-19 vaccine in the United States, a major ethical dilemma now stands in front of the companies and regulators: If the vaccine is authorized, what will happen to the thousands of people who volunteered to participate in Pfizer’s trial? That question was put forth before an independent committee of FDA advisors meeting Thursday to discuss the Pfizer vaccine...From the start, all the people who volunteered for the study knew there would be a 50-50 chance they might get a placebo shot. “You disclose to them at the outset that it’s possible they’re going to receive a placebo,” Harvard Law professor Glenn Cohen said. “It’s not considered unethical,” he added, because researchers don't yet know whether the experimental vaccine is effective...Having two groups of participants allows researchers to “hold everything equal, such that we are confident that any differences we see in the result are from the vaccine itself,” Cohen said. Big experiments are designed this way so scientists can know for sure if a vaccine is working significantly better than placebo. In the final analysis, Pfizer’s vaccine was 95% effective at preventing COVID-19 disease, and it has been shown to be safe over more than two months, the threshold for emergency authorization.

Infectious disease epidemiologist Dr. Monica Gandhi and Harvard Law professor and bioethics expert Glenn Cohen join Dr. Ian Smith to discuss taking thymosin alpha-1, a treatment that might show promise but is not FDA approved. Dr. Gandhi shares that she’s really concerned about people taking thymosin alpha-1 because it could lead to something far worse than COVID-19. Plus, Glenn shares that it’s actually unlawful for companies to promote this treatment.

As Election 2020 looms, the next Congress will have another important decision to make - what is permitted, and what is not, when it comes to human genetic editing of the gamete (sperm and eggs). Currently, a ban on federal funding of genetic editing of the human embryo is in place. This rider, dating from 2015 and renewed annually, prohibits approval or funding to go to any research project that intentionally creates or destroys a genetically modified human embryo. This ban disallows the FDA approving any drug or other biological products created from such an experiment. However, the rider is unclear if this ban on funding and research applies to genetically modifying sperm and eggs. In a recent article in The Journal of Law, Medicine, and Ethics, Professor I. Glenn Cohen of Harvard Law School, Professor Jacob Sherkow of the University of Illinois Urbana-Champaign, and Professor Eli Y. Adashi of Brown University state that the next Congress will need to address the question and ethics of gamete editing - that is - editing of the sperm and egg...There are many ethical issues when it comes to editing the embryo, yet some of these do not necessarily apply to the editing of the gamete. This is where Cohen, Sherkow, and Adashi step in. They argue that the ethical issues of editing an embryo are quite different from editing gametes. The coming Congress will need to decide if the current ban should include - or exclude - the editing of sperms and eggs... “Sperm and egg editing occurs before that moment [the moment that the sperm and egg meet and the genetic code is set], upending the claim that editing alters ‘a person.’ The activity is more like selecting a sperm or an egg donor,” say the authors.