US pharmaceutical companies have developed the world’s most effective vaccines for the coronavirus, helping Americans get inoculated faster than people in most other countries. Now President Joe Biden is being urged not just to share the vaccines with the less fortunate, but to share the knowledge that would allow developing nations to manufacture the vaccines themselves.
In a letter obtained by the Financial Times, over 100 Nobel laureates and 75 former world leaders are calling on Biden to suspend vaccine patents, by way of a waiver at the World Trade Organization, calling it “a vital and necessary step to bringing an end to this pandemic.”
The letter was signed by former UK Prime Minister Gordon Brown, former Soviet Union President Mikhail Gorbachev, and former French President François Hollande, the Times reported.
A waiver would allow WTO members to suspend the intellectual property rights currently enjoyed by the likes of Pfizer, Moderna, and Johnson & Johnson, enabling developing countries to produce vaccines and treatments without fear of reprisal. Last fall, South Africa and India submitted a proposal to the WTO seeking such a suspension “until widespread vaccination is in place globally.”
Resistance has been fierce, however. In March, the US, UK, and the European Union all voted to block such a waiver from being granted, arguing that they need to preserve an economic incentive for the development of new medical technologies.
Their opposition is shared by the private sector.
The US Chamber of Commerce called such proposals “misguided” and a “distraction” from efforts already underway to share vaccines with the developing world. The International Federation of Pharmaceutical Manufacturers & Associations likewise argued that a waiving of IP protections would be “counterproductive,” undermine confidence in a for-profit system that helped develop several highly effective vaccines.
But the charity group Médecins Sans Frontières (MSF), or Doctors Without Borders, has argued that mindset reeks of provincialism.
“Countries must stop obstructing and show the leadership required to deliver on the ‘global solidarity’ they have so often declared during the pandemic,” Dr. Christos Christous, the group’s president, said in a statement. “It’s time to champion access to medical tools for everyone, where they live.”
But medical research into these mind-altering compounds is still nascent. Psychedelic research was virtually barred for decades and most academic institutions have only recently restarted studies testing psychedelic compounds in people.
That research is beginning to deliver results. On Wednesday, scientists published a milestone report that directly compares psilocybin, the active compound found in magic mushrooms, with the depression drug Lexapro, or escitalopram.
A compound found in magic mushrooms works as well as a major depression pill
The study, in the prestigious New England Journal of Medicine, shows that psilocybin works about as well as escitalopram to treat patients with moderate or severe major depressive disorder.
Dr. Robin Carhart-Harris, head of the Centre for Psychedelic Research at Imperial College London, led the research team.
He told Insider that while he believes the findings support the potential of psilocybin to be an improvement on current antidepressants, they are also a reality check on what he called “a kind of unbridled optimism about psychedelic therapy” driven by for-profit psychedelics companies and investors.
He added that the findings in the report are consistent with previous studies on the effectiveness of psilocybin as a depression treatment.
The mid-stage trial was small, with just 59 participants, limiting scientists’ ability to draw strong conclusions. About half the volunteers were treated with psilocybin and the other half received escitalopram. All patients received psychological support throughout the trial.
Researchers found that although the reduction in depression occurred more quickly and in “greater magnitude” with psilocybin, the differences between the two treatments was not significant.
“Larger and longer trials are needed to compare psilocybin with established treatments for depression,” the article said.
Psilocybin could take a slice of a $100 billion market
Imperial’s study works to provide the academic foundation to show psilocybin’s effects on more moderate forms of depression.
“What’s on the table now is the prospect that psilocybin therapy could be an alternative to SSRIs, if it’s at least as good,” Carhart-Harris said. “What we’re showing is that people could consider psilocybin therapy earlier on in the course of a depression.”
Psilocybin has in recent years been seen as a potential disruptor to the market for depression treatments. Current treatment options don’t work for some patients and can take a long time to fully work. Canaccord Genuity has estimated that psychedelic-based medicines focused on mental health could take part in what could soon become a $100 billion market.
Carhart-Harris said that the results of the study are framed in a conservative way in the journal, but he emphasized that they’re impressive. He pointed to some of the study’s secondary findings, such as the fact that about 57% of patients who received psilocybin saw their depression go into remission, while that occurred in about a quarter of patients who received escitalopram.
“To say it in a conservative way, psilocybin therapy looks at least as good as the leading treatments for depression,” Carhart-Harris said. “What you see in the paper is a very conservative framing but when you look a little bit closer under the hood, you realize it’s pretty impressive findings.”
If the trial were longer, researchers say patients who received escitalopram may have seen better efficacy
Escitalopram takes several weeks to show its full effect and the researcher note in the article that if the trial had been longer than six weeks, patients who received escitalopram may have done better.
Carhart-Harris said the fact that psilocybin seems to work faster than existing depression drugs could be a noteworthy benefit of the psychedelic.
“We’ve become so accustomed to this principle that you have to wait a couple of months for your SSRI to work and that’s not good enough,” he said. “Many people with depression are seriously considering taking their own lives and you tell them you have to wait two months to see any improvements. It’s not a great message yet we’re just accepting that.”
Scientists say that more and bigger trials are needed
The next logical step for psilocybin for depression research is a late-stage trial involving more people. Carhart-Harris says that this is where for-profit and nonprofit entities step up to the plate.
Compass Pathways and the Usona Institute, a non-profit focused on psychedelic research, are furthest along in clinical trials of the compound. Both are in phase II trials, which involves testing the treatment in up to several hundred patients.
A smattering of other psychedelics companies are also in pre-clinical or early stage research around psilocybin
Different political initiatives – like Measure 109 in Oregon, which created a regulated therapeutic psilocybin program – also provide a route to providing psilocybin therapy to patients with depression. This offers an alternative to seeking approval from the FDA.
Moderna said on Wednesday that Americans could start getting booster shots later this year to protect against coronavirus variants.
“It is likely that the countries that have already achieved high vaccine coverage are going to be ready to shift their focus to boosters in 2022 and possibly even starting at the end of this year,” Corinne M. Le Goff, Moderna’s chief commercial officer, said during a call with investors.
Le Goff said that countries like the US that quickly inoculate their populations could start getting booster shots soon, but because just about 5% of the global population has been vaccinated, most countries would continue giving residents the initial shots.
“I hope this summer to get the vaccine authorized for a boost so that we can help people getting boosted before the fall, so that we all have a normal fall and not a fall and winter like we just saw in the last six months,” Moderna CEO Stéphane Bancel said in an interview with Insider on Tuesday.
The US had administered more than 85 million doses of Moderna’s two-dose COVID-19 vaccine as of mid-April. Nearly half of American adults have received at least one shot of a vaccine from Moderna, Pfizer, or Johnson & Johnson, according to the Centers for Disease Control and Prevention.
Though the vaccines authorized for emergency use in many countries are highly effective, delays in rollouts and the spread of variants have led to an increase in COVID-19 cases globally. Many European countries have enforced shutdowns and curfews in the “third wave” of the pandemic, and COVID-19 cases reached record highs in India and Brazil this spring.
Epidemiologists have predicted that COVID-19 will become endemic, likely to continue spreading as a mild, flu-like illness after the pandemic subsides. Researchers may regularly produce booster shots to protect against new variants, similar to how they develop vaccines for the flu every season.
Thousands of people are ringing every hour to obtain federal aid for the cost of burying a loved one who died from COVID-19.
On Monday, the Federal Emergency Management Agency announced that it was now beginning to process applications for $2 billion in funeral assistance made possible by the $1.9 stimulus packaged passed by congressional Democrats and signed into law by President Joe Biden last month.
The inclusion of the aid was made possible thanks to a push led by Rep. Alexandria Ocasio-Cortez and Senate Majority Leader Chuck Schumer.
At a joint press conference on Monday, the two Democrats urged people to call FEMA if they paid for any COVID-related funeral expenses in the past year – anything from the cost of a casket to the funeral ceremony itself.
“The phone number is run by people who are understanding, compassionate, and speak multiple languages,” Schumer said, per the New York Daily News.
The New York lawmakers initially requested the aid in April 2020, when New York City was first slammed by the coronavirus.
“As the tragic number of deaths from COVID-19 continues to rise in New York, individuals who are facing incredible loss are also being saddled with an additional financial burden,” they wrote in a letter to FEMA.
Over 500,000 people in the US have died from the coronavirus since that letter was sent.
Here’s how to apply
FEMA is only accepting applications by phone, a process that has overwhelmed the agency. On Monday alone, it received over a million inquiries, Ocasio-Cortez announced on Twitter.
FEMA declined to provide the latest tally. But when Insider called the hotline (844-684-6333) Tuesday afternoon, more than 2,900 people were ahead in the queue.
The funeral assistance program is open to anyone, regardless of income, who paid a funeral expense associated with a coronavirus death in the US; the deceased need not be a US citizen, but applicants must provide proof of their legal status.
Specifically, FEMA is requesting that applicants provide both their own Social Security number and that of the person or persons who died, saying that while that information is not mandatory it will speed up the disbursement of funds.
Applicants must also provide a copy of an official death certificate; receipts indicating funeral expenses and the dates they were incurred; any applicable funeral insurance information; current annual household income; as well as a phone number and current address.
A person may receive up to $9,000 per funeral and up to $35,500 in total, the money sent either by check or direct deposit, depending on the applicant’s preference.
FEMA says the phone call should take about 20 minutes. There is no deadline to apply.
The 27 member states, Norway, and Iceland, had started receiving doses of the Johnson & Johnson on Monday. The bloc was expecting 55 million doses by June, and 120 million doses in the following quarter.
“We have been reviewing these cases with European health authorities,” the company said in a statement Tuesday. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”
Officials with the US Centers for Disease Control and Prevention said Tuesday that health agencies should immediately pause giving the shot, citing an “abundance of caution” over extremely rare reports of blood clotting among the millions of doses administered.
Six women between 18 and 48 years old who received the vaccine developed the clots within two weeks of being vaccinated, the CDC and the Food and Drug Administration said in a joint statement Tuesday.
Federal agencies immediately suspended using the shot, and many state and local health authorities followed suit Tuesday morning.
Following the announcement, Sweden said it would be reviewing its use of the Johnson & Johnson shot in the next couple of days. Belgium and the Netherlands said that, for now, they would continue to use the shot.
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” Johnson & Johnson said.
Zients said in a statement that his team is working with federal and state partners to have anyone scheduled to receive a Johnson & Johnson vaccine rescheduled for a Pfizer or Moderna vaccine.
“Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” he said in the statement. “Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans.”
US officials recommended an immediate pause on the rollout of the Johnson & Johnson vaccine on Tuesday, citing reports of blood clots forming in people who have received the shot.
The Centers for Disease Control and Prevention and the Food and Drug Administration said on Tuesday that six women between 18 and 48 years old developed blood clots between six and 13 days after receiving the vaccine.
Zients said in his statement that there are enough Pfizer and Moderna shots to make up for paused Johnson & Johnson doses.
“Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines,” he added. “This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office-and continue on to reach every adult who wants to be vaccinated.”
Six women who had received the vaccine had developed the clots six to 13 days after vaccination with the shot, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) said in a joint statement Tuesday.
One woman died and another was in critical condition at the hospital, the CDC and FDA said.
So far 6.8 million doses of J&J vaccine have been given to Americans, according to the CDC and FDA.
“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases,” the statement said.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.”
One of the people was a volunteer in the vaccine’s clinical trial, who died of a clotting disorder. The other three were people who got the shot after it was approved by the FDA, the EMA said in a statement. These are likely to be the same cases described by the FDA and CDC.
The federal government has the authority to pause vaccinations that it is carrying out directly, but not those being administered by state officials. The New York Times reported that US officials expect states will also choose to pause their use of the vaccine.
The recommendation follows some vaccination sites in the US pausing the shots for different reasons.
Vaccination sites in Colorado, North Carolina and Georgia temporarily stopped giving people J&J’s shot last week after about 45 people in total experienced minor adverse reactions involving nausea, dizziness, fainting, or lightheadedness within 15 minutes of being given a dose.
India has authorized Russia’s Sputnik V COVID-19 vaccine.
The news was confirmed by the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, announced that India approved the vaccine for use.
The RDIF says this means that Sputnik V is now authorized for use for 3 billion people, or 40% of the world’s population. India’s population is the second largest in the world, with about 1.4 billion people.
India is already using two vaccines: the Oxford/AstraZeneca vaccine and another made by Indian firm Bharat Biotech.
Interim analysis of phase-3 data published in The Lancet in February found that Russia’s vaccine is 91.6% effective. Russia has been giving it to its population since December.
India’s coronavirus cases have been reaching record highs, and the country is looking to increase its vaccination rate as it battles a surge.
The last year has been busy for Xavier Palomer, the founder of Spanish virtual reality mental health startup Psious. The platform, which is a tool for mental health professionals to place their patients in a variety of different situations to try treatments such as exposure therapy or cognitive restructuring, doubled in the number of patients from 2019 to 2020. In all, 20,000 people have been treated using Psious’s platform.
And while the COVID-19 pandemic has strained many healthcare systems, it has shown the need for Psious’s tech and demonstrated the use case, too. Telehealth – where people are treated remotely from their medical professionals – has long been tomorrow’s technology. The promise has long been acknowledged, but the reality has always been that face-to-face meetings were preferred. The pandemic has challenged that notion.
“The adoption rate and interest from both healthcare professionals and patients is growing,” Palomer said. “If people are suffering, they want to use VR.” The normalization of technology in health treatment has been one beneficiary of the long stretches spent at home. “If you do something for a week, you’ll forget it,” Palomer said. “If you do it for a year or more, you get used to it. We’ve normalized this remote use.”
It’s not before time, either. While the pandemic has helped improve uptake of telehealth solutions, time spent away from loved ones, and away from physicians and psychiatrists is generating an enormous backlog of cases that Psious and Palomer hope to be able to help with.
“We’ve been locked down and isolated, with social distancing and a lot of things that make us anxious,” Palomer said. “We’re way more alone now. I used to go every day to the office; I can’t remember when I was last in the office. I don’t interact with my co-workers. When I interact with someone it’s often through a virtual connection. We don’t just talk anymore.”
Palomer thinks the increase in mental health issues is excacerbated by social distancing restrictions, increasingly negative news coverage, and general economic uncertainty for many people. “It’s like the worst mix ever,” Palomer said. “Being alone so you can’t exchange concerns or share problems. A lot of new stuff like face masks – inputs telling you something is wrong – and then bad news in everything you see or watch. It’s very easy to understand that at some point that will blow our minds.”
A mental health crisis on the horizon
Healthcare experts are already seeing the first wave of mental health issues starting to break on the horizon. “Most of us will be able to deal with it and get through it very easily, but a huge part of us won’t go through it very easily, which leads us to a growth in the number of mental health issues like anxiety and depression,” Palomer said. More than just sheer numbers, Palomer thinks physicians are also likely to see the severity of cases increase when the pandemic begins to subside. People will have lost family members; they’ll have spent a year or more locked indoors; they’ll have spent most of it worrying about what the future holds; and they may not have jobs to return to.
Palomer spoke to the head of psychiatry treatment at one of Spain’s largest hospitals. There, the department chief reported a 60% increase in caseload between January 2020 and January 2021. “For a hospital of that size, having that kind of growth in 12 months is just mindblowing,” Palomer said.
He’s concerned that we’re unsuited for what’s about to happen. “Are the systems ready, meaning healthcare providers, public and private systems? Are we ready to answer this demand?” he asks. “The answer is no. We’ll need to find, in the startup language, scalable solutions, and for me one of the best candidates is technology. Virtual reality has a very good clinical background and good validation. The scalability is there. We believe a solution like ours is needed more than ever before.”
Palomer believes Psious is a complement to, rather than a replacement for, face-to-face mental health treatment. But he thinks it’s better suited than most kinds of treatment, citing the way his back pain – the result of caring for three children and a life spent sitting at a computer – is being treated mostly through phone- and app-based physical therapy.
In 12 months’ time Palomer expects to see an even more meaningful increase in patient numbers being treated using Psious’s virtual reality systems. “We want to keep this pace in 2021,” he said. The mental health of us all may depend on it.
Spring has sprung, and there is a sense of relief in the air. After one year of lockdowns and social distancing, more than 171 million COVID-19 vaccine doses have been administered in the US and about 19.4% of the population is fully vaccinated. But there is something else in the air: ominous SARS-CoV-2 variants.
I am a virologist and vaccinologist, which means that I spend my days studying viruses and designing and testing vaccine strategies against viral diseases. In the case of SARS-CoV-2, this work has taken on greater urgency. We humans are in a race to become immune against this cagey virus, whose ability to mutate and adapt seems to be a step ahead of our capacity to gain herd immunity. Because of the variants that are emerging, it could be a race to the wire.
Five variants to watch
RNA viruses like SARS-CoV-2 constantly mutate as they make more copies of themselves. Most of these mutations end up being disadvantageous to the virus and therefore disappear through natural selection.
Occasionally, though, they offer a benefit to the mutated or so-called genetic-variant virus. An example would be a mutation that improves the ability of the virus to attach more tightly to human cells, thus enhancing viral replication. Another would be a mutation that allows the virus to spread more easily from person to person, thus increasing transmissibility.
None of this is surprising for a virus that is a fresh arrival in the human population and still adapting to humans as hosts. While viruses don’t think, they are governed by the same evolutionary drive that all organisms are – their first order of business is to perpetuate themselves.
Currently there are five variants of concern circulating in the US: the B.1.1.7, which originated in the UK; the B.1.351., of South African origin; the P.1., first seen in Brazil; and the B.1.427 and B.1.429, both originating in California.
Each of these variants has a number of mutations, and some of these are key mutations in critical regions of the viral genome. Because the spike protein is required for the virus to attach to human cells, it carries a number of these key mutations. In addition, antibodies that neutralize the virus typically bind to the spike protein, thus making the spike sequence or protein a key component of COVID-19 vaccines.
India and California have recently detected “double mutant” variants that, although not yet classified, have gained international interest. They have one key mutation in the spike protein similar to one found in the Brazilian and South African variants, and another already found in the B.1.427 and B.1.429 California variants. As of today, no variant has been classified as of high consequence, although the concern is that this could change as new variants emerge and we learn more about the variants already circulating.
More transmission and worse disease
These variants are worrisome for several reasons. First, the SARS-CoV-2 variants of concern generally spread from person to person at least 20% to 50% more easily. This allows them to infect more people and to spread more quickly and widely, eventually becoming the predominant strain.
Another concern is that these new variants can escape the immunity elicited by natural infection or our current vaccination efforts. For example, antibodies from people who recovered after infection or who have received a vaccine may not be able to bind as efficiently to a new variant virus, resulting in reduced neutralization of that variant virus. This could lead to reinfections and lower the effectiveness of current monoclonal antibody treatments and vaccines.
What does this all mean? While current vaccines may not prevent mild symptomatic COVID-19 caused by these variants, they will likely prevent moderate and severe disease, and in particular hospitalizations and deaths. That is the good news.
However, it is imperative to assume that current SARS-CoV-2 variants will likely continue to evolve and adapt. In a recent survey of 77 epidemiologists from 28 countries, the majority believed that within a year current vaccines could need to be updated to better handle new variants, and that low vaccine coverage will likely facilitate the emergence of such variants.
What do we need to do? We need to keep doing what we have been doing: using masks, avoiding poorly ventilated areas, and practicing social distancing techniques to slow transmission and avert further waves driven by these new variants. We also need to vaccinate as many people in as many places and as soon as possible to reduce the number of cases and the likelihood for the virus to generate new variants and escape mutants. And for that, it is vital that public health officials, governments, and nongovernmental organizations address vaccine hesitancy and equity both locally and globally.