Its invariably the most expensive part of vaccine development and the longest of the three phases, says Stanley Plotkin, former head of vaccines at Sanofi Pasteur. More than anything, he says, the time frame depends on the incidence of the disease.
The global effort to create a vaccine on such short notice is unprecedented. New technology has led drug makers to move quickly, and regulators have never pushed paper so fast. But with covid-19 getting beaten back in cities like New York, where new cases have fallen from more than 6,000 a day to less than 600, successful efforts to suppress the disease could perversely make it harder to test a vaccine.
Vaccine makers say its a concern. Speaking to Wall Street analysts on a conference call this week, Tal Zaks, chief medical officer at Moderna, whose mRNA vaccine was first to enter human studies in March, said: The challenge is, how do I ensure I have enough cases? If I go and vaccinate a lot of people, it doesnt matter how many if there is no circulating virus.
The irony is that the process will go faster if the covid-19 outbreak keeps flaring up. Vaccine researchers are also expected to pick nurses, doctors, and other at-risk groups to join their studies, so theres a bigger chance of subjects catching it. They will advise people to stay safe, even while hoping some get sick.
You still have to tell people to try not to get infected. You dont say Stop wearing a mask, or Why dont you meet people in a closed space. How is that for a weird dilemma? says Arthur Caplan, a bioethicist at NYU Langone Health in New York. The world is trying to get this under control, which I admire, but it does undermine the ability to study a vaccine.
While companies are the ones to decide what a trial looks like, in the US they need approval from the Food and Drug Administration, which has already said it expects to see randomized double-blind trials, the gold standard for proving that a treatment really works.
That means in the big studies starting this summer, some people will get the real vaccine and others will likely get a placebo shot. Then researchers will look to see how many in each group get infected or develop covid-19.
According to Clinton Hermes, an attorney at Bass, Berry & Sims and an outside counsel to the Coalition for Epidemic Preparedness Innovation, a placebo arm is necessary to keep both scientists and subjects in the dark. Knowing who got the vaccine can bias the researcher on a subconscious level in the way they collect data, and bias the behavior of the subject too, says Hermes. What you find is that if people are told they were given a vaccine, they are more likely to expose themselves to a virus than if they are uncertain. Its just human nature to engage in riskier behavior if they think they have been vaccinated.
To run their studies, vaccine companies are likely to look for volunteers among higher-risk populations in big, dense cities, according to Cynthia Dukes, vice president for drug development services at Icon Clinical Research, which is coordinating several covid vaccine and drug trials.
Most people to be vaccinated will likely be first responders, health care workers, or members of the National Guard, she says. Its a good population to go into and get an answer. We do want them to have a risk of exposure. If they are sitting at home, its not going to work.
Dukes says shes seen draft plans for vaccine trials involving 6,000 to 10,000 volunteers, in which researchers estimated that as many as 3.7% of volunteers would be exposed to the virus. That means theyre expecting about 100 to 150 infections in the placebo arm and fewer, or ideally none, among those who get vaccinated. That would be statistical proof the shot works.
During the trials, people will regularly be checked to see if they are infected as well. In a clinical study, at the first sign of a sniffle you get tested, says Dukes.
According to Dukes, it is possible to speed up the studies by filling them more quickly. She expects that wont be a problem; volunteers have been calling in by the thousands. Another way to get them done faster is simply to make them larger. That is what the Department of Health and Human Services signaled it planned to do with the AstraZeneca trial, which it said would involve 30,000 people in the US.
Like a horse race, Operation Warp Speed could end up backing trials of several vaccine contenders. That means the total number of volunteers needed could soar to more than 150,000, Reuters reported. But it's far from clear there will be enough covid-19 around. Adrian Hill, the Oxford University scientist behind the AstraZeneca shot said he thought there was a 50% chance a trial would lead to "no result at all."
"It's a race against the virus disappearing," Hill told The Telegraph.
The British pharmaceutical company pledged to have 300 million doses ready by October, but some are skeptical that large trials will have delivered answers that soon. Experts keep saying well have a vaccine in the fall, but we wont even have any data by then, says Caplan, who adds that it would be ethically impossible to distribute a vaccine before theres proof it works safely. People wouldnt take it. Also, you might be worried about an adverse event that is one in 25,000, he says. Thats rare, but if you are vaccinating a billion people, then relatively rare events are going to be more common.
Anthony Fauci, head of the US National Institutes of Allergy and Infectious Diseases, projected that it will take at least four or five months for a big trial to generate enough evidence that a vaccine works. If we are successful, we hope to know that in the late fall and early winter, he told a Senate hearing in May.
Hermes, the vaccine lawyer, agrees that you wont see anything deployed in general population without proof of efficacy, but he thinks governments will be likely to permit emergency use of a vaccine in frontline workers even before all the data is inperhaps within a few months. If a vaccine has a good safety profile and might possibly work, you could see people on the front line getting it, he says.
As clues roll in, the whole world is hanging on any hint a vaccine will end the covid crisis. On May 18, Moderna Pharmaceuticals sent the entire US stock market up nearly 4% after it said volunteers who got its vaccine in a safety trial made antibodies at levels similar to convalescent covid-19 patients, a hint that its vaccine might be effective.
In some volunteers, the antibodies were neutralizing, meaning they countered the virus when their plasma was tested in a petri dish.
The company was quickly attacked for doing science by press release, but Fauci, whose agency is testing the Moderna vaccine, says there is good reason to believe it could work. Its definitely not a long shot, he told Senator Mitt Romney during the Senate hearing. This is a virus that induces an immune response, and people recover the very fact that the body is capable of spontaneously clearing the virus tells me that at least from a conceptual standpoint, we can stimulate the body with a vaccine that would induce a similar response.
Thats a very different situation from HIVwhere (with rare exceptions) people never naturally defeat the virus, something that may explain why vaccines for AIDS have flopped time and again. With covid-19, by contrast, about 99 out of 100 people survive and appear to eventually cleared the virus.
The early data from the Moderna trial is an example of what vaccine makers call correlates of immunity. A correlate is something they can measure, like antibody levels, and which they can also cause to increase to a certain level with a vaccine. What they need to prove now, in the efficacy trial, is whether or not these factors can predictor actually causereal protection against the virus.
There are lots of kinds of immune responses. So which of these are you creating, and which is responsible for protection, if there is protection? That is the question, says Plotkin. Neutralizing antibodies are not always sufficient, but its a good guess. For many diseases its the key to protection, but not always.
Whats extraordinary now is that covid-19 vaccines are advancing to big tests even as the parallel scientific effort to understand our immune response to the coronavirus remains in its early stages. Zaks, the chief medical officer of Moderna, compared the process to "flying a plane" while building it.
And some voices are rising to warn that Operation Warp Speed could easily crash on takeoff. Normally, it takes up to 10 years to make a vaccine, Rick Bright, the former head of the US agency responsible for the vaccine push, told lawmakers on May 14. A lot of optimism is swirling around a 12-to-18-month time frame, if everything goes perfectly. Weve never seen everything go perfectly.
So what can go wrong? Dukes, who runs studies on behalf of companies, says that in her experience its usually manufacturing. If there's a problem scaling-up supplies, the process can face a big setback, since everything from animal studies to human studies is supposed to be based on an identical product.
For his part, Plotkin says the usual downfall of a vaccine is that researchers pick the wrong part of the virus to include in it or fail to inject enough of the substance. Other times its the biology of the virus thats the problemas in the case of HIV, a shape-shifter that attacks the immune system.
Its also well known that a perfectly effective vaccine can fail to make a difference for a much more mundane reason: people dont get vaccinated.
That happens more often than you think. Many people dont bother with flu vaccines, anti-vaccine movements are sowing fear, and there are regions of the world where shots for preventable disease never get delivered.
With covid-19, all those problems remain on the horizon. Theres also the fact that its going to be hard to make enough vaccine for everyone. In the context of a pandemic, we expect demand to far outstrip supply, Zaks said of his companys vaccine. During the call with stock analysts, his boss, Stphane Bancel, the companys CEO, agreed: Trust me, it was not part of our business plan to have a billion doses.
During the 2009 H1N1 pandemic, Sandra Quinn asked hundreds of Americans if theyd be willing to take a hypothetical vaccine that was authorized for emergency use but wasnt formally approved by the Food and Drug Administration. Most were hesitant: Quinn, the senior associate director of the Maryland Center for Health Equity at the University of Maryland, found that only around 8 percent of people said that theyd definitely take the vaccine.
An emergency H1N1 vaccine never came to be, but the questions Quinn asked 10 years ago are back in the spotlight today, as pharmaceutical companies in the US and around the world fight to produce a coronavirus vaccine as quickly as possible. Its a real possibility that the FDA could allow for emergency use of a vaccine this time around. The United States Department of Health and Human Services (HHS) said that it aims to have doses of the AstraZeneca vaccine candidate by October and that emergency use authorization or licensure of this vaccine from the U.S. Food and Drug Administration (FDA) would be required to make the vaccine available.
Far more than 8 percent of people would probably line up for an emergency coronavirus vaccine: the virus that causes COVID-19 is a much larger threat to most people than H1N1, which didnt trigger a societal shutdown and was far less deadly. But peoples concerns and misconceptions around experimental products havent gone away, and they will have to be addressed in the lead-up to any emergency use of a coronavirus vaccine.
Its going to be a critical point going forward, Quinn says.
If a pharmaceutical company develops a vaccine that it wants to distribute in the United States, it has to send mountains of data about it to the FDA. The agency carefully reviews that data and decides if there was clear enough evidence that it was safe and effective to approve it.
A coronavirus vaccine wont necessarily have to go through that process. The country has been under a public health emergency since the end of January, which means that the FDA can authorize a vaccine for emergency use as soon as theres a signal it might be effective and that its benefits outweigh the risks. Its faster than the regular approval process, but the bar is lower: the agency just has to find that it may be effective.
The FDA has already given emergency use authorization to companies making diagnostic tests, antibody tests, and treatments for COVID-19. The same law that lets the agency sidestep the usual process during an emergency can also be used for vaccines. The capability exists, says Alison Bateman-House, a bioethicist and assistant professor in the department of population health at the NYU Grossman School of Medicine. It was meant to be used for vaccines, otherwise there would have been a specific carve-out.
The FDA would have to be more cautious with vaccines than it has been in issuing emergency authorization for drugs, though. Drugs, for the most part, are given to people who are already sick. Vaccines, on the other hand, are intended for people who are healthy. You always have a greater burden when doing something to a healthy person versus trying to intervene on behalf of a sick person, Bateman-House says.
The agency should have data showing that a vaccine can help prevent disease (not just that it helps people produce antibodies) and clear data on at least short-term safety, former FDA officials told the Pink Sheet. Bateman-House told The Verge that shed be comfortable with an emergency vaccine authorization with stipulations. Thered have to be a really good reason you couldnt just push through the normal way, and the evidence would have to look good, she says.
The US is trying to speed vaccines through clinical trials as quickly as possible through Operation Warp Speed, which includes a program called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) through the National Institutes of Health. In July, this program will test vaccine candidates on tens of thousands of people who sign up for clinical trials. The trials will look for evidence that the vaccines can blunt the spread of the virus in areas where its still spreading.
Experts think the October timeline proposed by HHS and AstraZeneca is unrealistic. Itll take at minimum four or five months for researchers to have enough data to tell if people who receive the vaccine are less likely to catch COVID-19. But once that data starts to come in, if its promising, the FDA could go through with an emergency authorization.
Creating an effective vaccine takes a herculean effort, but getting one across the finish line isnt the only challenge. In order for a vaccine to beat back the pandemic, people have to actually agree to take it. If a vaccine is authorized by the FDA for emergency use, its vital that each person taking the vaccine understand exactly what it is and isnt. You have to make sure someone understands that this is not an FDA approved vaccine, like the ones youve taken your entire life, Bateman-House says. Given the severity of the situation, we dont have anything better, and were going to allow this product to be used.
The challenge is, Quinns research shows that most people dont have a good sense of the difference between drug approval and emergency authorization. She found that Americans have a limited understanding of FDA terminology around experimental products. People dont understand that kind of language, she says. In one survey, she found people were unfamiliar with terms like emergency use authorization, off-label (which is when a drug is used for different disease than the one it was approved for), and investigational new drug (a drug thats being tested in clinical trials).
Tagging a vaccine as an experimental product or something thats being offered for emergencies only could also make people less likely to trust it. People had negative associations with terms like experimental, investigational new drug, and emergency use authorization, Quinns survey found. Half of people asked about a hypothetical, experimental H1N1 vaccine said they would be very or extremely worried about it.
People may be more willing to override their concerns about unproved or emergency use vaccines now than they said they were during the 2009 H1N1 pandemic. Those who said they were more affected by H1N1 were more likely to say theyd take an emergency vaccine, and nearly everyone in the US has been touched by COVID-19 either by the illness directly or by the shutdowns.
The perceived severity of the disease is going to be quite different. That could make a difference in terms of willingness to take a vaccine, but its an open question, Quinn says.
Anti-vaccine sentiments, though, are stronger than they were in 2009, and theres less trust in the government more generally. This constant erosion over the last several years of trust and science and trust in experts, were seeing it on a daily basis right now. Thats a dramatic difference from 2009, she says.
Willingness to take an emergency vaccine would also vary between racial and ethnic groups. During the 2001 anthrax attacks, for example, the Centers for Disease Control and Prevention offered postal workers who may have been exposed to the bacteria the option of taking an investigational form of the anthrax vaccine that could prevent illness. Most people didnt take that offer and African American workers were particularly resistant.
It was an immediate red flag, Quinn says. Many of the postal workers cited the 1932 Tuskegee syphilis study as the reason why they didnt trust experimental products. During that study, the US withheld syphilis treatments from black men. Government scientists let them suffer through the course of the disease in the name of research. The erosion of trust in science from the black community has never fully recovered. Quinns H1N1 survey also found that black and Latino respondents were less likely to say that theyd take an emergency vaccine.
If historic distrust of scientific research leaves those communities less likely to take a vaccine if its offered under emergency use, vaccination gaps could contribute to the already devastating racial disparities in the impact of the COVID-19 pandemic, Quinn says. The virus is already devastating black communities: the majority of COVID-19 deaths are in disproportionately black counties.
The FDA will be under enormous pressure to authorize a vaccine as soon as possible. Without one, COVID-19 will stay a looming threat. An emergency authorization may be the best path forward, Bateman-House says, but there could be long-term consequences to public trust in vaccines. If a vaccine is tagged as something that regulators allowed to be distributed without as rigorous a review, people who are already skeptical of vaccines might take it as evidence that vaccines are risky or dangerous.
If you hear that the government is pushing out a vaccine, and its not fully approved, that hits all the cognitive dissonance you already have, she says.
If there end up being side effects from an emergency vaccine, even if theyre minor or far less severe than COVID-19 itself, that could be additional ammunition for people who are already suspicious of vaccines. The ramifications could be significant and are important to consider.
People tend not to think of vaccines in isolation. They think of them as a group. If theres suspicion of a COVID-19 vaccine, there will be suspicions of other vaccines, Bateman-House says. When youre making this decision, you have to be aware that it could have a multi-year fallout.
A Seattle man who is taking part in a COVID-19 vaccine trial is opening up about experiencing an adverse reaction that briefly left him unconscious.
Ian Haydon, 29, said volunteering was the right thing to do when he shared his story with TODAY last month after receiving the first dose of the vaccine candidate.
The adverse reaction came after the second shot on May 5. Haydon is only now revealing the details in part because it wasnt clear what happened at first and because he found it hard to talk about vaccine safety without triggering anti-vaccine activists, he tweeted Tuesday. "There's no failure here," he emphasized.
Haydon felt some arm pain at the injection site, just like after the first dose, but it came on much more quickly than before, he said.
Then, 12 hours after getting the second injection, I suddenly had severe chills. I decided to go to sleep but woke up in the middle of the night with a fever that was over 103 degrees. I also found I was nauseous, fatigued and had quite a headache, Haydon told TODAY.
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His partner called the 24-hour hotline for the vaccine study and Haydon was advised to go to urgent care. There, he was met by the study's lead doctor and medical staff who were all wearing full personal protective equipment, including face shields, masks and gowns. One nurse even had a powered air-purifying respirator.
Haydon received intravenous fluids and Tylenol. He was given a COVID-19 nasal swab and had blood drawn from his arms to use for a series of viral panel tests. It turned out he did not have COVID-19.
After leaving urgent care, Haydon went home to rest. His fever rose back to 101 degrees and he had to throw up.
On my way back to bed I fainted. My girlfriend caught me as I went down and kept me from hitting my head. She woke me up. I remember being confused at the sight of my living room ceiling, Haydon recalled.
The symptoms he experienced weren't life threatening and they're over, Haydon said, adding hes now feeling fine and back to marathon training.
Haydon recently found out he received the highest dose of the vaccine tested in the trial 10 times the amount some other participants were injected with. In a news release last week, Moderna, Inc., the Massachusetts-based biotechnology company that helped develop the vaccine, said the most notable adverse events were seen at this highest dose level affecting three participants, but only after the second dose.
The symptoms included fever, muscle pains and headaches, and all went away after a day, Dr. Tal Zaks, chief medical officer at Moderna, told The New York Times. The high dose wont be used in future studies because the lower doses appear to work well, he added.
The company said its vaccine candidate can prompt an immune response in the human body and was found to be safe and well-tolerated in a group of 45 patients. The drug is now being tested in larger studies.
The potential of adverse reactions isn't a surprise: Participating in a clinical trial comes with the risk of serious side effects or feeling uncomfortable, the National Institutes of Health noted.
Haydon said he consented to be in the study and everyone admitted could have received any dose of the vaccine. He praised the excellent medical care he received during the incident.
This is exactly the kind of event that a phase 1 study is built for. The clinicians are looking to see how people react to different doses of the vaccine, Haydon said.
Vaccines are the single most important medicines we have. It's important to test them carefully which is what's happening here. I remain cautiously optimistic.
Haydon is still in the study and will be monitored periodically for about another year, just like all the other participants, he said.
A. Pawlowski is a TODAY contributing editor focusing on health news and features. Previously, she was a writer, producer and editor at CNN.
President Trump and China's President Xi Jinping, shown in 2019, have faced criticism for their handling of the coronavirus. Both are now pushing hard for a vaccine. The United States has already agreed to pay a drug company more than $1 billion to produce a vaccine that's yet to be approved. Xi says if China succeeds in developing a vaccine, it will be declared "a global public good." Kevin Lamarque/Reuters hide caption
President Trump and China's President Xi Jinping, shown in 2019, have faced criticism for their handling of the coronavirus. Both are now pushing hard for a vaccine. The United States has already agreed to pay a drug company more than $1 billion to produce a vaccine that's yet to be approved. Xi says if China succeeds in developing a vaccine, it will be declared "a global public good."
The race to defeat the coronavirus can be viewed in two very distinct ways. One is based on international cooperation, with a vaccine treated as a "global public good." The other is competitive, a battle between nations that's being described as "vaccine nationalism."
Many are hoping for the former, but are seeing signs of the latter.
The main competition, on this and many other global issues, appears to be between the United States and China. Both President Trump and China's President Xi Jinping have faced criticism for their handling of the coronavirus outbreak. Success with a vaccine at home could make up for the earlier shortcomings.
"We're about to have an unprecedented battle over access to the vaccines, which will be far more challenging if we're in a U.S.-versus-China Cold War environment," said Ian Bremmer, president of the Eurasia Group, a political consulting firm.
Trump's Operation Warp Speed is designed to develop a COVID-19 vaccine for Americans as soon as possible, and with an eye on the November presidential election.
Last week, the U.S. government announced it was paying up to $1.2 billion to the drugmaker AstraZeneca to start work on a vaccine that could be ready as early as October, though there's not yet a vaccine that's been proved to be safe and effective.
China's line
Meanwhile, China's Xi has adopted a somewhat softer public line that some are describing as "vaccine diplomacy."
Xi says China will spend $2 billion to help developing countries. China also is among dozens of countries that have signed on to a resolution by member states of the World Health Organization that says a vaccine should be treated as a "global public good" to be distributed widely, fairly and cheaply.
China faced global condemnation for its early efforts to downplay the severity of the virus and has sought to rewrite the narrative by promoting its efforts to find a vaccine and assist other countries.
China is making a major push to develop a vaccine at home and has at least four trials underway.
Xi wants China to be a world leader in the most important technologies of the 21st century, including biopharmaceuticals. If China became the first to develop a vaccine, it would consider it a huge victory.
However, some U.S. national security officials say the Chinese efforts include attempts to hack into American and other Western drug companies to steal valuable research information.
"We have the full expectation that China will do everything in their power to obtain any viable research that we are conducting here in the U.S.," said Bill Evanina, the director of the National Counterintelligence and Security Center. "That will be in line with their capabilities and intent the last decade plus, and we are expecting them to continue to do so."
Global pandemic, global solution
While one country, or one company, may take the lead when it comes to a vaccine, the worldwide nature of the problem points to the need for a truly global solution, according to those in the international health community.
For example, AstraZeneca, which is getting the U.S. government funding, is a Swedish-British firm, which is hoping to produce vaccines based on promising research conducted at Oxford University in Britain. AstraZeneca, like all the major Western pharmaceutical companies, has offices and manufacturing plants spread around the globe.
Many players in many countries are likely to be involved. But it takes time to ramp up vaccine production, and this points to a crucial question: In a world of more than 7 billion people, who's at the front of the line, and who's at the back?
"The challenge is going to come in the first year in terms of capacity, combined with disagreements about who should be first, second and third in line," said Nancy Kass, professor of bioethics and public health at Johns Hopkins University.
New drugs and vaccines traditionally go first to the wealthiest countries, and that's the expectation in this case as well. But the exact order could depend on where the vaccine is first developed. The U.S. and China could have very different priorities on how to distribute a vaccine.
Pharmacist Michael Witte (left) gives Neal Browning a shot in the first-stage study of a potential coronavirus vaccine on March 16 in Seattle. Countries and companies are racing to find a vaccine with some describing the competition as "vaccine nationalism." Ted S. Warren/AP hide caption
Pharmacist Michael Witte (left) gives Neal Browning a shot in the first-stage study of a potential coronavirus vaccine on March 16 in Seattle. Countries and companies are racing to find a vaccine with some describing the competition as "vaccine nationalism."
Rich countries have been hit hardest by the virus so far. But in many of these nations, COVID-19 cases are leveling off or declining, while they are rising rapidly in the developing world, including countries such as India, Brazil and Peru.
Assessing needs
Global health organizations are working on plans with a focus on poorer nations.
Kate Elder of Doctors Without Borders says her organization often faces challenges in dealing with Western pharmaceutical companies that have tremendous leverage because they are the only one, or one of just a few, that make a critical drug.
"We can design things as a global community," she said. "But ultimately, since the power is in the pharmaceutical corporation's hands to make those decisions, it's up to them. At what scale they produce these vaccines, at what price they set them, and who are the first customers that they'll cater to."
Because the demand for a new vaccine will be so great, nations, political leaders and drug companies are likely to face a range of conflicting pressures. They will need to provide the vaccine at home but will also face intense scrutiny to share it widely, fairly and cheaply abroad.
"It's set up to be a massive geopolitical battle," said Bremmer, of the Eurasia Group. "Not just around the discovery of the vaccine, but the manufacturing chain with billions of doses needed, and the challenges of a global vaccination campaign."
Greg Myre is an NPR national security correspondent. Follow him @gregmyre1.
Announcing several partnerships today, Merck will pursue two vaccines and a therapy for COVID-19.
By Jon CohenMay. 26, 2020 , 3:20 PM
Sciences COVID-19 reporting is supported by the Pulitzer Center.
Merck, one of the largest pharmaceutical companies in the world, has been conspicuously absent from the race to develop COVID-19 vaccines and drugs. No longer. The company this morning announced it has cut deals to develop and manufacture two different COVID-19 vaccines and a much-discussed experimental antiviral compound that is already in early clinical trials.
Roger Perlmutter, president of Merck Research Laboratories, portrays the company as deliberate rather than a latecomer. And the immunologist believes Mercks skills and experience can accelerate the progress that other, smaller developers already have made. Clearly, we have a lot of heft, says Perlmutter, who declined to disclose how much Merck is investing in each project.
According to the World Health Organizations latest table of COVID-19 vaccines, 124 candidates are at various stages of development with eight different technologies, or platforms. Mercks new investments focus on a platform, known as the replicating viral vector, that takes longer to develop than others, but will potentially lead to robust immune responses triggered by a single dose. Most vaccine projects failits very difficult to make a vaccine, Perlmutter says. So if Im going to start making a vaccine, Id like to be thoughtful about which vaccine platforms have the greatest likelihood of success. Being first hasnt been the companys priority. Its likely that the world will need more than one COVID-19 vaccine to meet demand, Perlmutter says. And different populations like the elderly or children may need different preparations, he adds.
One of the COVID-19 vaccine candidates that Merck decided to back aims to build off the success it had with an Ebola vaccine that came to market last year. That vaccine uses an engineered vesicular stomatitis virus (VSV) to shuttle a gene for the Ebola virus surface protein into a hosts cells. Merck now plans to develop a VSV-based COVID-19 vaccine in partnership with the International AIDS Vaccine Initiative (IAVI), a nonprofit that was originally set up to push forward HIV vaccines but has broadened its portfolio to include vaccines for a wide range of other diseases.
Mark Feinberg, who heads IAVI and previously worked at Merck on the Ebola vaccine project, notes that IAVI scientists have been working with the VSV platform for vaccines against Lassa fever, Marburg virus, and a different Ebola virus. Theyve now stitched into VSV the surface protein, or spike, for SARS-CoV-2, the virus that causes COVID-19. Feinberg says Merck approached IAVI in March about collaborating.
The multiple shots on goal analogy [for the COVID-19 vaccine pursuit] makes enormous sense here, Feinberg says. With 100-some candidates, not all of them are going to advance to the clinic or be able to be produced at scale. There will have to be a rigorous, thoughtful, data-driven process to select the most promising ones. As part of the deal, the U.S. government has awarded Merck$38 million through the Biomedical Advanced Research and Development Authority (BARDA).
For the second vaccine project, Merck is acquiring Themis, an Austrian company that licensed a platform based on the established measles vaccine and developed at the Pasteur Institute. The vaccine contains a weakened, safe version of that virus that causes measles, which Pasteur scientists showed could serve as a carrier for genes from a wide range of pathogens, including the coronavirus that causes severe acute respiratory syndrome. Adding the spike gene from SARS-CoV-2 to this attenuated measles virus was a logical next step. Themis, the Pasteur Institute, and the University of Pittsburgh in March received $4.9 million to develop the approach from a nonprofit, the Coalition for Epidemic Preparedness Innovations.
Perlmutter says neither IAVI nor Themis has yet tested whether these vaccine candidates can protect monkeys from SARS-CoV-2 infections or serious COVID-19 symptoms. But he says both platforms have proved themselves in human studies for other diseases and we have a high confidence that they can work. The live replicating viruses, he says, have the advantage of stimulating both B cells, which make antibodies, and T cells that clear infected cells. And unlike the many COVID-19 vaccine candidates that use nonreplicating vectors or just engineered versions of the coronavirus surface protein, this approach may only need a single shot because the viruses copy themselves, potentially producing high levels of spike that elicit strong immune responses. When you start thinking about immunizing billions of people, the idea of having to track people down for boosters is very problematic, Perlmutter says. Its not impossible, but youd prefer not to do it.
Lawrence Corey, a vaccine developer at the Fred Hutchinson Cancer Research Center who co-chairs a committee at the National Institutes of Health that aims to speed testing of COVID-19 vaccines, welcomes Merck to the race. Im delighted to see them undertake two novel platforms for potential COVID vaccine development, Corey says.
On the therapy front, Merck has chosen to back development of EIDD-2801, a compound designed to inhibit diverse viruses that use RNA as their genetic material, which includes SARS-CoV-2. Merck is collaborating with Ridgeback Biotherapeutics, which licensed the drug from a nonprofit at Emory University called Drug Innovation Ventures at Emory (DRIVE). Ridgeback recently started a safety trial of the drug in healthy patients in the United Kingdom.
The drug, which inhibits a polymerase enzyme used during viral replication, has been at the center of a controversy involving Ridgebacks attempt to win BARDA funding. The agencys former director, Rick Bright, filed a whistleblower complaint that went into great detail about how his bosses allegedly pressured him to fund EIDD-2801s development, which he worried could present serious toxicities. BARDA did not award the moneywhich could have totaled $300 millionto Ridgeback or DRIVE.
At least one other pharmaceutical company abandoned development of a compound similar to EIDD-2801 because it has mutagenic properties. Perlmutter agrees that ordinarily you prefer not to advance a mutagen, but he says the drug, which can be given as a pill, has been well tolerated in the U.K. trial and that they plan to look closely at its cancer-causing potential in reproductive and developmental biology animal studies. Other mutagenic drugs that treat infectious diseases have come to market, he notes.
Perlmutter stresses that there are no easy solutions to the COVID-19 pandemicparticularly when it comes to developing and evaluating vaccines. One of the things I think is disturbing is I dont want people to imagine thatnot that they wouldthat Merck is coming in now and its all going to get taken care of in 12 months, Perlmutter says. Its not. These things take a long time.
*Correction, 27 May, 10:40 a.m.:This story was corrected to specify that BARDAs grant of $38 million to the IAVI/Merck partnership was awarded to Merck.
In a medical research project nearly unrivaled in its ambition and scope, volunteers worldwide are rolling up their sleeves to receive experimental vaccines against the coronavirus only months after the virus was identified.
Companies like Inovio and Pfizer have begun early tests of candidates in people to determine whether their vaccines are safe. Researchers at the University of Oxford in England are testing vaccines in human subjects, too, and say they could have one ready for emergency use as soon as September.
The findings will pave the way to development of a human vaccine, said the investigators. They have already partnered with Janssen, a division of Johnson & Johnson.
In labs around the world, there is now cautious optimism that a coronavirus vaccine, and perhaps more than one, will be ready sometime next year.
Scientists are exploring not just one approach to creating the vaccine, but at least four. So great is the urgency that they are combining trial phases and shortening a process that usually takes years, sometimes more than a decade.
Its an easier target, which is terrific news, said Michael Farzan, a virologist at Scripps Research in Jupiter, Fla.
What people dont realize is that normally vaccine development takes many years, sometimes decades, said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston who led the monkey trials. And so trying to compress the whole vaccine process into 12 to 18 months is really unheard-of.
If that happens, it will be the fastest vaccine development program ever in history.
More than 100 research teams around the world are taking aim at the virus from multiple angles.
Modernas vaccine is based on a relatively new mRNA technology that delivers bits of the viruss genes into human cells. The goal is for cells to begin making a viral protein that the immune system recognizes as foreign. The body builds defenses against that protein, priming itself to attack if the actual coronavirus invades.
Some vaccine makers, including Inovio, are developing vaccines based on DNA variations of this approach.
But the technology used by both companies has never produced a vaccine approved for clinical use, let alone one that can be made in industrial quantities. Moderna was criticized for making rosy predictions, based on a handful of patients, without providing any scientific data.
Other research teams have turned to more traditional strategies.
Some scientists are using harmless viruses to deliver coronavirus genes into cells, forcing them to produce proteins that may teach the immune system to watch out for the coronavirus. CanSino Biologics, a company in China, has begun human testing of a coronavirus vaccine that relies on this approach, as has the University of Oxford team.
Other traditional approaches rely on fragments of a coronavirus protein to make a vaccine, while some use killed, or inactivated, versions of the whole coronavirus. In China, such vaccines have already entered human trials.
Florian Krammer, a virologist at Icahn School of Medicine at Mount Sinai in New York, predicted that at least 20 additional vaccine candidates will make their way into clinical trials in the weeks to come.
Im not worried at all about it, he said of the prospects for a new vaccine.
Many of these vaccines will stumble as the trials progress. As more people are inoculated, some candidates will fail to protect against the virus, and side effects will become more apparent.
But from what scientists are learning about the coronavirus, it ought to be a relatively easy target.
The coronavirus sports tempting targets on its surface, unique spike proteins the pathogen needs to enter human cells. The immune system readily learns to recognize these proteins, it appears, and to attack them, killing the virus.
Viruses can challenge vaccine makers by mutating rapidly, changing shape so that antibodies that work on one viral strain fail on another. Thankfully, the new coronavirus seems to be a slow mutator, and a vaccine that proves effective in trials should work anywhere in the world.
When work on a coronavirus vaccine started, some researchers worried that antibodies actually might worsen Covid-19, the illness caused by the coronavirus. But in early studies, no serious risks have emerged.
That doesnt mean that there wont be, but so far there hasnt been any indication, so Im cautiously optimistic on that point, said Dr. Alyson Kelvin, a researcher at the Canadian Center for Vaccinology and Dalhousie University.
Ensuring that vaccines are safe and effective demands large trials that require careful planning and execution. If successful vaccines emerge from those trials, someones going to have to make an awful lot of them.
Almost everyone on the planet is vulnerable to the new coronavirus. Each person may need two doses of a new vaccine to receive protective immunity. Thats 16 billion doses.
When companies promise of delivering a vaccine in a year or less, I am not sure what stage they are talking about, said Akiko Iwasaki, an immunobiologist at Yale University. I doubt they are talking about global distributions in billions of doses.
Manufacturing vaccines is profoundly more complex than manufacturing, say, shoes or bicycles. Vaccines typically require large vats in which their ingredients are grown, and these have to be maintained in sterile conditions. Also, no factories have ever churned out millions of doses of approved vaccines made with the cutting-edge technology being tested by companies like Inovio and Moderna.
Facilities have sprung up in recent years to make viral-vector vaccines, including a Johnson & Johnson plant in the Netherlands. But meeting pandemic demand would be an enormous challenge. Manufacturers have the most experience mass-producing inactivated vaccines, made with killed viruses, so this type may be the easiest to produce in large quantities.
But there cannot be just one vaccine. If that were to happen, the company that made it would have no chance of meeting the worlds demand.
The hope is that they will all, at some level, be effective, and certainly thats important because we need more than just one, said Emilio Emini, a director of the vaccine program at the Bill and Melinda Gates Foundation, which is providing financial support to many competing vaccine efforts.
As part of a public-private partnership the White House calls Operation Warp Speed, the Trump administration has promised to design a kind of parallel manufacturing track to run alongside the clinical trials, building up capacity well before trials are concluded, in hopes that one or more vaccines could be distributed immediately upon approval.
President Trump said on Friday that the goal of the project was to distribute a vaccine prior to the end of the year. To do that, Mr. Trump is relying on the Defense Department to manage the manufacturing logistics related to vaccine development.
But in an interview on Thursday, Gen. Gustave F. Perna, who will manage the manufacturing logistics, said discussions about the equipment and facilities needed for production were just beginning.
He described his work as a math problem: how to get 300 million doses of a vaccine that doesnt yet exist to Americans by January.
He added: Now, how am I going to distribute it? What is it going to be distributed in? What do I need to order now to make sure I have the distribution capability? The small bottles, the trucks.
Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins University Center for Health Security, said that seemingly minor aspects of production and distribution could complicate progress later on.
This is on a scale weve never seen since the polio vaccine, he said. Its the little things like the syringes, the needles, the glass vials. All of that has to be thought about. You dont want something that seems so simple to be the bottleneck in your vaccination program.
A coronavirus vaccine doesnt yet exist, but already there are questions about who will be able to afford it.
Oxfam, an international charity, has published an open letter from 140 world leaders and experts calling for a peoples vaccine, which would be made available for all people, in all countries, free of charge.
These vaccines have to be a public good, said Helen Clark, a former prime minister of New Zealand, who signed the letter. Were not safe till everyone is safe.
Sui-Lee Wee contributed reporting from Singapore.
The truth will set us free (and/or justify prolonged restrictions on our freedom). Photo: Diego Azubel/EPA-EFE/Shutterstock
These days, studies heralding some hopeful or horrifying new finding about the coronavirus are multiplying nearly as fast as the bug itself. As medical researchers the world over give COVID-19 their undivided attention, each week brings a new smorgasbord of working papers that leave lay-observers either jubilantly awaiting the imminent reopening of Americas underground mud-wrestling rings or despondently preparing for another 18 months of awkward Zoom happy hours, depending on which items they happen to sample.
To help you get a better handle on the latest things weve learned about the novel coronavirus, and our prospects for vanquishing it, Intelligenceris assembling periodic rundowns of all the good and bad news thats come our way. (You can check out last weeks list here.)
Critically, the findings described here are preliminary. Humanity has only had a few months experience with the virus formally known as SARS-CoV-2. Our understanding of it is partial and subject to change. So take the following with a grain of salt (but not, under any circumstances, anunprescribed dose of hydroxychloroquine).
1) The coronavirus may not be able to get by without large public gatherings.
The novel coronavirus has been nearly as confounding to human reason as its been to the human immune system. Our species likes to fit threats into clear, cause-and-effect narratives in which human agency plays a decisive role. And weve managed to construct several credible morality tales about the COVID-19 pandemic (e.g., an ounce of preemptive lockdown is worth a pound of cure).
But the pandemic has routinely complicated these stories by casting chaos as a protagonist: Although decisions about when and how to implement lockdowns contributed to disparate outcomes between jurisdictions, a good amount of divergence has been ostensibly random. For example, despite resisting widespread closures of nonessential businesses for months after its first confirmed case of COVID-19, Japan has enjoyed one of the lowest per-capita coronavirus death rates of any affected country (which is especially remarkable given that Japan has the second-oldest population in the world). Meanwhile, policy alone cant seem to explain why some of the worlds large, dense cities have seen mild outbreaks, even as others have been devastated. Which raises the question: Is there no guidance when random rules?
Happily, new research has yielded a theory that helps explain the pandemics most puzzling aspects and just might allow us to curb the viruss spread through means less onerous than total lockdowns.
All viruses thrive on large public events and individual super-spreaders. But the novel coronavirus appears to be unusually dependent on both. The media conversation about SARS-CoV-2 has popularized one key epidemiological variable R, the average number of people an afflicted individual infects. Before social-distancing measures were enacted, the coronavirus had an R of about three. And yet, this average obscures the profound variation between individuals. Estimates vary, but multiple research teams believe that the typical COVID-19 patient does not infect a single other person, a reality that is concealed by the prolific transmission rates of so-called super-spreaders. In fact, according to a new study from the London School of Hygiene & Tropical Medicine (LSHTM), about 10 percent of coronavirus patients are responsible for 80 percent of all new infections. This means that the coronaviruss high R is potentially mitigated by its low k a variable that describes how reliant a disease is on clusters of infection in order to spread. Viruses with a high k, such as the 1918 influenza, can spread diffusely through a large number of individuals. Those with a low k such as the novel coronaviruss close relatives SARS and MERS cannot sustain themselves without super-spreaders. This was one reason why both of those coronaviruses burned out quickly and never recurred. Research from the University of Bern suggests that the coronavirus has a slightly higher k than SARS or MERS but one that is much lower than that of the Spanish flu.
This finding makes some of the random disparities in outcomes easier to understand. A virus with a low k value needs a bit of luck to get off the ground. If such a bug gets itself into the right human say, one whos too committed to choir practice to let a cold keep them home it can gain a foothold in a community. If it infects a bunch of lonely homebodies, meanwhile, it will die out before making its presence felt (as the novel coronavirus ostensibly did in France last December). If SARS-CoV-2 has a k as low as the LSHTM study claims, then it would need to be introduced to a new country four separate times before securing a 50/50 chance of infecting enough people to sustain a prolonged outbreak.
Of course, the viruss odds of landing on a super-spreader arent determined by luck alone. The fewer mass (indoor) gatherings a society holds, the fewer opportunities SARS-CoV-2 will have to hit pay dirt. This could explain while partial reopenings havent produced giant surges in cases as of yet; Georgians still arent generally attending large concerts, conferences, or sporting events. Its possible, then, that a combination of banning large gatherings including those convened on a daily basis at open-plan offices and meatpacking plants and encouraging ubiquitous mask-wearing will prove sufficient to contain COVID-19. Which is to say: We may be able to enjoymany forms of nonessential commerce without sparking a surge caseloads (though we may need to eat a bit less meat).
2) It is possible that a significant number of people whove never been infected with the novel coronavirus already possess some immunity to it.
In last weeks roundup, we featured a study that found that a survivor of SARS possessed an antibody that ostensibly confers immunity to COVID-19. This was auspicious for our odds of developing an effective novel-coronavirus vaccine since an antibody capable of neutralizing viruses as distinct as SARS and the COVID-19 bug should be versatile enough to neutralize all mutated versions of the latter.
This said, even if every SARS survivor were immune to the novel coronavirus, it would make little immediate difference epidemiologically, as only an infinitesimal fraction of humans were ever infected with SARS.
But SARS and MERS werent the only forerunners of our present affliction. Several common colds are also coronaviruses. And if a significant percentage of people whove recovered from such colds possess cross-reactive immunity to SARS-CoV-2, then the population liable to contract COVID-19 and spread the novel coronavirus would be smaller than previously feared.
A recent study from the Center for Infectious Disease and Vaccine Research and the La Jolla Institute for Immunology suggests that this might be the case. Examining blood samples taken between 2015 and 2018 (when the novel coronavirus was still just a twinkle in Satans eye), researchers found that roughly 50 percent of these blood-givers possessed SARS-CoV-2-reactive CD4+ T cells which is to say, their immune systems appeared capable of immediately recognizing and combating the novel coronavirus. Since none of these individuals could have been exposed to SARS-CoV-2, the most likely explanation for their possession of such T cells is previous exposure to a common-cold coronavirus.
Now, this was just a single study of blood samples. It remains unclear how prevalent these T cells actually are in the general population and how effective they truly are in combating COVID-19. But its at least possible that SARS-CoV-2 will suffer a fate not entirely dissimilar to the 2009 H1N1 swine flu, whose spread was undermined by the immunological head start humanity had derived from similar influenza strains.
3) Coronavirus patients cease to be infectious two weeks after developing symptoms.
This was already conventional wisdom. But a new study from Singapore fortifies the consensus by finding that 100 percent of its 73 observed coronavirus sufferers ceased to have a viable virus in their bodies 11 days after the onset of symptoms.
4) Scientists appear to have identified biomarkers that can predict whether a COVID-19 patient will develop severe illness ten days in advance.
Most people who contract the novel coronavirus do not develop serious illness. Even among demographically vulnerable populations, there are wide disparities in individual outcomes. If it were possible to drill down beneath age and common comorbidities to even more fine-grained predictors of COVID-19 vulnerability, medical and public-health officials would be better able to shield those most at-risk.
A recent study in the journal Nature Machine Intelligence identifies such predictors. Researchers analyzed 485 coronavirus patients in Wuhan, China, using machine-learning tools to isolate biological characteristics unique to the subset of patients who ultimately perished from COVID-19.
They found that three biological markers are so predictive of mortality, they can signal whether a COVID-19 patient will develop life-threatening illness with 90 percent accuracy more than ten days ahead of time. The three so-called biomarkers, all of which can be measured using a single drop of blood, were:
1) Elevated levels of the enzyme lactic dehydrogenase (LDH).
2) Low levels of lymphocytes (i.e., white blood cells).
3) High-sensitivity C-reactive proteins, which are indicative of respiratory inflammation.
By widely testing for these biomarkers, medical professionals could separate patients who will experience COVID-19 as a bad cold from those who will experience it as a mortal threat long before the distinction becomes apparent to the patients themselves. This would allow hospitals to better concentrate resources and thus, theoretically, reduce COVID-19s overall fatality rate.
5) The coronaviruss mutations dont appear to have made it more infectious.
Viruses evolve constantly. And SARS-CoV-2 is no exception: According to researchers at University College London (UCL), the novel coronavirus has produced 273 mutations; of these, 31 have become prevalent.
One nightmare scenario for SARS-CoV-2 is that it will evolve into something even more lethal and infectious, as the 1918 influenza virus did before its devastating second wave. Fortunately, a new study from UCL indicates that none of the 31 prevalent mutations of the novel coronavirus are more virulent than the original brand.
6) The evidence that people who contract the coronavirus develop immunity-conferring antibodies is steadily growing.
Last weeks roundup included multiple studies indicating that COVID-19 survivors develop neutralizing antibodies and thus face no immediate risk of reinfection (how long such immunity lasts remains unclear). Now, a study of 160 French doctors and nurses who contracted mild cases of COVID-19 finds that 159 possessed neutralizing antibodies 41 days after showing symptoms. This is significant because many have feared that mild cases of COVID-19 might be insufficient to confer immunity.
7) The story is in the sewer; keep your ear to the grate.
Most of the metrics we have for assessing COVID-19 outbreaks are lagging indicators. Since it takes several days for patients to develop severe symptoms and often weeks to display life-threatening ones confirmed cases and death counts tell us more about how widely the virus was circulating in the recent past than how prevalent it will be in the near future.
But researchers at Yale University believe theyve discovered a metric that can predict major municipal outbreaks a week in advance the concentration of the coronavirus in a citys sewers.
1) Herd immunity will take a lot more time and death to achieve than Sweden had hoped.
Sweden decided to make itself into Europes control group by forgoing formal lockdown orders or the closure of nonessential businesses. Instead, the Swedes opted for a herd immunity strategy to battling the novel coronavirus: By keeping its most vulnerable people isolated while allowing healthy young people to circulate freely (and contract COVID-19 prolifically) the nation would accelerate the process of collective immunization against the virus, thereby suffering less economic damage in the short run and fewer COVID-19 deaths in the long run than all those overreacting sucker countries.
Things arent working out as planned. The Swedish economy has suffered roughly as severe a downturn as that of Denmark. And in recent days, its had the highest per-capita coronavirus death rate in Europe.
Until last week, defenders of the Swedish strategy could still argue that it might pay off eventually: The policy was never intended to minimize coronavirus deaths in the immediate term, after all. And if keeping things open gets Sweden to herd immunity faster than other countries do, then the strategy could yield an aberrantly high fatality rate in the early months of the pandemic but an exceptionally low one over its full duration.
Unfortunately for Sweden and for anyone hoping Americas reopenings will get us to herd immunity in short order a recent study of residents in Stockholm found that just 7.3 percent of people in the Swedish city possessed COVID-19 antibodies in late April.
As mentioned above, it is possible that cross-reactive immunity from the common cold could accelerate the achievement of effective herd immunity. But that remains a hypothetical. Meanwhile, multiple studies have now indicated that if herd immunity can only be won through 60 to 70 percent of a population contracting the novel coronavirus, then the path to such a resolution will be far longer and deadlier than many had hoped.
2) If Americans return to the office this summer, they could accelerate COVIDs spread; if they stay home, they could plunge whole cities into darkness.
Some hope that summer will provide America with the comprehensive COVID-19 containment plan the Trump administration hasnt. But while theres evidence that the virus isnt a huge fan of heat and ultraviolet light, the warming weather may do less to inhibit COVID-19s spread than the growing use of air conditioners does to facilitate it.
Researchers from the Guangzhou Center for Disease Control and Prevention discovered that 10 people from three different families had contracted COVID-19 after all had dined at the same restaurant. After conducting a thorough investigation and study of their cases, the team concluded that an AC unit in the eatery had concentrated its blast of air on an infected diner, blowing the unwitting super-spreaders viral droplets across three adjacent tables, thereby sickening the other families. As New Yorks Justin Davidson reports, this study is indicative of the broader epidemiological hazard posed by poorly ventilated AC systems in densely occupied public buildings.
For this reason, many firms will hesitate to fully reopen their offices this summer. And yet, if Americas white-collar workers stay at home en masse and each run their personal air conditioners all day long then there will be dark times ahead. As the Daily Beast reports:
[T]he power infrastructure in residential areas is typically designed to accommodate heavy use in the early mornings and evenings, with hours to cool off during the day. Consumption patterns in these districts have already changed during the crisis, with demand spiking in the daytime. Overall usage is already up by an average of 7 percent in New York City apartments, and by 15 to 20 percent in homes in California.
As the summer heat peaks, and juice-sucking air conditioners remain on through the afternoon, the risk of failure in aged transformers and other equipment increases.
The fact that Lower Manhattan is using less power is not going to help to deliver power to people in Queens, many of whom for health reasons may be intolerant to high temperatures, and whose buildings are connected to a very old transmission line with limited margins to carry extra power, said [assistant professor at New York Universitys Tandon School of Engineering Yury] Dvorkin. Whats going to happen this summer, if we have stay-at-home orders, if we have consumption which the grid was not designed to accommodate, it will push the system to its limits.
3) Even as COVID-19 cases decline overall, rates of infection among the young may be holding steady.
Washington has bent the curve about as well as any U.S. state. But while its new case count has plummeted since early April, among Washingtonians ages 0 to 19, there has been no decline in cases, according to a new study from the University of Washington. In other words, declines have been concentrated among the old and vulnerable. This is a desirable demographic disparity in the immediate term. But since the young are less likely to become ill from the coronavirus and thus less likely to ever get tested the plateau in confirmed cases among young people may be the tip of a larger iceberg of youthful infection. Further, since the young tend to have close contacts with a wider pool of people than the elderly and are more likely to carry the virus asymptomatically the fact that cases are disproportionately concentrated among the young may heighten the probability that a new wave of infection emerges.
4) In the developing world, young people are dying from COVID-19 at unprecedented rates.
In wealthy countries, COVID-19 deaths have been overwhelmingly concentrated among the old. But as the novel coronavirus gains ground in less prosperous places, fatality rates are rising among the young. As the Washington Post reports:
In Brazil, 15 percent of deaths have been people under 50 a rate more than 10 times greater than in Italy or Spain. In Mexico, the trend is even more stark: Nearly one-fourth of the dead have been between 25 and 49. In India, officials reported this month that nearly half of the dead were younger than 60. In Rio de Janeiro state, more than two-thirds of hospitalizations are for people younger than 49.
At present, this alarming trend appears more attributable to grotesque international inequalities than to any viral mutation: Due to high levels of extreme poverty and underfunded health systems, many young people who would recover from COVID-19 with proper medical care are dying in the developing world without it.
In its first months, the pandemic focused its fury on the parts of the world best prepared to contain it. If SARS-CoV-2 becomes more pervasive in poor countries, its fatality rate could surge. (And at present, the wealthy world is giving every indication that any coronavirus vaccine will go first to nations with the greatest means, not those with the greatest need.)
5) Trumps favorite coronavirus treatment appears to make coronavirus patients more likely to die from their illness.
The U.S. president has so much faith in hydroxychloroquine as a panacea for coronavirus, he not only recommended its use over the objections of government scientists but also started taking it himself as a prophylactic against COVID-19 (even though there is no scientific basis for believing that the anti-malarial drug prevents infection from the coronavirus).
Unfortunately, a new study of 96,000 coronavirus patients across six continents found that COVID-19 sufferers who were treated with hydroxychloroquine died at higher rates than those who were spared Dr. Trumps miracle tonic.
6) Even as America reopens, half of its states have uncontrolled coronavirus spread.
A study from the Imperial College of London suggests that 24 U.S. states have an R higher than one meaning that, on average, every person infected with the novel coronavirus gives the bug to at least one other person.
Meanwhile, a separate, peer-reviewed study published in Health Affairs indicates that areas of the U.S. that refused to impose social-distancing orders saw 35 times greater spread of the novel coronavirus than those that did implement such orders.
Neither of these findings bodes well for Americas nascent reopening.
7) On a global level, the daily count of new coronavirus infections is as high as its ever been.
Worldwide, the number of new, confirmed coronavirus cases is growing by about 100,000 a day, which is the highest sustained rate of new infections weve seen since the pandemic began.
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U.S. Secretary of Defense Mark Esper speaks as President Donald Trump listens during a news briefing on the latest development of the coronavirus outbreak in the U.S. at the James Brady Press Briefing Room at the White House March 18, 2020 in Washington, DC.
Alex Wong | Getty Images
WASHINGTON Secretary of Defense Mark Esper doubled down on Friday by saying the Pentagon will meet an aggressive timeline tohave a coronavirus vaccine by the end of the year, a deadline doubted by leading health officials.
"You know, our medical experts, our researchers have been working on this vaccine now, and therapeutics and diagnostics for a few months," Esper explained on NBC's "TODAY." "We've been ahead of the curve and in the fight from day one, and this is the next phase of this battle, and we will deliver on time the vaccines," he added, saying he was "completely confident" that the Pentagon will deliver.
Esper downplayed characterizations made by health officials that a vaccine within the year would be "aspirational."
"Well, you know, when Eisenhower launched the U.S. military against Nazi Germany, he didn't say, 'We might win World War II, we'll try.' When John F. Kennedy aspired to put a man on the moon, he didn't say, 'We'll give it a good shot.' He said, 'We will do it,'" the Pentagon chief said.
"The Defense Department, once again, is committed to get this done. We're going to live up to the expectations, and we're going to deliver on this virus," he said, adding that the Pentagon is preparing for a potential second wave of the coronavirus.
Last week, President Donald Trump unveiled a federal task force in charge ofa $10 billion effort that will help produce and widely distribute a coronavirus vaccine by the end of 2020.
"We will deliver, by the end of this year, a vaccine, at scale, to treat the American people and our partners abroad," Esper said alongside Trump.
The coronavirus originated near the city of Wuhan in China's Hubei province and has since triggered a global pandemic that has hit the U.S. harder than any other country. More than 1.6 million cases and at least 95,000 deaths have so far been counted in the U.S.,data from Johns Hopkins University show.
The White House's top infectious disease expert said Friday that it is "conceivable" for the U.S. to roll out a coronavirus vaccine by December.
"I think it is conceivable if we don't run into things that are, as they say, unanticipated setbacks, that we could have a vaccine that we could be beginning to deploy at the end of this calendar year, December 2020, or into January 2021," Dr. Anthony Fauci said in an interview with NPR on Friday.
Fauci's comments came less than a week after U.S. biotech companyModernapublished positive results from its phase one human trial on its potential vaccine.The National Institutes of Health has partnered with Moderna to accelerate development of a vaccine.
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On a spring morning in 1955, a pair of press officers greeted a mob of reporters in a stately hall on the University of Michigan campus. The officers had hot news: A clinical trial of the long-awaited polio vaccine had proved it to be safe and effective. The reporters nearly rioted in their scramble to spread the word. Once they did, church bells rang, and people ran into the streets to cheer.
In the midst of our current pandemic, collective hope for a vaccine is just as palpable and regularly reinforced as it was with this weeks news of promising results from a small coronavirus vaccine test. The federal governments top infectious-disease expert, Dr. Anthony Fauci, said that the ultimate game changer in this will be a vaccine. President Trump assured us that a vaccine is not far off. Television hosts and pundits claim that this goal is within reach because weve beaten infectious killers, such as polio, with vaccines in the past.
But Americas experience with polio should give us pause, not hope. The first effective polio vaccine followed decades of research and testing. Once fully tested, it was approved with record speed. Then there were life-threatening manufacturing problems. Distribution problems followed. Political fights broke out. After several years, enough Americans were vaccinated that cases plummeted but they persisted in poor communities for over a decade. Polios full story should make us wary of promises that we will soon have the coronavirus under control with a vaccine.
The first polio epidemic in the United States hit Vermont in 1894, killing 18 and leaving 58 permanently paralyzed. It was only the beginning. Over the next several decades, warm-weather outbreaks became common, striking communities one year and sparing them the next, sometimes only to return later with added force. A New York City outbreak killed more than 100 people in 1907. In 1916, polio returned and killed 6,000. The disease primarily struck children. It could kill up to 25 percent of the stricken. And it left many paralyzed, consigning some to life in an iron lung.
Scientists knew polio was caused by a virus but did not know how it spread. (We know now that it was spread by consumption of food or water contaminated by the virus in fecal matter.) Then, as now, the only way to stay safe was not to be infected. Towns with cases closed movie theaters, pools, amusement parks and summer camps. They canceled long-planned fairs and festivals. Parents kept children close to home. Those who could afford to do so fled to the country. Still, cases mounted. Among three early polio vaccines developed in the 1930s, two proved ineffective, another deadly.
Finally, in April 1954, a promising vaccine, developed by Jonas Salks laboratory at the University of Pittsburgh, entered a large, yearlong clinical trial. On the day in 1955 when the press officers greeted the reporters in Ann Arbor, they shared the results: The vaccine, containing inactivated polio virus, was safe. It was also 80 percent to 90 percent effective in preventing polio.
The federal government licensed the vaccine within hours. Manufacturers hastened into production. A foundation promised to buy the first $9 million worth and provide it to the nations first and second graders. A national campaign got underway.
But less than a month later, the effort ground to a halt. Officials reported six polio cases linked to a vaccine manufactured by Cutter Laboratories in Berkeley, Calif. The surgeon general asked Cutter to recall its lots. The National Institutes of Health asked all manufacturers to suspend production until they met new safety standards. Federal investigators found that Cutter had failed to completely kill the virus in some vaccine batches. The flawed vaccines caused more than 200 polio cases and 11 deaths.
The vaccine program partly restarted two months later, but more mayhem followed. With the vaccine in short supply, rumors spread of black markets and unscrupulous doctors charging exorbitant fees. One vaccine manufacturer planned to vaccinate its employees children first, and then sent a letter to shareholders promising their children and grandchildren priority access, too.
States asked the federal government to create a program to ensure fair distribution. A Senate bill proposed making the vaccine free to all minors. A House bill proposed free vaccines only for children in need; according to newspaper accounts from the time, discussion of the bill triggered an angry row that forced the speaker to call a cooling off recess. The $30 million Polio Vaccination Assistance Act that President Dwight Eisenhower signed that August was a compromise that essentially let states decide for themselves.
Polio cases fell sharply over the next few years. Then in 1958, as national attention began to flag, cases ticked back up among the unvaccinated. Polio cases clustered in urban areas, largely among poor people of color with limited health care access. States pattern of polio, government epidemiologists noted, had become quite different from that generally seen in the past.
Three years later, the federal government approved an oral polio vaccine, developed by Albert Sabins laboratory in Cincinnati, containing weakened, not inactivated, virus. By the end of that year, polio infections were down 90 percent from 1955 levels. In 1979, the country recorded its last community-transmitted case.
Today, decades into a global vaccination campaign, polio persists in just three countries. The battle against the disease has been a century-long march. And it has required a sustained commitment to continuing polio vaccination a commitment now compromised as global polio vaccination efforts have been put on hold to slow the coronaviruss spread.
Granted, there are countless differences between the fight against the coronavirus and the long-ago fight against polio. The global capacity for vaccine research and development is far greater than it was in the 1950s. Drug approval and manufacturing safety protocols have been refined since then, too. Already, just months into the current pandemic, there are far more vaccines in development against the coronavirus than there ever were against polio.
But the regulatory thresholds weve spent decades putting into place are being swept aside to speed that development. And some of the coronavirus vaccines now in lightning fast development by new biotech firms, university labs and familiar pharmaceutical giants are as novel as the first polio vaccine was in 1955.
If one does prove safe and effective, we will face the same challenges we faced then of making enough to protect the population, without causing harm, and distributing it without exacerbating existing inequities in our society.
Elena Conis is a historian and a professor in the Graduate School of Journalism at the University of California, Berkeley, where Michael McCoyd is a doctoral candidate in computer science and Jessie A. Moravek is a doctoral student in environmental science, policy and management.
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All baseball, softball, batting cages, golf courses, miniature golf, local and public pools and aquatic centers, tennis facilities, skills training for all sports, and general non-contact sports including bowling alleys are permitted to reopen or remain open within the State so long as all safety standards are met.
5/22/20
