Subject: Reference to French study +Israeli-made oral vaccine progress +Cell phone contact tracking + Excerpts from New York Times newsletters 3-24-20
Israeli-made oral vaccine for coronavirus on track, but testing will take months [ …it won’t be available for months because of the lengthy and sometimes bureaucratic testing and approval process ]
State-funded Migal Galilee institute has been working for 4 years on a vaccine that could be customized for various viruses, so it had a head start when COVID-19 emerged
An effective Israeli-developed vaccine for coronavirus is on track to be ready for testing within “a few weeks,” though it won’t be available for months because of the lengthy and sometimes bureaucratic testing and approval process, a member of the development team said Tuesday.
Chen Katz told The Times of Israel that the new oral vaccine for adults and children could “turn this disease into a very mild cold.” He said that for many people who are inoculated and then infected by COVID-19, “potentially it will not affect them at all.”
The rapid potential progress by the state-funded Migal Galilee Research Institute stems from the fact that the institute has been working for four years toward a vaccine that could be customized for various viruses, and has now adapted that work to focus on the coronavirus, he said.
Nonetheless, while Israel’s science ministry made headlines last week by touting the institute’s work and saying that its vaccine could be three months away, Dr. Asher Shalmon, the Health Ministry’s director of international relations, has warned against placing “false hopes” in it.
The vaccine will consist of a specially produced protein, and Katz said he expects to be clutching a bottle of it within “a few weeks.” But then comes clinical testing, which will take place in conjunction with a partner, and the paperwork, both of which will take time.
Katz, Biotechnology Group Leader at the institute, said: “By the time the protein is ready, we hope to have found the right partner who can take us through the clinical stage. The clinical testing experiments themselves are not so long, and we can complete them in 30 days, plus another 30 days for human trials. Most of the time is bureaucracy — regulation and paperwork.”
Time could also be lost because of “waiting points” between the different stages of the process, until regulators give the nod for things to move forward.
He spoke of the excitement that his team felt when it realized that the research it had been engaged in for four years could be tweaked to combat coronavirus. “The opportunity is amazing here,” he said. “Everyone wants to know we can contribute something to humanity and when we found we had the right tools to do it this became is very exciting.”
Katz’s group at Israel’s state-funded Migal Institute has become a source of hope to many around the world since it revealed on February 27 that it is working on the vaccine, and said it hoped to achieve “safety approval” in 90 days.
For four years, the research of Katz’s team had been focused on developing a vaccine that could be customized to various viruses. It was piloting it with Infectious Bronchitis Virus, but as as coronavirus swept China, started adapting the vaccine for COVID-19.
Its February 27 announcement prompted a widespread expectation among the public that people would soon be protected against coronavirus, which prompted Shalmon’s warning against “false hopes.”
Katz clarified that the 90-day time frame in the February 27 statement was until the product is ready for human testing, and said he still believes this is realistic. He said that skeptics should understand that his team is not working on new research, but rather customizing an existing innovation, meaning that a fast turnaround is realistic. He stated: “The important thing is that we were working on a vaccine, unrelated to this outbreak, and this is a great advantage.”
Katz revealed that the development process is sufficiently advanced that his ten-person team doesn’t need the virus. Instead, it went on the internet soon after the outbreak began, found the sequence of the virus which had been published, and got to work.
He said that the vaccine will be double-barreled, deploying two means to defend people against coronavirus.
The first protection triggers a response in the mouth to stop COVID-19 entering the body. Katz explained: “We are developing the proteins that are needed for our technology of the oral vaccination. They are special proteins which, when sprayed in to the mouth, penetrate the epithelial cells inside the mouth and activate a mucosal immune response, which is the part of the immune response in our body that protects the entry point of the virus.”
The second level of protection kicks in if COVID-19 enters the body. It will bolster the immune system in such a way “that when viral particles penetrate, there will be an immune protection, of antibodies and the right white blood cells.”
He said it will be administered by an oral spray, and will protect people who encounter COVID-19 two weeks after being administered. He stressed: “This is not a drug, not for treatment, only for prevention.”
When The Times of Israel talked to him on Tuesday, Katz’s team, like many in Israel, was also celebrating the Purim festival with fancy dress — in Katz’s case a wig — and hamantaschen. Katz explained that there isn’t much that the team can do to further speed its work along, as it is waiting for scientific processes to chug through in their own time. “This is biology, so it takes its time,” he said.
Much of the work is done by bacteria, he stated, explaining a central part of the process, saying: “We take part of the virus DNA and introduce it to bacteria and make the bacteria produce the viral proteins.”
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The coronavirus isn’t mutating quickly, suggesting a vaccine would offer lasting protection
[ By Joel Achenbach]
The coronavirus is not mutating significantly as it circulates through the human population, according to scientists who are closely studying the novel pathogen’s genetic code. That relative stability suggests the virus is less likely to become more or less dangerous as it spreads, and represents encouraging news for researchers hoping to create a long-lasting vaccine.
All viruses evolve over time, accumulating mutations as they replicate imperfectly inside a host’s cells in tremendous numbers and then spread through a population, with some of those mutations persisting through natural selection. The new coronavirus has proofreading machinery, however, and that reduces the “error rate” and the pace of mutation. It looks pretty much the same everywhere it has appeared, the scientists say, and there is no evidence that some strains are deadlier than others.
SARS-CoV-2, the virus that causes the disease covid-19, is similar to coronaviruses that circulate naturally in bats. It jumped into the human species last year in Wuhan, China, likely through an intermediate species — possibly a pangolin, an endangered anteater whose scales are trafficked for traditional medicine.
Scientists now are studying more than 1,000 different samples of the virus, Peter Thielen, a molecular geneticist at the Johns Hopkins University Applied Physics Laboratory who has been studying the virus, told The Washington Post.
There are only about four to 10 genetic differences between the strains that have infected people in the United States and the original virus that spread in Wuhan, he said.
“That’s a relatively small number of mutations for having passed through a large number of people,” Thielen said. “At this point, the mutation rate of the virus would suggest that the vaccine developed for SARS-CoV-2 would be a single vaccine, rather than a new vaccine every year like the flu vaccine.”
It would be more like the measles or chickenpox vaccines, he said — something that would likely confer immunity for a long time.
“I would expect a vaccine for coronavirus would have a similar profile to those vaccines. It’s great news,” Thielen said.
Two other virologists, Stanley Perlman of the University of Iowa and Benjamin Neuman of Texas A&M University at Texarkana, both of whom were on the international committee that named the coronavirus, told The Post that the virus appears relatively stable.
“The virus has not mutated to any significant extent,” Perlman said.
“Just one ‘pretty bad’ strain for everybody so far. If it’s still around in a year, by that point we might have some diversity,” Neuman said.
Neuman contrasted the coronavirus with influenza, which is notoriously slippery.
“Flu does have one trick up its sleeve that coronaviruses do not have — the flu virus genome is broken up into several segments, each of which codes for a gene. When two flu viruses are in the same cell, they can swap some segments, potentially creating a new combination instantly — this is how the H1N1 ‘swine’ flu originated,” Neuman said.
It is possible that a small mutation in the virus could have outsized effects in the clinical outcome of covid-19, the experts say. That has been known to happen with other viruses. But there’s no sign this is happening with the novel coronavirus.
The dramatic death rates in Italy, for example, are most likely due to situational factors — an older population, hospitals being overwhelmed, shortages of ventilators and the resulting rationing of lifesaving care — rather than some difference in the pathogen itself.
“So far, we don’t have any evidence linking a specific virus [strain] to any disease severity score,” Thielen said. “Right now, disease severity is much more likely to be driven by other factors.”
Although one team of scientists earlier this year suggested there might be two distinct strains of the virus with different levels of typical disease severity, that conjecture has not been embraced by the scientific community.
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Is the cure worse than the problem?
Already, America’s shift to social distancing has caused widespread layoffs, from restaurants to hotels to the oil industry. Unemployment has health consequences as well as economic consequences, economists have noted. Forecasters on both sides of the debate are trying to weigh these losses against deaths from the coronavirus as well as other medical emergencies that won’t be treated properly if the health-care system becomes overrun with covid-19 patients.
“One of the bottom lines is that we don’t know how long social distancing measures and lockdowns can be maintained without major consequences to the economy, society, and mental health,” John Ioannidis, a medical and epidemiology expert at Stanford University, wrote in an essay last week. “Short-term and long-term consequences are entirely unknown, and billions, not just millions, of lives may be eventually at stake.
“I am deeply concerned that the social, economic and public health consequences of this near total meltdown of normal life … will be long lasting and calamitous, possibly graver than the direct toll of the virus itself,” David L. Katz, a preventive-medicine specialist at Yale University, wrote this weekend. “The unemployment, impoverishment and despair likely to result will be public health scourges of the first order.”
Such arguments raise important points about the full impact of the current strategy, said Inglesby, the infectious-disease expert at Johns Hopkins. But those are long-term scenarios, he pointed out. “What social distancing does is buy us time to replenish supplies like masks and ventilators, deal with the immediate crisis in hospitals and come up with additional strategies."
The question in the long run is how to balance competing economic interests and public health needs when basic questions about the pandemic — like how many Americans are infected — are unknown, said Gregg Gonsalves, an epidemiologist at the Yale School of Public Health. “If anybody tells you they have the answer to how to thread this needle, they’re lying to you."
While Trump is debating new federal recommendations that the country reopen, orders to stay at home have largely come from state governors, who may simply ignore Trump. But public health experts say the contradictory messaging would make persuading people to comply — already a difficult job — even harder.
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No easy way back to ‘normal’
Instead, they have voiced a more nuanced point — that there should at least be a plan for eventually getting workers back into offices.
Lloyd Blankfein, a former chairman and chief executive of Goldman Sachs, said in a phone interview Monday that U.S. leaders should begin work to identify which milestones would allow the economy, perhaps in stages, to move back toward normalcy. “Let’s have a conversation on what the metrics should be,” he said.
“It would be heartening if people were at least contemplating that this will not go on forever,” he added. “But I’m not really hearing that.”
Even in a hypothetical world where the economy was valued above human life, many economists say it wouldn’t necessarily make sense to sacrifice the elderly, abruptly send everyone back to work and allow the virus to run its course. Restarting international flights, for example, wouldn’t mean consumers would buy tickets. And the shock from the spreading infections and mounting deaths would make any sense of normalcy hard to maintain.
“The best way to get control of the economy is to get through this as quickly as possible,” said Edward Kaplan, who teaches economic policy and public health at Yale University. He said that means adhering to social distancing and drastically increasing testing.
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The real question: Are we doing enough?
The agency has permission to use the data, which the Shin Bet has collected from Israeli carriers since at least 2002, for the next 30 days. By directing individuals who may have come into contact with the virus to quarantine themselves immediately via text message, the government could greatly speed up the isolation process. The agency has not made public precisely what data it collects, but experts told the Times that the Israeli government can use it to track almost anyone’s location.
“We must preserve the balance between individual rights and general needs, and we are doing so,” Netanyahu said yesterday at the Prime Minister’s Office in Jerusalem, where the plan was announced.
An anonymous security official told the Times that the data would be used narrowly, in a “focused, time-limited and limited activity.”
While this is the first high-profile instance of a government using cellphone tracking for public health purposes, such data has been used for advertising and law enforcement in many countries. Last year, Motherboard reported that AT&T, T-Mobile, and Sprint have sold customer location data to data sellers, who sold it to over 250 bounty hunters and related firms. The data included the phones’ assisted GPS data, which is intended to help first responders locate 911 callers, and can accurately pinpoint a user within a few meters.]
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Building a new workforce on antibodies
Those with presumed immunity could then deliver goods, bolster hospitals and restart the economy without worrying about transmitting the virus. Such a strategy has never been used on such a large scale, Rivers said, but during Ebola outbreaks in Africa, survivors were often the ones who provided care, watched over the children of sick patients and buried the dead.
“If we’re serious about restarting the economy and easing restrictions, we need to have strategy for replacing those restrictions,” she said. “It’s doable, but not without a plan.”
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