The UK faces having to wait longer and pay more to acquire a coronavirus vaccine because it has left the EU, health experts and international legal experts warn today.
In an article published today on the Guardian website, the academics and lawyers say Boris Johnsons determination to go it alone, free of EU regulation, after Brexit means the UK will probably have to join other non-EU countries in a queue to acquire the vaccine after EU member states have had it, and on less-favourable terms.
The authors include Martin McKee of the London School of Hygiene and Tropical Medicine, and legal academics Anniek de Ruijter of Amsterdam Law School and Mark Flear of Queens University, Belfast.
The UK will leave the European Medicines Agency (EMA), the body responsible for the scientific evaluation, supervision and safety monitoring of medicines, at the end of the transition period on 30 December. This means it will no longer be part of the EUs regulatory regime, which allows for accelerated assessment of products developed by drugs companies during a pandemic.
The UK has already withdrawn from the EUs emergency bulk-buying mechanism for vaccines and medicines, under which member states strike collective agreements with pharmaceutical companies, which speeds up their access to the latest products during a crisis.
The academics write: For all these reasons ... the UK is likely to have to join the queue for access with other countries outside the EU, and to pay more than it would otherwise as an EU member state.
Looking further ahead, this problem will not be limited to emergencies and the UK can expect slower and more limited access to medicines, especially those for rare conditions or those used to treat children, where the market is small.
They argue that the UK could still avoid the worst by agreeing to align fully with the EMAs regulations from outside the EU. But they say Johnson has so far indicated that his team have no intention of doing so and do not want to operate as rule takers.
While it appears the UK government wants to press ahead with its own regulatory system and rapid market authorisation system for emergencies, the experts say this will be all but impossible to put in place in time for a new Covid-19 vaccine, which is expected in about a year.
Even then the view in medical circles is that pharmaceutical companies are likely to look first to the EU for regulatory approval and an agreement on sale, given the scale of the market they would be selling into.
Olivier Wouters of the London School of Economics and Political Science, said: After the Brexit transition period, the UK will no longer be part of the EMA and will therefore have to make its own regulatory decisions, unless ongoing EU-UK trade negotiations result in the UK aligning itself with European rules.
The UK could, in theory, choose to recognise any approval decision made by the EMA to prevent delays, but this seems at odds with the UK governments pledge to take back control. If the UK authorities instead choose to set up a separate review and approval process for medicines and vaccines, then it might delay access to a new coronavirus therapy.
The country could experience disruptions as the Medicines and Healthcare products Regulatory Agency (MHRA), the countrys counterpart to the EMA, works to fill the gap left by the departure of the EMA.
Vaccine makers and drug companies may decide to first seek approval from the EMA, which represents some 500 million patients, before seeking approval from the UK MHRA, which covers a smaller patient pool.
Asked about the prospect of the UK having to pay higher prices for a vaccine, he said: If a coronavirus vaccine is developed, EU countries may choose to band together to jointly procure the vaccine. This would give EU countries more bargaining power against a vaccine maker to try to secure a lower price. If the UK were excluded from such a joint procurement scheme, its possible that the UK would end up paying a higher price than the EU for the same vaccine.
EMA was based in London until January last year, when Brexit saw it relocate to Amsterdam.
A Department of Health and Social Care spokesperson said: The UK and our friends and partners across Europe are part of a concerted international effort to combat the threat of COVID-19. We are confident that our current close working relationships will continue as we ready ourselves for all eventualities. Were fully supporting the UKs world-leading, disease research sector to play a key role in the global effort, with 40 million of new funding for rapid research into the virus.
As COVID-19 continues to spread both around the world and in the U.S., two separate efforts to find a medical solution to the virus are moving forward. At the University of Nebraska, the first patients have volunteered to test an experimental drug to treat COVID-19. And at Kaiser Permanente Washington Health Research Institute, researchers have begun recruiting people to test a possible vaccine.
A number of U.S. passengers aboard the Diamond Princess cruise ship were brought to Nebraska for quarantine; two of these passengers have agreed to participate in a trial for remdesivir, an antiviral drug originally developed for Ebola, but which showed encouraging results in animals in fighting SARS and MERS, two other illnesses caused by coronaviruses.
The drug is designed to treat infections that are moderate to severe, and is targeted to those with the most intensive symptoms. In order to qualify for the remdesivir study, run by the National Institute of Allergy and Infectious Diseases (NIAID), patients must test positive for COVID-19 and have pneumonia. Of the more than two dozen people diagnosed with COVID-19 from the cruise ship who were brought to Nebraska for quarantine, four required hospitalization and two developed pneumonia. Those two patients were asked if they wanted to volunteer for the study, and both agreed, says Dr. Andre Kalil, professor of medicine in the division of infectious disease at University of Nebraska Medical Center.
The study will eventually include 400 patients; initial results wont be analyzed until the first 100 have completed treatment. Given the relatively low rate of moderately to severely affected patients in the US at this point, Kalil says that NIAID plans to collaborate with health officials from other countries with higher case volumes, including Korea, Japan and Italy. For now, the trial will stay open for three years in order to recruit the needed number of patients.
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This study, says Kalil, is also designed to be more flexible than most drug trials. This is not just a remdesivir trial, he says. It will test as many [COVID-19] therapies as possible, and remdesivir is just the first. Lets say a couple of months from now, we realize that remdesivir is a good drug, that it works better than placebo. Then patients receiving the placebo would be offered the drug and we would move on to test another drug. If remdesivir turns out not to be effective, then we would remove it from the study and bring another drug to test against placebo. Its a dynamic, fast way to run a randomized trial. The design is a way to accelerate testing of antiviral drugs against COVID-19, since infections are on-going and there is no treatment yet.
Meanwhile, other labs are working on developing vaccines that would provide some protection against the virus in the first place. The vaccine study that is furthest along (and which is also overseen by NIAID) is currently recruiting its first participants at Kaiser Permanente Washington Health Research Institute. Unlike the remdesivir trial, this study will enroll healthy volunteers. Dr. Lisa Jackson, lead investigator on the study, says 45 healthy people will be recruited to test three different doses of the vaccine.
Kaiser is currently getting thousands of daily online requests from people interested in participating. Researchers are contacting the volunteers by phone to assess their eligibility for the study. Once the participants are chosen, they will be given one of the three vaccine doses being tested. The scientists will track patients immune responses after that injection, and then give each patient a second injection (of the same dosage). The goal is to figure out which dosage is most effective, and whether one or two shots of that dosage is needed.
Theyll be looking for levels of antibodies that the bodys immune system produces against the so-called spike protein, one of the proteins that stud the surface of the SARS-CoV-2 virus responsible for causing COVID-19. Scientists will analyze antibody levels in the participants a year after their second vaccination, so results wont be available for at least 12 to 18 months, says NIAID director Dr. Anthony Fauci. Given that coronaviruses like the one behind COVID-19 seem to be appearing more frequently, however, having a vaccine against this particular virus could be useful in creating future coronavirus vaccines as well.
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America is still more than a year away from a COVID-19 vaccine, but a treatment for the disease caused by the new coronavirus could be available in several months.
Since the first case was identified in the U.S. on January 21, more than 560 people have tested positive for the virus, including instances of community spread in multiple states. As cases increase, so does public concern about the virus, raising questions about the progress that's being made on a vaccine and a cure.
Thanks to the rapid sequencing of the virus' genetic sequences, experts have been able to develop a potential vaccine at an unprecedented pace. Clinical trials are expected to start less than six months after the virus was identified in humans for the first time. But Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said it would be more than a year until the vaccine is widely administered.
"The good news is that we did it fast. The bad news is the reality of vaccinology means this is not going to be something we're going to have tomorrow," Fauci told a House Appropriations subcommittee on March 4.
It's likely health professionals will have a treatment before a vaccine, according to Fauci. Several options have already been administered to animals, and trials are underway in Washington state and the University of Nebraska for a drug called remdesivir.
If it's at least "somewhat effective" in reducing the viral load, the intervention could be available in the next "several months," Fauci said.
To determine the drug's efficacy, participants were divided into a placebo group and a treatment group. On the first day, the treatment group received 200 milligrams of remdesivir and 100 milligrams on each subsequent day, for up to 10 days. The placebo group received a solution that resembles remdesivir at equal volumes.
On March 2, President Donald Trump and members of the Coronavirus Task Force discussed how the federal government could accelerate vaccine and treatment development with pharmaceutical and biotechnology companies. Trump claimed they were "working very hard" to expedite the process of bringing a vaccine to the public but acknowledged that a treatment would "likely" be available first.
"It always goes faster than vaccine, because you're dealing with someone who is already sick," Fauci said. "So the safety issues are going to be much, much different. And you will know your result almost immediately, whereas with vaccines it takes a long time."
Biotechnology company Moderna shipped its first batch of a potential vaccine to the NIAID on February 24, and a trial is expected to begin in about four weeks. After the Phase I trial, which is expected to take three to four months, a larger trial involving hundreds of people will be conducted over six to eight months, according to Fauci.
Daniel O'Day, chairman and CEO of Gilead Sciences, which makes remdesivir, told Trump his company should know whether the treatment is effective at some point in April.
According to Fauci, if a company knows by June that the treatment is effective, a company can scale it up, manufacture it and "you're good to go."
Newsweek reached out to the NIAID for comment but did not receive a response before publication.
Antivirals are much less strain-specific than vaccines because they target parts of the virus that don't change as easily, Dr. William Haseltine, chair and president of ACCESS Health International, told Newsweek. So researchers can develop a potential antiviral for a coronavirus strain before an outbreak even occurs.
However, Nicole Errett, a disaster researcher at the University of Washington, said that this requires government investment because pharmaceutical companies have less of a vested interest in developing a product for a market that doesn't yet exist.
After three coronavirus outbreaks in 20 yearssevere acute respiratory syndrome, Middle East respiratory syndrome and now SARS-CoV-2it's an investment that needs to be made, Haseltine said,
"These diseases are as much a natural disaster as earthquakes and hurricanes," he noted. "We can't prevent natural disasters, but we can certainly prepare for them, and we should treat these the same way we treat other natural disasters."
A mix of legacy drugmakers and small startups have stepped forward with plans to develop vaccines or treatments that target the infection caused by the novel coronavirus.
COVID-19, which was first detected in December in Wuhan, China, has sickened more than 100,000 people worldwide and killed at least 3,400. There are no Food and Drug Administration-approved vaccines or therapies for the disease.
In the U.S., the companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. Some companies have received funding from Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo. Other companies are funding trials by themselves or through partnerships with other life sciences companies.
Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:
Company: Gilead Sciences Inc. GILD, -2.61%
Type: Treatment
Stage: Phase 3 clinical trials
Name: remdesivir
Background: Gilead is a longtime drug maker that is best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine. Along with U.S. trials, Gilead is conducting a randomized, controlled clinical trial in Wuhan, testing remdesivir as a treatment for mild to moderate forms of pneumonia in people with the virus. The trial was given the go-ahead by Chinas Food and Drug Administration in February.
Clinical trials:
1. On Feb. 21, the National Institute of Allergy and Infectious Diseases started enrolling patients in a randomized, double-blind, placebo-controlled Phase 3 trial evaluating 394 hospitalized patients with COVID-19 at up to 50 sites worldwide. The trial is expected to conclude April 1, 2023. Sites include the National Institutes of Health in Bethesda, Md., (not recruiting), the University of Nebraska Medical Center in Omaha (recruiting), the University of Texas Medical Branch in Galveston (not recruiting), and Providence Sacred Heart Medical Center in Spokane (recruiting).
2. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 600 patients with moderate COVID-19. The trial is expected to start enrolling patients in March, with results to come in May.
3. On March 3, Gilead said a randomized, open-label Phase 3 trial will evaluate remdesivir in 400 patients with severe COVID-19. The trial is expected to start enrolling patients in March, with results in May.
Year-to-date stock performance: Shares of Gilead are up 17.6%.
Company: GlaxoSmithKline GSK, -11.04%
Type: Pandemic adjuvant platform for vaccines
Name: AS03 Adjuvant System
Background: GSK is another leading vaccine maker, having brought to market vaccines for human papillomavirus (HPV) and the seasonal flu, among others. On Feb. 3, it said the CEPI-funded University of Queensland will have access to the British drugmakers vaccine adjuvant platform technology, which is believed to both strengthen the response of a vaccine and limit the amount of vaccine needed per dose. On Feb. 24, GSK said that Clover Biopharmaceuticals Inc., a Chinese biotechnology company, is also using adjuvant technology in combination with its vaccine candidate, COVID-19 S-Trimer, in preclinical studies. Dr. Thomas Breuer, chief medical officer for GSK Vaccines, is leading work on vaccines and the adjuvant platform.
Year-to-date stock performance: Shares of GSK have tumbled 12.8%.
Company: Inovio Pharmaceuticals Inc. INO, -14.86%
Type: DNA-based vaccine
Stage: Preclinical
Name: INO-4800
Background: Another CEPI grantee, Inovio has said it already began preclinical testing and small-scale manufacturing.
Timeline: Inovio develops immunotherapies and vaccines but hasnt yet had a product approved for treatment. For INO-4800, preclinical testing was performed between Jan. 23 and Feb. 29. The company plans to begin clinical trials in the U.S. with 30 participants in April. It also plans to launch human trials in China and South Korea that same month, and that it has a total of 3,000 doses prepared for the trials in the three countries. Inovio said it expects to have the first results from the trial in the fall and to have 1 million does of the vaccine ready for additional clinical trials or emergency use by the end of the year.
Year-to-date stock performance: Shares of Inovio have soared 278.2%.
Company: Johnson & Johnson JNJ, -5.33%
Type: Vaccine
Name: TBD (We are still in the process of identifying a vaccine candidate, so no there is no name at this time, a spokesman said March 4.)
Background: On Feb. 11, J&J said it is working with BARDA to test its vaccine candidate, with both organizations providing funding for research and development and the public-health organization funding the Phase 1 trials. Similar to GSK, J&Js AdVac and PER. C6 technologies are used to improve the development process for a vaccine and were also used to develop J&Js experimental Ebola vaccine. We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world, Dr. Paul Stoffels, J&Js chief scientific officer, said in a statement. J&J also said Feb. 18 that it is partnering with BARDA on a project that aims to screen existing antiviral medications, including experimental or approved therapies, that may be effective against COVID-19.
Timeline: The company aims to start a Phase 1 clinical trial by the end of 2020, compared to the typical five to seven years it takes for this milestone in vaccine development, Stoffels said on Dr. Paul Stoffels, J&Js chief scientific officer and leader of J&Js global COVID-19 response, said March 2.
Year-to-date stock performance: Shares of J&J are down 4.8%.
Company: Moderna Inc. MRNA, +24.36%
Type: RNA-based vaccine candidate
Stage: Preclinical
Name: mRNA-1273
Background: On Jan. 23, Moderna received funding from CEPI to develop an mRNA vaccine against COVID-19. On Feb. 24, it said it had shipped the first batch of mRNA-1273 to the NIAID for a Phase 1 clinical trial in the U.S.
Clinical trials: On Feb. 21, the NIAID said it would begin enrolling 45 healthy adult patients in an open-label Phase I clinical trial at one location to test mRNA-1273 as a vaccine for COVID-19 on March 19. The trial is expected to conclude June 1, 2021. Participants will be followed for one year. The trial will be conducted at Kaiser Permanente Washington Health Research Institute in Seattle.
Year-to-date stock performance: Modernas shares have gained 45.7%.
Company: Regeneron Pharmaceuticals Inc. REGN, -5.31%
Type: Treatment
Stage: Preclinical
Name: No name yet
Background: On Feb. 4, Regeneron announced it is working on developing monoclonal antibodies as treatments for COVID-19. The companys VelocImmune platform uses genetically-engineered mice with humanized immune systems in preclinical testing. We are aiming to have hundreds of thousands of prophylactic doses ready for human testing by end of August, a spokesperson said. Christos Kyratsous, VP of infectious disease R&D and viral vector technology, is running the project.
Year-to-date stock performance: Regenerons shares are up 27.8%.
Company: Sanofi SNY, -5.03%
Type: Vaccine
Stage: Preclinical
Name: No name yet
Background: Starting Feb. 18, Sanofi is working with BARDA to test a preclinical vaccine candidate for severe acute respiratory syndrome (SARS) for COVID-19 using its recombinant DNA platform. It has a long history of producing vaccines in its Sanofi Pasteur business and acquired this candidate through its 2017 acquisition of Protein Sciences for $750 million. The French drugmaker previously worked with the organization on flu vaccines. Scientists in Meriden, Ct., are working on the vaccine; David Loew, Sanofi Pasteurs EVP, is leading the project.
Timeline: A spokesperson said Sanofi aims to put a vaccine into a Phase 1 clinical trial between March 2021 and August 2021.
Year-to-date stock performance: Shares of Sanofi are down 4.3%.
Company: Takeda Pharmaceutical Company Ltd. TAK, -10.18%
Type: Treatment
Stage: Preclinical
Name: TAK-888
Background: Takeda is one of the most recent entrants to the race to develop a treatment for COVID-19. The Japanese drugmaker said March 4 it plans to test hyperimmune globulins for people who are at high risk for infection. As part of its research, which will be performed in Georgia, Takeda said it would need access to plasma from people who have recovered from COVID-19 or those who have received a vaccine if one is developed. Dr. Rajeev Venkayya, president of Takedas vaccine business, is the co-lead of the companys COVID-19 response team. Like J&J, Takeda plans to examine whether other therapies, both experimental or with regulatory approval, may have treatment potential.
Year-to-date stock performance: Shares of Takeda are down 8.7%.
Company: Vir Biotechnology Inc. VIR, +4.81%
Type: Treatment
Stage: Preclinical
Background: Vir said Feb. 25 it is collaborating with Shanghai-based WuXi Biologics to test monoclonal antibodies as a treatment for COVID-19. If the treatment is approved, WuXi will commercialize it in China, while Vir will have marketing rights for the rest of the world. The preclinical company is run by George Scangos, the former CEO of Biogen.
Year-to-date stock performance: Vir shares have jumped 279%.
Editors note: An earlier version of this report referred to Gilead as a vaccine maker. The company is a drug maker. The story has been updated.
With the U.S. now in a state of emergency, international travel restricted and the economy in danger of slipping into recession, one of the central questions for resolving the crisis is how long it will take to develop a vaccine for the coronavirus.
There will be a vaccine. The question is as we sit here in March of 2020, when will it be available? Jonathan D. Moreno, a professor of medical ethics and health policy at the University of Pennsylvania, told Yahoo News in an interview. The best we can say is that hopefully, by some time in early 2021, there will be a vaccine available, maybe a little earlier given the advances in our technology.
Even once a vaccine is available, making it available to the U.S. population will take time. Here's an irony on our current situation, we don't have that production capacity in this country. Where is it? It's mostly in China, said Moreno. So we are going to be getting millions and millions, we hope, of doses of vaccine from China in the next eight or 10 or 12 months, as soon as we have the formula of the vaccine.
Yet with reports of billionaires jetting off to survival bunkers and paying for concierge doctors, another public concern is likely to be over who will get access to any new therapies or vaccines. We have to be very careful about reassuring the public that the dissemination of the vaccines, when these vaccine doses are available ... is done fairly and that nobody is unfairly advantaged because they have the money or because they have the power to get access to them, said Moreno, who is the co-author of the recent book, Everybody Wants to Go to Heaven but Nobody Wants to Die.
Even now, Moreno mentioned that members of Congress were able to get tested at a time when testing kits are in short supply. That is probably not a good thing because they were not, as far as we can tell, they were not symptomatic, he said, and frankly, it's entirely possible that the tests that those people got are taking tests, at least theoretically, away from people who are symptomatic and are more vulnerable than they were.
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Once the vaccine is available the priority should be first responders and healthcare professionals, they absolutely have to be protected, Moreno said. Not only because we need them to take care of us, but also because we need them to come to work. We need them to feel safe. We need them to feel that they're not taking it home to their families.
Next in line for vaccination might be members of the military, especially if the Defense Department assists with domestic medical care. I wouldn't be surprised if the Defense Department starts standing up hospitals and clinics, the way that was done in Liberia in 2014 in the outbreak of Ebola.
Yet with the vaccine still perhaps a year away, the challenge, said Moreno, is getting people to limit the spread of the virus, just as previous generations had to do with illnesses such as polio before a vaccine became available. That was in 1955. We just don't have a memory of this anymore in this country, he said.
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Read more from Yahoo News:
The world was not prepared for coronavirus. Despite the clarion calls that were the SARS and MERS outbreaks and early warnings from doctors, governments had neither the policies nor equipment in place to impede COVID-19's spread from a Chinese animal market.
The United States' strategy was to impose a medical bubble of travel restrictions and mandatory quarantines. "We have contained this. I won't say airtight but pretty close to airtight," White House National Economic Council Director Larry Kudlow said last monthdespite contrary warnings from Centers for Disease Control and Prevention (CDC) officials.
At that time, there were a handful of known cases. As of March 11, more than 1,000 people across 38 states have tested positive for the disease.
For many hope lies in the development of a vaccine, but while the first vaccines should enter Phase 2 testing by summer, that leaves an efficacy-tested product months away. Anthony Fauci, head of the National Institute of Allergy and Infectious Disease, estimates the first vaccines won't be ready for "a year to a year-and-a-half."
As companies hurry to test potential vaccines, the National Institute of Health (NIH) is hoping new bio-engineering techniques to help us restrain coronavirusand its next mutation, too.
A synthetic biology research laboratory at NASA Ames.
(Photo: Wikimedia Commons)
As reported by Sharon Begley in STAT, NIH is looking toward synthetic biology for the next advancement in vaccination development. This research is funded, in part, by the Bill and Melinda Gates Foundation's $100 million commitment to strengthening global "detection, isolation, and treatment efforts" directed at COVID-19.
In synthetic biology, scientists re-engineer organisms to sport new abilities or biological purposes. They do this by stitching together strands of DNA and inserting them into an organism's genome. This artisanal DNA can come from other organisms or be a completely original strand.
Scientists begin the process by engineering nanoparticles out of proteins. Using a computational algorithm, they experiment with a million variants to discover the optimal structure. This structure not only allows the nanoparticle to house the viral antigens, but arranges those antigens for maximal arousal of the body's immune response.
After lab-crafting DNA to code for the nanoparticle, the scientists place it in E. coli bacteria. Once the bacteria begin manufacturing the desired protein, it is extracted, purified, and studded with viral antigens.
"If tests in lab animals of the first such nanoparticle vaccine are any indication, it should be more potent than either old-fashioned viral vaccines like those for influenza or the viral antigens on their own (without the nanoparticle)," Begley writes.
According to Lynda Stuart, immunologist and physician who directs the Gates Foundation's vaccine research, synbio vaccines may have advantages beyond potency. The increased immune response could eliminate the need for adjuvants (additives used to boost said response). They could reduce the need for refrigeration, making deployment to poor countries easier. And they could be designed to house antigens from several viruses, making one vaccine capable of fighting multiple diseases.
The ability to take past viral designs and quickly retrofit them to new, mutated forms of a virus could also reduce the development time for new, necessary vaccines.
"We may need an approach that can get you millions and even billions of doses," Stuart told STAT.
Synbio vaccines are still in the preliminary phases, and more traditional vaccines won't be available for months. During the interim, the virus will continue to spread, and its novelty means we'll need to encounter it before our bodies can build immunity. Many will become sick, but few will develop serious illness.
As Nancy Messonnier, director for the National Center for Immunization and Respiratory Diseases, notes in the video above, the disease affects older adults most seriously. The greatest risk is faced by people over the age of 80 and those with underlying health conditions.
Without a vaccine to curb its spread, it will be up to us to do what we can to maintain our health and prevent spreading the disease.
Wash your hands. Americans are awful when it comes to hand hygiene, but it's one of the best ways to prevent the spread of disease. Wet your hands with warm water, lather them with soap, and scrub them all over for 20 seconds. Rinse your hands, and finish with a paper towel or air dry.
Hand sanitizers can work, but they have to be rubbed in for 20 seconds and contain at least 60 percent alcohol. You should also sanitize frequent-contact surfaces like smartphone screens.
Stay home if you are sick. It's good advice in general as your fellow students and coworkers don't need you to share your lung grimes. But it's especially important to do so if you have coronavirus symptoms. If your symptoms become serious, contact a doctor for instructions and the next steps.
Limit potential exposure. If you are at higher risk, you'll want to avoid crowds as much as possible, especially in poorly ventilated places. You should also avoid non-essential plane travel.
Have supplies on hand. You don't need a doomsday prepper's supply, but make sure you have a two-week supply of the essentials on-hand in case you get sick and have to stay in. If you have an underlining medical condition, ensure you have enough medication on hand.
Face masks. If you are healthy, you likely do not need to wear a face mask for protection. The CDC advises face mask use for people who have COVID-19, are showing symptoms, and do so under the recommendation of a healthcare professional as it may prevent them from spreading the disease to others. Wearing a face mask needlessly limits the necessary supply available to health and care providers.
Stay informed. Visit the CDC's coronavirus website for situation updates and information on the virus. Don't rely on hearsay or social media to inform you about local conditions. Monitor your state and local health department websites instead for accurate, reliable information.
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A collective of biohackers has begun circulating a document proposing a plan to create, test, and distribute a vaccine to battle SARS-CoV-2. To get started, they say they need "between $10-25k."
Reason's Zach Weissmueller sat down with the lead biologist on the project, who requested anonymity due to fear of retribution from the Food and Drug Administration (FDA). Reasonhas verified his identity, as well as that of his business partner and a Silicon Valley investor who has confirmed his interest in the project.
The anonymous biologisthas worked in the commercial biotech sector and has long been involved in the "biohacker" community, a grassroots movement of professional and amateur scientists who experiment with genetic engineering in their homes and community labs. People like Josiah Zayner, founder of The Odin, which distributes kits allowing anyone to experiment with the gene-editing tool CRISPR.
Member of this community have created glowing yeast by inserting jellyfish genes, injected themselves with homemade vaccines, attempted to reverse-engineer patented pharmaceuticals, and tried to genetically engineer dogsall without seeking FDA approval.
"If someone is trying to develop and distribute an unapproved medicine, [the FDA] will come down hard, and they have," says the anonymous biohacker. "It's a severe risk to our livelihoods outside of this project if we were to be deanonymized."
The standard methods for creating vaccines are to combine a sample of a virus with a less infectious variant, or to inactivate the virus with heat or chemicals and then allow it to propagate immunity throughout the body. This team is attempting to create a vaccine using synthetic DNA constructed in a lab, which could save both money and time, though it might require a special device to deliver an electrical pulse to help the vaccine penetrate cell membranes.
There are no vaccines on the market created this way, but the pharmaceutical company Inovio is pursuing the same approach, and the Bill and Melinda Gates Foundation has expressed interest in funding projects that use this method.
"The company that we are, shall we say, cribbing the most off ofthey have a phase two clinical trial using the exact same approach for MERS [Middle Eastern Respiratory Syndrome]," says the biohacker.
The method has successfully produced antibodies to MERS but remains untested on a large population because there has been no outbreak since it was developed. Still, this gives the biohacker and his team enough confidence to proceed.
The proposal says the team will first look for positive responses in blood samples, rely on safety testing results from the company whose techniques they are mirroring, and then begin distributing dried versions of the vaccine to willing volunteers who would self-report results daily in exchange for free access to the vaccine.
He hopes to rely on a network of biohacker "community labs" to help with this process. He acknowledges that most people won't be willing to inject a non-FDA-approved vaccine but believes that if the pandemic gets bad enough they could fill a gap between the time the government approved an official vaccine and the time that vaccine is shown in trials to be relatively safe and able to generate antibodies in the blood.He says that DNA plasmid-based vaccines are less likely to cause injury than virus-based ones.
"Maybe it seems a little crazy, but at a certain point not doing something that seems pretty safe in the face of a disease that could kill you or loved ones.It depends on where everyone's particular risk threshold is," he says. "And I don't blame anyone waiting for an FDA-approved vaccine."
The biohacker places the group's odds of success at "less than 50 percent," but he still believes it's better to try than to do nothing in the face of a pandemic. He also believes the failure of public health agencies such as the World Health Organization and the Centers for Disease Control to act swiftly and decisively early in the outbreak increases the likelihood that an unapproved vaccine could play a useful role in slowing the spread of the virus.
"The people who are on the ground at these [public health] organizations, they mean well, but governments have to, as they say, 'Make number go up' with the economy, even if that means putting people's lives at risk," he says.
The Coronope document says that after the team successfully constructs a synthesized plasmid, which they believe they could do in 2 to 4 months, they could begin "producing thousands of doses per day." From there, the biohacker says, it's simply "an economy of scale," since replication of a bacterial-based DNA vaccine is far more efficient than a viral one that must be cultivated in slower-replicating animal cells.
Watch the video above for the full interview. The team suggests anyone interested in learning more or contributing contact them at coronope@protonmail.com, or use their public bitcoin wallet address bc1qccn54y3l4a9un7dhqnuewd22jx5vnruhf0dqve.
Produced by Zach Weissmueller. Camera by Justin Monticello and John Osterhoudt. Music: "Cendres" and "Fryeri," by Kai Engel.Photo credits: Coronavirus in Rome, Matteo Trevisan/ZUMA Press/Newscom.
In the United States, the sense of being cut off increasingly seems to apply to the states themselves, as Washington has been slow to produce either promised aid or a coherent strategy and President Trump advised governors some of whom were shocked that they should look to buy their own ventilators and respirators, which are in desperately short supply.
On Monday, health officials ordered millions in six counties in the Bay Area to shelter in place, one of the most significant restrictions yet to American life in the race to stop the coronavirus outbreak from surging in the United States.
The order, which goes into effect Tuesday, is expected to disrupt life for millions of residents in Alameda, Contra Costa, Marin, San Francisco, San Mateo, and Santa Clara Counties. The City of Berkeley also issued the same order.
And families were left to worry about lost wages, about inadequate supplies of medicine and protective gear, about leaving the ill and elderly even more isolated and vulnerable, and about jobs, institutions, relatives and neighbors that might vanish and never return.
Scientists tracking the spread of the coronavirus reported Monday that, for every confirmed case, there are most likely another five to 10 people in the community with undetected infections. These often-milder cases are, on average, about half as infectious as confirmed ones, but responsible for nearly 80 percent of new cases, according to the report, which was based on data from China.
The researchers modeled the viruss natural spread in China before the government instituted a travel ban and an aggressive testing policy. During that time, from December of last year through late January, about 6 in 7 cases went undetected. That situation is analogous to the current state of affairs in the United States and other Western countries, where tests are not widely available, the researchers said.
If we have 3,500 confirmed cases in the U.S., you might be looking at 35,000 in reality, said Jeffrey Shaman, an epidemiologist at Columbia University and the senior author of the new report, which was posted by the journal Science.
Since the first U.S. case of the coronavirus was identified in Washington state on January 21, health officials have identified thousands of cases across the U.S. By March 16, the virus had expanded its presence from several isolated clusters in Washington, New York, and California to 49 states and the District of Columbia. To date, there have been over 70 deaths across the country.
Social distancing is widely seen as the best available means to "flatten the curve of the pandemic," a phrase epidemiologists use to describe slowing the spread of infection. This approach can save lives by keeping local health care systems from being overwhelmed.
In response to mounting cases, states have begun closing schools, banning large gatherings, and urging people to stay home when possible. On Monday, President Trump announced new guidelines recommending Americans avoid gathering in groups of more than 10 people, discretionary travel, and going out to eat.
To avoid spreading the disease, the CDC also recommends basic precautions like hand washing and cleaning frequently touched surfaces every day.
Globally, the respiratory disease has spread to dozens of countries and killed several thousand people since it was first reported in Wuhan, China in December.
Warnings issued by the CDC recommend avoiding nonessential travel to dozens of countries with outbreaks of COVID-19, including China, Iran, South Korea, and much of Europe. The government has banned travel from Europe, although the ban makes exceptions, including for American citizens and legal permanent residents.
Follow NPR's ongoing coronavirus coverage.
SAN FRANCISCO A website intended to facilitate nationwide testing for coronavirus that was promoted by President Trump in a news conference on Friday quickly reached capacity when it went live in a small pilot project late on Sunday night.
The website, created by Verily, a life sciences unit of Googles parent company, Alphabet, fell far short of the wide-ranging capabilities administration officials described on Friday. In its initial rollout, it was meant to point people to testing locations in two San Francisco Bay Area counties.
It ran into two issues: First, it was telling people with symptoms of the virus that they were not eligible for the screening program. And second, they were asked to create an account with Google or log in to an existing Google account and sign an authorization form.
Still, within a few hours of launching, Verily said it could not schedule any more appointments at the time because it had reached capacity.
Daniel Hom, 77, a pharmacist who lives in Berkeley, Calif., and works in nursing homes, said he filled out the survey on Sunday night around 8 p.m. and found out that he qualified for the test. He said he thought his age was the primary factor for becoming eligible, because his son, who is in his 30s and also works in health care, was not selected.
On Monday morning, Mr. Hom said he drove to the parking lot of the San Mateo County event center where he got a nasal swab. They stuck it way up there, he said. Mr. Hom was told that results should arrive within four days by email depending on how quickly Quest Diagnostics can process the test.
I was impressed how organized they were, considering it was the first day, he said.
Verily said it was trying to help public health officials expand access to testing in areas with a high volume of known cases. The new site is supposed to direct so-called high-risk individuals to newly opened testing centers in Santa Clara and San Mateo Counties, which include Silicon Valley.
The first issue appeared to be a result of what the site was intended to do. It started with an initial survey asking whether people were currently experiencing severe cough, shortness of breath, fever or other concerning symptoms. If they selected yes, the site abruptly ended the survey and said in-person testing through the program is not the right fit. In smaller font, Verily suggested seeking medical help.
Responding no to the symptoms led to more questions to gauge eligibility for testing by asking age, location and other factors. This caused confusion among people trying to use the site.
When reporters and users asked if disqualifying people with symptoms was done in error, Verily said it wasnt a mistake.
The initial question is meant to ensure that anyone who is seriously ill does not come to our sites because they are not prepared to provide medical attention, said Carolyn Wang, a Verily spokeswoman, in a written statement. We are early in this pilot and are going to be learning more that will help us refine this COVID-19 risk screening and testing.
Once deemed eligible and depending on availability, people were directed to a mobile testing center run by Verily in conjunction with local health officials. The actual coronavirus test will be a nasal swab conducted by nurses and nurse practitioners with oversight from the companys clinical research staff.
Ms. Wang declined to say how many tests were being performed. As more testing sites come online, the program aims to cover the entire state, Verily said.
Verily is rolling out its virus-screening tool at a moment when its parent company, Google, is facing intense scrutiny for it push to acquire and analyze health data. A group of U.S. senators is looking into a deal that Google made with Ascension, the nations second-largest hospital system, which gave the tech giant access to millions of medical records without patients explicit knowledge or consent.
Verily said that having people sign in with their Google account would allow it to connect people with tools like electronic screening that it has built for Project Baseline, its research effort to collect comprehensive health data and map human health. The company also said it would not connect peoples virus screening data with their Google account data without explicit consent.
But some privacy experts said requiring a Google account for the virus screening could create barriers to participation or dissuade people concerned about what the company might do with their information. A free self-assessment tool for coronavirus offered by government health services in Alberta, Canada, for instance, does not require any login.
What we need are substantive and absolute promises of care, loyalty and confidentiality that will keep participants safe and convince them that this project is being done entirely for public health purposes, said Woody Hartzog, a professor of law and computer science at Northeastern University in Boston.
The website has been mired in controversy from the start. In a news conference on Friday, Mr. Trump said Google had 1,700 engineers working on the project, claiming that the company had made great progress.
The website was actually the work of Verily and Sundar Pichai, Alphabets chief executive. Mr. Pichai said a planning effort" was underway in an internal memo a day before the White House news conference. The project was limited to the Bay Area and the 1,700 engineers hailed by Mr. Trump appeared to be the number of Google employees who had volunteered to help Verily.
A Verily spokeswoman has said there is no current timetable for a national rollout of its screening program. The website became publicly available one day before a Monday deadline that Verily had announced.
Separate from Verilys efforts, Google announced that it was working on a nationwide website to provide information on virus symptoms and testing sites. The company had made no mention of that project on Friday when it directed all inquiries about Mr. Trumps website announcement to Verily.
Daisuke Wakabayashi reported from San Francisco and Natasha Singer reported from New York.
