Apple will donate a portion of sales from Product Red products to a COVID-19 relief fund, the company announced today. Product Red donations normally go toward fighting HIV/AIDS, but the organization has started directing money toward COVID-19 responses in light of the pandemic.
Now through September 30th, the tech giant will distribute some of the proceeds from the sale of Product Red gadgets and accessories to the Global Funds COVID-19 Response. This includes Apple accessories, like Apple Watch bands or iPhone cases, and iPhones, including the Product Red color variant of the recently announced iPhone SE, which is slated to launch on April 24th.
Product Red is an ongoing partnership between Red and major companies, like Apple, Nike, and Starbucks, to raise funds, spread awareness, and eradicate HIV/AIDS in African countries. However, amid the COVID-19 pandemic, Apple said this new program will provide critical support in health systems that are impacted by the novel coronavirus.
In 2018, Apple said it had raised $200 million for Product Red and that it was the organizations largest corporate donor. Apple does not say how much money it redirects from each sale to the charity.
Apple has taken several actions to help address the pandemic, including partnering with Google to develop a contact tracking system for iOS and Android devices, which will share data through Bluetooth.
The Coronavirus has prompted thousands of information security professionals to volunteer their skills in upstart collaborative efforts aimed at frustrating cybercriminals who are seeking to exploit the crisis for financial gain. Whether its helping hospitals avoid becoming the next ransomware victim or kneecapping new COVID-19-themed scam websites, these nascent partnerships may well end up saving lives. But can thisunprecedented level of collaboration survive the pandemic?
At least three major industry groups are working to counter the latest cyber threats and scams. Among the largest in terms of contributors is the COVID-19 Cyber Threat Coalition (CTC), which comprises rough 3,000 security professionals who are collecting, vetting and sharing new intelligence about new cyber threats.
Nick Espinosa, a self-described security fanatic, author and public speaker whos handling communications for the CTC, said the group does most of its work remotely via a dedicated Slack channel, where many infosec professionals seem eager to counter the gusto with which the cybercriminal community has sought to profit by exacerbating an already difficult situation.
A nurse or doctor cant do what we do, and we cant do what they do, Espinosa said. Weve seen a massive rise in threats and attacks against healthcare systems, but its worse if someone dies due to a malicious cyberattack when we have the ability to prevent that. A lot of people are involved because theyre emotionally attached to the idea of helping this critical infrastructure stay safe and online.
Using threat intelligence feeds donated by dozens of cybersecurity companies, the CTC is poring over more than 100 million pieces of data about potential threats each day, running those indicators through security products from roughly 70 different vendors. If at least 10 of those flag a specific data point such as a domain name as malicious or bad, it gets added to the CTCs blocklist, which is designed to be used by organizations worldwide for blocking malicious traffic.
For possible threats, meaning between five and nine vendors detect an indicator as bad, our volunteers manually verify that the indicator is malicious before including it in our blocklist, Espinosa said.
Another Slack-based upstart coalition called the COVID-19 CTI Leaguespans more than 40 countries and includes professionals in senior positions at such major companies as Microsoft Corp and Amazon.com Inc.
Mark Rogers, one of several people helping to manage the CTI Leagues efforts, told Reuters the top priority of the group is working to combat hacks against medical facilities and other frontline responders to the pandemic, as well as helping defendcommunication networks and services that have become essential as more people work from home.
The group is also using its web of contacts in internet infrastructure providers to squash garden-variety phishing attacks and another financial crime that is using the fear of COVID-19 or the desire for information on it to trick regular internet users, wrote Reuters Joe Menn.
Ive never seen this volume of phishing, Rogers told Reuters. I am literally seeing phishing messages in every language known to man.
Among the more mature organizations working to counter the threat from COVID-19 scammers is the Cyber Threat Alliance, a industry group founded in 2017 that counts among its members more than two dozen major cybersecurity firms that are all required to regularly share threat intelligence with other members.
One thing were paying attention to in addition to phishing and malware attacks is anything targeting stuff involved in the pandemic response, such as the manufacturers of protective gear, testing kits, or hospitals, CTA President Michael Daniel told KrebsOnSecurity. One of those organizations getting hit with ransomware now would be really bad, and we want to make sure if we see that were alerting and working with law enforcement.
Earlier this month, the international police network INTERPOL issued a warning to law enforcement in nearly 200 member countries, saying it had detected a significant increase in the number of attempted ransomware attacks against key organizations and infrastructure engaged in the virus response.
The alert came after several top ransomware gangs pledged a moratorium on attacking hospitals and other care centers for the near future. Nevertheless, these group have continued to target companies on the periphery of the pandemic response, including virus testing labs, N95 mask production facilities, and companies engaged in vaccine research.
The CTCs Espinoza said it would be a potentially fatal mistake to assume all cybercriminal groups might observe such a cease-fire.
We might have independent criminal groups saying they wont hit hospitals but theyll hit everyone else, but that doesnt prevent them from sending phishing emails and masquerading as the World Health Organization or the Centers for Disease Control, he said. These are people who have no problems locking out little old ladies out of their computers for 800 bucks, and of course there are state-sponsored hackers who love any opportunity to sow discord and disrupt things.
The CTAs Daniel said while its great to see so much voluntary collaboration between the cybersecurity industry, governments and law enforcement, hes been thinking a lot lately about how to sustain these relationships and networks once the urgency of the pandemic subsides.
Formerly special assistant to President Obama and cybersecurity coordinator on the National Security Council, Daniel said he sees preserving and enhancing this information sharing effort post-COVID as one of the biggest policy issues facing the federal government over the next few years.
Information sharing is easy to talk about, and hard to do in practice, Daniel said. I dont use the term public-private partnership because its been bandied about so much over the years that I dont know what it means anymore. Its probably best described as working together on an operation.'
What prevents private companies from working more closely and frequently with governments on operations to target cybercrime organizations and networks? Daniel said on the government side, there are real concerns that working with one or two particularly clueful or effective companies (versus all of them) might give the impression that the government is showing favoritism, or picking winners and losers in the market.
But you have to do that to some extent because the truth is some companies matter in this space, and a lot dont, Daniel said. The government has to accept that, determine what are the objective rules, and establish transparency so that [their efforts] arent seen as some secret club but as part of a normal process.
Daniel said governments in general also need to get more comfortable sharing information about operations targeting specific crime groups in advance of those actions.
The government has to figure out how to let the private sector in on some of the planning and preparation, he said. If you want [the cybersecurity industrys] help against certain targets, you have to tell us who they are ahead of time. But this goes against how governments operate in almost every way.
On the private sector side are issues of how for-profit companies can closely collaborate with the government without being perceived as potentially compromising the privacy and security of their customers, or as simply an agent of the government.
For companies, the question is how do you deal with the liability and other questions that come with that, Daniel said. These are very real impediments, and why I think we need to get past the endless discussions of public-private partnerships and start talking about what we can do to coordinate actions against these groups so we can have a more strategic impact on the adversary.
Tags: COVID-19 Cyber Threat Coalition, Cyber Threat Alliance, Joe Menn, Mark Rogers, Michael Daniel, Nick Espinosa
This entry was posted on Wednesday, April 15th, 2020 at 11:28 amand is filed under The Coming Storm.You can follow any comments to this entry through the RSS 2.0 feed.You can skip to the end and leave a comment. Pinging is currently not allowed.
CHEEKTOWAGA, N.Y. Drive-thru COVID-19 testing started in the Walmart parking lot on Walden Avenue in Cheektowaga Wednesday.
The most important thing you need to know about the testing site is that you need to make appointment online before you show-up. Walk-ups are not allowed.
Quest Diagnostics and Walmart teamed up to do this. New York State Police are there making sure things run smoothly. Wednesday was just a soft launch with appointments starting Wednesday afternoon. Thursday, appointments run from 9 a.m. to 4 p.m.
You're asked to get there no more than ten minutes before your appointment time.
Many of viewers have asked some great questions about the testing site.
Lyn asked, "Can anyone get tested?"
Not quite. While you can make the appointment online yourself, tests are limited to people showing coronavirus symptoms, all health care providers, and first responders.
Another person said, "I've scheduled an appointment for myself already. How soon will I get the results? Are they the 24-hour tests?"
Quest says turnaround time is typically less than two days from the time of pick-up but can vary. Some people, including healthcare workers with symptoms, might get their results in less than a day.
Ralph asked whether you need a script from your doctor.
No, you don't. You can get an appointment online without your doctor's help.
Paula asked, "Can ANYONE with both a fever of 100.4 or over AND a cough/shortness of breath get tested?"
Any health care worker, first responder, or anyone showing coronavirus symptoms as defined by the CDC can make an appointment.
Brian wanted to know if this is testing to see who has, and has not had, the virus. Being an essential worker, he says he'd love to know for sure that he's already had this virus back in January.
If you aren't a healthcare worker or first responder, you have to have symptoms now to get an appointment.
When you get to your appointment, you'll get a nasal swab test that you'll do yourself in your car while a trained medical volunteer watches you. When you're done, you'll simply drop the sealed sample into a container.
And, you might be wondering what you need to bring with you. You need to have your appointment confirmation, along with your insurance card, and a valid photo ID.
Chuck wants to know if this includes the immediate family members of healthcare workers and first responders who are in the same household.
Quest says to qualify for a test if you aren't a healthcare worker or first responder, you have to be symptomatic, as defined by the CDC.
Brian also asked, "Is it only for people with symptoms or is it to find out if you have already had it? Would they consider making a special section for essential workers to get in and get out that have been out in the public since the beginning, as I am sure its probably tough to get an appointment."
Right now, it's just for people in the three groups we mentioned.
Quest said earlier this week, it's now able to do 45,000 tests a day.
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Three potential coronavirus vaccines are making fast progress in early-stage testing in volunteers in China and the U.S., but its still a long road to prove if theyll really work against COVID-19.
CanSino Biologics of China has begun the second phase of testing its vaccine candidate, the Chinese Ministry of Science and Technology said Tuesday.
In the U.S., a shot made by the National Institutes of Health and Moderna Inc. isnt far behind. The first person to receive that experimental vaccine last month returned to a Seattle clinic Tuesday for a second dose.
NIH infectious disease chief Dr. Anthony Fauci said there are no red flags so far and he hoped the next, larger phase of testing could begin around June.
A third candidate, from Inovio Pharmaceuticals, began giving experimental shots for first-step safety testing last week in the U.S. and hopes to expand its studies to China.
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Initial tests in a clinical trial focus on safety, and researchers in both countries are trying out different doses of different types of shots.
But moving into the second phase is a critical step that allows vaccines to be tested in many more people to look for signs that they protect against infection.
Last week, CanSino filed a report showing it aimed to enroll 500 people in its phase 2 study, comparing two doses of the vaccine to placebo shots. As of Monday, 273 of the volunteers had been injected, state media said.
Looking ahead, Fauci said if the new coronavirus continues to circulate widely enough over the summer and fall, it might be possible to finish larger studies slightly sooner than the 12 to 18 months hed originally predicted maybe toward mid to late winter of next season.
Please let me say this caveat: That is assuming that its effective. See, thats the big if, Fauci stressed. Its got to be effective and its got to be safe.
During a news conference in China, authorities also cautioned that the studies must be done properly.
Although we are in an emergency, we cannot lower the standards of safety and effectiveness in the reviews of vaccines, said Wang Junzhi, a Chinese biopharmaceutical expert. The public is paying huge attention.
The World Health Organization this week counted more than five dozen other vaccine candidates in earlier stages of development being pursued around the world. Many research groups are teaming up to speed the work. On Tuesday, vaccine giants Sanofi and GSK announced that they had became the latest to partner on a candidate.
The WHOs list includes a wide variety of ways to make vaccines, so if one approach doesnt pan out, perhaps another one will.
CanSinos vaccine is based on a genetically engineered shot it created to guard against Ebola. The leading U.S. candidates use a different approach, made from copies of a piece of the coronavirus genetic code.
When will we have a Covid-19 vaccine? Public-facing scientists such as the UKs chief scientific adviser, Sir Patrick Vallance, and his US counterpart, Anthony Fauci, keep repeating that it wont be before 12 to 18 months. But other voices including some of those in the race to create a vaccine themselves have suggested that it could be as early as June. Who is right?
The former, probably, but its complicated because this pandemic is forcing change at almost every step in the process by which a new vaccine arrives at a needle near us.
It really depends on what you mean by having a vaccine, says Marian Wentworth, president and CEO of Management Sciences for Health, a Massachusetts-based global not-for-profit organisation that seeks to build resilient health systems, and a long-time observer of vaccine development. If you mean one that can be used in a mass vaccination campaign, allowing us all to get on with our lives, then 12 to 18 months is probably right.
But in terms of an experimental vaccine that is deemed safe and effective enough to be rolled out in a more limited way to high-risk groups such as health workers, say that could be ready within weeks or months, under emergency rules developed by drug regulatory agencies and the World Health Organization in the context of the recent Ebola epidemics in Africa.
When the University of Oxfords Adrian Hill told the Guardian that his groups Covid-19 vaccine candidate could be ready by the summer, it was this kind of readiness to which he was probably referring. The group, led by Sarah Gilbert, has since stated that a vaccine shown to be effective in phase-3 clinical trials that could be manufactured in large quantities wont be ready before the autumn even in a best-case scenario. And that scenario is highly ambitious and subject to change.
Normally, a vaccine is developed in the lab before being tested on animals. If it proves safe and generates a promising immune response in this pre-clinical phase, it enters human or clinical trials. These are divided into three phases, each of which takes longer and involves more people than the previous one. Phase 1 establishes the vaccines safety in a small group of healthy individuals, with the goal of ruling out debilitating side effects. Phases 2 and 3 test efficacy, and in an outbreak like the present one they are conducted in places where the disease is prevalent. In parallel with these later phases, production capacity for the candidate vaccine is gradually built up, so that factories are capable of producing it on a large scale if and when regulatory agencies judge that it should be licensed.
In an article published in The New England Journal of Medicine on 30 March, representatives of the Oslo-based not-for-profit Coalition for Epidemic Preparedness Innovations (Cepi), which is helping to finance and coordinate Covid-19 vaccine development, laid out an accelerated version of this process that they believe is more suited to a pandemic. This pandemic paradigm implements certain steps in parallel, such as animal and phase-1 clinical testing. It also involves scaling up production capacity before sufficient safety and efficacy data are available a financially risky step, given that that may never materialise, and one that requires governments and not-for-profit organisations such as Cepi to share that extra financial risk with pharmaceutical companies if they want them to engage. Mass production is critical in a pandemic, when hundreds of millions if not billions of doses are needed and many countries are now scrambling to build new vaccine production facilities.
People now appreciate that the lengthy process of conventional licensing of vaccines is not going to be helpful in the context of an epidemic, says Beate Kampmann, who heads the vaccine centre at the London School of Hygiene and Tropical Medicine.
Bringing a new vaccine to the clinic has taken 10 to 20 years in the past
Prudently, Cepi did not attach a timeline to its accelerated paradigm, but the 12- to 18-month estimate already takes it into account. Bringing a new vaccine to the clinic has taken 10 to 20 years in the past. Nevertheless, the accelerated paradigm is being implemented now. A Boston-based biotech firm, Moderna, saw its experimental Covid-19 vaccine enter human trials on 16 March, just 10 weeks after the first genetic sequences of Sars-CoV-2 the virus that causes the disease were released. Others will follow soon.
Were getting to candidates much more quickly, says Kampmann, who puts this progress down to advances made in the fight against Ebola. The step-up in technology that we have seen in the last five years has really made a difference.
There are many hurdles ahead, though. Most of the 70-odd Covid-19 vaccine candidates being developed and tested will not make it to the licensing stage, and those that have been fastest out of the blocks may still encounter problems later on. Modernas innovative technology allowed it to generate a candidate quickly, but no vaccine using this platform has been licensed to date.
At the Pasteur Institute in Paris, on the other hand, a Covid-19 vaccine candidate is still in pre-clinical development, but because it piggybacks on established technology a licensed measles vaccine the testing and licensing processes will go faster. And this kind of vaccine can already be produced in large quantities.
While there can be no shortcuts to establishing safety and efficacy, proposals have been put forward for how these experimental vaccines might be tested more rapidly without sacrificing scientific rigour. In February, for example, the WHO published a draft protocol for phase 2 and 3 trials that would test a number of candidates simultaneously, in multi-country trials according to standardised criteria.
Another proposal is to conduct controlled human challenge trials, in which healthy volunteers are given a candidate vaccine and then infected with Sars-CoV-2. These are ethically questionable, especially before scientists understand why young and otherwise healthy people are ending up on ventilators. A similar approach, being implemented by the London-based clinical research group Hvivo, invites volunteers to be infected with a milder coronavirus but how applicable its findings will be to Sars-CoV-2 is not clear.
If our own body cant prevent us from getting it again, that would be one pretty damning signal
There are still many unknowns with respect to Covid-19, including for how long any vaccine will provide protection. A strong indication of this will be whether people who have recovered from the disease can catch it again. There have been anecdotal reports of re-infection, but the phenomenon is not well understood. If our own body cant prevent us from getting it again, that would be one pretty damning signal, says Wentworth.
Once a vaccine is licensed, there will still be political obstacles to getting it to where its needed, because each country or public health jurisdiction has to make its own decision to roll it out. There will also be issues of prioritisation who should get it first, if supplies are limited which authorities are discussing now.
A vaccine that is approved a year from now may arrive after the end of the current pandemic, but if so it wont be wasted first because Covid-19 may recur seasonally, and second because the vaccine could itself be repurposed in the event of an outbreak of a different coronavirus. That will be no consolation to victims of this pandemic, or their relatives, but it does mean that humanity will be better protected in future. As Wentworth says: That learning, we wont unlearn.
Due to the unprecedented and ongoing nature of the coronavirus outbreak, this article is being regularly updated to ensure that it reflects the current situation as best as possible. Any significant corrections made to this or previous versions of the article will continue to be footnoted in line with Guardian editorial policy.
Not long after the COVID-19 pandemic began, hopes for a vaccine were raised. Even US president, Donald Trump, a former vaccine skeptic, demanded a coronavirus vaccine, saying: Do me a favor, speed it up, speed it up.
So where does that leave the anti-vaxxers those who are critical or oppose vaccination. Will they now be quiet in the face of a real-life reminder of a time before vaccines controlled many diseases?
During a pandemic, the position of those who oppose vaccination is often voiced, even if a vaccine is not yet available.
Some celebrities and high-profile personalities have also spoken out about their unwillingness to have a vaccine. The British rapper MIA, for example, attracted controversy for her tweet: If I have to choose the vaccine or chip Im gonna choose death. YALA.
MIA experienced a significant backlash from many followers who disagreed with her views. Indeed, in general, the heightened stakes of a very present disease threat may lead to a stronger countering by those who are in support of vaccination.
Read: [Bill Gates to fund 7 coronavirus vaccines for quicker results, likely wasting billions]
While the anti-vax constituency was seen as politically attractive in pre-coronavirus times, today, vocal vaccine critics looking for votes may find it harder. As a Vermont governor candidate has found, his stance against government-mandated vaccination has been questioned by opponents.
Anti-vaxxers are a target right now for those looking for enemies in the crisis. While tempting, it is important not to fuel tensions and polarization. The worries that anti-vaxxers might have of government encroachment into private lives (through surveillance and possible enforcement of vaccines) should be addressed, as should the spread of misinformation and influencers offering alternative natural cures that are useless or even harmful.
It is difficult to assess, at this stage, what the publics reaction to a coronavirus vaccine might be. Looking at vaccines that were rolled out in response to other disease outbreaks, you will find different reactions. For example, there was a high demand for the polio vaccine in the 1950s because the risk was very present. But there were concerns over a new vaccine being rushed or not tested well during 2009 H1N1 swine flu pandemic.
A vaccine for COVID-19 will have to go through all the same safety and effectiveness tests as any other vaccine that is introduced. But negative comments in the media about the speed and rigor of vaccine trials is worrying. As are references to trial participants as guinea pigs.
Even more worrying is the spread of misinformation and disinformation, which can stem from skepticism about the motivations of those who have developed a new vaccine and may lead to questions about how safe and useful it is. This sort of thing could derail a vaccination campaign, as has happened in the past. For example, in 2017, a rumor that vaccination would make children impotent hampered the Indian governments vaccination campaign for new measles and rubella vaccines being rolled out in five states.
To address this risk, health authorities and governments need to quickly react to information that is false or misleading. Social media platforms are already aware of their role against COVID-19 fake news and met with government leaders early on in the crisis.
Where there are very limited control and oversight is with private messaging, such as WhatsApp, email, and text messages. Even though WhatsApp recently announced it will limit frequent forwards,by restricting the times a message can be forwarded by five, we still need to rely on the public to be aware of what sources to trust and also bring attention to fake news.
With the many concerns about opposition to vaccination, what should not be neglected are the routine immunization programs that protect people against vaccine-preventable diseases. While it may be harder to routinely vaccinate people if health resources are directed elsewhere, and there is difficulty or reluctance to go to the doctor or other places where vaccination takes place (such as schools, due to closure), making the best use of the vaccines already available is crucial to avoid other disease outbreaks on top of COVID-19.
This article is republished from The ConversationbySamantha Vanderslott, Postdoctoral Researcher in Social Sciences, University of Oxfordunder a Creative Commons license. Read the original article.
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Johnson & Johnson says it aims to have more than half a billion coronavirus vaccines ready early next year.
The pharmaceutical giant will have 600 million to 800 million vaccines available in early 2021, when it expects the US government to approve the drug it plans to start testing in humans this September, chief financial officer Joe Wolk said Tuesday.
The timeline still is pretty certain, Wolk told Yahoo Finance in an interview. Were manufacturing at risk to ensure that should the clinical development and the trials be successful, we are in a position to kind of flip the switch and ready to go to create great access across the globe.
The company aims to ramp up production to 1 billion doses annually by the end of next year, Wolk said in the interview. J&J and the federal Biomedical Advanced Research and Development Authority announced a $1 billion investment last month to help achieve that goal.
J&J plans to set up a new manufacturing facility in the US to supplement the companys plant in the Netherlands that can produce up to 300 million doses. The stateside factory will be up and running later this year or early next year, Wolk told Yahoo.
With Post wires
SAN DIEGO As the race to find a vaccine for the coronavirus ramps up, so does the competition. San Diego based Sorrento Therapeutics is working to develop a vaccine for the coronavirus as well as antibody therapy and testing.
Theres not many companies in the world that can do what were doing, put them all together, said Chairman and CEO of Sorrento Therapeutics, Henry Ji.
From concept, to development, to the vial, Ji says the company plans to be involved every step of the way. Additionally, he says the companys access to labs and testing abilities means results will come expeditiously.
I love the spirit of the employees, said San Diego Mayor Kevin Faulconer who stopped in for a visit Wednesday.
They are working literally 24/7 and they are proud of their work. They know the work they are doing in this building is going to save lives. So, it is my honor, my privilege to come in and say great job.
Ji says theyre currently working on a handful of vaccines and due to relaxed FDA regulations, having one of them ready for use by the end of the year, is within the realm of possibility.
They are also working on creating a test to detect antibodies, an indicator someone may have already been exposed to the coronavirus and recovered.
Equally important is antibody therapies. Ji said they are working on the therapeutic and neutralizing variety. The neutralizing version could be especially helpful for people in the health care industry.
Every two weeks you inject the antibody, Ji explains. Nurses, doctors, you want to neutralize the antibody and inject them before they enter the hospital so they are protected from the virus.
Sorrento Therapeutics isnt the first company to enter the race for therapies and vaccines. Dozens of others around the world have also chased the goal. Ji says even if others beat them to the finish line, the target may end up shifting if the virus mutates.
The guys that are doing it first may get it wrong, and were trying to get it right.
The company says they are also waiting on FDA approval for something that could serve as a blocker for lung inflammation to people who already have coronavirus and patients in hospitals on ventilators.
We are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for COVID-19.
This process is used for the treatment of blood products such as plasma, platelets and whole blood to prevent disease transmission when people receive transfused blood. It utilizes a common food ingredient, vitamin B2, or riboflavin, which is a light-sensitive chemical. When used in combination with ultraviolet light of specific wavelengths, B2 can alter genetic material, whether RNA or DNA, of infectious pathogens in the blood, making them unable to transmit disease.
Those genetic changes prevent pathogens, such as viral, bacterial and parasitic contaminants, in blood from replicating. By stopping the replication process, the method protects people from disease they could acquire through a blood transfusion.
Heres how we believe this technology can be applied to COVID-19 virus: When creating a vaccine candidate, the goal is to destroy the replication potential of the virus while preserving its proteins and antigens, the substances in the virus that prompt the body to produce antibodies. The presence of those proteins and antigens allows the body to recognize the virus as foreign and mount an immune response against it.
When this method is applied to a pure virus grown in cell culture, the B2 damages the viruss genetic material and thus blocks it from replicating. But the B2 treatment leaves the rest of the virus notably the viral proteins undamaged. That is important because the vaccine needs to contain proteins that appear on an infecting virus in order for a person to produce effective antibodies and protect against the disease.
Why it matters
Vaccines require an inactive form of a virus that cannot cause disease to stimulate the immune system. In 2009, during the H1N1 influenza outbreak, the U.S. experienced shortages in the manufacturing of needed vaccines, as the need to grow the virus was in high demand and the manufacturing plants that required the use of eggs to grow the virus were insufficient.
This resulted in the expansion of new ways to manufacture vaccines, some of which are now in use. Yet, there is still a lag time in the production of needed vaccines for the current coronavirus outbreak.
Most methods that are used today to prepare inactivated viruses employ chemicals that are both toxic and in some cases even pose explosion risk, meaning that facilities have to be constructed and operated in ways that protect workers and the public from their use and exposure.
Riboflavin is a compound that is generally recognized as safe because of its low toxicity in humans and animals and its presence in common products people routinely ingest. Using this approach can make this step in virus production much easier and applicable for use in appropriate biological containment facilities.
What other research is being done
Over the last decade, there have been advances in manufacturing and in strategies to rapidly produce a vaccine.
Our work has been made possible by the investments made in the U.S. research infrastructure through the National Institute of Allergy and Infectious Diseases in order to expand research and manufacturing capacity and to address concerns over the potential threat of bioterrorism. It led to the construction of a manufacturing plant and research labs which are currently used by industry, government and academic partners pursuing manufacturing and process development for vaccines, therapeutics and diagnostic reagents.
Although the threat from bioterrorism never materialized to the extent that was initially envisioned, there is a need for rapid vaccine development to address emerging pathogens that threaten human health on a global basis, such as Zika.
Whats next
Our vaccine construct, which we call SolaVAX, is undergoing animal testing and further laboratory characterization, such as studying the nature of the damage to the viral RNA that this process induces and its immunological effect when given to animals. We began our initial vaccine challenge studies earlier this month. These tests will determine if we can protect animals that are vaccinated with SolaVAX from developing the disease when they are later exposed to the live virus. This work is a first step on the path to human clinical evaluation. We also possess the nonprofit BioMARC manufacturing operation at Colorado State University, where testing and development of this inactivation method for vaccine production can be piloted.
If initial results in animal testing and pilot production of the vaccine are positive, the next steps into human clinical testing and evaluation and ultimate regulatory approvals represent the next major hurdle.
Alan Rudolph is affiliated with the Colorado Biosciences Industry Association, Colorado Federal Laboratory Consortia, Founder of Cellphire Inc. and Board Member of PhotonPharma.
Raymond P. Goodrich consults for Terumo BCT, Inc. This organization is the owner of the Mirasol PRT technology which is utilized in the production of the SolaVAX vaccine. He is an inventor of that technology and holds patents on the use of the technology for the treatment of blood products and use in preparing vaccines. These patents are assigned to Colorado State University. He is also a founder of PhotonPharma, Inc. He serves as a member of the American Association of Blood Banks committee on Public Policy and Strategy.
This article by Alan Rudolph and Raymond P. Goodrich first appeared in The Conversation on April 4, 2020.
Image: Reuters.
