Eight states and Washington DC are holding primaries on Tuesday in the most widespread trial yet over whether America can safely hold an election amid the pandemic and unrest as days of protest over the police killings of African Americans continues.
Election officials, who have been encouraging people to vote by mail, already faced an enormous challenge in providing access to voting while protecting public health against Covid-19. Now, they face an additional challenge of conducting an election that guarantees people can vote without risking their physical safety and without police intimidation as curfews clash with voting hours.
One of the most closely watched states on Tuesday is Pennsylvania, a battleground state, where lawmakers are already seeing an unprecedented flood of requests for mail-in ballots. More than 1.8 million people have requested an absentee ballot so far; during the 2016 primary, just 84,000 people voted by mail.But some voters are still expected to cast a ballot in person, as well.
Pennsylvania law requires voters to return their mail-in ballots to the polls by 8pm on election day. But on Monday evening Pennsylvanias governor, Tom Wolf, a Democrat, extended the deadline for voters in six counties in the state to return their ballots, saying they could be counted if they were received in the next week and postmarked by Tuesday.
That came after concern that some voters in the state might be disenfranchised because officials could not get them ballots in time. In Delaware county, just outside Philadelphia, elections officials said Monday they were mailing 6,000 ballots, the day before the election. The county conceded there were 400 ballots that wont be mailed due to timing and staffing constraints.
In Philadelphia and Pittsburgh, election officials have severely limited in-person voting locations because of the coronavirus pandemic. In Philadelphia, officials are monitoring whether they will have to change any of those few locations because of the recent protests, according to the Philadelphia Inquirer. At at least one voting location in Philadelphia, there were long lines on Tuesday morning as poll workers set up voting machines.
Voting rights groups monitoring the elections throughout the country said they were fielding calls from voters reporting problems. In many states, voters reported not receiving mail-in ballot requests in time to vote.
By Tuesday afternoon, about 500 people in Pennsylvania had called in to an election protection hotline run by the groups, about half of the voters were seeking information about their polling location, Suzanne Almeida, the interim executive director of Common Cause Pennsylvania, a watchdog group, told reporters.
In Baltimore, which is holding a Democratic mayoral primary, some voters reported never receiving the ballots they requested, forcing them to go to the polls on election day.
It is unclear how the increased police presence from the protests will mesh with established polling place hours. In Washington DC, Mayor Muriel Bowser announced a 7pm curfew for Tuesday, but polls will be open until 8pm. As the curfew approached, there were still people in line who expected to wait for more than an hour. Bowser said Tuesday no one who was voting would be subject to the curfew.
But there was confusion in the city as the day went on.
Sherene Joseph was in line to vote at Hardy Middle School in the Georgetown neighborhood of DC just before curfew when a police car drove by twice used a loudspeaker to tell everyone they needed to go home. The announcement set off confusion, she said, and elections staff came out to talk to police and encouraged everyone to stay in line and a volunteer gave out I voted stickers for voters to show police.
It didnt happen again and the folks working there made it clear everyone in line that they would be able to vote, she wrote in an email.
Some voters in DC said they never received their ballots and there were still long lines across the city on Tuesday. Only 10 people at a time were allowed into voting locations to allow for social distancing, according to The Washington Post. One voter told the Washington Post he had been told he sent his application to the wrong email address, even though he sent it to the one he was instructed to. Another woman said she couldnt get help requesting a ballot online so she wouldnt vote.
In Philadelphia, there will be an 8.30pm curfew and polls will be open until 8pm. Larry Krasner, the Philadelphia district attorney, said on Monday no one will be arrested for going to vote in violation of the curfew.
But Almeida said there hasnt been clear guidance on protections for people who were still waiting to vote and poll workers who remained at voting sites beyond the curfew time.
She also noted Center City in Philadelphia had been shut down to traffic and was being heavily patrolled, which was obviously a detriment to voters trying to cast a ballot there. The Pennsylvania Convention Center, located in the area, is hosting voting for 18 districts on Tuesday.
Imposing a 6pm curfew on election day threatens to disenfranchise the very people marching to be heard, along with all Philadelphians, said Quentin Palfrey, chair of Voter Protection Corps, a voting advocacy group. We applaud district attorney Krasners clear statement that no voter will be arrested or prosecuted for going to vote, but no such assurances can overcome the suppressive impact of the curfew.
She also noted that one of the voting sites in Wilkinsburg, a borough that is majority African American just outside of Pittsburgh, was in a government building that shared space with the police. It meant that voters would have to wait in line with law enforcement nearby, which could be intimidating.
In addition to Washington DC and Pennsylvania, Tuesday is primary day in Indiana, Iowa, Maryland, Montana, New Mexico, Rhode Island and South Dakota.
It wasnt open to the public, it was an invitation only event," explained Reverend Firmin. "So we were able to know everyone who was there. We actually had seating charts and there was space throughout the cathedral. We took every precaution that we needed plenty of hand sanitizer, rerouted the way we distributed communion even. We knew everyone who was there everyone has been notified and so were covering all our bases in that way.
Even as scientists race to develop a COVID-19 vaccine, experts acknowledge that children could be among the last members of society to be vaccinated.
At least 10 vaccines are being tested in people across the globe, with the United States' top infectious disease doctor, Anthony Fauci, optimistically estimating we could have a viable vaccine by early 2021. While preliminary data on these vaccines has been encouraging, children have been excluded from early studies.
Fauci told ABC News it's possible that studies in children might "catch up" to those in adults, if they are done correctly.
"There is no reason not to believe that [a vaccine] wouldn't be available simultaneously for adults and children," Fauci said.
But other vaccine experts interviewed by ABC News said studies among children could take much longer to complete, and a hard look at the timeline of ongoing vaccine trials raises questions about whether families can expect their children to be vaccinated at some point in the upcoming academic school year.
"Children will be vaccinated, in time," said Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, who sits on the Food and Drug Administration's vaccine advisory committee.
"To date, my sense is that children are not part of these initial studies," Offit added. "It would be unfathomable giving children a vaccine that has not been adequately tested in children."
Work on a COVID-19 vaccine is underway at American biotechnology company Moderna in Massachusetts. Moderna plans to start phase II of its vaccine trials soon and phase III in the summer of 2020.
The process for testing a COVID-19 vaccine in children could take "extra months and maybe years longer," according to Paul Duprex, PhD, Director of the Center for Vaccine Research and professor of microbiology and molecular genetics at the University of Pittsburgh.
Throughout history, scientists have constantly been reminded that children are not simply small adults. Their bodies and immune systems work differently than adults, so they need to be studied separately -- preferably after safety has already been well-established in adults.
"Every person is special, but kids are especially special," said Duprex. "They are our charges. The emotional baggage that goes with something going wrong in clinical trials involving kids -- and I'm not saying adults are not important -- it's just different."
For now, vaccine trials remain laser-focused on members of society deemed to have the highest risk, such as front-line workers and adults. Although some groups have announced their intention to test vaccines in children, ABC News contacted four vaccine groups and none said they have actually started studies in children yet.
Typically, vaccines are tested in a stepwise approach: phase 1 for safety, phase 2 to start testing effectiveness and a massive phase 3 study with thousands of people.
The pharmaceutical company Pfizer told ABC News it will advance a vaccine into children once positive data from phases 1 and 2 is available in adults. Another company, Inovio said it plans "to assess pediatric populations in the future."
The University of Oxford, which has partnered with the pharmaceutical company AstraZeneca, is one of the few vaccine groups that has announced formal plans to start testing in children.
But a University spokesperson told ABC News that children will not be injected right away, and will only be given the vaccine once "all of the adults studies are moving along and have generated sufficient safety data."
In the United States, the National Institute of Allergy and Infectious Diseases (NIAID), which is collaborating with pharmaceutical companies for vaccine trials, told ABC News the agency would continue to work with CDC to better understand how the virus affects children.
In a statement, the agency said: "We will continue to plan for follow-on clinical trials to include younger age groups so such trials can commence if epidemiological CDC data indicate a need to test COVID-19 vaccines in children."
With vaccine skepticism on the rise, experts stressed that it will be important to proceed with caution. According to an ABC News/Washington Post poll, 27% of American adults said they were not inclined to get a vaccine -- even if it was available for free.
With any new vaccine, the ethical thing to do is test for safety in healthy adults first, and then begin testing it among people who need it the most, explained Jennifer Miller, Ph.D., an assistant professor at Yale School of Medicine and founder of Bioethics International and the Good Pharma Scorecard.
For COVID-19, that means older adults, front-line workers and people with underlying medical conditions. Children are far less likely to die of this disease.
"About 2% of the cases reported are in the pediatric population," said Dr. David Kimberlin, professor and co-director of the Division of Pediatric Infectious Diseases at the University of Alabama-Birmingham.
"It's about minimizing risks, it's about informed consent and it's about the population that needs it the most," Miller said.
Minimizing risk is important, especially when it comes to children and vaccines, experts agreed.
Very rarely have candidate vaccines caused a disease to become more severe when the individual is subsequently exposed to the natural infection.
This happened in 1966, when a chemically inactivated vaccine candidate for a childhood lung disease called RSV led to the death of several children. "That tragic event set the RSV vaccine field back decades," said Duprex. "In fact, there still is no licensed RSV vaccine."
Fauci proposed that children might be tested in a so-called "bridging study," in which children are studied in a Phase I trial to ensure the vaccine is safe, and then quickly folded into a large phase 3 study.
Other experts noted it's theoretically possible that studies in children could "catch up" to those in adults, though unprecedented. But even if we do not have a vaccine for children right away, that doesn't necessarily mean children will have to remain socially distant indefinitely.
Eventually, widespread vaccination of adults could end up protecting children thanks to "herd immunity," which is when enough people are vaccinated to snuff out an ongoing chain of infections.
"Usually it's the older way around -- vaccinating children protects older adults," Kimberlin said. But in the case of COVID-19, if we find a successful vaccine and most adults become immune to the virus, "parents could still very legitimately look at that as a win for children because it's a win for society."
The novel coronavirus crisis has introduced us a to a different world one with a new normal. Temperature checks, social distancing, masks, work-from-home and distance learning are some of the new norms that all of us need to embrace and adapt to. Governments have imposed strict measures in order to break the chain of infections, this includes travel restrictions and citywide lockdowns. The COVID-19 virus is not only a health threat, but has also decimated livelihoods, local businesses and the economy in general.
It is believed that until an effective vaccine is found,the new normal is likely to stay indefinitely. This can be seen from the recent announcement made by the President of the Philippines, Rodrigo Duterte who said that he will not allow face to face classes in schools until a COVID-19 vaccine is made available.
To date, over 6.2 million people have been infected with the COVID-19 virus and total deaths recorded have already passed the 370,000 mark. Scientists and pharmaceutical giants around the world from ASEAN member state, Thailandto European countries are currently working at breakneck speed to develop a vaccine for the disease since it first emerged in Wuhan, China.
According to the Global Alliance for Vaccines and Immunisation (GAVI), as of 11 May, there are more than 102 candidate vaccines that researchers are working on, of which at least nine are now being tested in clinical trials on humans.
So, what are some of the latest developments in the race to find a COVID-19 vaccine?
When candidate vaccines make it to human clinical trials, they first go through Phase 1 trials primarily to test the vaccines safety, determine dosages and identify any potential side effects in a small number of people. Phase 2 trials further explore safety and start to investigate efficacy on larger groups. The final stage, Phase 3 trials, which few vaccines ever make it to, are much larger, involving thousands or tens of thousands of people, to confirm and assess the effectiveness of the vaccine and test whether there are any rare side effects that only show up in large groups, stated GAVI.
Some candidate vaccines that are in Phase 2 include the Beijing Institute of Biological Products and Wuhan Institute of Biological Products, which both belong to Chinas state-run Sinopharm Group. Others include BioNtechs MRNA Vaccine in Germany and the University of Oxfords Viral Vector Vaccinein the United Kingdom (UK).
There is good news from the Beijing Institute of Biological Products, as it was recently reported that the vaccine jointly developed by the organisation and China National Biotec Group Co. has completed Phase 2 testing and may be ready for the market at the end of 2020 or early next year, according to a report published in the official WeChat account of the state-owned Assets Supervision and Administration Commission.
Nevertheless, Phase 3 would not be endured without challenges. Media reports have stated that the final stage of testing needs to be done in a place where the virus is still spreading rapidly, and Chinas cases seem to have been plummeting every day. Other than that, a viable vaccine needs massive production capabilities in order to meet global distribution demands.
Although many are hoping for a vaccine or a cure to be deployed very soon, "unfortunately, we really do not know which vaccine will work and whether there will be one at all. If we're lucky, we'll receive indications in autumn as to (a potential vaccine's) effectiveness," GAVI head Seth Berkley told a Swiss newspaper.
There are other concerns regarding the search for a vaccine; domestic interests and that a vaccine would first go to high-income countries.
Based on a statement by GAVI, when a COVID-19 vaccine is ready, scaling-up manufacturing capacity to produce enough for the world will be a difficult task. Even with the current investment into greater manufacturing capacity, it is not enough to vaccinate everyone straightaway.
So, when vaccines do become available, it will most likely be those at greatest risk of the coronavirus health workers, older people and those with underlying conditions, such as diabetes that will be prioritised first.
Dr Koh Mia Tuang, a consultant paediatrician with a subspecialty in paediatric infectious diseases at the University of Malayas Medical Centre in Malaysia recently wrote an article in the local media discussing the affordability of a COVID-19 vaccine when it is eventually made available.
There is no guarantee that less developed countries will be able to afford and have access to the vaccine, explained Dr Koh.
Even now, certain more powerful and rich nations have an understanding with potential vaccine manufacturers to have exclusive rights to the first vaccines, which will likely culminate in an artificial global vaccine shortage, he added.
At the moment, drugs such as antivirals lopinavir/ritonavir (for HIV treatment) and remdesivir (originally developed for Ebola) have been rebranded as temporary treatments for COVID-19 patients with severe conditions.
Until a viable, safe and effective vaccine is found, it is important to adhere to guidelines and safety measures provided by health authorities. In reference to the popular proverb prevention is better than cure, and as advised by many medical specialists such as Dr Koh Mia Tuang himself: stay healthy, practice social distancing and diligent handwashing, wear face masks when possible and avoid crowded areas as preventive measures against the COVID-19 coronavirus.
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COVID-19: SARS-CoV-2 mutation study from Gujarat to help in development of coronavirus vaccine | Photo Credit: Reuters
New Delhi: The novel coronavirus was discovered last year, in the last week of December. Since almost five months, a lot of new information on the virus has come in. According to a study conducted in Gujarat, analysis of mutations across the SARS-CoV-2 genome may help in the development of a single COVID-19 vaccine, says Professor Chaitanya G. Joshi, Director at Gujarat Biotechnology Research Centre (GBRC), reported news agency IANS.
As already known, the coronavirus seems to be mutating at a high speed, and it was reported that the virulent L-strain of the coronavirus is responsible for high mortality, though no conclusive evidence of the same has been found as yet. It was also found that the A2A type mutation, which has become predominant, also increases the efficiency of the entry of the virus, into the human body through cells.
"In the samples sent to us so far, we have seen four S strains and the rest all are L-strains. We have analyzed nearly 150 samples. At this stage, it is not correct to attribute deaths to L-strain. Various factors are involved in death due to this viral infection. The virus is mutating and it has already spread into many parts of the country. Analysis of mutation will help in vaccine development," said Joshi, reported the news agency.
Mr Joshi further added that the vaccine will undergo testing and trials, to establish its efficacy. Hinting that developing a vaccine is no cake-walk, Joshi said that some diseases get a vaccine while some don't, giving an example of malaria and HIV, which do not have a vaccine yet, even after being around for years.
However, the analysis of the genome will definitely help in the development of the vaccine, as well as treatment for the viral infection, Joshi assured.
The COVID-19 cases in India cross the 2 lakh mark today, with more than 5800 deaths. The toll of confirmed cases all over the world stands at 6.8 million. More than 17,000 cases have been reported from Gujarat alone. There exists no specific cure or vaccine for the novel coronavirus. Researchers from all over the world, including India, are racing towards finding an effective vaccine against the recently discovered virus. India is currently developing 11 vaccines against COVID-19.
June 2 (UPI) -- Army scientists are testing coronavirus vaccines developed by outside laboratories -- but also one created by the Army itself -- and are optimistic they'll have a vaccine ready by the end of the year.
Using a virus isolated from the blood of a Washington state man who was the virus' first U.S. death, Army researchers are testing vaccines in hundreds of mice, and researchers are also working to evaluate test vaccines produced by pharmaceutical companies under the White House's "Operation Warp Speed," which has a stated goal of producing a virus by the end of the year.
Human clinical trials could begin as soon as the end of the summer.
"We've done a lot of work that you'll hear about in the near future showing that all the [COVID-19-linked] viruses circulating in the world can be covered by a single vaccine," Kayvon Modjarrad, director of emerging infectious diseases at the Walter Reed Army Institute of Research, told reporters Tuesday.
Some reports suggest there are multiple coronavirus strains -- perhaps as many as eight -- circulating around the world, and that some may be more contagious than others, so the possibility of a vaccine that could handle multiple strains would be a significant development.
"There's no evidence currently that there are new strains," Modjarrad said Tuesday, but the Army's vaccine is being designed with a long-term approach to combating new strains of the novel coronavirus, so researchers could more easily fight any strains that arise.
There are still other unknowns researchers have to contend with -- including the possibility of re-infection and the wide variety of health outcomes for the infected.
It's also too early to tell exactly how long the vaccine's effects will last after patients receive it -- since researchers don't yet know how long it lasts from people who get infected naturally.
Ensuring access to the vaccine once it's been developed is also out of the Army's hands.
Instead it will be up to the Centers for Disease Control to execute a campaign to deploy the vaccine broadly, and the the Food and Drug Administration will also have a "very strong hand" in deciding who gets immunized, according to Nelson Michael, the director of the Center for Infectious Disease Research at the Walter Reed Army Institute of Research.
Washington, D.C., June 02, 2020 (GLOBE NEWSWIRE) -- As the COVID-19 vaccine race accelerates, experts recognize that the challenge will not end with the development of a vaccine. The extraordinary effort to make a vaccine available across the globe will only be effective if the majority of people achieve immunity through vaccination. Meeting the Challenge of Vaccination Hesitancy, a new report released today by the Sabin-Aspen Vaccine Science and Policy Group, calls for an urgent, coordinated effort to strengthen vaccine acceptance and address the risk that vaccination hesitancy the reluctance or opposition to vaccination despite the availability of safe and effective vaccines poses to communities around the world.
The global call for a vaccine to end the COVID-19 pandemic highlights the value of vaccines for the health and economic stability of individuals and communities. While the world eagerly awaits the day when COVID-19 vaccines will be widely available, the threat of deadly vaccine-preventable outbreaks is at our doorstep. Just last year, the United States suffered its largest measles outbreak in 20 years, concentrated in communities with low immunization rates. Similar outbreaks have occurred around the world in communities susceptible to measles because of under vaccination.
Designed to maintain, restore and strengthen confidence in the value of vaccines, the report includes three big ideas that alone and together can contribute to reversing the trend. The report calls for:
Progress toward increasing immunization coverage has stalled in recent years, opening the door to outbreaks of measles and other vaccine-preventable diseases. This trend is often fueled by complacency and loss of confidence in the system that develops, produces, recommends and delivers vaccines. Hesitancy toward vaccination can be exacerbated by the spread of misinformation about the safety and efficacy of vaccines across the internet.
With misleading and conspiratorial vaccine theories proliferating online, it has become critical to effectively measure and understand the impact of vaccine misinformation, and to devise a strategy to enhance public trust in all vaccines. These actions are needed to protect overall health for the next generation and to ensure successful uptake of a COVID-19 vaccine when it is available.
The new report presents an in-depth analysis into the root causes of vaccine hesitancy, an exploration of the current landscape of misinformation and actionable steps to address these trends. The report is a product of the Sabin-Aspen Vaccine Science & Policy Group, a joint initiative of the Sabin Vaccine Institute (Sabin) and the Aspen Institute, made up of 24 global innovators and thought leaders with converged expertise across public health, medicine, philanthropy, venture capital, biotechnology, biology, ecology, ethics and journalism. Misinformation on social media and skepticism and distrust in government, industry and science are detailed in the five background papers that frame the report.
In order to shift the conversation and address the dangers of misinformation, we need to learn how people make decisions about vaccines, said Shirley M. Tilghman, president emerita of the university, professor of molecular biology and public affairs at Princeton University and Sabin-Aspen Group co-chair. This requires understanding the social processes that contribute to attitudes around vaccines and conducting effective education and outreach to activate awareness and support for immunization.
Developing strategies to counter vaccine hesitancy will require significant investment, as well as broader engagement with new disciplines and collaborators, especially within the social and behavioral sciences and with social media platforms, said Harvey V. Fineberg, M.D., Ph.D., president of the Gordon and Betty Moore Foundation and a Sabin-Aspen Group co-chair. Many of the tech companies are aware of and have begun to be responsive to vaccine misinformation; now its up to us to deepen this partnership to improve vaccine acceptance and protect the health of individuals and communities around the world.
Misinformation is emerging about COVID-19 vaccines, even as they are early in development, increasing the urgency to understand vaccine hesitancy and put forth actionable solutions, said Bruce Gellin, M.D., M.P.H., Sabins president of Global Immunization. We are proud to share this report, and grateful for our partnership with the Aspen Institute and the leaders who have brought their creativity and determination to this issue.
Vaccines face another obstacle their own success. Decades of diligent vaccination campaigns have established community immunity (or herd immunity), in which the percentage of a population immune to a disease is high enough to prevent its spread. As a result, the potentially deadly consequences of not vaccinating have become less apparent to the general public, leading to a rise in complacency.
Vaccine uptake is just as critical to understand and improve as vaccine access said Ruth Katz, executive director of the Aspen Institute Health, Medicine and Society (HMS) Program. If the factors that contribute to vaccine hesitancy complacency, convenience and confidence are not properly understood or addressed, the health and wellbeing of future generations will be at risk.
The Sabin-Aspen Vaccine Science & Policy Group is a partnership that brings together senior leaders across many disciplines to examine some of the most challenging vaccine-related issues and drive impactful change. This second meeting of the Sabin-Aspen Vaccine Science & Policy Group and its research and report were funded by the Bill & Melinda Gates Foundation.
Read the full report.
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BACKGROUND
About Sabin-Aspen Vaccine Science & Policy Group
Co-chairs:
Members
About the Sabin Vaccine Institute
The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non-profit with more than two decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on Twitter, @SabinVaccine.
About the Aspen Institutes Health, Medicine and Society Program
Established in 2005, the Aspen Institutes Health, Medicine and Society Program brings together influential groups of thought leaders, decision-makers, and the informed public to consider health challenges facing the U.S. in the 21st century and to identify practical solutions for addressing them. For more information, visit www.aspeninstitute.org/programs/health-medicine-and-society-program. TheAspen Instituteis a global nonprofit organization committed to realizing a free, just, and equitable society. Founded in 1949, the Institute drives change through dialogue, leadership, and action to help solve the most important challenges facing the United States and the world. Headquartered in Washington, DC, the Institute has a campus in Aspen, Colorado, and an international network of partners.
BILTHOVEN, Netherlands andPROVIDENCE, Rhode Island, June 2, 2020 /PRNewswire/ --Intravacc, one of the world's leading translational research and development vaccine institutes, with an extensive track record in developing viral and bacterial vaccines, and EpiVax, a biotechnology company based in Providence with expertise in developing vaccines and therapeutics, announce that they have entered into a collaboration agreement to further progress an novel vaccine against COVID-19, based on Intravacc's proprietary Outer Membrane Vesicles (OMV) technology platform.
For this joint research project, Intravacc will combine its safe and immunogenic OMV delivery platform with synthetically produced COVID-19 epitopes (protein allergens), designed and optimized by EpiVax using advanced immunoinformatics tools, in order to generate a safe and highly effective T-cell response against SARS-CoV-2 and related coronaviruses. Pre-clinical studies will start immediately so as to select the best candidate peptides for the vaccine. Intravacc will utilize its in-house pilot-scale facility for the GMP production of the OMV-peptide vaccine, for clinical (phase I) studies expecting to start in Q4 2020.
Annie De Groot, MD, CEO and CSO of EpiVax, said:
"We are thrilled to enter into a partnership with Intravacc using their very novel 'click-on' OMV technology and the highly immunogenic and safe SARS-CoV-2 multi-epitope-bearing peptides designed using the iVAX toolkit at EpiVax. We believe that the combination of technologies and the strength of our longstanding collaboration with Intravacc will lead to the development of an effective and safe vaccine that could rapidly benefit hundreds of millions of people around the globe."
Dr. Jan Groen, CEO of Intravacc, stated:
"A COVID-19 vaccine based on this approach is expected to be very safe and to reduce the morbidity and mortality rates associated with COVID-19. The vaccine is expected to lower the risk that individuals infected with SARS-CoV-2 will require hospitalization and/or intensive care. It also expected to induce long-term memory responses to prevent COVID-19 disease and infection from other beta-corona viruses. We expect that leveraging Intravacc's unique vaccine development expertise, broad-based network and successful track record in global technology transfer to vaccine manufacturers will bring success".
About Intravacc's OMV platform technology
For the development of vaccines against pathogens, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) spherical particles with intrinsic adjuvating properties. Using genetic engineering, the OMVs can be decorated with immunogenic peptides that combine T- cell epitopes that will drive effective adaptive immunity. Heterologous OMV vaccines are a suitable alternative approach to protect against pathogens that require a high level of containment, that are difficult to cultivate, or that contain viral and/or parasitic proteins. The antigens of choice are attached to the 'empty' OMV carrier resulting in a more effective immune response.
Intravacc also has developed genetic tools to increase the yield of OMVs, to reduce toxicity, and to achieve the desired antigenic composition. Intravacc's OMV platform is fully scalable and allows for fast and efficient modification of antigen composition, either via genetic modification of the bacterial host or by associating antigens to stockpiled carrier OMVs.
About Intravacc
The Netherlands-based Intravacc is one of the world's leading institutes for translational vaccinology. As an established independent R&D organization with over 100 years' experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF), and biotech and pharmaceutical companies.
Intravacc also has its own proprietary vaccine platform. Intravacc has established state-of-the-art research and production (GMP) facilities. Its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.
About EpiVax
EpiVax is a 22-year old privately-held biotechnology company located in Providence, RI, with a broad portfolio of projects including vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. Scientists at EpiVax, led by co-founders Annie De Groot, MD and Bill Martin, have a strong history of developing and applying innovative approaches to improving vaccines and biologics, making the former more immunogenic and the latter less immunogenic using their advanced immunoinformatic tools. The ISPRI and iVAX toolkits for therapeutics and vaccines are used by a global roster of companies. Visit www.epivax.com for more information.
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SOURCE Intravacc
COVID-19 vaccine to be tested on 30 monkeys in NIV Pune, Forest Department gives its nod | Photo Credit: iStock Images
New Delhi: As the race towards developing and testing vaccines against the novel coronavirus infection intensifies, with India playing a major role in treatment and vaccine trials, ICMR'S National Institute of Virology, Pune, has been granted the use of 30 monkeys for vaccine trials, TOI reported.
30 monkeys of the female gender, in the age of three to four years, will be given to the institute to test the COVID-19 vaccine. The monkeys will reportedly be procured from the Vadgaon forest range in Pune.
Sources have, however, said that the institute will have to do the monkey catching itself, with the forest department only assisting them in the process.
Forest Minister Sanjay Rathod said, The vaccine will be tested on the monkeys and I have granted permission for it. He added, NIV will have to ensure their daily routine is not disrupted and the project cannot be used on a commercial basis. He also said that the permissions were granted on the condition that NIV will take good care of the animals.
The permissions were granted keeping in view that NIV was a government institution. More than 10 vaccines areunder trial in the country. Dr Harsh Vardhan last week said that around 4 vaccines are likely to enter the phase of clinical trials in the next 3 to 6 months.
A vaccine is one of the only ray of hopes against the novel coronavirus, SARS-CoV-2, the virus responsible for causing COVID-19. There is no specific cure, or vaccine available against the virus, as of now.
In recent weeks, cities and states across the country have seen a steady decline of COVID-19 cases.
But even as many doctors breathe a quiet sigh of relief, those racing to develop a COVID-19 vaccine are growing increasingly worried this good news will stymie efforts to find a vaccine quickly.
Vaccines can only be studied in places where outbreaks are ongoing. That's because the studies themselves rely on volunteers getting exposed to the virus to prove the vaccine actually works.
Snuff out an outbreak, and the pace of research slows to a crawl.
While the nation's top infectious disease doctor, Anthony Fauci, has optimistically estimated that a vaccine could be ready by January 2021, experts say this timeline could be pushed back if we see a dramatic drop off in new infections.
This will become increasingly important as we move out of the early safety studies -- which only include a small handful of healthy adults -- and into massive vaccination studies designed to determine effectiveness in large groups of people.
To have a vaccine by early 2021, "you'd have to do a trial where there were enough people in the placebo group who got sick," said Dr. Paul Offit, who co-invented the rotavirus vaccine and sits on the Food and Drug Administration's vaccine advisory committee. And, he said, "you would have to be doing it in a region or time when this virus is still causing disease."
"I've been worried for months that the standard way of doing a trial will take well into next year to get a result because of this tamping down of the virus," said Dr. Arthur Caplan, director of the Division of Medical Ethics. New York University Grossman School of Medicine.
A health worker process for COVID-19 antibodies after getting the blood from the patient at the the Diagnostic and Wellness Center, May 5, 2020, in Torrance, Calif.
"You can start to see it in Oxford and Moderna," said Caplan in reference to two vaccine developers that already have relatively advanced research studies underway. "They are getting nervous that the virus there is going to lower the natural infection rate so they won't be able to interpret if the vaccine did anything, or if it's safe."
Last month, one of the lead researchers working on the Oxford vaccine told The Telegraph newspaper that the next stage of studies only had a 50% chance of success thanks to "the virus disappearing" in the United Kingdom.
And Rinke Bos, principal scientist and immunologist for Johnson and Johnson, told ABC News it's very difficult to set a timeline for vaccine development because "the trial has to be in a country where there is still a virus going around, so those are quite complicated discussions."
An Oxford spokesperson said ongoing studies will not be interrupted by this potential issue, and a Moderna spokesperson did not respond to ABC News' request for comment.
This paradox of vaccine development -- that we tend to gain control over an outbreak just as trials get up and running -- has felled prior vaccine development efforts.
In 2015, for example, the Zika virus swept across Latin America and vaccine researchers sprang into action, quickly launching research studies. But as the epidemic was brought under control, those studies were never completed.
To date, we still have no approved Zika virus vaccine, leaving us vulnerable to the next outbreak.
In this current coronavirus pandemic, doctors and vaccine developers are now considering new ways to keep research moving at a rapid pace so that a vaccine can be ready by next year.
FILE PHOTO: A scientist conducts research on a vaccine for the novel coronavirus (COVID-19) at the laboratories of RNA medicines company Arcturus Therapeutics in San Diego, California, U.S., March 17, 2020
One option is to launch studies in places like Brazil and India, where infections are currently on the rise.
"It makes sense to go to hotspots as trial sites," said Dr. Jennifer Miller, an assistant professor at Yale School of Medicine and founder of Bioethics International and the Good Pharma Scorecard.
"It's not just the U.S.," Offit said. Vaccine developers "have the world at their disposal."
But this approach could be challenging as well, with bioethicists warning it may not be ethical to conduct studies among citizens of one country, and then -- if the vaccine proves successful -- prioritize vaccination for the citizens of another.
Another option could be a so-called "challenge trial," which is also considered ethically fraught.
Normally, to see if a vaccine works, researchers give tens of thousands of volunteers either a placebo or an active vaccine shot. Those people are told to go about their daily lives, and typically only a small fraction will get exposed to the virus. If the people who got the placebo get sick but those who got the real shot do not, it's highly likely the vaccine has worked.
In a challenge trial, there's no wait-and-see. A small group of people are given the real shot -- then they are injected with live virus. If they don't get sick, the vaccine likely worked.
"Everyone agrees we want to save the most amount of lives possible using responsible means," said Miller. "If it's going to take too long allowing patients to naturally get infected, then we could shift to a challenge [trial]."
A member of myCovidMD administers a COVID-19 antibody blood test in Los Angeles, May 20, 2020.
"I'm one of the outspoken advocates," of challenge trials, said Caplan. "I knew this would be an issue of recruitment months ago."
Caplan says that challenge trials would change the game in terms of the number of people that must volunteer -- dropping that number from more than 10,000 to less than 500, and dramatically accelerating the pace of research.
To reduce the risk that people die of COVID-19, these trials would only include healthy adults with no underlying medical conditions, Caplan said.
However, vaccine developers have not announced their intention to launch a challenge trial.
A spokesperson for Oxford said the research group would not consider doing so until more effective treatments were available for COVID-19, offering greater certainty that volunteers could be rescued should they fall ill from the virus.
"All I can say at this stage is that we are not currently looking at human challenge studies," the spokesperson said. "The current vaccine trials in the U.K. are still producing sufficient data for our work. We have been looking at expanding the trial into other regions where there are still increasing numbers of cases."
Because of the global nature of the pandemic, it's likely that other vaccine makers may also need to look beyond their borders and that future vaccine research will demand an unprecedented level of international cooperation.
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