(The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts.)

Brian Allan, University of Illinois at Urbana-Champaign; Chris Stone, University of Illinois at Urbana-Champaign; Holly Tuten, University of Illinois at Urbana-Champaign; Jennifer Kuzma, North Carolina State University, and Natalie Kofler, University of Illinois at Urbana-Champaign

(THE CONVERSATION) This summer, for the first time, genetically modified mosquitoes could be released in the U.S.

On May 1, 2020, the company Oxitec received an experimental use permit from the U.S. Environmental Protection Agency to release millions of GM mosquitoes (labeled by Oxitec as OX5034) every week over the next two years in Florida and Texas. Females of this mosquito species, Aedes aegypti, transmit dengue, chikungunya, yellow fever and Zika viruses. When these lab-bred GM males are released and mate with wild females, their female offspring die. Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population.

However, as vector biologists, geneticists, policy experts and bioethicists, we are concerned that current government oversight and scientific evaluation of GM mosquitoes do not ensure their responsible deployment.

Genetic engineering for disease control

Coral reefs that can withstand rising sea temperatures, American chestnut trees that can survive blight and mosquitoes that cant spread disease are examples of how genetic engineering may transform the natural world.

Genetic engineering offers an unprecedented opportunity for humans to reshape the fundamental structure of the biological world. Yet, as new advances in genetic decoding and gene editing emerge with speed and enthusiasm, the ecological systems they could alter remain enormously complex and understudied.

Recently, no group of organisms has received more attention for genetic modification than mosquitoes to yield inviable offspring or make them unsuitable for disease transmission. These strategies hold considerable potential benefits for the hundreds of millions of people impacted by mosquito-borne diseases each year.

Although the EPA approved the permit for Oxitec, state approval is still required. A previously planned release in the Florida Keys of an earlier version of Oxitecs GM mosquito (OX513) was withdrawn in 2016 after a referendum indicated significant opposition from local residents. Oxitec has field-trialed their GM mosquitoes in Brazil, the Cayman Islands, Malaysia and Panama.

The public forum on Oxitecs recent permit application garnered 31,174 comments opposing release and 56 in support. The EPA considered these during their review process.

Time to reassess risk assessment?

However, it is difficult to assess how EPA regulators weighed and considered public comments and how much of the evidence used in final risk determinations was provided solely by the technology developers.

The closed nature of this risk assessment process is concerning to us.

There is a potential bias and conflict of interest when experimental trials and assessments of ecological risk lack political accountability and are performed by, or in close collaboration with, the technology developers.

This scenario becomes more troubling with a for-profit technology company when cost- and risk-benefit analyses comparing GM mosquitoes to other approaches arent being conducted.

Another concern is that risk assessments tend to focus on only a narrow set of biological parameters such as the potential for the GM mosquito to transmit disease or the potential of the mosquitoes new proteins to trigger an allergic response in people and neglect other important biological, ethical and social considerations.

To address these shortcomings, the Institute for Sustainability, Energy and Environment at University of Illinois Urbana-Champaign convened a Critical Conversation on GM mosquitoes. The discussion involved 35 participants from academic, government and nonprofit organizations from around the world with expertise in mosquito biology, community engagement and risk assessment.

A primary takeaway from this conversation was an urgent need to make regulatory procedures more transparent, comprehensive and protected from biases and conflicts of interest. In short, we believe it is time to reassess risk assessment for GM mosquitoes. Here are some of the key elements we recommend.

Steps to make risk assessment more open and comprehensive

First, an official, government-funded registry for GM organisms specifically designed to reproduce in the wild and intended for release in the U.S. would make risk assessments more transparent and accountable. Similar to the U.S. database that lists all human clinical trials, this field trial registry would require all technology developers to disclose intentions to release, information on their GM strategy, scale and location of release and intentions for data collection.

This registry could be presented in a way that protects intellectual property rights, just as therapies entering clinical trials are patent-protected in their registry. The GM organism registry would be updated in real time and made fully available to the public.

Second, a broader set of risks needs to be assessed and an evidence base needs to be generated by third-party researchers. Because each GM mosquito is released into a unique environment, risk assessments and experiments prior to and during trial releases should address local effects on the ecosystem and food webs. They should also probe the disease transmission potential of the mosquitos wild counterparts and ecological competitors, examine evolutionary pressures on disease agents in the mosquito community and track the gene flow between GM and wild mosquitoes.

To identify and assess risks, a commitment of funding is necessary. The U.S. EPAs recent announcement that it would improve general risk assessment analysis for biotechnology products is a good start. But regulatory and funding support for an external advisory committee to review assessments for GM organisms released in the wild is also needed; diverse expertise and local community representation would secure a more fair and comprehensive assessment.

Furthermore, independent researchers and advisers could help guide what data are collected during trials to reduce uncertainty and inform future large-scale releases and risk assessments.

The objective to reduce or even eliminate mosquito-borne disease is laudable. GM mosquitoes could prove to be an important tool in alleviating global health burdens. However, to ensure their success, we believe that regulatory frameworks for open, comprehensive and participatory decision-making are urgently needed.

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This article is republished from The Conversation under a Creative Commons license. Read the original article here: https://theconversation.com/genetically-modified-mosquitoes-could-be-released-in-florida-and-texas-beginning-this-summer-silver-bullet-or-jumping-the-gun-139710.

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Genetically modified mosquitoes could be released in Florida and Texas beginning this summer silver bullet or jumping the gun? - Thehour.com

By Melissa Healy

Los Angeles Times

To capture the speed and audacity of its plan to field a coronavirus vaccine, the Trump administration reached into science fictions vault for an inspiring moniker: Operation Warp Speed.

The vaccine initiatives name challenges a mantra penned by an actual science fiction writer, Arthur C. Clarke: Science demands patience.

Patience is essential for those who ply the science of vaccines. But in that field, challenging economic conditions and a forbidding regulatory system converge with the immune systems complexity and the resilience of microscopic pathogens. Add in drug companies preference for big profits and the result is a trash heap of failed and abandoned efforts.

In the last 25 years, the U.S. Food and Drug Administration has approved new vaccines for only seven diseases. A vaccine to protect against the Ebola virus won approval just last year, three years after the epidemic in West Africa ended.

But in the midst of a COVID-19 pandemic that has killed more than 100,000 Americans and cratered the U.S. economy, Trump has shown little tolerance for sciences deliberate pace. And scientists, with fingers crossed, are falling in line.

The president declared that he wants 300 million doses enough to protect as many as 90% of Americans developed, manufactured and delivered by January 2021. He has ordered academics, government officials, private companies and the U.S. military to work together to make it so.

That means big and it means fast, Trump said. A massive scientific, industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project.

The new effort will demand the support, development, testing and assessment of several promising vaccine candidates by scientists at the National Institutes of Health, the FDA and companies and academic institutions across the world.

It will require the manufacture, procurement and storage of complex biologic medicines, as well as the vials, needles, syringes and storage equipment needed to deliver them. All will be needed on a massive scale.

And all that materiel will need to be transported, distributed and possibly administered by an army of logistics specialists.

Wherever possible, Operation Warp Speed envisions that many steps that have always followed each other in strict sequence clinical trials and production, for instance, or government approval and supply-chain development be done in parallel.

The program has awarded a total of $2.16 billion so far to five companies with vaccine candidates at different stages of development.

To lead the effort, Trump tapped immunologist Moncef Slaoui, a pharmaceutical venture capitalist and former chairman of vaccines at the drug giant GlaxoSmithKline. The U.S. Armys most senior logistics and procurement specialist, Gen. Gustave Perna, will be the operations chief operating officer. Both expressed confidence in the operations success.

Pena called the project herculean. Slaoui, who has been criticized for holding a major stake in at least one of the vaccine makers that stands to benefit from Operation Warp Speed, told Trump we will do the best we can.

The time is short and the stakes are high. Just over four months after the coronavirus announced its presence inside the United States, President Trump is determined to send the country back to work.

With no effective treatment in sight, and no indication that the coronavirus would magically disappear, as Trump has frequently predicted, a vaccine will be the ultimate game changer in the pandemic, according Dr. Anthony Fauci, the nations leading expert on the outbreak.

Theres never a guarantee of success, Fauci said. But he added that he was cautiously optimistic that by winter, at least one of nearly a dozen promising vaccine candidates would have shown itself to be safe and effective in inducing immunity in humans.

Vaccine scientists are similarly cautious, especially of a testing schedule that will compress both the size and duration of safety and effectiveness trials and even overlap them in a bid to save time.

Its fine for politicians to say were going to have a vaccine next month, said Mayo Clinic immunologist Dr. Gregory Poland. But the literature is littered with false starts and unanticipated safety effects in vaccines.

Poland noted that a vaccines rarer side effects are often not recognized until its put into broad use. To ferret out an adverse outcome that only occurs in one person in 100,000, for instance, a company would need to test it in 384,250 people from broad backgrounds and with a variety of medical conditions, he said.

Such large trials are unlikely in the rush to field a vaccine, Poland said, and he fears the result could be a dangerous erosion of public trust. The yearly flu shot carries a risk of less than 1 in 1 million cases of the neurological complication Guillain-Barre syndrome, he said. And even with that low a risk, close to half of Americans refuse to get it.

You have a whole spectrum of people out there who wont be reassured by any amount of information, Poland said. If we dont pay strict attention to safety, this is going to backfire.

Money may help. Congress approved $8.3 billion in early March to fund federal agencies pandemic response. And scientists across the world have been scrambling to design vaccines to protect a population with no immunity to the deadly new pathogen.

Scientists in China, Kazakhstan, India, Russia, Germany, Sweden and the United States have brought 10 potential COVID-19 vaccines to the point where they are being evaluated in humans in some form. Another 115 are considered by the World Health Organization to be in the preclinical stage of development.

In some cases, these preclinical vaccine candidates are scarcely off the drawing board. In others, they are still being tweaked or tested in cells. Some are being tried in lab animals.

The prospective vaccines range widely in their design and novelty. There are those that challenge a persons immune system with a killed or attenuated virus, the traditional approach used by the polio vaccine and other immunizations. Others are products of genetic engineering and have never been tried in a vaccine before.

The vaccine candidates also vary in their ease of manufacture, the number of doses a patient needs to gain lasting immunity, and the way they are administered.

FDA Commissioner Dr. Stephen Hahn has said his agency evaluated about 10 vaccine candidates in early studies. By late May, it had narrowed its focus to five candidates that will begin a rapid and sometimes overlapping progression through human studies of safety and effectiveness.

Meanwhile, the groundwork for large-scale production is already being laid. Trump has said that the U.S. military may aid in the manufacture, and companies with the capability to produce vaccines will be recruited to do so.

Given the pressing urgency of the administrations deadline, vaccine candidates that can be produced fastest, transported most easily and administered to patients most efficiently will likely win the most and earliest support, experts said.

The redundancy built into Operation Warp Speed may also prove a vital safeguard against failure.

If the coronavirus shows signs that it is mutating in ways that could make one vaccine candidate ineffective, the scientific judges could swiftly shift their preferences toward a competitor that can be adapted more readily to changes in the virus. If rare but untoward effects show up with broader use, back-up vaccines could be brought on line. Some vaccines will be found to work better or worse in specific populations, and can be used accordingly.

The result will be an evolving panoply of vaccine choices, not only because some will be ready earlier than others, but because some will be more effective than others in certain populations.

There will be of necessity multiple types of vaccines, Poland said.

Link:
Can Operation Warp Speed deliver a COVID-19 vaccine by the end of the year? - The Daily World

Samir Kumar Saha and his daughter Senjuti Saha.Facebook photo

The first-ever sequencing of the new coronavirus genome in Bangladesh indicates that the strain sequenced entered the country from the United Kingdom, according to the team that accomplished the sequencing.

We believe that the strain we sequenced was carried to Bangladesh by someone travelling from the UK, said Samir Kumar Saha, the leader of the team of scientists from Child Health Research Foundation, a non-governmental organisation that successfully ran the sequencing.

He said that the time was yet to come to say with one hundred per cent certainty where the virus strain they sequenced came from for a similar strain could also be found infecting people in Saudi Arabia, Russia and Taiwan.

But it is most likely that it came from the UK, said Samir, an eminent microbiologist and the executive director of CHRF.

He said that they were working with genetic engineers and biotechnologists to determine whether the virus strain underwent any unique mutation after entering Bangladesh.

He said that the virus strain supposedly underwent nine mutations by the time it entered Bangladesh and there were signs that it mutated after it entered the country.

A transmission map available on the website of GISAID, a database of thousands of genetic sequencing done across the world on the new coronavirus, showed that the strain sequenced from the UK travelled a long way.

The strain travelled out of the UK early February towards other European countries such as the Netherlands, Germany, Austria, Hungary and then moved on to infect people in Turkey, Iran, Afghanistan, Pakistan and India.

The map was produced by analysing data provided by 5,234 genome sequencings that also showed that the strain first went out of China late December toward Africa via Asia and the Middle East and reached Latin America by early January.

It entered the USA within a few days and then travelled towards the UK, where it reached early February, showed the GISAID transmission map.

The strain that was sequenced in Bangladesh entered the country in April and the person from whom the virus was isolated for sequencing got infected on April 18, said Samir.

Bangladesh announced its firs coronavirus infection on March 8 and the first death from the infection 10 days later.

So far the virus killed 298 people in Bangladesh and more than 300,000 around the world while infecting over four million people globally. More than 20,000 people got infected in Bangladesh.

Bangabandhu Sheikh Mujibur Rahman Agricultural University biotechnology and genetic engineering professor Tofazzal Islam said that genome sequencing was all about finding out the basic structure of an organism.

The coronavirus is made of four nucleotides arranged in about 30,000 permutations and combinations as revealed in genome sequencings across the globe, Tofazzal added.

A virus starts duplicating itself once inside a host and the duplication often comes with error in RNA virus, resulting in changes in the order of the constituting nucleotides, which is called mutation, he explained.

Different strains may appear as the mutation continues as the virus is always trying to adapt to new conditions as the pandemic caused by it progresses across geographical and environmental conditions, he said.

Scientists around the world still debate the number of strains the new coronavirus has developed and they are far from specifying the order of nucleotides responsible for a certain quality in the virus such as its virulence or transmissibility or resistance against medication.

Scientists at the Los Alamos National Laboratory in the US revealed in April that a mutation strengthens the protein spike through which the coronavirus attaches to host cell.

The scientists said that the mutated strain was primarily very uncommon but later became dominant in Europe, North America and Australia.

We are dealing with one of the smartest viruses in history, said Samir.

He said that changing symptoms in infected people bears testimony to the coronavirus mutating fast in various environments.

Soon after the emergence the virus caused loose motion among patients in China but the people it infected in countries such as the UK complained about losing sense of taste and smell, he said.

The virus causes hypoxia that can remain hidden until it pushes the patient to the verge of dying, he said.

Until a stage the established notion was that the virus could only be found in the respiratory system but lately it was detected in semen samples in Europe, he said.

It is likely that it gets to brain as well, said Samir.

Samir plans to sequence 80 to 100 samples in the next two months from different localities and times to find out if different strains were prevalent in Bangladesh and the way they were mutating.

We need to block mutations where it can get even more deadly. Genome sequencing helps us to go there, said Samir.

Continued here:
Coronavirus may have come to Bangladesh from UK: Samir Saha - newagebd.net

BILTHOVEN, Netherlands and PROVIDENCE, 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 http://www.epivax.com for more information.

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SOURCE Intravacc

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Intravacc and EpiVax Team up in Development of COVID-19 Emerging Vaccine - Stockhouse