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New COVID Vaccine Ready By Autumn Maybe - Cambridge Researchers
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In Lancet today: "The best-case scenario is that by the autumn of 2020, see full text below.
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Professor Sarah Gilbert, a vaccinologist at Oxford, has said she is "80 per cent" confident it will be a success.
There is now hope that the jab, developed by the clinical teams at the Jenner Institute and Oxford Vaccine Group, could be ready from as early as September....https://www.independent.co.uk/news/science/coronavirus-covid-19-vaccine-oxford-university-human-trials-a9467061.html
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Coronavirus vaccine could be ready by September, says Oxford professor working on trials
https://www.independent.co.uk/news/uk/home-news/coronavirus-vaccine-september-oxford-professor-sarah-gilbert-trials-a9460481.html
An Oxford professor has claimed that a vaccine for Covid-19 could be ready by autumn.
Sarah Gilbert is a professor of vaccinology at the University of Oxford and leads a team of researchers in developing a vaccine for the coronavirus, which has so far infected more than 1.7 million worldwide.
The global Covid-19 death toll passed 100,000 on Friday, according to data from John Hopkins University.
Professor Gilbert told The Times she was "80 per cent confident" the vaccine being developed by her team would be successful in protecting people against the disease.
She was quoted as saying: "I think there's a high chance that it will work based on other things that we have done with this type of vaccine. It's not just a hunch and as every week goes by we have more data to look at."
Developing a working vaccine by September was "just about possible if everything goes perfectly", added Professor Gilbert, but she warned that nobody could promise it would work.
The government is poised to spend millions of pounds for a viable vaccine to have it ready for use and the team is in talks with the government about starting production of the vaccine before the final results become available.
Professor Gilbert said: "We don't want to get to later this year and discover we have a highly effective vaccine and we haven't got any vaccine to use."
Other experts have expressed confidence in Professor Gilbert's claim, and said the Oxford team is highly advanced.
Professor of microbial pathogenesis at the London School of Hygiene and Tropical Medicine, Brendan Wren, said: "The Oxford vaccine group are among the most advanced groups in the world and have been working on vaccine biopreparedness for several years.
"This means that they can test and evaluate Covid-19 vaccine candidates rapidly (even in human volunteers). A strong vaccine candidate available by September would not be surprising."
However, Professor Brendan warned that because the UK lacks manufacture capabilities, it might be "at the back of the queue" if it depends on other countries with manufacturing capacity, such as Germany, Belgium and France.
"Desperate times require desperate measures, so upscaling and manufacture would be justified before data is fully known," he said.
"Even if the vaccine didn't prove effective this would be a useful trial run for the manufacture of alternative Covid-19 vaccines and vaccines against other viral and bacterial diseases."
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Gilbert is understandably cautious when asked to map out a timetable for the trial, but hopes to have vaccinated 500 volunteers by mid-May; this will be followed by an extension of the maximum age of trial volunteers from 55 to 70 years, later moving on to the over-70 age group. Phase 3 expansion is expected to involve 5000 volunteers; results from the earlier trials will be included in the efficacy follow-up. "The best-case scenario is that by the autumn of 2020, we have an efficacy result from phase 3 and the ability to manufacture large amounts of the vaccine, but these best-case timeframes are highly ambitious and subject to change", Gilbert says. "Our ability to determine vaccine efficacy will be affected by the amount of virus transmission in the local population over the summer, and we are also beginning to think about initiating trials with partners in other countries to increase our ability to determine vaccine efficacy", she says.
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Sarah Gilbert: carving a path towards a COVID-19 vaccine
Lancet Published:April 18, 2020
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30796-0/fulltext
It was the news from Wuhan, China, in the first days of 2020 that made Sarah Gilbert sit up and think. As Professor of Vaccinology at the University of Oxford in the UK, and a leading scientist at the university's Jenner Institute, her research team wasted no time in getting involved. "We had recently started thinking about an appropriate response to Disease X; how could we mobilise and focus our resources to go more quickly than we had ever gone before. And then Disease X arrived", she says. Once the genome sequence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became available in mid-January, Gilbert's team set to work to design a vaccine, using recombinant DNA techniques to create a SARS-CoV-2 antigen and embedding it within a primate adenovirus vector. "At this point it all felt quite theoretical, our goal then being to design a vaccine and to have a paper published showing what was possible in terms of a rapid response to an unknown outbreak, using our adenoviral vectored vaccine technology", she says.
Gilbert's team was awarded a £2·2 million grant from the UK's National Institute for Health Research and the UK Research and Innovation in March, 2020, to scale up her team's efforts to move into coronavirus disease 2019 (COVID-19) vaccine preclinical and clinical trials. "The way various grants have been awarded to different strategic aspects of the project is important, as much of the work can go on in parallel—for example, my colleague Sandy Douglas has received funding for work on scaling up vaccine manufacturing processes at the same time as we are progressing work in developing trials", she says. Preclinical work at Public Health England's Porton Down facility is the immediate priority, complementing parallel initiatives taking place at the US National Institutes of Health and at the Commonwealth Scientific and Industrial Research Organisation in Australia, among others. Gilbert's team has received ethical approval for a clinical trial, and conditional approval from the UK Medicines and Healthcare products Regulatory Agency to screen volunteers for trial enrolment. Another reason for speed is for her team to assess the efficacy of a vaccine in volunteers who have not yet been infected. "Ideally, we need the clinical trial to be taking place when the majority of volunteers have not been exposed to the virus. We will exclude volunteers who have a positive PCR test for SARS-CoV-2, or who have had fever or cough in the past month. Some will inevitably have been exposed, and that is useful too, as we want to know what the vaccine means for people who have been exposed to the coronavirus", she says.
Gilbert's early vaccine work at the University of Oxford started in 1994 with Adrian Hill, who today is Director of the Jenner Institute, with a focus on malaria vaccine research, and, given her particular interest in cellular immunology, the importance of T-cell responses to parasite infection. "From what we were seeing in malaria endemic regions, individuals with a specific HLA type did much better after becoming infected with malaria than others with different HLA profiles. This led us to look at creating vaccine candidates that could trigger favourable T-cell responses, rather than relying solely on antibody responses, the prevailing vaccine model at that time", she explains. This approach coincided with advancements in recombinant DNA techniques, with vaccinologists being able to generate specific antigens that could be safely incorporated in a host virus, as an alternative to the risks associated with using live attenuated vaccines. The ability to create recombinant viral vector vaccines is a core function of Gilbert's research group at the Jenner Institute, which over the past few years has progressed work on many vaccines, including those for influenza and Zika virus and early stage trials for Middle East respiratory syndrome coronavirus vaccine, a helpful template for the work on a COVID-19 vaccine. As Chair of the management committee that oversees initial vaccine production within the University of Oxford, Gilbert and colleagues have suspended all other concurrent vaccine research to prioritise efforts on COVID-19.
Gilbert is understandably cautious when asked to map out a timetable for the trial, but hopes to have vaccinated 500 volunteers by mid-May; this will be followed by an extension of the maximum age of trial volunteers from 55 to 70 years, later moving on to the over-70 age group. Phase 3 expansion is expected to involve 5000 volunteers; results from the earlier trials will be included in the efficacy follow-up. "The best-case scenario is that by the autumn of 2020, we have an efficacy result from phase 3 and the ability to manufacture large amounts of the vaccine, but these best-case timeframes are highly ambitious and subject to change", Gilbert says. "Our ability to determine vaccine efficacy will be affected by the amount of virus transmission in the local population over the summer, and we are also beginning to think about initiating trials with partners in other countries to increase our ability to determine vaccine efficacy", she says.
Sharing knowledge with parallel COVID-19 vaccine efforts worldwide is crucial. "WHO is in the process of creating a forum for everyone who is developing COVID-19 vaccines to come together and present their plans and initial findings. It is essential that we all measure immunological responses to the various vaccines in the same way, to ensure comparability and generalisability of our collective findings. Work is continuing at a very fast pace, and I am in no doubt that we will see an unprecedented spirit of collaboration and cooperation, convened by WHO, as we move towards a shared global goal of COVID-19 prevention through vaccination", Gilbert says.
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