Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Pandemic Preparedness and Learning from the Past
A roundtable discussion about COVID-19 featuring distinguished vaccine experts. Topics include progress so far, challenges that still lie ahead, and how we prepare for the next pandemic.
https://www.youtube.com/watch?v=jqNY3XXCckk&feature=emb_logo&ab_channel=TheMedicineMaker
Chair Professor Sir Terence Stephenson reflects on the role of the HRA in the race from lab to jab.
“The government has been clear that a portfolio of vaccines will be needed to ensure as many people as possible can be protected from the virus, and whilst this week’s result should be celebrated, more research is needed to generate evidence to inform a long-term vaccination strategy.
This may include new candidates, or new types of study, for example a human vaccine challenge approach where healthy volunteers are deliberately infected with coronavirus to test the efficacy of a particular vaccine.”
https://www.hra.nhs.uk/about-us/news-updates/vaccine-review-and-reassurance/
Thought I’d wait until after the close to share this one and hopefully allow a few more weak share holders to exit.
Great comments by the Chair of the HRA ref Covid CHIM’s.
Based on some of the recent news flow and tweets – I think we may be hearing some official news fairly soon!
GL to all LTH's
‘Scientists have run past human challenge studies for influenza, malaria, typhoid, dengue, and cholera, but this will be the first for #COVID19’
https://twitter.com/hVIVO_UK/status/1334439737298464769
https://www.vox.com/future-perfect/2020/11/17/21540773/covid-19-vaccine-human-challenge-trial-ethics
Interesting tweet & timing by hVIVO in the last hour, quoting the above statement and referencing an article discussing ethical approval.
I wonder if some news is imminent?
When recently questioned about the share price and shareholders, Cathal stated:
“I’ll probably wind down. I’ll do one or more presentations before Christmas and let them (weak shareholders) go. We think going into next year, we’ve really exiting….the opportunity is so huge with hVIVO”.
Forward ~ 27 min 50 sec
https://www.youtube.com/watch?v=RL4si_KAuDI&ab_channel=Proactive
Seem’s like Cathal’s plan to let weak shareholders go is working. Personally, I think it’s not a bad strategy and allows LTH’s to reap the rewards after they’ve left.
The National Institute for Health Research (NIHR) Great Ormond Street Hospital Biomedical Research Centre (BRC) Overview and Future Strategy
Professor Thomas Voit Thursday 26th November 2020
Developing the Zayed Centre
- Develop a sustainable business plan
- Integrate (as for now) COVID research/hVIVO
- SARS2 synthesis project in ZAYED (hVIVO industry project)
Click on:
Thursday 26 November at 1:30pm
Download meeting papers - section a
https://www.gosh.nhs.uk/about-us/who-we-are/our-organisational-structure/trust-board/trust-board-meetings
Codagenix Inc. Completes Dosing for Phase 1 Trial of Live-Attenuated, Intranasal Vaccine for Respiratory Syncytial Virus
https://www.prnewswire.com/news-releases/codagenix-inc-completes-dosing-for-phase-1-trial-of-live-attenuated-intranasal-vaccine-for-respiratory-syncytial-virus-rsv-301182228.html?tc=eml_cleartime
https://twitter.com/DDS_DocHoliday/status/1333761250564694017
Sum's it all up, in my opinion!
‘Ethical approval is a multi-stage process, and we are just about to get approval to start the screening,” said Dr Chiu. ‘I hope that we will be able to start recruiting (volunteers) around late November.’….
… Dr Chiu. ‘We hope to present our findings to the ethics committee around the time we start screening, and we will be publishing the protocol and the public engagement findings as well.”
https://www.sciencemuseumgroup.org.uk/blog/coronavirus-should-we-infect-young-people-with-covid-19/?utm_source=Twitter&utm_medium=Organic%20Link&utm_campaign=L%20AP:%20Science%20Museum%20Group%20Blog%2018/11/20
Based on the above, Dr Chiu should have presented his evidence to the Ethics Committee by now, so presumably we are due a regulatory decision from this week onwards?
‘In this paper, the researchers present an interactive model for exploring some of the risks of a SARS-COV-2 dosing study, which is a prerequisite for COVID-19 human challenge trials….
….since this infection fatality rate will be further reduced in an actual HCT through screening for comorbidities and providing aggressive treatment for any cases that do occur, the team projects the actual risk to be only around 3.1 per 100,000, with a 99.85% probability of no fatalities and a 98.7% chance of no one getting hospitalized….
…According to the authors, it is likely that HCTs are a viable method of rapidly testing vaccine efficacy, which is even more critical during a raging pandemic.’
“It seems likely that Challenge trials are a viable way to rapidly test vaccine efficacy, which is particularly critical now for testing second-generation vaccines, which may prove superior to first generation vaccines, or at least help fill the demand unmet by first-generation candidates.”
https://www.news-medical.net/news/20201130/What-are-the-risks-associated-with-human-challenge-trials-for-SARS-CoV-2-vaccine-candidates.aspx
https://www.medrxiv.org/content/10.1101/2020.11.19.20234658v1.full.pdf
Similar to the recent liability insurance cover (announced by the UK Gov business secretary)last week, this is another important prerequisite and positive ‘tick in the box’, for the Covid CHIM implementation.
Prime Minister Boris Johnson said:
“This new £20m fund will significantly increase the capacity and resilience of our medicines and diagnostics manufacturing supply chains and equip us to fight future health crises.
Throughout the pandemic we have seen a coming together of British scientific industry and innovation and this new fund will enhance the UK’s manufacturing capabilities even further.”
Business Secretary Alok Sharma said:
“The positive and timely response of our medicines manufacturers to the pandemic has been remarkable, but we want to ensure that the UK’s supply chains are even more resilient in the future.
“There are huge opportunities for innovation in medicines and diagnostics, and this new fund will put the UK head and shoulders above others, boosting the UK’s capabilities and generating significant economic opportunities across the country.”
The pandemic has shown the importance of having a strong domestic medicines and diagnostics manufacturing industry. This new fund has been established to grow and strengthen the UK’s capabilities, by encouraging companies to develop new technologies, build new factories and harness new advances, including bioprocessing, data and using greener manufacturing processes.”
https://www.gov.uk/government/news/prime-minister-announces-20m-to-grow-medicines-manufacturing-in-the-uk
Not specifically related to vaccine testing but signals a great future for UK companies like ORPH.
Cathal has previously described the future of ORPH linked to “entering a decade of exponential vaccine development".
If any further proof was needed, below is a European Union tender for Future Infectious Disease Threats to Europe, stating:
‘The goal of this tender is to: ‘Identify the threat spectrum from emerging infectious diseases (EID) in Europe over the next 3 to 8 years’…..
….and drive vaccine development that can be used for infectious disease control and countermeasures.’
https://etendering.ted.europa.eu/document/document-old-versions.html?docId=80972
As ORPH is the world’s leading company in vaccine and anti viral testing, the short to long term future, looks extremely secure.
IMHO
https://www.cbc.ca/player/play/1825106499716
Dr Catchpole adding to the ongoing debate in Canada over Covid CHIM’s – always comes across very well when interviewed.
Conclusion
In this report, we show that risks associated with the experimental infection of human volunteers with SARS-CoV-2 can be minimized if proper mitigation strategies are put in place, leaving a residual risk that should be weighed carefully against the scientific and social values of such a human SARSCoV-2 model.
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1784/6009505?searchresult=1
https://hvivo.com/aboutus/clinical-trial-consortium/
Good to see our partners at Leiden Universtity, progressing the Covid CHIM discussion in the Netherlands.
I would anticipate an ORPH RNS at some point, once the discussions have been completed and they are nearer to implementation.
IMHO
EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities (ICMRA) that urges all stakeholders, including vaccines researchers and investigators, academia, regulators and the pharmaceutical industry, to continue COVID-19 vaccine trials beyond the time when the pre-defined cases of COVID-19 disease for final analysis in a trial have been reached. This can provide important additional and more precise information on longer-term safety and efficacy of a vaccine against COVID-19.
‘The work of ICMRA in streamlining regulatory requirements for vaccines through global cooperation has supported the rapid development of COVID-19 vaccines,’ said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. ‘Vaccines will be a key component in overcoming COVID-19, and we must ensure that robust and convincing evidence is being generated to enable the continuous assessment of their benefits and risks.’
https://www.ema.europa.eu/en/news/global-regulators-urge-continuation-covid-19-vaccine-trials-longer-term-safety-efficacy-follow
'hVIVO is leading a consortium, on behalf of HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines against pathogens, and the Wellcome Trust, to generate regulatory style guidelines on the manufacture of human challenge agents for subsequent use in controlled human infection studies (CHIM).'
Meta Roestenberg
Organisation Lead
Leiden University Medical Center, Department of Parasitology
Angela Van Diepen
Scientific Adviser Role
Leiden University Medical Center, Department of Parasitology
https://hvivo.com/aboutus/clinical-trial-consortium/
“The latest group of intrepid scientists to test the boundaries of virology and medical ethics belongs to the Leiden University Medical Center in the Netherlands. A team of Dutch researchers has already recruited a team of more than 240 volunteers for what's called a "human challenge" study…
….Though Reuters didn't name it in the version of its report published online, the biotech firm referenced above appears to be Open Orphan, a British firm that one Twitter user said "is the only company in the world with a commercial human challenge study model for Covid 19."
https://www.zerohedge.com/geopolitical/dutch-study-involves-exposing-hundreds-people-covid-19-test-effectiveness-vaccines
https://wellcome.org/news/four-reasons-why-we-need-multiple-vaccines-covid-19?utm_source=twitter&utm_medium=o-wellcome
Apologies if previously posted.
Contingent liabilities relating to the contract signed between the Government and Imperial College London for the human challenge project.
“The first step of the project is the virus characterisation study. This will begin in January 2021”
https://hansard.parliament.uk/commons/2020-11-26/debates/20112638000005/DepartmentalContingentLiabilityNotificationHumanChallengeProject
Another important step and confirmatory statement from UK Gov ref Covid CHIM’s in the New Year.
Everything seems to be slotting into place nicely.
IMHO
https://issuu.com/shares-magazine/docs/spotlight_shares_2611120
Good to see there is interest and demand else where for Covid CHIM’s.
Note that the article relates to ‘experimental research’ at present (along with the usual ethical and regulatory considerations), so they appear way behind ORPH at present.
It does show that there is demand for ORPH’s services and CHIMs in general though.
GLA