Source : 'Scrip Intelligence'
The UK government is to provide funding of up to £10m ($12.95m) to what could be the world’s first human challenge study of COVID-19 vaccines, in which volunteers will be deliberately infected with the virus after immunization.
Human challenge studies are controversial, and have divided experts in the field of vaccines development. That is because of the ethical questions and medical dangers of deliberating infecting healthy volunteers before a vaccine has been developed, including concerns that there are limited treatment options if volunteers develop severe symptoms.
But the UK government has been reassured by the precautions taken by the London-based Open Orphan, a specialist contract research organisation, which claims to be the world leader in the testing of vaccines and antivirals using human challenge studies.
Its subsidiary hVIVO has now signed a contract with the UK government to develop a COVID-19 (SARS-CoV-2) human challenge study model, which is expected to start in 2021.
The UK government has secured the first three slots to test vaccines using hVIVO's COVID-19 challenge study, which we expect start in 2021, each slot reservation has been secured at a cost of £2.5m each. bringing the total value to £7.5m.
The research will begin with a characterization study in January, which aims to identify the most appropriate dose of the challenge virus. This will require regulatory and ethical approval, and could be completed by May 2021.
The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital's specialist research unit in London, with monitoring carried out by experienced scientists and medics.
hVIVO has a long history of successfully delivering human challenge studies. The Company, formerly called Retroscreen Virology, was originally established in 1989 as a spin out from Queen Mary University, London.
The company is already working on challenge study in other viral diseases, and said its study of respiratory syncytial virus (RSV) is booked to maximum capacity until Summer 2021.
Alok Sharma, the UK government’s business secretary said: "We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine.
"The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life."
The Indian Council of Medical Research (ICMR), the country’s research body whose priorities include control and management of communicable diseases, is set to consider a revision in COVID-19 treatment protocols.
The move follows publication of findings by the World Health Organization’s large-scale open-label trial of re-purposed drug treatments for COVID-19, named SOLIDARITY, on a pre-print server MedRxiv.
India is part of the trials which concluded that antiviral remdesivir, immune-modulator interferon β1a, anti-HIV combination of lopinavir/ritonavir and antimalarial hydroxychloroquine had “little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay."
ICMR, which coordinated the trials in the country, through 26 actively randomizing sites and 937 participants, said the study showed no benefits in any group of COVID-19 (asymptomatic/mild/moderate/severe/critical) patients and it reliably answers to critical public health questions concerning therapeutics.
While hydroxychloroquine has been approved for off-label use in moderately ill COVID-19 patients by the Drugs Controller General of India, remdesivir has been approved under the emergency use authorization and the HIV drug combination has been approved for use in severely ill patients.
Gilead Sciences, Inc. , on its part, has questioned the robustness of its design and findings saying the SOLIDARITY trial has not yet been peer-reviewed. ()
It has partnered several Indian companies, including Cipla Limited, Zydus Cadila, Jubilant Life Sciences Ltd., Dr. Reddy's Laboratories Ltd. and Hetero Drugs Ltd. for the production and distribution of remdesivir, making the product available free of royalties, with individual licensees free to decide the pricing of the drug. ()
Earlier, another trial by ICMR to test convalescent plasma as a therapeutic had also indicated no benefit in COVID-19 treatment.
While a revision in treatment protocols will impact pharma sales, the extent of the impact can’t be accurately predicted as physicians don’t necessarily stick to protocols, being guided by patient symptoms and other factors like cost and availability of medicines as well to treat the disease which has been spreading like wildfire across the country though mortalities have reduced significantly.
As of 19 October, India had 772,055 reported active cases of COVID-19 with 114,610 deaths being reported and over 6.7 million patients having either been discharged/migrated from hospitals or cured.
A number of cyberattacks have been launched over the past six months on research institutions in Japan conducting development work on coronavirus vaccines, according to information just released by the US computer security company CrowdStrike.
Reports in Japan say the origin of the attacks appeared to be China, given the specific methodology used (an mail with virus attachment), but that there had been no compromises of proprietary or confidential data from the institutions. The names of the targeted institutions were not released.
Japan's Agency for Medical Research and Development is coordinating and supporting around 20 vaccine development projects at a mix of pharma companies, national institutes and universities.
There have been various other reports since the pandemic began of hacking and cyberattack attempts, including by researchers in North America and Europe who suspected groups linked to Russia (which that country denied). ()
US authorities have also said that a number of Chinese nationals in the country had attempted to hack into multiple computer systems related to vaccine research, an allegation denied by China.
By Scrip Team