Following last week’s news that MIT and 3M were collaborating on a paper-based coronavirus diagnostic solution and Pfizer and BioNTech were told they could fast-track two investigational vaccine candidates by the FDA, the global race to develop a vaccine really heated up this week.
Much headway has been over the past seven days by scientists from across the world of pharma, with positive results coming out of studies in the UK and China. Below we present our pick of pharma industry developments in the battle to halt the spread of Covid-19 from over the past week.
Vaccine shows robust immune responses
Interim results from the ongoing Phase I/II COV001 trial led by the University of Oxford has found that a potential vaccine, AZD1222, can be tolerated and generated robust immune responses against the SARS-CoV-2 virus.
The vaccine, which showed the result in all evaluated participants, was co-invented by the University of Oxford and its spin-out company Vaccitech. Phase I/II interim data demonstrated that AZD1222 could generate a rapid antibody and T-cell response against SARS-CoV-2.
The results, which were published in The Lancet, confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95 per cent of participants one month after injection.
Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at the University of Oxford and co-author of the trial, remarked: “The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type.
“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial program to confirm this.”
Pollard added that the team saw the strongest immune response in participants who had received two doses of the vaccine.
Late-stage Phase II/III trials are now underway in the UK, Brazil and South Africa, and are set to begin in the US.
Regulators will cooperate on Covid-19 vaccine claims WHO scientist
World Health Organization (WHO) chief scientist Soumya Swaminathan has said that country and regional regulators will cooperate and combine efforts to speed through approvals on Covid-19 vaccines when they become available.
With more than 200 Covid-19 vaccines in development, there has been concern about the speed with which the vaccines will be approved and made available to the general public.
Swaminathan warned: “While speed is important, it cannot be at the cost of compromising on the safety or the efficacy standards.”
The scientist’s comments came as animal tests of a potential Covid-19 vaccine being developed by Chinese researchers showed signs that it triggers an immune response against the novel coronavirus.
ARCoV, a messenger RNA vaccine, is the second potential Covid-19 vaccine China’s military-backed research unit has moved to clinical trials.
Prospective study focuses on personalizing treatment of severe Covid-19 patients
Researchers at Israel’s Rabin Medical Center have published prospective data, in collaboration with MeMed, on a host immune biomarker used in managing the care and treatment of patients with severe Covid-19 infection.
The study is the first of its kind to investigate how real-time measurements of IP-10, a host-immune protein biomarker, can be used to monitor and regulate inflammation in severe Covid-19 patients. The researchers used MeMed’s technology platform MeMed Key to conduct the study which revealed that the IP-10 biomarker could be a valuable resource for predicting disease severity and progression.
Dr. Boaz Tadmor, head of Rabin Medical Center’s Central Research Authority explained: “In the majority of Covid-19-positive patients, the host mounts a localized immune response sufficient to clear the virus from the upper airways and possibly the lungs, following which the immune response recedes and the patient recovers. But in some patients, less than 15 per cent, hyperinflammation or a ‘cytokine storm’ is triggered, which has been implicated in acute lung injury, multiple organ failure and mortality.
“A key challenge for clinicians in managing care for these patients is the lack of sufficient data on predictive biomarkers, as well as preventive measures and continuous ways to measure Covid-19-induced hyperinflammation,” Dr. Tadmor added.
Download 4G Clinical’s white paper to understand the challenges associated with basket and umbrella trial design within oncology studies and learn how to innovate your study design strategy to increase trial flexibility and agility during Covid-19.