As this annus horribilis draws to a close, the prospect of not just one but several effective vaccines against Covid-19 is a shining beacon of hope. Despite the ravages of the pandemic, scientific innovation coupled with human endeavour will ultimately save the day and hopefully help to deliver an end to the coronavirus crisis.
In sharp contrast to the typically glacial pace of drug development, the speed and scale at which the life-sciences industry has worked to produce a range of vaccine options is unprecedented. To date, the record-breaker was the mumps vaccine, developed and produced in just four years.
But a staggeringly short 12 months after the first cases of a mysterious viral pneumonia were reported in Wuhan, China, healthcare workers and vulnerable groups will begin lining up to receive a jab against the virus. A number of vaccine candidates have completed late-stage clinical trials and are already seeking emergency authorisation, while hundreds more remain in various stages of development.
This expediency can at least partly be attributed to the absence of competition in this time of crisis; indeed, collaboration on technologies between life-sciences companies, as well as commercial, academic and regulatory partners, has accelerated in line with the pandemic.
Recent weeks saw a flurry of press releases as companies began to release interim results from their human clinical trials. Pfizer and BioNTech's BNT162b2 was the first, reporting 95 per cent effectiveness 28 days after the first dose. Moderna's mRNA-1273 vaccine appears to have similar efficacy, at 94.5 per cent. The vaccine ChAdOx1 nCoV-19, developed by researchers at the University of Oxford and AstraZeneca is reportedly 70 per cent effective in preventing Covid-19 and may even be 90 per cent effective when given in the right dose. At least three more vaccine developers will reveal the findings of their clinical trials in the coming weeks.
Concerns
Yet concerns remain, such as manufacturing capacity, long-term safety issues and, of course, vaccine hesitancy. Irish life-sciences companies will be grappling with all of this as the biggest immunisation programme the country has ever seen is rolled out over the weeks and months ahead.
Joanelle O’Cleirigh, partner at Arthur Cox, says the firm has recently advised clients on market access for Covid drug therapies and vaccines. She points out that one of Ireland’s key strings in its life sciences bow is the presence of a “strong and well-regarded regulator”.
“The Health Products Regulatory Authority will have a challenge ahead of it in ensuring it is effectively resourced and that it has the necessary expertise to quickly and effectively assess and authorise a vaccine for roll-out in Ireland and to continue to monitor the vaccine once it has been rolled out,” she adds.
Colin Kavanagh, partner and head of life sciences at Arthur Cox, says Ireland’s life-sciences sector will have a key role to play in the vaccine story.
“Ireland has a lot of expertise in the research and development but also the production of vaccines and testing services,” he says.
“We also have world-leading expertise in the technology sector. Smart collaborations across these industries are creating opportunities and helping the world get back to normal. It is great to see the industry playing such an important role in the situation we all find ourselves in.”
One of those world-leading companies is Icon, which is one of the most experienced clinical research organisations (CRO) for vaccine development. A global provider of outsourced drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public-health organisations, Icon is supporting more than 100 Covid-19 related trials which include both vaccines and therapies. In September this year, Icon was awarded best CRO at the Vaccine Industry Excellence Awards for the third time.
Covid-19
Dr Nuala Murphy, president of clinical research services at Icon, explains that the organisation had been watching the outbreak of Covid-19 in China closely since early 2020. “Using guidance from global and national health organisations, we were quick to put in place a range of measures to protect the safety of our employees, the welfare of patients and to ensure the continuity of clients’ research programmes,” she says.
They also quickly developed a rapid-response delivery team to support the fight against the lethal virus and established a cross-functional vaccine and infectious-disease team of medical and drug development experts to support government and commercial clients in the initiation of Covid-19 clinical trials investigating vaccines and therapies. “A full range of scientific support services were made available including data management, biostatistics and medical writing,” says Murphy.
Icon also adapted its typical clinical trials process, ensuring that this could continue while following public-health guidelines, she adds.
“In the early stages, clinical monitoring visits to clinical sites and hospitals were either stopped or restricted to avoid infection and this required us to adopt a decentralised, remote approach, incorporating activities such as eConsent, arranging in-home visits with healthcare professionals for patient assessments and monitoring the regulatory compliance of studies either through the phone or online,” says Murphy. “Icon’s ability to conduct decentralised trials including in-home health care has been pivotal to our success in trial execution in this field.”
She says that collaboration across the industry, including pharma, regulators, doctors and technology vendors has been “astounding”.
“Everyone has worked together to find solutions to the unique situation of a pandemic,” she says, adding that earlier this year Icon was selected as preferred partner by the Biomedical Advanced Research and Development Authority, an organisation focused on strengthening US emergency-preparedness and response to pandemic influenza and emerging infectious diseases.
Murphy adds that the commitment and collaboration of Icon’s study teams was “really outstanding”.
“They have worked tirelessly around the clock, rethinking how we do things and coming up with new ways to ensure patient safety and quality compliance in supporting clients to develop new vaccines and therapeutics for Covid-19.”