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Developing a COVID-19 vaccine

The pharma industry ramps up its efforts as case numbers continue to rise

As governments around the world introduce strict lockdown measures to stem the spread of COVID-19, the pharmaceutical industry has ramped up efforts to develop an effective vaccine targeting the novel coronavirus.

One caveat to those efforts, however, is the length of time it takes to bring a vaccine through research and into the market – at best, an effective vaccine will not be available for wide-scale human use for at least a year, according to experts.

Despite this, there is no shortage of companies and academic institutions trying to bring a successful COVID-19 vaccine through the clinic. At the front of the race is Cambridge, Massachusetts-based biotech company Moderna, which dosed the first patient in the US in March with its COVID-19 vaccine candidate.

The mRNA-based vaccine candidate reached clinical testing in record time, only 63 days after the genetic code of the virus, SARS-CoV-2, was identified by Chinese scientists and shared in January.

The phase 1 study, which is being conducted by the US National Institutes of Health (NIH) at Kaiser Permanente Washington Health Research Institute in Seattle, aims to recruit 45 healthy men and women aged between 18 and 55 to test two doses of the vaccine given 28 days apart, with 12 months’ follow-up after the second dose.

To win approval for public use, a larger phase 2 trial is need, which Moderna says is already in the planning stages and could start within a few months.

Pharma giant Johnson & Johnson is also at the forefront of developing a COVID-19 vaccine, having said it plans to start clinical trials of its lead candidate in September. If efficacy data is available by the end of the year, the vaccine could be approved for emergency use by early 2021, says J&J.

Researchers from Oxford University have also said they plan to start clinical trials of their COVID-19 vaccine this month. The research team, like Moderna, began working on a vaccine in January when the genetic sequence of COVID-19 was published by Chinese researchers, and they have now identified a lead candidate to take forward into human testing.

Another vaccine, developed by Chinese military scientists, was also given to patients for the first time last month. A trial of the Chinese vaccine candidate is enrolling 108 residents in Wuhan, Hubei Province, the epicentre of the novel coronavirus outbreak.

The volunteers will be isolated for 14 days after being dosed with the adenovirus-based Ad5-nCoV shot, which was developed in collaboration with CanSino Biologics, and will then be monitored for six months.

GlaxoSmithKline has also partnered with Chinese biotech company Clover Biopharmaceuticals on a protein-based coronavirus vaccine candidate, named COVID-19 S-Trimer. GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Primer in preclinical studies, with the aim of rapidly scaling-up and producing large batches of the potential COVID-19 vaccine.

French drugmaker Sanofi also currently has two ongoing collaborations to develop a COVID-19 vaccine candidate. That includes an agreement with the US Biomedical Advanced Research and Development Authority (BARDA) on the development of a recombinant, protein-based vaccine candidate.

The second agreement, with Translate Bio, will focus on developing an mRNA vaccine for COVID-19. Translate has already begun to produce multiple mRNA constructs and will use its platform to discover, design and manufacture a number of coronavirus vaccine candidates.

The Coalition for Epidemic Preparedness Innovations (CEPI), an Oslo, Norway-based nonprofit, is helping to coordinate the development of a COVID-19 vaccine and is leading the efforts to finance the most promising programmes.

In March the CEPI called for new funding for the expansion of potential vaccine candidates, saying that $2bn is needed to support the development of a successful COVID-19 vaccine.

The CEPI has currently initiated eight COVID-19 vaccine developments with Curevac, Inovio Pharmaceuticals, Moderna, Novavax, The University of Hong Kong, The University of Oxford, The University of Queensland and a consortium led by French non-profit Institut Pasteur to develop vaccine candidates.

Even with a slew of vaccine candidates, there is still a significant time frame before the general population will be able to access a safe and effective shot against COVID-19.

In an article published by The New England Journal of Medicine, Nicole Lurie, Melanie Saville, Richard Hatchett and Jane Halton from the CEPI urged caution: ‘Vaccine development is a lengthy, expensive process. Attrition is high, and it typically takes multiple candidates and many years to produce a licensed vaccine.’

However, due to the urgency of the pandemic, the time frame is likely to be shorter, and they maintain that vaccine development is still of the utmost importance, even if the status of the pandemic changes.

‘Although it’s unlikely, if the pandemic appears to abruptly end before vaccines are ready, we should continue developing the most promising candidates to a point at which they can be stockpiled and ready for trials and emergency authorisation should an outbreak recur,’ the group from the CEPI added.

COVID-19: managing clinical trials during the pandemic

EMA and FDA provide guidance as impact of virus intensifies

The European Medicines Agency (EMA) and The US Food and Drug Administration (FDA) have both provided guidance on how to manage clinical trials during the COVID-19 pandemic.

The EMA has acknowledged the impact the pandemic may have on clinical trails and trial participants. In response, it identified that ‘extraordinary measures’ could be implemented as a result and trials may need to be adjusted.

“The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials,” said the EMA in a statement.

That includes possible changes to ongoing trials and the initiation of new trials, with the EMA recommending that trial sponsors need to keep in mind that “the safety of the participant is of primary importance, and risks of involvement in the trial, in particular with added challenges due to COVID-19, should be weighed against anticipated benefit for the participant and society”.

Any changes to a trial’s conduct needs to be agreed with and communicated to investigator sites, and trial participants should be informed by their investigator about relevant changes in the conduct of the clinical trial they are involved with.

The FDA has also released guidance which recognises the possible changes to clinical trials as a result of the pandemic. The agency has outlined considerations to assist sponsors in assuring the safety of trial participants, as well as maintaining compliance with good clinical practice while minimising the risk to trial integrity.

The recommended considerations include sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits, and offering additional safety monitoring for those trial participants who may no longer have access to investigational product or the investigational site.

Victory of the people in the fight against COVID-19

NHS sees record numbers respond to call for volunteers

The NHS temporarily paused recruitment to its volunteer responders group after an impressive 750,000 applied to the service. NHS Volunteer Responders is a new group, set up by the health service, that will carry out simple, non-medical tasks to support people in England who are self-isolating as per government advice.

This includes people with underlying health conditions and those over the age of 70. Individuals who registered to join the Volunteer Responders group will collect and deliver shopping, medication or ‘other essential supplies’ for people who are isolating.

Other jobs include transporting medically-well patients to hospital appointments and ensuring they get home safely, as well as transporting equipment and medication between NHS services and sites.

“On the evening of 24 March, Royal Voluntary Service readied itself to launch the biggest call for volunteers in England since the Second World War,” said Catherine Johnstone CBE, chief executive of Royal Voluntary Service.

“Less than 24 hours later, we had hit our target of 250,000 sign-ups and now that number is at 750,000. We have been absolutely overwhelmed by the response and cannot thank the public enough.

“Our team is now working flat out with colleagues in NHS England to process the many thousands of applications we’ve received, so we can get volunteers up and running as soon as possible and matched with patients that they can begin to support,” she added.

Along with the NHS Volunteer Response group, a new initiative – named TeamGP – has been launched by a team of doctors and supporters, which called for GPs to help the NHS 111 phone service cope with an overwhelming workload caused by the coronavirus outbreak.

Hundreds of GPs across the country have volunteered to work outside their usual hours, and have dedicated time to speak to 111 callers to support the NHS.

The dedicated sign-up site was created by Kit Latham, a former A&E doctor and founder of digital health company Credentially, which is providing its digital healthcare professional onboarding service and software free to any UK healthcare organisation that needs to build an emergency workforce.

“We know everyone is working as hard as they can in these unprecedented times. If any GPs feels they have an extra hour, and feels they can spare it, we’re asking them to sign up – as every hour counts,” said Latham.

“We want to offer our tech to anyone who is trying to build an emergency healthcare workforce of volunteers, returning retirees or student doctors and nurses, enabling them to automate the process, including sign-up, verification and training, so they can start working as quickly as possible,” he added.

Article by
PMGroup

28th April 2020

COVID-19 Updates and Daily News

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