With the rapid spread of the coronavirus 2019-nCoV through China and now globally, governments and organisations have implemented a range of preventative measures. Chinese provinces including Beijing and Shanghai have shut down long-distance bus services and entirely closed off some cities. Despite these measures, the mayor of Wuhan predicted that around five million residents fled the city before the lockdown.

The situation is rapidly becoming critical. As of 26 January, just over 2,000 cases have been confirmed, up by 694 from the previous day. In Wuhan alone, hospitals are extremely overstretched, many running out of beds and basic equipment. China has committed to build two new hospitals in a matter of weeks to deal with additional cases.

With cases already reported in America, Australia and around Asia, it is clear that preventative measures are not enough: a vaccine for the illness is needed, and quickly. 

What are Pharma Companies Doing?

A number of companies have already stepped up to the challenge of combating 2019-nCoV. Biotech Novavax has announced it is working on a flu vaccine and is currently cloning samples from the virus. The company previously worked on another coronavirus, MERS.

Another pharma company, Moderna, is working with the National Institutes of Health on a potential cure. Moderna creates synthetic mRNA which can ensure the body produces antibodies to fight infection.

Two other companies, BioCryst Pharmaceuticals and Inovio Pharmaceuticals, have also hinted they are set to begin working on combative vaccines. The Coalition for Epidemic Preparedness Innovations (CEPI) has provided millions in funding to the two companies. Like Moderna’s, Inovio’s R&D efforts do not need the input of a live virus. This method, the company said, is much faster than alternatives. 

CEPI has set a challenge to match the spreading epidemic: for its partners to have fully finished R&D on a vaccine in only 16 weeks. For a vaccine to reach human testing stage normally takes years of work.

The problem is that vaccines are incredibly difficult to make under pressure and to speed. When pharma giant Merck attempted to create a vaccine for Ebola, the process took scientists from three continents more than four years to finish. Even then, several circumstances were simply down to luck.

Attempting a problem of this magnitude will naturally tax any small biotech, diverting them from their other work and straining investor relations. Moderna’s CMO has expressed confidence in the company achieving success within the 16-week timeline, however. Should it be successful, manufacture of the drug could be completed in months. A much larger distributor would be required, though, to ensure global delivery.

How to Speed Up Vaccine R&D

Generally, the process to create a vaccine takes from ten to 15 years to complete, from R&D to manufacture. 

Some solutions can already be found in vaccine-makers today. CEPI asked the University of Queensland to develop a 2019-nCoV vaccine in “unprecedented speed”, due to the novel technology it owns. Given these instruments the university could produce a vaccine within six months.

This innovation is a new ‘molecular clamp’ platform, backed by CEPI, to ensure “targeted and rapid vaccine production”. The clamp utilises a ‘backbone’ that can be rapidly altered to fight different viruses by inserting new genetic or protein sequences, making viral proteins more stable. 

Another solution is drug repurposing. Already known to most pharma companies, drug repurposing is the taking of one drug already on the market and testing its efficacy in the current situation. Should a suitable drug be found, rapid dissemination is possible due to already-passed safety tests and manufacturing procedures. 

Where these efforts fail, the need for new platform technologies grows. Created before an epidemic hits, the intimate knowledge developers already have of these platforms enables a swifter response and development time when creating a vaccine. Employing these could save vast amounts of time and money in combating new illnesses. 

An example of these platforms is replication-deficient simian adenovirus platform. Developed initially for gene therapies, replication-deficient adenoviral vectors can infect cells expressing the CAR receptor and insert a specified gene within the cell. The immunogenicity of adenoviral vectors makes them well-suited to vaccines.

Replicant-deficient simian adenovirus-vectored vaccines are already being developed for every pathogen on the WHO’s priority list, including Ebola, SARS and Zika, with varying levels of progress. 

For more experimental, unvalidated platforms, veterinary vaccines have been posited as a swifter means of validation vaccine performance. These veterinary versions can quickly ascertain the ability to scale up and approvability. They can also supply considerable and cheap efficacy data in animal species. 

Regulation

On the regulatory front, procedures are already in place to speed up approval of novel vaccines. In times of public health emergency the FDA establishes internal teams to help develop drugs quickly. However, for many vaccines regulatory pathways are not always clearly set out. Confusion remains around the testing and efficacy requirements for approval of certain vaccines. Platform technologies are assumed to be useful in this regard also, as safety data of any vaccine using the same platform will be relevant to one another. 

Another possible improvement in the regulatory forum is the introduction of tiered regulatory standards. These would be tailored differently for experimental and commercial vaccines, allowing for a more streamlined approach to approval. 

Conclusion

It is clear from the literature of recent years that a great deal is being done to speed up vaccine creation and delivery. However, in many cases – for example Ebola and Zika – the virus often diminishes considerably before vaccines have passed clinical trial stage. In order for vaccines to reach peak potential, more needs to be done to ensure manufacturing before the virus is played out and potentially hundreds have died. 

Answers exist for the evolution of vaccine R&D. Adoption of cutting-edge new technologies, further research in preparation for future outbreaks (particularly looking at platform technologies) and a streamlining of the regulatory stage can improve the situation immeasurably. Unlike so many drugs, vaccines are not catering to an ever-present, small patient group. When vaccines take too long, hundreds of thousands of lives are on the line. 

Joshua Neil, Editor
Proventa International