Covid-19 has ushered in a new era of drug manufacturing and supply

16 Dec 2020

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Barry Heavey reflects on the global, collective scientific effort to produce and distribute vaccines for Covid-19, and the long-term impacts that will be seen from rising to this challenge.

We are ending 2020 in the same way it began, with the whole world heading into an unprecedented experience. The difference this time is that we have assembled some exciting tools to fight the pandemic in addition to our efforts to slow its spread. Vaccines for Covid-19 have been developed at a pace never seen before by utilising all of the scientific developments of the last 40 years, since the dawn of the biotechnology industry.

Now, the supply chain needs to deliver billions of vaccines to every corner of the planet. This requires significant investment to keep pace, but the parameters for what it will take are at least understood.

In Ireland, where we play host to many of the world’s largest biopharma manufacturers, we have an excellent reputation when it comes to regulatory compliance around the manufacturing and shipment of drugs – meeting Good Manufacturing Practice, Good Laboratory Practice and Good Distribution Practice (GDP) requirements. The Irish Exporters Association has been running GDP training programmes for the last 10 years, ensuring all of the key actors in the pharmaceutical supply chain know what’s required in the distribution of biologic drugs.

The groundbreaking mRNA vaccines heading our way, however, present very new challenges. They are less stable than traditional vaccines and will degrade quickly unless they are held at ultra-low temperatures.

Ultra-cold chains

It has been widely commented on that the Pfizer-BioNtech vaccine has to be stored at minus 70 degrees Celsius while Moderna’s needs to be stored at minus 20 degrees Celsius to keep it stable for six months. Temperature-controlled supply chains – so-called ‘cold chains’ – typically operate at fridge temperatures and the regulatory requirement around vaccines had been set between two and eight degrees Celsius until now.

Pfizer has taken care of its side of the ultra-cold supply chain, developing deep-freeze suitcases that are packed with dry ice and able to contain 1,000 to 5,000 doses for up to 15 days. Where the ultra-cold requirement becomes a bigger challenge is in the last mile, where vaccines go from large distribution hubs to the smaller dispensaries where they will be delivered to individual patients.

The Irish Government has already invested in nine freezer lorries, super-cold trucks that are standing by in Citywest, Dublin, waiting to deliver the Pfizer vaccine to different parts of the country. This may be sufficient for the first wave of vaccinations, where supply is still limited, and focus will be on the most vulnerable and needy. But further investment and coordination in refrigerated transport and storage nodes will be required as more vaccines come through manufacturing and are available for more widespread vaccination campaigns.

‘2021 will see that scientific innovations will be largely successful in controlling the spread of the coronavirus’

If mRNA can be kept stable up to the point of injection, it will provide a temporary ‘instruction’ on the patient’s cells to make the spike protein, a distinguishing feature of the Covid-19 virus. This spike protein is then recognised by the patient’s immune system as something it needs to attack, preparing the body for fighting off infection by the Covid-19 virus itself.

There is another wave of vaccines coming that involves making a form of the spike protein in a factory for direct injection into the patient. The good news is that these protein-based vaccines are more stable than mRNA-based vaccines. The most advanced is the Oxford-AstraZeneca Covid-19 vaccine which is currently under review with a number of health authorities.

So far, the data collected suggest that both the protein-based vaccine from AstraZeneca and the University of Oxford, as well as mRNA vaccines produced by companies including Pfizer, BioNTech and Moderna, all exceed the 70pc efficacy level that experts had hoped for. As a point of comparison, according to CDC data from 2009 to 2019, the flu vaccine is 44pc effective.

There will likely be a lot to consider over the coming month regarding efficacy and safety levels, speed of approvals, cost and ease of manufacturing and distribution of these various vaccines, but there is no doubt that the rate of scientific developments has been incredibly impressive.

Accelerated research

The scale of the pandemic has been matched by the scale of the response from the biopharma industry. Overall, there is the widespread belief that 2021 will see that scientific innovations will be largely successful in controlling the spread of the coronavirus.

In the longer term, the Covid-19 pandemic has triggered two gamechangers for the biopharmaceutical industry, the first being an unprecedented acceleration in the time from basic research to regulatory approvals and mainstream production, and the second being the emergence of mRNA-based therapies and vaccines.

‘We are on the cusp of a whole new era of biologic drug manufacturing that Ireland should be looking to play a part in’

Research and development around RNA therapies and vaccines is only likely to accelerate as it provides the potential to quickly design drugs that can provide superb control of the biology of a variety of diseases. We are on the cusp of a whole new era of biologic drug manufacturing that Ireland should be looking to play a part in.

Right now, mRNA-based drugs are not manufactured here and local facilities have not been involved in the coming wave of Covid-19 vaccines. That’s not to downplay Ireland’s role in the pharmaceutical industry – just as the health service has had to carry on treating non-Covid-19 conditions, pharma facilities in Ireland have continued to manufacture life-saving therapeutic drugs for diseases such as cancer, as well as vaccines for a number of diseases such as HPV and pneumococcal disease.

There is a case to be made, however, for ensuring Ireland’s life science sector is at the forefront of new technologies such as mRNA and other forms of advanced cell and gene therapies and vaccines. Our manufacturing sector will also need to be more closely aligned to research and development activities if the accelerated pace of R&D that we have seen with Covid-19 is to be maintained.

Barry Heavey is managing director of life sciences at Accenture Ireland