UK bolsters Covid-19 vaccine manufacturing capacity

THE UK Government has increased the nation’s Covid-19 vaccine manufacturing capacity. It has agreed to a multi-million-pound up-front investment to expand vaccine manufacturing capacity, and secured  “crucial” fill and finish services for the vaccine manufacturing process.

The multi-million-pound joint investment was made as part of an agreement in principle by the Government with Valneva, a specialty vaccine company, which will use the funding to expand its manufacturing site in Livingston, Scotland. Through the agreement, the Government has secured early access to 60m doses of Valneva’s promising Covid-19 vaccine candidate. If the vaccine is proven successful, the Government has the option to acquire a further 40m doses from the expanded site.

According to Valneva CEO Thomas Lingelbach, the facility has been dedicated to the production of commercial-grade vaccines for more than a decade and is well-suited to being the hub for the company’s Covid-19 production. It will be used for drug substance production of the Covid-19 vaccine candidate.

Upping capacity will come from a combination of expanding the existing facility and building a new one at the Livingston site, explained Lingelbach. Valneva will build a total of five production lines equipped with modern, disposable cell-culture systems of about 500 L.

Initial funding is being used for the first expansion steps of the Livingston manufacturing site. Potential additional funding is still being negotiated, which is intended to expand production and possibly to cover clinical investment costs. Further funding from the Government could also allow Valneva to hire new staff to manage and run the new production.

If trials are successful, vaccine manufacture at the Livingston facility will help to ensure manufacture at a scale to protect millions of people in priority groups, such as health and social workers, and those at increased health risk.

The facility will be at the heart of efforts to produce a new coronavirus vaccine, and it will advance Scotland’s manufacturing capacity and support highly skilled jobs for scientists and technicians at the site. Currently, the site employs more than 100 people with a quarter working directly with the virus. The number of researchers working on the vaccine’s manufacture is expected to grow by a further 75 once production gets underway.

The total investment amount has not yet been disclosed.

Valneva’s Covid-19 vaccine candidate is expected to enter clinical trials by the end of the year, with regulatory approval potentially coming in the second half of 2021.

The capacity to support Valneva’s initial 60m dose supply commitment to the UK Government is expected by the end of 2021. Going forward, and on an annualised basis, Valneva expects to install capacity of more than 200m doses for a potential Covid-19 vaccine, said Lingelbach.

Kate Bingham, Chair of the UK’s Vaccine Taskforce, said: “In order to vaccinate our high-risk populations at the earliest opportunity, the Government has agreed to proactively manufacture vaccines now, so we have millions of doses of vaccine ready if they are shown to be safe and effective. This important investment in Valneva’s Scottish manufacturing plant will not only help us with this, but also ensures we are well-placed as a country to be able to cope with any pandemics or health crises in the future.”

David Lawrence, CFO at Valneva, said: “We are working as hard and as fast as possible to develop the vaccine to meet the UK’s needs and indeed to try to address the broader need for a vaccine.”

The Livingston facility will be in addition to the Vaccine Manufacturing and Innovation Centre (VMIC) under construction in Oxfordshire, UK which received a £131m investment from the UK Government. That investment includes £38m (US$28.6) for a rapid deployment facility. Once the VMIC is completed – expected in Q3 of 2021 – it will provide flexible capacity to manufacture millions of vaccine doses at scale.

Fill and finish partnership

The Government has also announced that it is partnering with global pharmaceutical and biotechnology company Wockhardt, in a deal that will increase capacity for the crucial fill and finish stage of Covid-19 vaccine manufacture. This expands efforts to ensure that a successful vaccine is widely available to the public.

Fill and finish is a process in the pharmaceutical industry which involves filling vials with vaccine and finishing the process of packaging the medicine for distribution. Many manufacturers use a third party for fill and finish of their vaccines.

As per an 18-month agreement, Wockhardt has reserved manufacturing capacity – in the form of a fill and finish production line – to allow the supply of multiple coronavirus vaccines to the UK Government, including AZD1222. This vaccine candidate was co-invented by the University of Oxford and its spin-out company Vaccitech, and licensed by AstraZeneca.

The process will take place at CP Pharmaceuticals, a subsidiary of Wockhardt, based in Wrexham, North Wales, which has the capacity to finish millions of vaccine doses.

The fill and finish line is expected to startup this month.

Normally, in pharmaceutical development and manufacture a number of elements of the manufacturing process need to be conducted in parallel with any regulatory review and approval process. The capacity at Wockhardt will help the Government to be ready in advance so that a vaccine can be delivered to the population as quickly as possible.

The agreement with Wockhardt complements the VMIC, which is currently under construction. The UK’s vaccine manufacturing efforts are also supported by an additional state-of -the-art Cell and Gene Therapy Catapult Innovation Centre, to accelerate mass production of a successful vaccine. The Government invested £100m in the facility, which will be achieved by upgrading an existing site in Braintree, Essex, UK.

According to Kate Bingham, Chair of the UK’s Vaccine Taskforce, both the recent deals will help to ensure that the UK is able to make a vaccine available for the people who need it, once a candidate is proven successful. She added that the investment in Valneva’s Scottish manufacturing site will ensure the UK is well-placed to cope with pandemics and health crises in future.

The Vaccine Taskforce was launched in April to drive the rapid development and production of a coronavirus vaccine.

The UK Government is supporting the manufacture of a coronavirus vaccine in various ways. This includes a global licencing agreement signed with AstraZeneca and the University of Oxford to research, to develop, and manufacture 100m doses of a Covid-19 vaccine for the British public, as well as a partnership with BioNTech and Pfizer for 30m doses if their trials are successful. Additionally, at the end of July, the Government announced an agreement with GSK and Sanofi to secure 60m doses of a vaccine candidate.

The Government invested a further £40m in a vaccine candidate being developed by Imperial College London. The candidate is now being trialled with more than 200 people across six locations.