With established manufacturers and new entrants racing to complete clinical trials of their experimental coronavirus vaccines in record time, some are already looking beyond their new-found COVID-19 expertise to better prepare for future pandemics.
AstraZeneca head of R&D Sir Mene Pangalos
One of the furthest advanced contenders is AstraZeneca PLC, the U.K.'s biggest drugmaker, which is expecting results of its experimental coronavirus vaccine by year-end. Recently knighted head of R&D Sir Mene Pangalos said the Cambridge, U.K.-based company's move into COVID-19 research was not a big leap from its work attacking respiratory viruses with monoclonal antibodies.
Traditionally focused on cancer, respiratory, cardiovascular and renal medicines, the company broke into the vaccines business April 30 by striking an alliance to accelerate the development and manufacturing of Oxford University's candidate, AZD1222. Pledging to work at record speed and assisted by large injections of capital from the U.S., as well as the U.K. and other European governments, Pangalos hopes to have results of the phase 2/3 trial by the end of the year.
"I'm not sure we're interested in becoming a vaccines company," Pangalos said in an interview with S&P Global Market Intelligence. "We are, as part of the collaboration with Oxford, going to be supporting the [Oxford-based] pandemic preparedness group ... so we'll be thinking about future pandemics, next-generation vaccines, to make sure that we can react even more quickly if this was to happen again, and also very interested in creating the next generation vaccines to SARS-COVID-2, as and when they're needed."
Vaccine manufacturing at scale
The deal, which caught many by surprise, resulted from conversations with Sir John Bell, regius professor of medicine at the University of Oxford, and a pivot toward immune-led science in the face of the COVID-19 pandemic. Within a couple of weeks, an agreement was in place. Although undeterred by the complexity of the manufacturing process for vaccines, for which sprawling new sites normally take up to five years to build at a cost of hundreds of millions of dollars, Pangalos admitted that the scale required was unprecedented.
"It's a very, very similar process to making monoclonal antibodies," Pangalos said. "Actually, I would say the manufacturing of this particular non-replicating virus [vaccine] is somewhat easier. What's different is the scale, just how many doses and how much manufacturing you have to do to be able to supply billions of doses, versus millions of doses. ... But the process itself is relatively straightforward."
Only five large global pharmaceutical companies make vaccines, including Pfizer Inc., Merck & Co. Inc. and CSL Ltd. Europe's largest vaccine companies, Brentford, U.K.-based GlaxoSmithKline PLC and Paris-based Sanofi, have joined forces on a coronavirus vaccine using GSK's antigen, or booster, while also working separately on a number of other approaches to tackling the virus. Industry executives, including Sanofi CEO Paul Hudson, have been vocal about the lack of manufacturing capacity for vaccines in Europe, amplified by the COVID-19 pandemic, and the absence of a unifying body equivalent to the U.S. Biomedical Advanced Research and Development Authority, or BARDA, to spearhead experimental treatments at the risky, early stage of development.
Both Sanofi and AstraZeneca have benefitted from BARDA's funding largesse, the latter receiving $1.2 billion for its U.S. manufacturing and late-stage trials of the coronavirus vaccine. But smaller vaccine companies like Italy's ReiThera Srl, which has formed a pan-European alliance to develop and produce a coronavirus vaccine based on a novel gorilla adenoviral vector, are using their own funds to speed development.
Rome-based ReiThera — formed by the team behind Okairos AG, which was acquired by GSK in 2013 for €250 million — has combined its vaccine development capability with the formulation know-how of German company Leukocare AG and rapid manufacturing scale-up from Univercells SA of Belgium. The consortium hopes to start trials this summer, with results in less than a year, given that the vaccine candidate — one of a family of simian adenoviral vectors already deployed against multiple infectious diseases such as Ebola — has an established safety profile and a formulation is already in place.
Leukocare CEO Michael Scholl expects between five and eight vaccines to be ready for approval by the summer of 2021, out of about 150 in development, ranging from DNA-based and RNA-based candidates to virus-spliced vaccines like ReiThera's, antibody-based vaccines and inactivated antigens. "Coming up with a single candidate and covering 5, 6, 7 billion doses, it doesn't make sense," Scholl said in an interview with S&P Global Market Intelligence. "We need different candidates from very different sources with different classes of compounds to [provide] as much as possible of the requested vaccines."
Scholl is optimistic that the ReiThera-led consortium will secure funding in addition to the €5 million loan it received from Italian bank UniCredit SpA. But even deep-pocketed peers like Sanofi have repeatedly called for support in shouldering the cost of developing these shots 'at risk' — ahead of approval in order to be able to manufacture enough doses once the trials read out.
"When it's hundreds of millions of doses, that's a risk that we need to share — we're happy to take risk ourselves but it's something you work on together," Hudson said at the FT Global Leaders conference in May. "It's a well-tested model; that model doesn't exist in Europe."
Hudson's call for a unified body to direct cross-sector efforts in Europe may have fallen on deaf ears so far, but the European Union has stepped in to provide some funding from the €2.7 billion emergency support instrument, following injections of capital from GAVI, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations. Even this is unlikely to resolve the longer-term struggle to retain so-called "warm-based capacity" across the industry, where critical manufacturing sites will need to be maintained so they are ready for a surge in demand, such as another global pandemic.
"As an industry, we've pulled together to do this for the good of the world first," AstraZeneca's Pangalos said.