Vaccine makers around the world face a shortage of vital components, including large plastic grow bags, according to the head of the company which manufactures a quarter of the UK’s jab supply.
Stan Erck, CEO of Novavax – which makes the second vaccine to be grown and bottled entirely in Britain – told the Observer that the shortage of 2,000-liter bags in which the vaccine cells were grown was a major obstacle to global supply.
His warning came as bag makers revealed that some pharmaceutical companies were waiting up to 12 months for disposable sterile single-use plastic containers, which are used to make drugs of all kinds, including Pfizer vaccines, Moderna and Novavax Covid-19.
But Erck and his UK partners have said they are confident they have enough suppliers to avoid disrupting Novavax’s supply. The vaccine is awaiting approval from the Medicines and Health Products Regulatory Agency (MHRA) but the first of 60 million doses ordered by the government are already in production at Teesside.
The Fujifilm Diosynth Biotechnologies plant this month began growing the first cells for the Novavax vaccine in Billingham, County Durham and in a few weeks they will fill the bioreactor bag, ready to be transported to the plant in GlaxoSmithKline at Barnard Castle to be placed in vials for distribution. .
“The first hurdle is showing that it works and we don’t have that hurdle anymore,” Erck said.
But he added that there were still others to overcome. “There are the media in which the cells have to grow,” Erck said. “You grow them in those 2,000-liter bags, which are rare. Then you pour it in and you have to filter it, and filters are scarce. Little things matter.
Novavax nearly ran out of bags at one of its 20 factories earlier this year, but there had been no delays for the UK operation, according to Martin Meeson, global managing director of Fujifilm Diosynth.
“We started working on our part of the supply chain last summer,” he said. “We had to step up some of the investment here, but the commitment we made last summer to start manufacturing in February has been met.”
Meeson and Erck both said the UK Vaccine Task Force has been helpful in addressing supply issues so far, but other countries and other medical supplies could be affected.
ABEC manufactures bioreactor bags at two factories in the United States and two in Fermoy and Kells in Ireland, and delivered six 4000-liter bags to the Serum Institute in India last year for its Covid vaccines.
Brady Cole, vice president of equipment solutions at ABEC, said, “We hear from our customers about lead times of nine, 10, or even 12 months to get bioreactor bags. We usually run out of 16 weeks to send a customer a personalized bioreactor bag. He said ABEC always managed to fill orders at about this rate.
“The bag making capacity cannot meet the demand right now,” he added. “And on the component side, the tubes and instruments and so forth that also go into the bag assembly – those time frames are starting to be stretched as well. But the biggest problem we see is that it’s just the ability to get bags in a reasonable amount of time. “
ABEC expanded its factories last year and has now started manufacturing 6000 liter bags, which are about the size of a minibus. Other companies, including MilliporeSigma, which is part of the German company Merck, have also expanded their manufacturing facilities. US-based Thermo Fisher Scientific expects it to eventually double its capacity this year.
The US government has also blocked exports of bags, filters and other components so it can deliver more Pfizer vaccines to Americans. Adar Poonawalla, director general of the Serum Institute of India, said the restrictions were likely to cause serious bottlenecks.
Novavax hopes to avoid delays and “vaccine nationalism” by operating on four continents, with 20 facilities in nine countries.
“A year ago we had no manufacturing capacity,” Erck said. “We are autonomous. The two main things we need to do are done in the UK. And in the EU, we have factories in Spain and the Czech Republic, and filling and finishing factories in Germany and the Netherlands. “
Vaccines did not have to cross borders to fulfill contracts, he said.
The Oxford / AstraZeneca vaccine was hit by a delay in the delivery of 5 million doses from India and an issue with a batch made in Britain, and the company was embroiled in a long dispute between the UK and the EU on vaccine exports.