Astra-Oxford Covid-19 vaccine works but doses could be in short supply

Pfizer and Moderna may have an initial advantage in dealing with manufacturing challenges, as their novel messenger RNA technology can be scaled up.

AstraZeneca Plc and the University of Oxford followed Moderna Inc. and Pfizer Inc. in announcing that their Covid-19 vaccine appears to work. Though the U.K. partners’ data don’t look quite as sparkling, regulators could clear any of the shots for emergency use in coming weeks.

The world needs as many vaccines as possible to end the pandemic, AstraZeneca Chief Executive Officer Pascal Soriot said. Pfizer, Moderna and AstraZeneca “don’t have enough production capacity for the world,” he said. “There’s no competition, really.”

Pfizer and Moderna may have an initial advantage in dealing with the manufacturing challenges, as their novel messenger RNA technology can be scaled up relatively simply. The U.S. company has said it can churn out 50 million doses of the shot it has developed with BioNTech SE by the end of the year. Moderna has said it can make about 20 million doses for the U.S. by January.

“We’ve always known we were going to need multiple vaccines for the world, because no one developer, no one manufacturer, is going to be able to produce enough to cover everywhere,” said Sarah Gilbert, the Oxford professor who led development of the vaccine. “We have to think about vaccinating communities, populations, reducing transmission within those populations, so that we really get on top of this pandemic.”

AstraZeneca has fallen behind schedule in its U.K. production targets. It expects to have 4 million doses available in vials for the country by the end of the year, far fewer than the 30 million previously slated to be ready by September.

In total, the company says it will have 20 million doses of bulk substance for the U.K. by the end of 2020 but those shots need to be filled into vials. By the end of the first quarter, it will have 300 million finished doses available worldwide, said Pam Cheng, head of global operations.

Reduced dosing

More will be on tap if AstraZeneca wins approval for a reduced dosing regime of a half shot followed by regular one, which was more effective than a full two-shot dosage in the results published Monday.

“These things are never easy,” said Matthew Duchars, the CEO of the U.K. government-backed Vaccines Manufacturing and Innovation Centre, or VMIC, which has helped with production. “It’s not the case of flicking the switch and being able to manufacture straight out of the gate.”

Getting production going for the AstraZeneca shot has taken months of preparation and test runs. It uses a harmless common cold virus to deliver the spike protein of the coronavirus to generate an immune response.

Vaccines using the technology have never been produced at this scale. The longest part of the manufacturing process involves growing cells in large stainless-steel vessels and then adding in the seed stock of the vaccine, which experts say takes a minimum of three to four weeks. The bulk substance then needs to be filled into vials and checked by regulators, taking additional time.

“The speed of the rollout is determined by the speed of the manufacture,” Health Secretary Matt Hancock said in an interview on BBC radio. “The bulk of the rollout will be in the new year.”

Oxford site

The VMIC, conceived in the wake of the Ebola outbreak more than four years ago, is using U.K. government funding to build a new facility south of Oxford to provide surge capacity to make vaccines to fight pandemics. When completed toward the end of next year, it will be able to manufacture 70 million doses of vaccines in as little as four months.

In the meantime, experts from the center worked with a gene therapy company called Oxford Biomedica Plc to help set up production lines for the AstraZeneca shot at its facility in Oxford. VMIC used 38 million pounds ($51 million) in government funding to buy and install 1,000-liter (220-gallon) bioreactors to brew the cells there, but it’s taken time to get up and running.

Oxford Biomedica began manufacturing in one suite over the summer and only got approval from British regulators to begin producing the vaccines at two additional manufacturing lines in September and October.

Outside the U.K., production is ramping up, and some countries may build up stocks more rapidly. The Serum Institute of India, the world’s largest producer of vaccines, is aiming to have 100 million doses ready by December. That initial amount will go to India, according to Serum’s chief executive officer Adar Poonawalla. It has already produced 40 million doses and next year plans to split supplies between India and the Covax initiative to buy shots for poor nations.

U.S. production

In the U.S., AstraZeneca struck a manufacturing deal with Emergent BioSolutions after it secured a $1.2 billion deal with the White House-led Operation Warp Speed for 300 million doses, but it began production only in mid-September. Emergent executives told Bloomberg News batches can take anywhere between 3.5 and 5 months to produce from start to finish, including quality-control checks on the filled vials.

Pall Corp. has helped vaccine manufacturers set up production by providing equipment such as bioreactors, tubing and single-use bags to brew cells. Clive Glover, Pall’s director of strategy, said one of the logistical challenges facing manufacturers is the sterile handling of thousands of liters of liquids as they try to ramp up to millions of doses. Pall is part of a U.K. consortium formed in the spring that aimed to make 1 million doses for the U.K. by September.

“The initial portion of the scale-up actually went very successfully,” he said.

If production can get up to speed, AstraZeneca could play a key role in ending the global pandemic. It signed multiple manufacturing deals with companies and governments ranging from Japan to Russia to produce more than 3 billion doses.

The AstraZeneca-Oxford vaccine is much easier to store and distribute, because it only needs to be kept chilled, while the Moderna and Pfizer mRNA vaccines need to be frozen.

AstraZeneca could also offer one of the cheapest Covid vaccines, at $4 to $5 per dose, according to the company. For poor countries, it may become the shot of choice.