Production snags likely to leave EU lagging in vaccinations for months to come

Rather than shooting citizens in the arm, European countries might be shooting themselves in the foot. 

Increasing numbers of European public health authorities and scientists say they will restrict the use of the Oxford/AstraZeneca vaccine to younger populations, citing the fact that current data doesn’t show the jab is effective in people over the age of 55.

Some British experts say EU countries are setting age restrictions only because of limited supplies.

“The Europeans … haven’t got as much Oxford/AstraZeneca as they have of the Pfizer vaccine, so they are taking a much more cautious approach,” Anthony Harnden, deputy chair of the U.K.’s Joint Committee on Vaccination and Immunisation, told British radio Friday. “But … the European Medicines Agency … have actually agreed that there is sufficient data within the elderly group to license the product.”

EU scientists say they’re merely making recommendations based on the science at hand. But restricting the use of such a cheap and easy-to-use vaccine — long seen as the closest thing to a silver bullet — will exacerbate the issue of getting jabs out to one of the EU’s most vulnerable populations, who are already watching their counterparts in the U.K., the U.S. and Israel move ahead. So far, less than 3 percent of people in the EU have at least received their first dose. 

This news is coming as the EU is facing systemic production issues that are pulling member countries even further behind — and facing the harsh reality that it will face sluggish a vaccine rollout for months to come.

Commission President Ursula von der Leyen confirmed in an interview Thursday that the EU underestimated how difficult it would be to ramp up manufacturing on a global scale and warned that supply issues will “certainly happen over and over again.”

“A start of vaccination does not mean a seamless flow of vaccine doses coming from the industry,” she told 10 European news organizations, including POLITICO. “This is a bitter learning part, and this we certainly have underestimated.”

Behind the UK

The EU has always adopted a more cautious approach than the U.K., the first country to authorize a jab via an emergency use authorization process and the first to delay second doses of vaccines past their clinical trials.

These controversial moves have largely been backed by science in retrospect. Many developing countries have subsequently approved the BioNTech/Pfizer vaccine, and new preliminary data from Oxford/AstraZeneca trials shows that delaying the second dose of its jab could actually boost immunity protection. The policies also allowed the U.K. to pass 10 million vaccinations this week. 

EU countries, however, starting with Germany, decided there wasn’t enough data to prove the vaccine is effective in older populations.

The European Medicines Agency, in its recommendation last week, confirmed it lacked enough data to show how effective the vaccine is in preventing COVID-19 in older people. But it said there’s no reason to believe it’s less effective than in the general population.

Still, the Netherlands, Sweden, Italy and France have joined Germany in limiting the vaccine to people under the age of 65. Greece set the age at 64, Poland at 60, while the cutoff in Belgium and Malta is 55. 

Experts don’t think it’s a bad idea as such — but only if a country has many doses of different vaccines.

“If you have effectively unlimited supplies of the Pfizer vaccine and you want to vaccinate the elderly, then prioritizing that vaccine for [the] elderly and reserving AstraZeneca for younger people is a perfectly reasonable decision,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

But the EU is not rolling in vaccines — nor will it be for some time. This month, Pfizer will begin to reverse a mid-January dip by increasing deliveries starting the week of February 15, but Moderna, another mRNA producer, anticipates shortages throughout the month. 

AstraZeneca, meanwhile, said the EU would get another 9 million doses by the end of March, but it’s still coming up at least 65 million doses short of what the company had planned to provide in the first quarter.

Johnson & Johnson will probably be the next company to bring its vaccine to European regulators, possibly within weeks. But it has already announced massive manufacturing hurdles, because compared to mRNA vaccines, it takes more time to cultivate cells to produce the adenovirus-based vaccine. The first deliveries of the 200 million EU-marked doses could begin in April. 

But diplomats became concerned when they realized that deliveries of the Johnson & Johnson jab have to be sent to the U.S. for fill-finish, and they feared that transatlantic shipments would add delays and possible export restrictions — an issue first reported by Bloomberg and confirmed by two EU officials. Another official said the Commission is talking to the company about having its fill-finish done in Italy instead.

Worried diplomats, having moved past their anger from January and onto bargaining in February, urged the Commission Wednesday during a meeting of deputy EU ambassadors to do all it could to ensure drug companies meet their supply commitments. 

The Commission said it would, according to an EU official. But there’s only so much it can do.

And sometimes, EU countries haven’t been helping themselves. French President Emmanuel Macron came under intense scrutiny by the scientific community last weekend when he claimed the Oxford/AstraZeneca vaccine was only “quasi effective” in older populations — right before the EMA’s positive approval. 

John Bell, a medical professor at Oxford University, chalked it up to Macron trying to reduce demand for the vaccine in the face of delivery delays. But even beyond Macron, some experts say, countries of setting age restrictions to reduce demand.

“I find it slightly strange that [politicians] complain about the efficacy but then make a great pass that they haven’t got the doses,” Evans said. “It makes me think that there are some other reasons. It could be that the European Commission wishes to divert attention from its own possible perception of failure.”

The Commission is working hard to change that perception, tasking Interior Market Commissioner Thierry Breton once again with getting companies to ramp up production. But instead of hand sanitizer and face masks, as in the early days of the pandemic, Breton is trying to find more manufacturers to create incredibly complex pharmaceutical products that all differ greatly depending on technology. 

Derek Lowe, writing in Science, called it “simply wrong” to claim that many other pharmaceutical companies can start producing the vaccines. Referring mainly to the mRNA jabs like BioNTech/Pfizer and Moderna, Lowe wrote there are in fact very few companies that have the right equipment to make these vaccines — especially machines that turn mRNA and lipids into one consistent product. 

There also aren’t many vacant production sites lying around, said Adrian van den Hoven, director general of generics lobby group Medicines for Europe. They “just doesn’t exist,” he noted.

A representative from Vaccines Europe and European Federation of Pharmaceutical Industries and Associations (EFPIA) explained that it costs millions of euros to have a drug manufacturing site, so companies need to have them operating to return on that investment. Beyond this, manufacturers have to be staffed with highly trained workers “to guarantee the production of quality vaccines which are amongst the most complex biological products to manufacture.”

Companies that make other kinds of vaccines could possibly shift production to making coronavirus jabs, but that would mean abandoning — at least for a set time — products that are in global demand, like flu vaccines.

“Vaccine manufacturers have the obligation from a public health perspective to continue the production of non-COVID-19 vaccines, which are highly needed to avoid outbreaks of other diseases, such as measles or pertussis,” the pharma and vaccine lobby groups wrote in an email. “Stopping the flu production is therefore not an option.”

And as van den Hoven pointed out, it would also be expensive, as there would have to have be a return on investment for these companies: “Someone has to pay in the end.”

James Love, director of Knowledge Ecology International (KEI), said it’s time for governments to start throwing money at companies to send both their intellectual property and know-how to any third parties that can develop the vaccines: “Whatever it takes to compensate people in a way that is considered fair … and to do so generously.”

These “are policy tools governments have at their disposal,” he said, even suggesting more radical ideas like forcing companies to transfer the technology to third parties or, most dramatically, having governments take over factories. “And if they’re not using those tools to scale manufacturing, they’re protecting the industry more than the population.”

But there are positive signs, too. BioNTech purchased a factory in Marburg and got it running in under five months. Other vaccine hopefuls that have either dropped out of the coronavirus vaccine race or are going back to the drawing table are helping out competitors, including Sanofi, GSK and IDT Biologika. 

Love doesn’t think the issue is quite as complex as others make it out to be. Rather than having the right equipment or revamping idle factories, Love thinks a bigger issue is sharing the “know-how,” including training employees to make the vaccines and testing batches properly.

He’s optimistic this can and should be done. Along with a team of researchers at KEI, he’s amassing a spreadsheet of manufacturing sites that could be used to help make more vaccines.

But despite his optimism, Love wonders why he and his team of researchers are doing this now, when governments should have been doing this months ago.

“Why are we having this conversation in February 2021?” he asked. “Isn’t it kind of a massive policy failure that people that work in governments and U.N. agencies don’t have this figured out?”

Jacopo Barigazzi, David M. Herszenhorn, Helen Collis and Paola Tamma contributed reporting.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.