Such are images of hope: Nurses getting vaccinated. Pallets of packaged vaccines distributed on special flights. Mayors exulting over “the beginning of the end of the pandemic.” A president who is preparing the country for better times.
These images are from the United States.
In Germany, on the other hand, you see desolate shopping streets, shuttered restaurants and a government that is preparing its population for long, dark days.
The contrast is unmistakable. On the one hand, there is the supposedly incompetent Trump administration, which will provide vaccines to 20 million Americans in the next two to three weeks alone. By the end of March, the plan is for around 100 million Americans to have received the two vaccine injections they need.
On the other hand, there is the supposedly well-prepared Europeans, who continue to have to wait for a vaccine that was developed in Germany. And who still don’t know exactly how much of the vaccine they will be getting in the coming months.
Initially, Germany’s health minister has announced, there will probably only be 400,000 vaccine doses for Germany, with another 11 to 13 million to follow by March — a fraction of the amount the Americans are getting.
It’s a politically dangerous situation that has now been recognized by the German government. Since last week, it has been taking hectic countermeasures. The European Medicines Agency (EMA) now wants to approve the vaccine a week earlier than planned, and vaccinations are slated to begin in Europe on Dec. 27. Negotiations are also underway with manufacturers to obtain more doses. On Thursday, German Chancellor Angela Merkel even spoke with BioNTech founders Özlem Türeci and Uğur Șahin in a livestream, part of which was broadcast publicly. The message couldn’t be any clearer: Vaccination is now the chancellor’s business.
That realization has come too late, however. For months, it has been clear that other countries would have more doses of the vaccine, would start vaccinating sooner and, as a result, would be able to take more effective action against the pandemic.
But in Berlin and at European Union headquarters in Brussels, too little action was taken for too long, and it was often justified with complacent arguments: In Europe, medicines are tested better and more precisely than elsewhere in the world, and vaccines are available in abundance thanks to good planning. Health Minister Jens Spahn announced that the critical mass of around 60 percent of the German population could be vaccinated.
Too Little, Too Late
But, so far at least, his optimism hasn’t been matched by reality.
And the late approval of the active ingredient in the BioNTech and Pfizer vaccine by the European Medicines Agency (EMA) appears to be the least of the problems. The bigger issue is that if the situation remains as it is now, there will not be enough vaccine available to get the pandemic under control in Germany before next autumn. The EU appears to have bought too little, too late and at times from the wrong producers. And it appears that it turned down hundreds of millions of vaccine doses that are now lacking.
Dramatic consequences are brewing for the German government: Without being able to vaccinate on a broad scale, the country won’t be able to stop the virus. Which means that the fall and winter of 2021 could be similar to this year, with high infection rates, contact restrictions and lockdowns. The only remedy would be a massive increase in the number of vaccines that are approved for use.
But Berlin has made an uncompromising commitment to European solidarity on the vaccination issue. And that means it’s not only the influential and economically strong member states that will have access, but also smaller countries like Romania and Slovenia. If Germany were to go out on its own and buy up vaccine doses that are in short supply, it would massively threaten cohesion in a Europe that is already fragile.
At the same time, though, the German federal government has an obligation to do all it can to protect its people.
Scientists estimate that 60 to 70 percent of Germany’s population would need to be vaccinated in order to stop the virus. That would require 100 to 120 million doses because, with one exception, all the vaccines currently available have to be administered in two doses before they deliver immunity.
The EU has ordered a total of 1.3 billion doses from six different manufacturers. Germany is entitled to 18.6 percent of those doses in a distribution mechanism calculated according to its share of the EU population. That amounts to around 250 million doses. But the number is misleading.
Currently, the only deliveries that are certain are those from German-American consortium BioNTech/Pfizer and the American biotech company Moderna.
BioNTech, whose vaccine is to be approved by the EU on Dec. 21, will be able to supply around 45 million doses to Germany in the first half of the year, according to current estimates. Moderna, whose vaccine is due to be authorized for use in Europe on Jan. 6, could supply around 15 million doses. Together, that’s a total of 60 million doses, which is far too little.
But When?
Additional supplies are to come from four other producers with whom the EU has contracts. But it remains highly uncertain when they will be able to deliver. No matter what happens, no significant quantities are expected before the summer.
The Anglo-Swedish pharmaceutical company AstraZeneca had to interrupt its vaccine trial and delivered disappointing testing data. French company Sanofi has postponed possible approval for its vaccine candidate to the end of 2021. Meanwhile, the vaccine from CureVac, based in Tübingen, Germany, isn’t expected until this summer. The only company that is close to delivering another vaccine candidate is Johnson & Johnson in the U.S., and it isn’t expected until March.
Of course, not all of these developments could have been foreseen. The U.S., for example, believed that Sanofi would be quicker in delivering its vaccine. Still, the procurement of vaccines in Europe has been a bumpy road from the start.
Germany initiated a small vaccine alliance in the spring together with France, Italy and the Netherlands. In a first step, they reached an agreement with AstraZeneca for 400 million doses. The move was primarily intended as a means of exerting pressure because there wasn’t enough happening in Brussels. “Many countries around the world have already secured vaccines, but Europe hasn’t yet,” Health Minister Spahn warned at the time.
In mid-June, the European Commission subsequently presented an EU vaccine strategy to “ensure fair and equitable access for all across the EU.” Sufficient supplies for the member states were to be ensured by providing purchasing guarantees to manufacturers.
Health care is actually one of the competencies that is reserved for the member states in the EU. But the vaccine supply was meant to serve as a symbol of solidarity in contrast to the U.S., where Donald Trump was propagating his “America First” stance and fueling merciless global competition for the coveted vaccines.
Between August and October, the EU concluded the first of its contracts: with the pharmaceutical giants Sanofi, Johnson & Johnson and AstraZeneca. Even at the time, though, it was conspicuous that the companies with the most promising vaccine candidates were not given firm contracts. BioNTech and Moderna had already obtained promising results from their studies in July and were entering the home stretch.
No Comment
Behind the scenes, this was the source of anger and irritation within government circles in Berlin. The irritation grew significantly in November, when the companies published data that their vaccine candidates are each up to 95 percent effective.
The manufacturers have repeatedly made it clear that they intend to distribute the vaccine according to two criteria: population size and when the contract was signed.
Way back in July, the U.S. secured 600 million doses of the BioNTech vaccine and 500 million doses from Moderna. Japan, Canada, Hong Kong and others signed contracts in the summer and autumn. The EU only reserved doses. It didn’t place concrete orders until mid-November. And even then, it ordered far less than it could have.
A future vaccination center in Husum, the Netherlands: a fraction of what the Americans are getting
Foto: Shutterstock
The EU only secured 200 million doses from BioNTech, with an option for 100 million more that would be manufactured later. According to sources with knowledge of the negotiations, BioNTech had additional capacity and apparently offered that capacity to the EU: up to 500 million doses in the first round.
But the European Commission reportedly rejected the offer. European Health Commissioner Stella Kyriakides would not comment on the exact reason. “We do not comment on the progress of negotiations,” a commission spokesman said.
Why were only 300 million doses of a vaccine secured that had already demonstrated 95 percent efficacy in clinical trials at the time? One that had been hailed as a sensation and was already on its way to regulatory approval? German Health Minister Spahn pushed for more to be purchased, but he failed to prevail in the end due to opposition from several EU member countries — in part, apparently, because the EU had ordered only 300 million doses from the French company Sanofi. “That’s why buying more from a German company wasn’t in the cards,” says one insider familiar with the negotiations. The European Commission has denied that version of events, saying it isn’t true that Paris took massive steps to protect Sanofi.
However, similar reports have emerged from the negotiations with the U.S. producer Moderna. Studies also showed its product to have efficacy of 95 percent. But the EU only ordered 80 million doses. It has an option for another 80 million, but they wouldn’t be manufactured until a later date. “We could have provided more,” says Stéphane Bancel, CEO of Moderna, saying it could have been up to 300 million doses. But he said the EU didn’t want more.
And now, that decision is looking even worse.
Storm of Outrage
Last week, Sanofi in France was forced to announce that it had suffered a significant setback in the development of its vaccine. The company says it is no longer feasible for its vaccine to gain approval before the fourth quarter of 2021. The second phase of the clinical trial demonstrated surprisingly poor efficacy data in the elderly.
Bad luck, to be sure, but it’s precisely the reason why it makes sense to first buy in large quantities from the companies that have already successfully completed their clinical trials and not just hope that everyone else will ultimately deliver, too.
“That’s why, right now, whether Germany fares well or not hinges on the AstraZeneca vaccine,” says Karl Lauterbach, the health policy point man for the center-left Social Democratic Party and also an influential voice in Germany on the political response to the pandemic. “If Spahn says that 60 percent of the population could be vaccinated by the end of summer, what that really means is that he’s hoping that the AstraZeneca vaccine will be approved.”
Right now, development of the British-Swedish vaccine isn’t going particularly well either. Experts weren’t happy even with the design of the company’s study. AstraZeneca simply combined data from two studies into a single analysis.
One subgroup of around 2,700 subjects revealed an efficacy of around 90 percent, similar to that of the vaccines from BioNTech and Moderna. But among the rest of the test subjects, efficacy was just 62 percent. The fact that AstraZeneca combined these disparate results into an average efficacy of 70 percent triggered a storm of outrage. Particularly because the company didn’t provide a meaningful explanation for the discrepancy. Further studies are to follow.
In September, reports on possible side effects also alarmed the public. All trials had to be stopped because one subject developed weakness in her arms and legs, symptoms of transverse myelitis. When it was discovered that another subject had previously developed similar symptoms, alarm bells went off.
The trials resumed after it was determined that there had been no connection between the illnesses and the vaccine. But the Food and Drug Administration (FDA) has already announced that the AstraZeneca vaccine is unlikely to be approved in the U.S. before summer, if at all. In light of all the problems, it seems highly unlikely at this stage that the European authorities would rush it through and approve it by spring.
But even if the vaccine ends up being approved, it will probably only have an efficacy of 60 to 70 percent. “What are you going to do with the 70 percent when you’ve got two (vaccines) that are 95 percent? Who are you going to give a vaccine like that to?” Anthony Fauci, the leading American expert on vaccines, recently wondered.
The other candidates still in development could wind up with similar results. No one can say right now whether they will be able to achieve efficacy at a similar level as the BioNTech and Moderna vaccines.
So, what now?
The EU intends to exercise its option on the further 80 million doses from Moderna and 100 million from BioNTech. It is unclear when they can be delivered, although it is most likely they will come in the second half of the year. And those supplies still won’t be enough to cover what is needed Europe-wide.
More than Enough
The European Commission, for its part, doesn’t see this as a problem and is instead praising its own management. “The EU vaccine portfolio is proof of what we can achieve when we work together as a strong European Health Union,” says Health Commissioner Stella Kyriakides.
She says the Commission has selected the most promising and advanced vaccine candidates, which are also based on different technologies. “To ensure that we have as a diverse a portfolio as possible,” Kyriakides says. “In total, we have bought more than enough doses for everyone in Europe,” European Commission President Ursula von der Leyen told the European Parliament on Wednesday, without any hint of self-criticism.
Sources in Brussels say that it wouldn’t have been possible to achieve much more in terms of vaccine procurement under the circumstances. The smaller companies, particularly, would have difficulty conducting simultaneous negotiations with various governments around the world. Brussels sources also say that negotiations with BioNTech partner Pfizer, in particular, were difficult.
In Berlin, the self-satisfaction in Brussels is being viewed increasingly critically. “Germany could also buy additional vaccine bilaterally, directly from the companies, and I think we should do that,” says SPD health policy coordinator Lauterbach.
The German government itself also appears to have recognized that it is too risky to leave procurement of vaccines to the EU alone. If, in fact, there are too few doses available in the coming months to effectively contain the pandemic, politicians will have difficulty explaining why they didn’t take this matter of life and death into their own hands.
Behind the scenes, work is already underway to order additional doses from BioNTech and Moderna. The additional deliveries would likely first come in the second half of the year, but it would ensure supplies if none of the other vaccines are convincing.
Months ago, the federal government worked to organize a national effort for procurement from all the vaccine manufactures in addition to the EU program. In September, BioNTech, CureVac and the Dessau-based company IDT Biologika all received a total of 750 million euros in funding from a special Research Ministry budget. In return, it was agreed that millions of doses would be secured exclusively for use in Germany. In the case of BioNTech, that figure is around 30 million.
Running Out of Time
But there is one hitch: Deliveries to the EU have priority. And a contract is also needed for that special contingent, but it hasn’t yet been signed, according to company sources. So far, there have only been declarations of intent. The contracts can only be concluded once the doses earmarked for the EU have been delivered.
Regardless whether the EU or the German government is negotiating: Time is running out. BioNTech’s and Moderna’s capacities are largely booked up until well into the summer. BioNTech is working a full speed to complete a new factory in Marburg, Germany, as early as this spring, considerably faster than originally planned. This was also the subject of the non-public part of Chancellor Merkel’s discussion with the BioNTech founders. This would allow additional doses to be produced, primarily for the EU and Germany. Until then, though, new orders will be placed at the end of the list.
Other countries are also pushing for more vaccine doses from BioNTech and Pfizer, most notably the U.S. As early as the beginning of December, the U.S. government sought to secure 100 million additional doses for the first half of the year..
Pfizer initially declined, saying its capacities are exhausted until summer. But now they are negotiating, after all. “The company could provide many of those doses in the third quarter of 2021, but the U.S. government is pushing for it in the second quarter,” Pfizer CEO Albert Bourla recently stated. Pfizer has very clearly told the U.S. government under which conditions this would be possible: If the U.S. government instructs the external American suppliers by decree to preferentially supply Pfizer with the raw materials needed for the vaccine – and not others.
This shows what is in store for the coming months: an ugly global race for enough vaccine that will by no means be fair. Those who lose will, at least initially, be denied a path out of the pandemic.
