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The European Union’s medical regulator approved AstraZeneca and the University of Oxford’s COVID-19 vaccine on Friday, for anyone age 18 or older.
The decision runs counter to the recommendation of top German government advisers who have argued that the lack of data about the vaccine’s efficacy in people age 65 or older—a group underrepresented in AstraZeneca’s trials—was a reason not to give the vaccine to the elderly.
However, the European Medicines Agency’s recommendation is in line with the stance of British regulators, who approved the vaccine’s use at the end of December, and with that of AstraZeneca itself.
“Most of the participants in these studies were between 18 and 55 years old. There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group,” the EMA said Friday.
“However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults. More information is expected from ongoing studies, which include a higher proportion of elderly participants.”
Still, that assessment may not win over some of Europe’s toughest critics. Prior to the EMA decision, French President Emmanuel Macron told reporters on Friday that “today everything suggests that it is almost ineffective for those over 65, and some say over 60.”
Bruno Sepodes, the vice chair of the EMA’s Committee of Human Medicinal Products, said at Friday’s press conference that the committee had made its recommendation by consensus, meaning representatives of every EU country ended up voting to green-light AstraZeneca’s vaccine for use among all adults.
However, the German vaccine commission said Friday that it was maintaining its recommendation not to give the vaccine to people aged 65 or over.
Waiting on data
“Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine, which is not only effective and well tolerated but also easy to administer and, importantly, protects fully against severe disease and hospitalizations,” said Pascal Soriot, AstraZeneca’s CEO, in a statement.
The EMA’s announcement is extremely good news for the EU’s vaccination efforts, as it is people in older age groups who are at most risk from COVID-19 and who are typically getting vaccinated before younger people.
However, in a press conference, EMA executive director Emer Cooke said AstraZeneca still hadn’t provided data to indicate its vaccine’s efficacy against the fast-moving new variants of the coronavirus.
Shot in the arm
Many European countries have been slower to vaccinate their populations than other countries. Denmark, which is currently leading in EU vaccinations, has administered at least one dose of a COVID-19 vaccine to about 3.6% of its population. This compares with more than 10% in the U.K., 45% in Israel, and about 6.5% in the U.S.
The rollout of vaccines across the region has been slowed by production delays at manufacturing sites, which has frustrated and angered European politicians. First it was Pfizer/BioNTech, then AstraZeneca. On Friday, Moderna became the latest vaccine maker to deliver bad news to Europe, telling France and Italy that it would deliver about 25% fewer doses in February than originally planned.
Of the three vaccines approved so far, AstraZeneca’s was less effective overall in clinical trials than those from Pfizer and Moderna, but it has several key advantages: It is less expensive and can be stored and transported at normal refrigerator temperatures, while the other vaccines must be stored in ultra-freezing conditions requiring specialized equipment. Europe has preordered 300 million doses of AstraZeneca’s jab, with an option for another 100 million more.
The AstraZeneca immunization will also be critical to vaccinating much of the world’s population in less developed countries, because of its lower cost and easier storage requirements. International vaccine funding bodies have provided AstraZeneca with hundreds of millions of dollars to supply 1.3 billion doses for low- and middle-income countries.
Unlike many rival drug companies, AstraZeneca has pledged to supply its vaccine “at cost” for the duration of the pandemic. However, the company’s contracts allow it to unilaterally declare the pandemic concluded this July.
European trouble
The company had initially told the EU it would deliver 80 million of those doses by the end of the first quarter of 2021. But owing to a manufacturing problem at its plant in Belgium, AstraZeneca said that it would be able to deliver only about 30 million doses, angering EU leaders who have threatened to sue the company to force it to deliver the promised amount.
Soriot has said that the company’s contract with the EU only required it to make a “best effort” to meet the production schedule, but the company initially refused to allow the European Commission to publish the confidential contract.
On Friday, however, AstraZeneca relented and allowed the commission to publish a redacted version of the agreement that did contain the “reasonable best effort” language Soriot had cited, but also contained a promise to deliver a certain number of doses in the first quarter. The exact amount and timeline for delivery were redacted.
Redaction errors in the document that the commission published showed that the total cost of its AstraZeneca order was €870 million.
The contract also says AstraZeneca could use manufacturing facilities in the U.K. To supply the EU. That may be critical because the EU has said it wants AstraZeneca to divert supplies from the U.K. And elsewhere to make up for the shortfall from its Belgian plant. AstraZeneca has said that it won’t do that, as it contracted to provide 100 million doses of the vaccine to the U.K. In a contract signed three months before it reached its agreement with the EU.
In a press conference Friday evening, Soriot said that AstraZeneca was trying to move in “raw drug substance” from other regions to the European Union, but he declined to specify where exactly these supplies were coming from, saying he “didn’t want to fuel other questions.”
The disagreement between AstraZeneca and the EU has been contentious, with European Commission President Ursula von der Leyen telling reporters that the company has still not offered an adequate explanation for why it cannot meet the promised delivery schedule. EU politicians are also angry that the company apparently waited weeks to notify the European Commission of the production delay as it scrambled to try to fix the problem, even though the contract says the company should notify the commission as soon as it becomes aware of any shortfalls.
Soriot said Friday that the company had notified the Commission as soon as it understood the nature of the production problem and how it would likely impact the dosages it could deliver, saying that it did require some time for AstraZeneca to ascertain why the plants were not producing as much as anticipated.
The CEO also expressed some frustration with the criticism from European politicians. “What we have done, no one thought was possible nine months ago and now it has been done everyone takes it for granted and thinks it is simple,” he said. “It is not simple.” He said the company was doing everything it could deliver as much vaccine to the EU as it could.
Export controls
Some EU lawmakers even accused the company of “sneaking doses” out of the region to supply other places. AstraZeneca has said that some doses made in the U.K. Are packaged into vials in Germany before being shipped back to the U.K. For distribution, but that it has not sent doses made within the EU elsewhere.
On Friday, the commission unveiled export restrictions that could stop vaccine manufacturers from exporting doses to many countries, if those manufacturers are not holding up their side of the EU’s existing preorders. Many countries are exempted—among them, European Free Trade Association (EFTA) countries such as Norway and Switzerland, low-income countries that are receiving vaccines on a humanitarian basis, and the EU’s eastern and southern neighbors—but the U.K. Is not one of these.
“The measure is not targeting any specific country,” said European Commission Executive Vice President Valdis Dombrovskis in a Friday press conference. However, the commission’s decision to implement export controls has drawn a rebuke from the International Chamber of Commerce, which said in a letter to President Von der Leyen that the restrictions—as well as likely retaliatory measures by other countries—would “very rapidly erode essential supply chains” for all the major vaccine producers.
The U.K. Has also imposed strict export controls that might prevent AstraZeneca from using its British plant to supply the EU, even if it were to agree to do so.
Also on Friday, Johnson & Johnson released interim data from its large-scale vaccine trial, suggesting a 66% efficacy rate when excluding mild cases of COVID-19. Investors were clearly displeased, sending J&J’s share price down more than 4% on the news.
J&J’s vaccine is, like AstraZeneca’s, low cost—both companies say they will be sold at cost during the pandemic—and easy to store and transport. What is more, it requires only one dose rather than two. That makes its prospects highly relevant to the question of how much the EU must rely on AstraZeneca’s vaccine over the course of this year. The EU has secured up to 400 million doses of J&J’s candidate vaccine.
As for its timeline, J&J said Friday that it intends to apply for U.S. Emergency authorization early next month.
J&J’s vaccine and AstraZeneca’s, the latter of which was jointly developed with scientists from the University of Oxford, use a similar underlying technology: A different kind of virus, called an adenovirus, is modified so that it can’t replicate and so that, when it infects a cell, it instructs it to make the same spike protein found on the coronavirus. This in turn prompts an immune response to the spike protein that should protect the person against the actual coronavirus. The J&J vaccine uses a human adenovirus while the Oxford/AstraZeneca vaccine uses a chimpanzee adenovirus.
In both cases, these viruses must be grown in specialized bioreactors, in a sensitive manufacturing process that some have equated more to a commercial baking or brewing operation than a traditional drugmaking plant. It is a problem with the bioreactor at the Belgian plant that is the source of the production problems for AstraZeneca.
This story has been updated to include additional comments from AstraZeneca CEO Pascal Soriot, and to note the German vaccine commission’s continued opposition to administering the vaccine to people aged 65 or older.
