The U.K., Canada and even Bahrain beat Brussels in approving the BioNTech/Pfizer coronavirus vaccine. And now, with the news late Friday that the U.S. has followed suit, pressure is mounting on the EU to pull the trigger.
The challenge for the EU: Unlike these other countries, which are green-lighting the jab on an emergency basis, the bloc is waiting for the European Medicines Agency to issue a conditional marketing authorization (CMA) — a one-year full approval. This process involves two independent scientific assessments, along with a consensus among EU countries (in most cases), and an agreement about the liability and responsibilities borne by the drugmakers.
The agency is expected to make a decision by December 29 at the latest. Regulators in the agency’s Amsterdam headquarters and in each EU country are working around the clock, and will do so thro
ugh the Christmas holiday, to pore over the data on vaccine safety, efficacy and manufacturing quality while the world waits.
To some, this lag isn’t justified. Hungarian Prime Minister Viktor Orbán criticized how slow the EU is moving earlier this month and, at the EU summit on Thursday, Polish Prime Minister Mateusz Morawiecki pressed Commission President Ursula von der Leyen to accelerate the approval to just eight to ten days, pointing to the U.K. which began using a vaccine just days earlier. She pushed back, insisting the EU can’t go any faster.
On top of the pressure from some politicians, the agency is also feeling pressure from another source: Vaccine skeptics.
Europe is the most vaccine skeptic continent in the world, and many citizens are worried about rolling out a vaccine in record time. During a European Parliament hearing this past week, Spanish MEP Margarita de la Pisa Carrión, from the far-right Vox party, cautioned the agency is moving too hastily. “There is simply not enough time to know the long-term effects,” she warned.
Approving a coronavirus vaccine is the EMA’s most high profile test ever, as it tries to strike the perfect balance between politicians’ need for a speedy way out of the pandemic and some of the public’s fear of vaccines.
For now, the EMA and Commission are playing the long game, betting that the extra time spent assessing the data will convince the Continent to actually use the vaccines when they are approved. The cost could be a few weeks’ lag behind other major Western countries, but it means all EU countries will have an approved vaccine to use at the same time.
“While speed is of the essence, safety is our No. 1 priority,” the agency’s new boss, Emer Cooke, told EU parliamentarians this week. “These vaccines will be given to millions of people in the EU, and we are keenly aware of the huge responsibility we have to get these recommendations right to protect the European population.”
Too many cooks?
The heat that von der Leyen faced Thursday pales in comparison to the pressure that U.S. President Donald Trump put on the U.S. Food and Drug Administration to approve a vaccine before the U.S. election and then before Europe.
On Friday, hours before the FDA approved the BioNTech/Pfizer jab, Trump tweeted that the agency is a “big, old, slow turtle” and urged its boss to “get the dam [sic] vaccines out NOW.”
So far, that sort of rhetoric hasn’t shaken the EMA, which has continually taken pains to explain why the CMA process takes longer. One of its key talking points is that a CMA is a full approval of a vaccine — albeit with less data than required for a standard authorization. By contrast, while an emergency use authorization allows a specific batch of vaccine to be used, it remains an “unlicensed” product.
As Saad Shakir, director of the University of Portsmouth’s Drug Safety Research Unit, explains it, the principles of the British and European authorizations are similar, but the processes are different.
Under the EMA system, a rapporteur and co-rapporteur conduct two independent assessments of the drug. Countries may also do their own internal assessments. This means that when the application finally gets to the EMA’s Committee on Human Medicinal Products, which is made up of representatives from member countries, the application has passed through numerous hoops, including assessments of the applicants’ risk management plan for when the drug is authorized. It then needs the signoff of a majority of the committee members — at least half the members plus one — to get a recommendation.
The last step is with the European Commission, which has to sign off on the EMA’s recommendation, which is almost always the case.
The agency and Commission have expedited these processes for coronavirus vaccines. For example, the consultation period from the EU’s standing committee has been shortened from 22 days to one. The agency has also reallocated resources and staff to assess coronavirus vaccines.
Both Cooke and von der Leyen have held up this process as the gold standard for vaccine authorizations, arguing it ensures the right systems are in place to monitor the safety of the vaccine after it’s approved.
The flip side is that having 27 member countries involved makes the process more bureaucratic. The participation of the “entire EU in the decision making” takes time, said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine and former independent expert member of the EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC).
“The consequence is that the workload is shared, that the decision making is shared,” Evans said. “When you do that, then it means you are going to be a bit slower when there’s an emergency.”
While pooling so many opinions may slow things down, it also gets the all important buy-in from the bloc, which is key for mass vaccination programs to work, said Daniel Morales, Wellcome Trust clinical research fellow in population health and genomics at the University of Dundee and independent expert on PRAC.
But no matter what, assessing a drug simply takes time, argues Thomas Lönngren, a former director of the EMA and currently a consultant at NDA Group: “It is a scientific assessment of a complex file with thousands of pages — it takes time to do it in the proper way.”
The other major difference between the two tracks involves liability in cases of unforeseen adverse reactions from the vaccine. Whereas the EU approval will hold drugmakers liable, the U.K. waived this right.
When the British government put the BioNTech/Pfizer vaccine on the market, it granted the company “civil legal indemnity to protect the company (and health care professionals) from civil claims for damages related to any unforeseen complications arising from administration of the vaccine,” said Vincenzo Salvatore, a former general counsel for the EMA and now counsel at the law firm BonelliErede. It is not “meaningless,” Salvatore said, in fact, it means that drugmakers have indemnity from most civil liabilities, with the government instead taking on this responsibility. The current option for patients is to claim through the U.K.’s Vaccine Damage Payment, although there have been calls for a more comprehensive scheme.
For this and other reasons, some European politicians openly criticized the U.K. for its haste. Pascal Canfin, the head of the European Parliament’s health committee, called it “the wrong” choice this week.
But most experts have held their fire. Many note that the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has long played a leading role in Europe for its regulatory assessments. As Shakir points out, if it weren’t for Brexit, the U.K. likely would have been one of the rapporteurs on the BioNTech/Pfizer application.
The U.K. may have been able to approve a vaccine more quickly because it no longer had to take part in the EMA’s drug assessments since the Brexit transition period began — which meant its in-house experts had more time to devote to the BioNTech/Pfizer authorization, explained Evans.
But some caution the good news might not last for long for the U.K. As more vaccines are submitted for approval, Evans believes, the MHRA, as a single national regulator, may not be able to assess several vaccines at one time. By contrast, the EMA could, because of the way it distributes assessments among member states.
As for the U.S. system, experts point out that it’s different from the EU in that FDA statisticians regularly re-analyze the raw data and reconstruct the tables that companies provide.
It’s not just in this respect where “the EMA is not a European FDA,” said Evans. The FDA also carries out its assessment reports by itself, while the EMA is a coordinating body for the 27 member states.
The different approval processes and timelines all have their rationales, but they’re still confusing to the public. “The different paces [of different agencies] … may put at stake the reliability and accountability of the regulatory system as a whole,” Salvatore said.
That said, pressure doesn’t help regulators, Lönngren warned. He was head of the EMA back in 2009, during the H1N1 swine flu pandemic, and he was grateful there was no external pressure then to speed things up. He notes that regulators feel the pressure themselves to do this quickly and correctly — and recalls working day and night to study those vaccines.
“There shouldn’t be any race between regulators,” Lönngren said. “There shouldn’t be speculation that someone didn’t do it right, or did it too fast, or did it too slow.”
“It doesn’t help the confidence people need to have in the regulatory procedure to get a vaccine on the market,” he cautioned.
Florian Eder contributed reporting.
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