The challenge for the EU: unlike these other countries, which are giving the green light to the emergency blow, the bloc is waiting for the European Medicines Agency to issue a conditional marketing authorization (CMA) – full approval one year. This process involves two independent scientific assessments, consensus among EU countries (in most cases) and agreement on the responsibility and responsibilities of drug manufacturers.
The agency is expected to make a decision by December 29 at the latest. Regulators at the agency’s headquarters in Amsterdam and in each EU country are working around the clock, and will do so thro
over the Christmas holidays, to review data on vaccine safety, efficacy and manufacturing quality while the world waits.
For some, this delay is not justified. Hungarian Prime Minister Viktor Orbán criticized the slowness with which the EU was making progress earlier this month, and at Thursday’s EU summit Polish Prime Minister Mateusz Morawiecki urged Commission President Ursula von der Leyen to step up approval after eight to ten days only, pointing to the UK which started using a vaccine a few days earlier. She pushed back, insisting the EU can’t go any faster.
In addition to pressure from some politicians, the agency is also feeling pressure from another source: vaccine skeptics.
Europe is the most vaccine-skeptical continent in the world, and many citizens are worried that a vaccine will be deployed in record time. During a hearing in the European Parliament last week, Spanish MEP Margarita de la Pisa Carrión, of the far-right Vox party, warned that the agency was moving too quickly. “There just isn’t enough time to know the long-term effects,” she warned.
The approval of a coronavirus vaccine is the EMA’s most publicized test, as it tries to strike the perfect balance between politicians’ need to get out of the pandemic quickly and some of the public fear to with regard to vaccines.
For now, the EMA and the Commission are playing the long game, betting that the extra time spent evaluating the data will convince the continent to actually use the vaccines when they are approved. The cost could be a few weeks behind compared to other major Western countries, but that means all countries in the EU will have an approved vaccine to use at the same time.
“Although speed is essential, security is our number one priority,” the agency’s new boss, Emer Cooke, told MEPs this week. “These vaccines will be administered to millions of people in the EU, and we are fully aware of the enormous responsibility we have to implement these recommendations to protect the European population. ”
Too many cooks?
The heat von der Leyen faced on Thursday is pale in comparison to the pressure that US President Donald Trump put on the US Food and Drug Administration to approve a vaccine before the US election and then before Europe .
Friday, hours before FDA approves BioNTech / Pfizer jab, Trump tweeted that the agency is a “big, old and slow turtle” and urged his boss to “get the dam [sic] vaccines NOW. ”
So far, this kind of rhetoric has not shaken the EMA, which has constantly struggled to explain why the CMA process is taking longer. One of its main talking points is that a MAC is a full approval of a vaccine – but with less data than what is required for a standard authorization. On the other hand, if an emergency use authorization allows the use of a specific batch of vaccine, an “unauthorized” product remains.
As Saad Shakir, director of the Medicines Safety Research Unit at the University of Portsmouth, explains, the principles of UK and EU authorization are similar, but the processes are different.
In the EMA system, a reporter and a co-reporter conduct two independent drug reviews. Countries can also carry out their own internal assessments. This means that when the request finally reaches the EMA’s Committee for Medicinal Products for Human Use, which is made up of representatives from member countries, the request went through many hurdles, including evaluations of the applicants’ risk management plan for when the drug is authorized. . It then needs the approval of the majority of the committee members – at least half of the members plus one – to get a recommendation.
The last step is with the European Commission, which has to approve the EMA recommendation, which is almost always the case.
The agency and the Commission have speeded up these processes for coronavirus vaccines. For example, the consultation period of the EU Standing Committee has been shortened from 22 days to one. The agency has also reallocated resources and staff to assess coronavirus vaccines.
Cooke and von der Leyen have both made this process the gold standard for vaccine authorizations, saying it ensures the right systems are in place to monitor the safety of the vaccine after it is approved.
The flip side is that the involvement of 27 member countries makes the process more bureaucratic. Involving ‘the whole EU in decision-making’ takes time, said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine and former independent expert on the Pharmacovigilance and Monitoring Committee. EMA risk assessment (PRAC).
“The consequence is that the workload is shared, that the decision making is shared,” said Evans. “When you do that, it means you’re going to be a little slower in an emergency. ”
While pooling so many opinions can slow things down, it also gets very strong buy-in from the bloc, which is essential for mass vaccination programs to work, said Daniel Morales, Wellcome Trust clinical researcher. in population health and genomics at the University. of Dundee and independent expert on the PRAC.
Either way, evaluating a drug simply takes time, says Thomas Lönngren, former director of the EMA and currently a consultant at NDA Group: “It is a scientific evaluation of a complex dossier of several thousand. of pages – it takes time. in the right way.
The other major difference between the two routes concerns liability for unforeseen adverse reactions to the vaccine. While the EU approval will hold drugmakers accountable, the UK has waived this right.
When the UK government brought the BioNTech / Pfizer vaccine to market, it awarded the company “civil compensation to protect the company (and healthcare professionals) from civil lawsuits for damages related to unforeseen complications.” resulting from the administration of the vaccine, ”said Vincenzo Salvatore, former EMA general counsel and now attorney at BonelliErede law firm. This is not “meaningless,” Salvatore said, in fact it means that the drug makers are indemnified for most of the civil liability, with the government taking on that liability instead. The current option for patients is to claim through the UK’s Vaccine Damage Payment, although there have been calls for a more comprehensive system.
For this and other reasons, some European politicians have openly criticized the UK for being rushed. Pascal Canfin, the head of the European Parliament’s health committee, called it a “bad” choice this week.
But most of the experts held on. Many note that the UK Medicines and Health Products Regulatory Agency (MHRA) has long played a leading role in Europe for its regulatory assessments. As Shakir points out, without Brexit, the UK would probably have been one of the rapporteurs on the BioNTech / Pfizer app.
The UK might have been able to approve a vaccine faster as it no longer had to participate in the EMA’s drug reviews since the start of the Brexit transition period – which meant its internal experts had more time to devote to BioNTech / Pfizer authorization, Evans explained.
But beware, the good news may not last long for the UK. As more vaccines are submitted for approval, Evans believes that the MHRA, as a single national regulator, may not be able to assess multiple vaccines at once. On the other hand, the EMA could, because of the way it distributes the evaluations among the Member States.
As for the US system, experts point out that it is different from the EU in that FDA statisticians regularly reanalyze raw data and reconstruct tables provided by companies.
It is not only in this regard that “the EMA is not a European FDA,” said Evans. The FDA also performs its own assessment reports, while the EMA is a coordinating body for the 27 member states.
The different approval processes and deadlines all have their justifications, but they are still confusing to the public. “The different rhythms [of different agencies] … Can jeopardize the reliability and accountability of the regulatory system as a whole, ”Salvatore said.
That said, the pressure isn’t helping regulators, Lönngren warned. He was the head of the EMA in 2009, during the H1N1 swine flu pandemic, and he was grateful that there was no external pressure to speed things up. He notes that regulators themselves feel the pressure to do it quickly and correctly – and recalls working day and night to study these vaccines.
“There shouldn’t be a race between regulators,” Lönngren said. “There shouldn’t be any speculation that someone didn’t do it right, or did it too fast, or did it too slowly. ”
“It doesn’t help the confidence people have to have in the regulatory process to bring a vaccine to market,” he warned.
Florian Eder contributed reporting.
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