January 29 was supposed to be a big day, when the EU finally got its cheap, easy-to-use coronavirus vaccine.
Instead, Friday’s expected thumbs-up from the European Medicines Agency is just a drop of good news amid a tsunami of AstraZeneca disappointment.
The EU has been in uproar following the news last Friday that the bloc would receive at least 75 million fewer vaccine doses than planned by the end of March.
The revelation sparked a week-long battle in which Brussels and AstraZeneca sparred with anger and threats — the company’s CEO blamed the EU for being too slow to sign its contract, and the Commission is making good on its threat to implement export controls after accusing the company of selling its stock elsewhere.
Now it’s the EMA’s turn to wade into the drama, all the more contentious after German scientists said Thursday that there wasn’t enough data to prove the effectiveness of the Oxford/AstraZeneca jab in people aged 65 and older. The statement followed hotly contested German media reports on Monday that the jab was only 8 percent effective in that age group.
In an explosive interview with la Repubblica Tuesday, AstraZeneca CEO Pascal Soriot said the paltry data for that cohort was deliberate.
“Oxford is an academic group; they’re very ethical, and very academic, so they didn’t want to vaccinate older people until they had accumulated a lot of safety data in the 18 to 55 group,” said Soriot. “They said it was not ethical to vaccinate old people until they had enough safety data in younger people.”
Regardless of whether this was intentional, the EMA’s scientific committee can only make a decision based on what data it has at hand. Earlier this week, EMA chief Emer Cooke declined to speculate on what kind of authorization its scientists would make Friday — but she didn’t rule out that it could be made exclusively for people under the age of 65.
“It is possible to conclude an authorization that would focus on a particular age group, or it’s possible to conclude for a wider age group,” she told MEPs on Tuesday. “The importance for us is to be very transparent about what data has been seen, what evaluation has been made to come to a conclusion on whatever the decision will be and why we are confident that this is the right decision.”
This is not the first time Oxford/AstraZeneva has lacked data. The duo’s clinical trials showed the vaccine was 90 percent effective in a group that accidentally received an initial half-dose, compared to 62 percent effective in the wider group that received the two full doses. Still, only a small group of 1,367 people received the initial half-dose.
So far, regulators in the EMA’s human medicines committee have looked at data as part of a rolling review. They should decide Friday whether to recommend the vaccine for a conditional marketing authorization, which would allow the jab to be used in all 27 member states for the next year as the drugmaker submits more data.
The CMA would also give the company the green light to start sending shipments of the 300 million doses secured by the Commission.
The broad expectation is that regulatory approval is likely, but thanks to the issues with the clinical trials and scant data in older people, there remains more uncertainty about what the EMA’s scientific committee will decide. Here are the possibilities:
Full conditional marketing authorization
The EMA’s committee could recommend a full conditional marketing authorization. If the application is similar to that for the U.K., then it’s for the active immunization of individuals 18 years or older with a full, two-dose regime of its viral vector vaccine. The U.K. said it could be administered with an interval of between four and 12 weeks, but it remains to be seen what interval the EMA might back.
The Commission could then grant the authorization within hours.
As with all conditional marketing authorizations, the license will be valid only for one year and will depend upon the company completing, as the law states, “ongoing studies, or [conducting] new studies, with a view to confirming that the risk-benefit balance is positive and providing the additional data.”
The EU’s authorizations for the BioNTech/Pfizer and Moderna jabs, for example, obliged the companies to submit more data on how the vaccines work in children and pregnant people, whether they decrease the transmission of the virus and other safety data. These two vaccines have ongoing clinical trials spanning two years.
Deliveries of the vaccine would then be approved to roll out across the bloc, albeit in smaller quantities than first promised.
The EMA could restrict the use of the vaccine to those under 65 if it feels the data is not strong enough.
“Any kind of marketing authorization, whether full or conditional, can limit the administration of the medicinal product to a specific set of the population,” said Vincenzo Salvatore, former general counsel for the EMA and current counsel at Milan-based law firm BonelliErede. An example, he explained, could be that the jab is administered only to adults between 18 and 55 years old.
Even if European regulators issue an authorization for people under the age of 65, as the German scientific committee has suggested, the EMA could expand its authorization to include that population after the company sends more data.
AstraZeneca is carrying out another large-scale clinical trial in the U.S. This is expected to deliver more data on the vaccine’s efficacy in older people soon, according to Peter Liese, the European People’s Party’s health spokesperson in the European Parliament. “We will know in weeks,” he told reporters Thursday.
Another scenario: The EMA’s committee rejects the company’s authorization application after concluding that the benefits of the vaccine don’t outweigh the risks.
In this case, the company can reapply, submitting more data to satisfy concerns raised by the agency — but this outcome is seen as unlikely.
The vaccine’s combined 70 percent efficacy rate is still above the minimum 50 percent threshold set by the EMA back in November. The scientists would have to find that the data do not show that the benefits outweigh the risks, and that the efficacy rate falls short of the target.
Ashleigh Furlong 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@example.com for a complimentary trial.
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