Europe's COVID Vaccine Bids Still Veiled in Secrecy

Applied Clinical TrialsApplied Clinical Trials-10-01-2020
Volume 29
Issue 10

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available.

It was around the spring equinox this year that the COVID-19 challenge really started to bite in Europe. Now, just after the autumn equinox, Europe is still a long way from finding vaccines to fight back—as a hearing in the European Parliament on Sep. 23 confirmed. Industry representatives made reassuring noises about progress with candidate vaccines, but recognized that there was no guarantee of success in their efforts, and it would be next year—at best—before any real response would be available. Officials from the European Medicines Agency (EMA)—which has to approve any vaccine before it can be used in Europe—confirmed, as of late September, that they had as yet received no data from any of the companies developing vaccines in Europe. And members of parliament anxious to check on industry progress were left dissatisfied or disappointed.

In particular, the hearing focused on the deals that drug firms are reaching with European authorities, in which companies are receiving billions of euros to speed up the development and production process, in return for commitments to supply the EU with specified quantities of vaccines. Members of European Parliament (MEPs) wanted to make sure that drug firms were not being given a blank check from public funds, while charging what they wanted for their products and dodging responsibility for any side effects.

“Is Europe getting value for money from the arrangement,” they questioned. “When can EU citizens expect safe and effective protection to be delivered?”

The answers—from senior executives of Sanofi, CureVac, and the vaccine industry’s European trade body—did not go far enough for the chairman of the parliament’s health committee, Pascal Canfin. “Today, we have very little information on the content of the contracts that have been signed by the European Commission and some laboratories,” he said at the end of the hearing. “We wanted to have more information on the state of research, the commitments made by laboratories, and whether they will be able to meet them. We do not even know how many of these contracts there are.” And like many of his fellow MEPs, he accused the industry and the European authorities of a lack of transparency.

German socialist Tiemo Wölken, an influential MEP in health matters, cited allegations that the industry was demanding unprecedented liability exemptions and wanted to know why the contracts—and all the details of prices and costs and criteria and milestones—were being guarded so secretively. It was, he said, an issue of trust on a matter of massive public interest. His approach was echoed widely by other MEPs during the two-hour session.

There were some answers. “Everyone will have the right to have the data—transparency will be there,” said Jean Stéphanne, board chairman of CureVac, which is in the final stages of agreeing a contract with the EU. But, he insisted, not yet.

Thomas Triomphe, EVP of Sanofi Pasteur, which has signed a contract to provide 300 million doses of its recombinant protein technology vaccine combined with an adjuvant provided by GlaxoSmithKline, currently in Phase I/II trials, said, “Our price will be made public.” He also said that costs will also be revealed. But they will be disclosed later, only when it becomes clear what the dosage is for the vaccine.

“We understand the interest in the details of the contracts,” said Sue Middleton, president of the industry association Vaccines Europe. But, she said, there are issues of competition that must be respected until all the contracts are complete. “There are commercial confidentiality reasons for the details not at present being in the public domain,” she said. Since the European Commission has already indicated that prices will be in the range of €5 to €15 (about $6 to $18 USD) a dose, that is sufficient for the moment, she added, and “it is right” that the exact prices are not yet available.

On responsibilities, Middleton told MEPs that manufacturers are liable if there is deliberate misconduct or good manufacturing practice violations, but for unexpected events in large populations there will be indemnification by the European Commission or member states on the costs of legal action.

Stéphanne added that without liability protection, there would be “no chance of vaccine development.”

Canfin concluded the hearing by stating that his committee would be coming back to industry with a detailed list of further questions. It is starting to look increasingly like it may be the next spring equinox before much clarity emerges on Europe’s vaccine hopes.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium

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