EU Makes More Vaccine Deals as Questions Mount Over Terms

Applied Clinical TrialsApplied Clinical Trials-09-01-2020
Volume 29
Issue 9

The European Commission has concluded exploratory talks, with Moderna, over the purchase of a fifth potential vaccine against COVID-19.

The European Commission concluded exploratory talks on Aug. 24 over the purchase of a fifth potential vaccine against COVID-19, following similar outline deals over the last fortnight with Sanofi-GlaxoSmithKline, Johnson & Johnson, CureVac, and the signature of a more definitive agreement on advance purchase with AstraZeneca.

The new contract envisioned under the outline deal with Moderna covers an initial purchase of 80 million doses plus an option to purchase up to a further 80 million—on the assumption that the vaccine is shown to be safe and effective. It would allow all European Union countries to purchase the vaccine for their own use, as well as to donate to lower and middle-income countries or redirect to European countries.

US-based Moderna’s vaccine is based on messenger RNA, transferring the instructions which direct cells in the body to make proteins, including proteins that may prevent or fight disease. Ursula von der Leyen, President of the European Commission, said, “We invest in companies using diverse technologies to increase our chances to have vaccines that are safe and effective.” Stella Kyriakides, commissioner for health and food safety, added that a diversified portfolio of vaccines is “a necessity to ensure eventual success and protect our citizens against coronavirus.” Any eventual advance purchase agreement for a vaccine would be financed through emergency instruments that the EU has created as part of its coronavirus recovery strategy.

The Commission is continuing talks with other companies on behalf of all 27 member states, after Germany, France, Italy, and the Netherlands dropped their four-country procurement alliance to join the EU approach. The group has asked the Commission to take over and finalize the contract the four were discussing with AstraZeneca and has committed to the principle of not carrying out parallel negotiations.

Meanwhile, questions continue to emerge over access to the vaccines, and over the terms of the agreements under negotiations. In addition to the long-running debate over whether purchases by rich countries will leave poorer countries unable to acquire stocks, and over how the EU will meet its declarations of access for all, individual EU member states are now pondering how to distribute their stocks when they become available. No consensus has yet emerged on whether to prioritize health workers, the elderly, other vulnerable sections of the population, or those in employment. In many countries, this discussion is further complicated by the issue of securing sufficient population coverage in the face of rising vaccine hesitancy, and whether vaccination should be made mandatory, conditional, or remain voluntary.

The allegations from many health activists of drug industry profiteering from blank checks in emergency procurement programs has also been given a new twist by controversy over AstraZeneca’s reported request for protection from liability in the event of late-discovered side effects of its vaccine. Thierry Vansweevelt, professor of medical law at the University of Antwerp, was quoted in Belgian media as calling the request “very exceptional” and even “slightly shocking,” in light of existing EU regulations on companies’ liability for what they put on the market. Yannis Natsis of the European Public Health Alliance, who is also a member of the management board of the European Medicines Agency (EMA), has accused companies of “pushing for unprecedented liability exemption for COVID-19 vaccines.” He wants the Commission to define who will be held legally responsible if things go wrong, and who will pay.

Ruud Dobber, a member of AstraZeneca’s senior executive team, told Reuters in July that such requests were normal in the circumstances. The company could “simply not take the risk” of being faced with liability claims if “in four years the vaccine is showing side effects,” according to the report. His point was echoed by Kaisa Immonen of the European Patients Forum, who commented, “Is this not an essential for vaccine confidence?” If the usual standard of safety and quality apply as for any vaccine, “why the need for exemptions?” she went on.

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

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