EU told to deal with adverse coronavirus vaccine effects as part of rush to buy doses

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Vaccines Europe has suggested the EU could protect its members from potential lawsuits as part of deals to procure millions of doses of pandemic-beating drugs. The lobby group, a subsidiary of the European Federation of Pharmaceutical Industries and Associations, said the research and development of the vaccines has been squeezed into months – but should have taken years. “The speed and scale of development and rollout do mean that it is impossible to generate the same amount of underlying evidence that normally would be available through extensive clinical trials and healthcare providers building experience,” a Vaccines Europe memo said.

The internal note said the rush to produce the vaccine creates “inevitable” risks.

Because of this, Brussels is urged to consider a “comprehensive no-fault and non-adversarial compensation system, and an exemption from civil liability” by the group.

The European Commission, the EU’s executive arm managing the procurement of vaccines, said it needed to act quickly but also ensure patient safety.

But it claimed eurocrats are already working up compensation schemes for “certain liabilities” via its advance purchase deals.

The Commission is doing this “in order to compensate for such high risks taken by manufacturers.”

The potential risk of legal action held up the bloc’s early effort to secure doses of the vaccine for more than 500 million citizens.

Member states were concerned about being lumped with the responsibilities of any adverse effects from drugs when they are eventually ready for distribution.

A senior diplomat told “The problem seems to be who will be liable if the vaccine has negative effects.”

The Vaccines Europe memo said people are likely to be hit by “adverse events” after vaccination.

“Even if such events may in fact not be related to the vaccines, such occurrences combined with the sheer scale of the vaccination programme and public attention to COVID-19, could lead to numerous damage claims,” it added.

The lobby group represents firms AstraZeneca, GlaxoSmithKline, Janssen, Merck, Novawav, Pfizer, Sanofi, Takeda, Abbot and CureVac.

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The Commission has been in contact with a number of the drugmakers about securing vaccine supplies, with some deals already concluded.

An internal EU document has revealed the bloc is hoping to secure over 200 million doses of the first available vaccines to give to the most vulnerable of its 450 million population.

“Adding up all risk groups presently known will designate probably 40 percent of the population, depending on the situation and demography in countries,” said the document.

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This will include shipping doses to non-member states, including Britain, Switzerland, Norway and the Balkans.

It identifies “priority groups” of people as those with chronic diseases, the elderly and health workers.

Other critical roles, such as teachers and public transport operators, could also be among the first to receive vaccine offers.

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