EU countries that decide to administer booster shots may face increased legal risks because the additional dose has not yet been given emergency recommendation by the EU drugs regulator, the European Commission has said.
The European Medicines Agency (EMA) has repeatedly said that more data is needed before it can approve the use of boosters, but eight European countries have decided to recommend the additional dose, and more than a dozen are to make similar moves shortly.
It comes after World Health Organization director-general, Tedros Adhanom Ghebreyesus, again said yesterday the data on the benefits and safety of a Covid-19 vaccine booster shot is inconclusive.
“Booster doses are currently not part of the marketing authorisation of Covid-19 vaccines and have not yet been subject to a scientific assessment by EMA in the absence of sufficient data,” the EU Commission said in a statement to Reuters.
The responsibility to decide to include boosters in their vaccination campaign remains with the member states. As long as the booster doses are not part of the marketing authorisation, companies’ liability is modified.
In light of the near-total absence of safety data, it could mean that in the event of unexpected side effects that can be linked to boosters, EU states might bear the brunt of any legal consequences and compensation demands.
The commission said, however, that companies’ liability would not disappear entirely if boosters are administered without the EMA’s approval. For instance, if a side effect after a booster is caused by manufacturing issues, the vaccine maker would remain liable for it, Reuters reports.
EU liability and indemnity rules – granting big pharma blanket protection from lawsuits – apply in cases of unexpected adverse effects linked to the general characteristics of the product or its manufacturing. Each company supplying Covid-19 vaccines to the EU has negotiated different clauses, which remain largely confidential.
The European Centre for Disease Prevention and Control (ECDC) said that Austria, Belgium, France, Hungary, Liechtenstein, Lithuania, Luxembourg and Slovenia are currently recommending the use of boosters, with Germany planning to do the same in the autumn. Thirteen other European states are discussing the matter.
In recent months, the EU has reserved billions of doses from several Covid-19 vaccine makers for the coming years, saying they may be needed for boosters or to fight new variants. They could also be donated to poorer nations.
Possible compensation for unexpected side effects from Covid-19 vaccines is managed at national level. Some EU countries, including the largest ones, have compensation schemes that are meant to indemnify potential victims outside courts, but criteria for reimbursements vary greatly. In others, alleged victims would need to go directly to courts to settle their case.
Since the beginning of the vaccination campaign in Europe, hundreds of claims have been submitted to authorities by potential victims, official data from Denmark, Germany, Norway and Switzerland show, with only a handful of compensation awards so far granted, for undisclosed amounts of money, according to Reuters.
Adhanom Ghebreyesus said yesterday:
On the boosters, first of all, its not conclusive, in terms of its benefits; and also, we don’t know, if it’s safe. The second problem is that when some countries can afford to have the booster and others are not even vaccinating the first and second round, it’s a moral issue.
Its technically wrong and morally wrong; and that’s why we had this two- month moratorium, so that countries could refrain from using boosters, so that other countries who don’t have vaccines at hand … could have access to vaccines. We’re in the same boat, and treating one part won’t help us recover soon from the pandemic. It’s in the interests of all of us to show real solidarity.
Hello and greetings to everyone reading, wherever you are in the world. Mattha Busby here to take you through the next few hours of global Covid developments. Thanks to my colleague Léonie Chao-Fong for covering the blog up until now. Please feel free to drop me a line on Twitter or message me via email (mattha.busby.freelance@guardian.co.uk) with any tips or thoughts on our coverage.
