The European Commission proposed on Thursday a change to rules on COVID-19 certificates that would allow participants in vaccine trials to get a valid pass despite having received unapproved shots.
The move follows concerns raised by Germany's BioNTech and Spain's Hipra about difficulties in enrolling volunteers for their COVID-19 vaccine trials because participants could face limitations to access public spaces and to travel.
The changes to the rules, which also extend by one year the validity of the EU COVID pass until the end of June 2023, will certify that EU countries can issue vaccination certificates to participants in trials. Some countries are already doing so.
The tweak however falls short of requiring EU countries to recognise these exceptional vaccine certificates when issued by other states in the bloc. As a result, when travelling across the 27-nation union, participants may be treated as not fully vaccinated and face restrictions.
A spokesman for the EU Commission said he expected EU countries will recognize the COVID passes issued to trial participants in other countries in the bloc.
The proposal must be adopted by EU lawmakers and governments.
COVID vaccination certificates are required in many EU countries to enter restaurants, gyms or cinemas. They are also necessary to travel across the bloc.
"A pharmaceutical company informed DE (Germany) that many participants would leave the clinical trial or refrain from participating because they would not be able to maintain their vaccination status with the not yet authorised specific booster dose," says an EU document with minutes of a meeting of EU health experts on Jan. 5.
An EU official said the company that raised concerns was BioNTech, which is conducting trials in Germany and other countries on a booster dose that would target the Alpha and Delta variants of the coronavirus.
BioNTech also launched last week with its U.S. partner Pfizer clinical trials for a vaccine adapted to Omicron. Those trials are taking place in the United States.
BioNTech said it would welcome changes allowing trial participants to have a valid COVID certificate.
Spanish drugmaker Hipra had raised similar concerns as BioNTech, a spokesperson said. The company plans to recruit 3,000 volunteers in Europe for the final phase of its clinical trials for a vaccine.
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