European officials aim to speed up trials for coronavirus vaccines containing genetically modified organisms, two EU sources told Reuters, in a move that could help shots developed by companies like AstraZeneca and Johnson & Johnson.
The European Commission is expected to put forward the plans as early as next week. They are part of a wider EU strategy aimed at securing enough doses of a possible vaccine for the bloc as it fears lagging behind the United States and China.
The reform is expected to reduce member states’ power to impose extra requirements on drug companies when they conduct clinical trials on medicines and vaccines containing genetically modified organisms (GMOs), according to the sources.
In some countries like Italy and France, for example, treatments must receive authorisation from government environment or research departments, as well as from health and drug authorities, under rules that are up to 20 years old and also cover the more publicly sensitive area of GMO crops.
This has long caused bottlenecks in a pharmaceutical industry that increasingly relies on genetic engineering.
Such delays could be particularly problematic now that Europe may quickly need to accelerate trials, an EU Commission official said, warning that some of the most promising COVID-19 shots under development contain GMOs.
A spokesman for the EU Commission, the EU executive, declined to comment.
Vaccines Europe, which represents many big pharmaceutical players including AstraZeneca, Sanofi, Pfizer, GSK and Novavax, said planned changes would create a level playing field between vaccines which contain GMOs and those that do not.
“GMOs are very specific to very few vaccines based on adenovirus vectors,” Michel Stoffel of Vaccines Europe told Reuters, citing those developed by AstraZeneca and Johnson & Johnson among those that contain GMOs and would benefit from the possible changes.
Vaccines developed by Chinese firm Cansino and U.S. giant Merck also contain adenovirus vectors, which cause the common cold, and other replicating viruses. They aim to introduce a gene from the novel coronavirus into our bodies, to elicit an immune response and protect from subsequent exposure.
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