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 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 authorization 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
increasing 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.
MASS TRIALS
The United States last week identified five companies as the most
likely candidates to produce a vaccine for the coronavirus. They
are: U.S. players Johnson & Johnson, Moderna, Merck, Pfizer as well
as Britain's AstraZeneca, which is working with Oxford university.
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Promising candidate vaccines may soon reach the stage of mass trials
involving thousands of volunteers in several countries. If the bloc
does not speed up its authorization process for GMO vaccines to
allow such trials to happen swiftly in Europe, the continent could
fall behind in gaining access to any successful shots in bulk.
Any decision by the European Commission to accelerate GMO vaccine
trials would need to be approved by EU lawmakers and member states.
The push by the bloc comes at a time when experts warn it is
becoming increasingly difficult to trial vaccine candidates in
Europe as the epidemic recedes there, because trials are usually
most successful when a virus is widely circulating in the
population.
A failure to come up with a vaccine would leave the region, and the
world, exposed in the event of a second wave of infections.
The GMO vaccine plans are expected to be announced as part of an "EU
strategy for the development of a COVID-19 vaccine", which the
Commission will unveil on June 17, according to a draft agenda of
the EU executive.
Officials have told Reuters that as part of the strategy the
Commission will also announce plans to use an emergency
2.4-billion-euro ($2.7 billion) fund to make advance purchases of
promising vaccines against the new coronavirus.
The EU rainy-day fund, known as the Emergency Support Instrument (ESI),
would also be used to increase vaccine production capacity in Europe
and offer liability insurance to pharmaceutical companies, officials
said.
($1 = 0.8818 euros)
(Reporting by Francesco Guarascio @fraguarascio; Additional
reporting by Christine Soares; Editing by Pravin Char)
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