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 The Phase III trial of the two-dose vaccination will be carried out
in nine hospitals throughout Spain on volunteers both with and
without previous health conditions, the AEMPS agency said in a
statement.
J&J started mid-stage phase II trials in Spain and other countries
in September and launched a late-stage trial in Britain on Monday.
The Phase III trials will be carried out on 30,000 volunteers in
nine countries.
The two-dose study will run in parallel with a trials of a single
shot regimen involving 60,000 participants which was launched in
September.
The Spanish hospitals involved in the trials will enrol volunteers
as soon as possible, the AEMPS said, adding that 20% will be younger
than 40 and 30% older than 60.
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They will be given a first dose of either a placebo or the experimental shot,
currently called Ad26COV2, followed by a second dose or placebo later.
Conclusions will only be available after analysing the data at the end of the
trials, the Spanish medicines agency said.
The news comes after Pfizer <PFE.N> and BioNTech <BNTX.O>, Russia and Moderna <MRNA.O>
all released interim data from Phase III trials of their potential vaccines
showing more than 90% efficacy, boosting hopes that vaccines against the
pandemic disease may be ready for use soon.
(Reporting by Inti Landauro and Ingrid Melander; Editing by Josephine Mason and
David Clarke)
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