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(Adds details on U.S. trial plans)
By Ludwig Burger and Pushkala Aripaka
Nov 5 (Reuters) - AstraZeneca will start discussing
emergency approval of its experimental COVID-19 vaccine with
U.S. regulators once it has good trial data from Britain, South
Africa and Brazil, as it has no indication the watchdog would
favour U.S. data.
If and when AstraZeneca reaches the first statistically
reliable efficacy and safety results from those trials, based on
more than 25,000 volunteers in total, it would present them to
the U.S. Food and Drug Administration (FDA) even though any
read-out from an ongoing U.S. trial will be months later.
"If you hit those thresholds we are going to have a
conversation with them," executive team member Mene Pangalos
told Reuters.
"What the FDA has signalled is what their expectations of
data are for an approval," he said, adding the company had not
spoken to the U.S. watchdog about where the data should some
from.
The future of the U.S. trial would not be called into
question by any successful non-U.S. trial result, Pangalos
stressed.
Some experts have argued that, once a successful vaccine is
widely available or soon expected, the runners-up in the vaccine
race may find it difficult to recruit volunteers willing to risk
being randomly assigned to a control group on placebo.
Pangalos said a vaccine would not be available for everyone
immediately following approval. "That is not how it happens. It
will take months to vaccinate people (widely)," he said.
"By the time the (UK) study reads out, we submit regulatory
documents, and assuming we get an approval and the vaccine
starts to be distributed across the U.S, I think there will be
more than enough time to get the study almost fully recruited."
"Being on a vaccine study is probably going to be a good way
... to get access to the vaccine," he said, adding that only one
in three U.S. trial participants will be on placebo.
(Reporting by Ludwig Burger and Pushkala Aripaka, additional
reporting by Kate Kelland; Editing by Mark Potter)
