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WASHINGTON, Sept 1 (Reuters) - The White House on Tuesday
pushed back on concerns expressed by the World Health
Organization after a U.S. health official said a coronavirus
vaccine might be approved without completing full trials.
"The United States will continue to engage our international
partners to ensure we defeat this virus, but we will not be
constrained by multilateral organizations influenced by the
corrupt World Health Organization and China," White House
spokesman Judd Deere said in a statement.
"This President will spare no expense to ensure that any new
vaccine maintains our own FDA's gold standard for safety and
efficacy, is thoroughly tested, and saves lives," he said.
U.S. Food and Drug Administration Commissioner Stephen Hahn
told the Financial Times in an interview published on Sunday
that the FDA was prepared to authorize a coronavirus vaccine
before late-stage Phase Three clinical trials were complete, as
long as officials are convinced that the benefits outweigh the
risks.
On Monday, World Health Organization officials said moving
too quickly to make a vaccine widely available could pose risks.
"If you move too quickly to vaccinate ... millions of
people, you may miss certain adverse effects," said Mike Ryan,
the head of WHO's emergencies program.
WHO chief scientist Soumya Swaminathan said the FDA's
approach was "not something that you do very lightly." She said
WHO's preferred approach would be to have a full set of data
which could be used for the pre-qualification of vaccines.
President Donald Trump has been critical of the WHO's
handling of the coronavirus pandemic, accusing it of being too
focused on China and issuing bad advice. In May, Trump announced
the United States was cutting ties to the organization.
Phase Three trials, in which randomized patients are treated
with a drug or a placebo without participants or doctors knowing
which group they were in, are considered the gold standard for
clinical trials.
(Reporting by Jeff Mason; Writing by Eric Beech; Editing by
Sandra Maler and Leslie Adler)