WASHINGTON: 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.
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