Washington:
On Tuesday, the White House rejected concerns expressed by the World Health Organization after a US health official said a coronavirus vaccine could be approved without completing full trials.
“The United States will continue to engage our international partners to ensure that we defeat this virus, but we will not be limited by multilateral organizations influenced by the corrupt World Health Organization and China,” said White House spokesman Judd Deere in a release.
“This president will spare no expense to ensure that any new vaccine upholds our own FDA’s gold standard for safety and efficacy, is thoroughly tested and saves lives,” he said.
US 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 clinical trials of the virus were completed. Phase Three in the last stage, provided officials are convinced that the benefits outweigh the risks.
On Monday, World Health Organization officials said acting too quickly for a vaccine to be widely available could pose risks.
“If you move too fast to vaccinate … millions of people, you can miss certain adverse effects,” said Mike Ryan, director of the WHO emergency program.
Soumya Swaminathan, WHO chief scientist, said the FDA’s approach “is not something to be done lightly.” He said WHO’s preferred approach would be to have a complete set of data that could be used for vaccine prequalification.
President Donald Trump has criticized the WHO’s handling of the coronavirus pandemic, accusing it of being too focused on China and giving bad advice. In May, Trump announced that the United States was severing ties with the organization.
Phase three trials, in which randomized patients are treated with a drug or placebo without the participants or doctors knowing which group they were in, are considered the gold standard for clinical trials.
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