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WASHINGTON: The White House on Tuesday (September 1) rejected concerns raised by the World Health Organization after a US health official said a coronavirus vaccine could be approved without completing full testing.
The Washington Post newspaper reported that President Donald Trump’s administration will not join a global effort to develop, manufacture and distribute a coronavirus vaccine due to WHO involvement.
About 172 countries are committing to the WHO COVID-19 vaccine plan to ensure equitable access to vaccines, the organization said recently.
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“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.
The global effort to develop a vaccine against the virus, which has killed more than 851,000 people, has seen recent launches of late-stage trials, but work on treatments has also accelerated.
There is no approved coronavirus vaccine, except for one licensed in Russia before large-scale trials.
FDA Commissioner Stephen Hahn told the Financial Times in an interview published Sunday that his agency was prepared to authorize a coronavirus vaccine before late-stage Phase Three clinical trials were completed, provided that officials are convinced that the benefits outweigh the risks.
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On Monday, WHO officials said rushing to make a vaccine 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.
WHO chief scientist Soumya Swaminathan 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.
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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