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Tags: covid-19 | clinical | trials | who | operation warp speed | fda | emergency use

US Will Go It Alone on COVID Vaccine

Female doctor with a stethoscope on shoulder holding syringe and COVID-19 vaccine
(Siam Pukkato/Dreamstime)

Tuesday, 01 September 2020 06:24 PM EDT

The United States will not be joining a global effort to develop, manufacture, and distribute a vaccine to prevent the coronavirus, partly because the World Health Organization is involved, The Washington Post reports.

Upward of 170 countries hope to take part in the COVID-19 Vaccines Global Access (Covax) Facility, the Post noted. The aim of Covax, which is co-led by WHO, is to speed development of a vaccine and distribute doses to all countries, getting them to those at most high-risk in each country.

Some members of the Trump administration were interested in the plan, as are American allies including Japan, Germany, and the European Commission. But 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.

"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.

"America is taking a huge gamble by taking a go-it-alone strategy," Lawrence Gostin, professor of global health law at Georgetown University, told the Post.

The United States is effectively assuming it will be first to find an effective vaccine.

Kendall Hoyt, assistant professor at Dartmouth's Geisel School of Medicine, told the Post the move was like not buying an insurance policy.

But she also said the United States might be looking at bilateral deals with drug companies while also participating in Covax, which would raise its chances of getting some doses of the first safe vaccine.

U.S. Food and Drug Administration Commissioner Stephen Hahn told the Financial Times in an interview published Sunday the FDA was prepared to authorize a coronavirus vaccine before late-stage Phase Three clinical trials were complete, as long as officials are convinced the benefits outweigh the risks.

World Health Organization officials said Monday 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.

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.

Reuters contributed to this report.

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The United States will not be joining a global effort to develop, manufacture and distribute a vaccine to prevent the coronavirus, partly because the World Health Organization is involved.
covid-19, clinical, trials, who, operation warp speed, fda, emergency use, authorization
Tuesday, 01 September 2020 06:24 PM
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