Late-stage study of first single-shot vaccine begins in US

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Johnson & Johnson is beginning a huge final study to try to prove if a single-dose COVID-19 vaccine can protect against the virus.

The study starting Wednesday will be one of the world’s largest coronavirus vaccine studies so far, testing the shot in 60,000 volunteers in the U.S., South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.

But many vaccine specialists question whether the Food and Drug Administration will stick to that goal under intense pressure from the Trump administration. President Donald Trump has consistently presented a faster timeline for a new vaccine than experts say is adequate to fully test the candidates.Meanwhile, testing of still another experimental vaccine, made by AstraZeneca, remains on hold in the U.S. as officials examine a safety question, even though studies have resumed in other countries.

And Dr. Anthony Fauci, the top U.S. infectious disease expert, added in the call to governors that he is confident in “a tried and true process” that has checks and balances built in, including an independent board evaluating the progress of each vaccine trial, as well as “the integrity of the FDA.”Senators were scheduled to question FDA Commissioner Stephen Hahn, Fauci and other administration officials later Wednesday about the pandemic response.

The Centers for Disease Control and Prevention wants states to get ready now to roll out vaccinations, which will present enormous logistical challenges. On Wednesday the CDC was set to announce distribution of $200 million in congressionally approved funds to help begin setting up operations.

 

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