Title: How drugmakers can keep their pledge and still deliver an October vaccine surprise
By: Michael Erman, Julie Steenhuysen, Reuters
As questions mount over whether the United States will authorize a coronavirus vaccine ahead of November elections, experts say there is a slim chance that enough evidence will be available to prove one is safe and effective in that time frame. . .
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Dr. Henry Miller, a senior fellow at the Pacific Research Institute think tank and former director of the FDA’s office of biotechnology, said an emergency use authorization based on a small number of infections would not deliver an adequate answer on the safety of a vaccine intended for use by millions of healthy people. Some side effects could take four to six months to occur, he said. . .