03 September 2020
The U.S. federal government has told health officials in all 50 states to be ready for a coronavirus vaccine by November 1.
The date is just two days before Election Day on November 3. Some public health experts have raised concerns. They worry that politics rather than science is driving the vaccine approval process.
Dr. Robert Redfield is director of the U.S. Centers for Disease Control and Prevention (CDC). He sent a letter to governors and state health officials dated August 27. In the letter, he said states will receive permit applications to provide vaccines to state and local health departments and hospitals. He asked the states to "consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020."
The health director noted the approval process will not compromise the safety or effectiveness of the vaccine. Several news organizations, including McClatchy, The New York Times and the Associated Press, received copies of the letter.
The CDC also sent planning documents, saying vaccines could be available as soon as the end of October and approved by the Food and Drug Administration under its emergency powers.
The documents described two unnamed vaccine candidates that must be stored at temperatures of minus 70 and minus 20 degrees Celsius. The requirements appear to be those from drug-makers Pfizer and Moderna.
The document, however, warned that only a limited amount of COVID-19 vaccine may be available by early November and that the supply will increase greatly by 2021. The health agency also asked state officials to make them available free of cost to health workers, national security workers and people at nursing homes.
James S. Blumenstock is a senior vice president at the Association of State and Territorial Health Officials. He told the Associated Press that the CDC was offering "an aggressive but necessary timetable" to approve the vaccines.
However, several public health experts said that drug makers are still in the process of signing up volunteers for final trials. Some questioned how information on the safety and effectiveness of the vaccine candidates could be available before November 1.
"Being ready is reasonable. Cutting short phase 3 trials before you get the information you need isn't," said Paul Offit. He is a Children's Hospital of Philadelphia immunization expert who sits on the FDA's vaccine advisory committee.
Peter Hotez, dean of Baylor University's tropical medicine school, said he was "very concerned" about the timetable. He wondered if the FDA would use its emergency power to approve a vaccine before knowing whether it is safe and effective.
"It gives the appearance of a stunt rather than an expression of public health concern,″ Hotez added.
Michael Osterholm is a University of Minnesota infectious disease expert. He told the Associated Press that he was concerned about an "October surprise" with a vaccine being introduced before the election. An "October surprise" describes an action or event close to Election Day that can affect election results.
When asked by CBS News whether politics rather than science is leading the vaccine approval process, Health and Human Services Secretary Alex Azar said Thursday: "Thanks to President Trump's leadership of this Operation Warp Speed. We're making historic progress towards a vaccine...President Trump has made it clear. And I have made it clear. These decisions will be driven by the standards of science and evidence..."
Kris Ehresmann is infectious disease director for the state of Minnesota. She told the AP the state would only move forward "once we know it is safe."
In Florida, Governor Ron DeSantis is a member of Trump's Republican Party. He said the effort to stop the virus will take more than a few months. "I would hope that the federal government would kind of take the lead on that." He added, "Hopefully, they have a plan to do it and will really focus on those vulnerable among us."
I'm Bryan Lynn.
Hai Do adapted this story from reports by the Associated Press and other sources. Mario Ritter, Jr. was the editor.
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Words in This Story
waiving –v. to officially say that will not require something that is normally required
facilities –n. (pl.) a building or equipment used for a specific purpose; something that makes an action, operation or activity easier to get done
timetable –n. a plan of things that need to be done and the time buy which they need to be completed
phase 3 –n. (medical) describes the part of drug tests that involves many people and is meant to find out if the drug causes bad reactions
stunt –n. something done to get the attention of the public
standard –n. a level of quality that is considered acceptable or is required
focus –v. to direct attention on something
vulnerable –n. easily hurt or harmed physically, mentally or emotionally
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