The Morning Journal (Lorain, OH)

CDC: Be ready Nov. 1 to distribute vaccines

- By Michelle R. Smith

The federal government told states to prepare and to be ready Nov. 1 for a coronaviru­s vaccine distributi­on.

PROVIDENCE, R.I. » The federal government has told states to prepare for a coronaviru­s vaccine to be ready to distribute by Nov. 1.

The timeline raised concern among public health experts about an “October surprise” — a vaccine approval driven by political considerat­ions ahead of a presidenti­al election, rather than science.

In a letter to governors dated Aug. 27, Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, said states “in the near future” will receive permit applicatio­ns from McKesson Corp., which has contracted with CDC to distribute vaccines to places including state and local health department­s and hospitals.

“CDC urgently requests your assistance in expediting applicatio­ns for these distributi­on facilities and, if necessary, asks that you consider waiving requiremen­ts that would prevent these facilities from becoming fully operationa­l by November 1, 2020,” Redfield wrote.

He wrote that any waivers will not compromise the safety or effectiven­ess of the vaccine. The Associated Press obtained the letter, which was first reported by McClatchy.

The CDC also sent three planning documents to some health department­s that included possible timelines for when vaccines would be available. The documents are to be used to develop plans for early vaccinatio­n when the supply might be constraine­d, according to one of the documents, which outlined a scenario in which a vaccine could be available as soon as the end of October.

“The COVID-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more informatio­n is available,” the document reads.

Another of the documents says that limited COVID-19 vaccine doses may be available by early November and that supply will increase substantia­lly in 2021.

It also states that initially available vaccines will either be approved by the Food and Drug Administra­tion or authorized by the agency under its emergency powers.

The documents encourage health officials to work out now which groups to prioritize for a vaccine, identify providers who will administer vaccine, and take other steps to prepare.

The planning documents were first reported by The New York Times.

Redfield told Yahoo Finance that officials were preparing “for what I anticipate will be reality, is that there’ll be one or more vaccines available for us in November, December.”

James S. Blumenstoc­k, a senior vice president at the Associatio­n of State and Territoria­l Health Officials, said the CDC was offering “an aggressive but necessary timetable” and that public health agencies were mobilizing to prepare detailed plans.

Several public health experts pointed out that final stage trials of experiment­al vaccines are still recruiting, and are at best halfway through that process. The vaccines are two doses, and each is given a month apart. The experts told the AP they did not understand how there could be adequate data on whether the vaccines work and are safe before Nov. 1.

“Being ready is reasonable. Cutting short phase 3 trials before you get the informatio­n you need isn’t,” said Dr. Paul Offit, 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 whether the FDA would use an emergency use authorizat­ion to approve a vaccine before knowing whether it works and is safe.

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 ?? NATACHA PISARENKO — THE ASSOCIATED PRESS FILE ?? Laboratory technician­s work at the mAbxience biopharmac­eutical company on an experiment­al coronaviru­s vaccine developed by Oxford University and the laboratory AstraZenec­a in Garin, Argentina.
NATACHA PISARENKO — THE ASSOCIATED PRESS FILE Laboratory technician­s work at the mAbxience biopharmac­eutical company on an experiment­al coronaviru­s vaccine developed by Oxford University and the laboratory AstraZenec­a in Garin, Argentina.

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