PFE Pfizer Inc

By Stephanie Armour 

WASHINGTON -- The Trump administration is asking states to speed up approval for vaccine distribution sites by Nov. 1, the latest sign the federal government is eager to get a vaccine out before the end of the year.

Centers for Disease Control and Prevention Director Robert Redfield urged state governors to remove barriers to building permits for distribution sites for use by McKesson Corp. and the drug wholesaler's subsidiaries, according to an Aug. 27 letter. The Dallas-based company has a deal with the federal government to distribute a coronavirus vaccine when it becomes available.

"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 Nov. 1, 2020," read the letter from Dr. Redfield to the states.

The administration has been pushing for a coronavirus vaccine. Food and Drug Administration Commissioner Stephen Hahn said in a recent interview with the Financial Times that an emergency authorization for a vaccine could be appropriate even before the vaccine has completed Phase 3 clinical trials.

An FDA vaccine advisory committee will meet Oct. 22 to discuss the development, authorization and licensing of vaccines to prevent Covid-19.

The CDC also provided documents to states outlining some of the most detailed descriptions to date of a vaccine rollout plan.

The agency said vaccines would either be approved as licensed vaccines or under emergency-use authorization and would likely need to be administered twice.

"Vaccine and ancillary supplies will be procured and distributed by the federal government at no cost to enrolled Covid-19 vaccination providers, " the documents state.

They also state that jurisdictions must be prepared to immediately vaccinate identified critical populations when the earliest Covid-19 vaccine doses are available.

A screening tool on the CDC website will help individuals determine their eligibility for a vaccine and direct them to a vaccine finder.

One scenario described the availability of about two million doses by the end of October and another 10 million to 20 million doses available by the end of November, according to the documents sent to states.

The Trump administration has prioritized a vaccine through an initiative it has dubbed Operation Warp Speed, and the Department of Health and Human Services has said it is preparing to launch a November public-awareness campaign across TV, radio and social media, focusing on vaccine safety, efficacy and patient hesitancy.

Dr. Hahn's comments and the push to set up distribution sites by Nov. 1 has concerned some public-health experts who worry a vaccine could be rushed because of political pressure before it is determined to be fully safe. Election Day is Nov. 3, though many voters will have cast their ballots by mail well before that date.

"From this report, expect a photo-op of vaccines being delivered November 1," Andy Slavitt, former acting administrator of the Centers for Medicare and Medicaid Services, tweeted Wednesday in reference to the CDC letter to states.

Trump administration officials have pushed back on the criticism, saying Americans can trust the vaccine process.

"We all recognize that the public will have confidence in our decisions only if they are supported by the science. My personal commitment is to assure that all decisions meet FDA's standard. The patient and the public always come first," Dr. Hahn tweeted Wednesday.

The administration on Wednesday ramped up its messaging on the safety of a vaccine. HHS Secretary Alex Azar and Dr. Moncef Slaoui, chief adviser to Operation Warp Speed, issued a release saying the optimistic target for a safe and effective vaccine is no later than January 2021.

"While one can never guarantee success in any scientific endeavor, it is now becoming increasingly likely we will deliver this historic victory for the American people and the world," they said in the release.

The administration this week said it won't join an international vaccine effort because it is co-led by the World Health Organization. President Trump has criticized WHO, saying it is too beholden to China.

Some public-health leaders have said the decision could mean the U.S. would have trouble getting vaccine doses if another country develops a successful vaccine more quickly. It also puts more pressure on the U.S. to develop a vaccine.

McKesson, one of the world's largest drug wholesalers, said last month that it would be a centralized distributor of future Covid-19 vaccines and the supplies needed to administer vaccinations.

"Vaccines and related supplies will be delivered to point-of-care sites across the country at the U.S. government's direction," the company said in an Aug. 14 press release.

National distribution plans call for prioritizing front-line health workers and people especially vulnerable to more severe symptoms of Covid-19.

Three vaccines are in Phase 3 clinical trials in the U.S. They are an AstraZeneca PLC vaccine developed with Oxford University, one from Moderna Inc., and a candidate from Pfizer Inc. and German-based BioNTech SE.

Pfizer said on Thursday that it expects to have results from its vaccine study by the end of October.

AstraZeneca and Oxford University are conducting a Phase 3 study of their vaccine candidate in the U.K., South Africa and Brazil with several thousand volunteers. The company expects to have results from the study between October and the end of 2020, depending on infection rates in the countries where the trial is being conducted, an AstraZeneca spokesman told The Wall Street Journal on Thursday. The company had previously said it expected results between September and November.

In a July conference call with reporters, AstraZeneca executives said on the call that data from the study could be sufficient to gain emergency-use authorization in the U.S., if the data are strong enough.

"We will be ready from a manufacturing viewpoint to start delivery," AstraZeneca Chief Executive Pascal Soriot said on the conference call. "The question is how quickly do we get a clinical readout and that's very much influenced by the infection rates in the community."

AstraZeneca said this week that it had launched a second Phase 3 vaccine study in the U.S. that aims to enroll 30,000 volunteers. "We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential Covid-19 vaccine," Mr. Soriot said in a statement Monday.

The AstraZeneca spokesman declined to comment on the CDC's Aug. 27 letter.

Thirty-five percent of Americans said they wouldn't get a free FDA-approved vaccine if it were ready, according to a poll released Aug. 7 by Gallup. Four in 10 nonwhite Americans and nearly half of Republicans said they wouldn't get vaccinated, while Democrats were more likely to say they would.

--Jared Hopkins and Joseph Walker contributed to this article.

Write to Stephanie Armour at stephanie.armour@wsj.com

(END) Dow Jones Newswires

September 03, 2020 13:42 ET (17:42 GMT)

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