The Centers for Disease Control and Prevention (CDC) asked state governors last week to speed applications for building permits for vaccine distribution sites that would be operational just before November’s elections.
In a letter to state governors and health departments obtained by The Hill, CDC Director Robert Redfield said the McKesson Corporation and its subsidiaries would soon be applying for permits to build distribution sites. He asked governors to consider waiving requirements that would delay construction or opening the sites.
“The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program,” Redfield wrote. “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 assured governors that the requirements that might need to be waived would not “compromise the safety or integrity of the products being distributed.”
Health and Human Services Secretary Alex Azar told governors on a call with the White House coronavirus task force on Tuesday that the CDC is working with states to develop a distribution model once a vaccine candidate proves itself safe and effective. Azar said the CDC is working with Minnesota, North Dakota, California, Florida and the city of Philadelphia, according to a top aide to one governor on the call.
The CDC and the National Institutes of Health convened a commission to recommend vaccine distribution plans even before a final vaccine is approved.
It is almost certainly not possible that a vaccine candidate would pass large-scale phase three trials before Nov. 1. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said since January that it is likely a vaccine would be ready between the end of 2020 and the first half of 2021.
On Wednesday, Fauci sounded more optimistic that a successful vaccine candidate could be delivered by the end of this year.
“I believe that by the time we get to the end of this calendar year that we will feel comfortable that we do have a safe and effective vaccine,” Fauci said on NBC’s “Today.”
Several vaccines have already begun phase three trials, spurred by what President Trump has called Operation Warp Speed. The United States has already signed contracts with some developers to purchase hundreds of millions of doses of vaccine if those candidates pan out.
Moderna launched a phase three trial in late July, with the goal of enrolling 30,000 people at 89 sites across the country. AstraZeneca and the University of Oxford have begun phase three trials in the United States, Brazil and South Africa, and more limited tests in the United Kingdom and India.
Pfizer launched its phase three trial the same day, aiming to enroll 30,000 volunteers in the United States, Brazil, Germany and Argentina. Pfizer said it could seek regulatory review of its candidate as early as October.
Once a candidate is finalized, distribution will become the major challenge facing public health officials. Hundreds of millions of doses will be manufactured, along with the vials to hold them, the syringes to inject them and other supplies necessary to getting those vaccines to those who need them.
In the United States, that massive logistical lift is being overseen by Gen. Gustave Perna, the chief operating officer of Operation Warp Speed. Perna most recently ran the United States Army Materiel Command, the Army’s chief logistics office, responsible for coordinating supply chains across the globe.