CDC Asks States to Be Prepared for COVID-19 Vaccine Distribution by Nov. 1

Centers for Disease Control and Prevention Director Robert Redfield has sent a letter to the governors of all 50 states urging them to be prepared for COVID-19 vaccine distribution by Nov. 1 — just two days ahead of the presidential election.

Redfield told governors in an Aug 27 letter that McKesson will be submitting permits for distribution facilities and asked them to expedite these applications and even waive some requirements to allow facilities to become fully operational by a Nov. 1 deadline.  HHS last month named McKesson as a “central distributor” of COVID-19 vaccines under the Trump administration’s Operation Warp Speed initiative (DID, Aug. 17).

Redfield told the governors that the requirements they are being asked to waive “will not compromise the safety or integrity of the products being distributed.”

The CDC in late August completed pilot programs in California, Florida, North Dakota, Minnesota and the city of Philadelphia that will help model other operations nationwide. And in mid-August, the CDC began holding weekly calls with state health officials about vaccine distribution. The pilot programs will be “the foundation” for programs across the country, Redfield said in a media briefing.

The CDC has also sent out documents outlining scenarios for distributing two COVID-19 vaccines beginning in the fourth quarter. One document is a checklist to assist states in planning for distribution. It said jurisdictions must be “prepared to immediately vaccinate identified critical populations when the earliest COVID- 19 vaccine doses are available.”

The other document describes scenarios for state and local jurisdictions to develop operations for early COVID-19 vaccination. It assumes that two vaccines, “vaccine A” and “vaccine B” will have generated enough data for an Emergency Use Authorization from the FDA before year’s end.

Moderna, Pfizer and AstraZeneca currently have vaccine candidates in phase 3 testing, so they may be first to assemble sufficient safety and efficacy data. The AstraZeneca vaccine is considered the most promising by many experts, but it must be maintained at minus 20 degrees Celsius, so it could only be made available at facilities that can provide those storage conditions.

This would be a major challenge because retail pharmacies or doctor’s offices do not have such low-temperature storage capabilities, so vaccinations would be limited to specially equipped hospitals.

Kathleen Dooling, a medical officer in the CDC’s division of viral diseases, said in an Aug. 26 meeting of the agency’s Advisory Committee on Immunization Practices that storage challenges alone will make it “very difficult for community clinics and local pharmacies to administer.”

Another complicating factor is that the vaccinations will require two doses about three or four weeks apart, which raises additional administrative and logistical problems. Early supply of the vaccine is likely to be constrained.

In published remarks, National Institutes of Allergy and Infectious Disease Director Anthony Fauci said FDA regulations stipulate that phase 3 vaccine trials can be stopped early if an independent Data Safety and Monitoring Board (DSMB) determines that interim results are decidedly positive or negative.

Fauci said the DSMB, comprised of independent trial experts, could determine that there is enough data to prove a vaccine is safe and effective, at which point researchers would have “a moral obligation” to end the trial early and make the vaccine available to everyone in the study.

If that happened, it is possible that a vaccine could be ready for widespread distribution before the end of the year. — Jordan Williams