September 18, 2020

Submitted by Devendra Mishra, Executive Director, BSMA, 09182020




The formidable task of distribution of the COVID-19 vaccines when they are approved continues to be plagued by lack of a national policy for its administration, compromise of the FDA and CDC to prematurely approve the candidate vaccines, wide-range of product specifications for temperature control, incomplete clinical trials with traditional standards of rigor, vaccine manufacturing lead time, onerous demands on distribution, and ethical issues of allocation of scarce inventory. The result is a wide-spread distrust among the masses about the safety and effectiveness of the vaccines when available. A storm is brewing while scientists, manufacturers and supply chain professionals are collaborating with government healthcare agencies. Fortunately, nine pharmaceutical companies (Pfizer, Moderna, AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi) issued a joint pledge that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy. The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from the Food and Drug Administration.

CDC planning documents indicate that all but one will require two doses, given 21 or 28 days apart. People getting vaccinated will get a COVID-19 vaccination record card that will tell them which vaccine they got, when they got it and when they should get their next shot. Assuming conservatively that a two-dose vaccine will be the panacea, the country will need 700 million doses. The adequacy of supply meeting demand over time will depend on manufacturing capacity, delivery capability, vaccine effectiveness and degree of acceptance of immunization by the population.

Whatever the timing of an FDA vaccine approval, the complexity of handling, storage, delivery and tracking multiple vaccines continue to be planned. While the clinical trials are being conducted, considerable operational requirements are being understood and practices being established in the supply chain from vaccine manufacturing to immunization. The trials are also identifying the glitches in the overall process.

Elizabeth Weise, reported in the USA TODAY on September 8, 2020, the “Mind-bogglingly complex: Here’s what we know about how COVID-19 vaccine will be distributed when it’s approved”. She pointed out that the “Process will be run by the CDC, which for decades has overseen vaccine distribution in the United States and ran the last national vaccination effort during the 2009 H1N1 influenza pandemic. All the vaccine supplied in the initial phases will be purchased by the U.S. government, and no one will be charged for the actual dose. As of early September, it was not clear whether clinics would be allowed to charge an administration fee to those getting their shots. If one were charged, it is not clear whether insurance could be reimbursed for it if the vaccine is issued under an Emergency Use Authorization, CDC documents say.”

Two of the seven vaccine candidates, from Pfizer and Moderna, have advanced to Phase 3 clinical trials with tests in humans that determine whether a vaccine works. A third, from AstraZeneca in the United Kingdom, is also in Phase 3 trials but is not included in CDC’s initial planning scenarios. The distribution challenges for the vaccines are unprecedented. The first two vaccines must be stored at different temperatures and will require very different handling, storage and dispensation.

Recognizing that demand will exceed supply by a long shot for the foreseeable future, CDC’s Advisory Committee on Immunization Practices has determined priority of product allocation to be front-line medical workers, first responders, estimated to be 30 million people; and, people at high risk for severe disease expected to number 70 million. According to Elizabeth Weise, “Medical offices, clinics, hospitals, pharmacies and other groups that want to vaccinate people for COVID-19 need to first enroll in the U.S. COVID-19 vaccination program They’ll sign an agreement with the CDC and prove they have the space, the necessary equipment and properly trained staff to administer the shots. Because the requirements for storing, handling and administering the shots are so challenging, the government will prioritize getting vaccine to sites that can reach large numbers of priority populations and vaccinate lots of people quickly.” “When a vaccine becomes available, a vaccination site will request doses through a state agency, usually its department of public health. That is how it was generally done during the 2009 nH1N1 influenza pandemic”, said Julie Swann, a professor of industrial and systems engineering at North Carolina State University who was a science adviser to the CDC at the time.

It is reported that the vaccine order will be electronically transmitted to the CDC which will decide how many doses to allocated to a given site if vaccine supplies are limited. Subsequently, CDC will transmit the order to its contracted partner McKesson which already has distribution centers across the country and is building more for COVID-19. The Distributor will ship within 24 hours of approval depending on supply, the CDC’s planning documents say. Walgreens and CVS, the national pharmaceutical chains, will partner directly with the CDC while military allocations would go through the Department of Defense. Along with the vaccine, a separate supply kit is required to be sent that includes needles, syringes, alcohol prep pads and a small supply of personal protective equipment, including surgical masks and face shields for the staff giving the vaccine.

The supply chain services provided for regional natural crises of hurricane, fire, earthquakes and tsunamis have given us ground to build upon. The governors of the 50 States of the nation will help shape the distribution of vaccines while the healthcare industry builds the required supply chain in an evolutionary manner. While the health of America will be restored over the next few years, an unprecedented infrastructure will be in place for the next human crisis. We must survive the immediate storm to navigate over calm waters from mid-2021.