With the Center for Disease Control finally moving forward with its task of providing critical ethical guidance on the order for access to COVID-19 vaccines, at least for first tier (Phase 1a) recipients, we must do everything possible to ensure that vaccine distribution occurs as quickly, efficiently and equitably as possible. In the United States, this requires not only anticipating inevitable supply chain breakdowns, but also placing transparency at the center of the public health system.
With three 90%-plus effective COVID-19 vaccines by Pfizer, Moderna and AstraZeneca ready for emergency marketing approval in the United States, it seems strange to many of my international colleagues that entities, such as the COVID Collaborative, preparing public information campaigns to convince U.S. citizens to get vaccinated.
This skepticism isn’t the result of U.S. exceptionalism in its most deadly form. It is the result of the failure of the federal government and public health officials to put transparency at the center of their interactions with the public. Perhaps the clearest example of the harm caused by disinformation is that victims dying from COVID-19 in the United States reportedly continue to insist even now that they cannot be dying from the disease because “it isn’t real.”
Regaining Trust in the Public Health System
With so many confusing messages during the past year about treatments, cures and the actual impact of the Corona Virus on health; public skepticism about the existence of an effective vaccine is understandable. For example, the Food and Drug Administration granted emergency use authorization to hydroxycloroquinine in March for treating COVID-19, which it did not revoke until June. Similarly, the Center for Disease Control failed to impose any protections for workers in meat packing plants, not even masks, protective equipment or even social distancing, despite exponentially rising mortality rates at the time. Tasked with creating the “playbook” for state, local and tribal entities on how to plan and operationalize COVID-19 vaccination distribution, the CDC initially announced that it would not revise its “interim” guidelines until at least December 10th and would not issue final guidelines, including critical ethical considerations on order of access, until the day after the FDA has actually issued an emergency use authorization for a particular vaccine. Fortunately, the CDC’s Advisory Committee for Immunization Practices just completed an emergency viral meeting yesterday December 1st and recommended that the first recipients of anticipated vaccines A and B (Pfizer and Moderna) should be front line health care professionals and elderly residing in assisted living facilities. The recommendation has to be accepted by the head of the CDC before it is incorporated into the CDC’s playbook. But at least it plainly demonstrates that the timeline for guidance has been stepped up. It offers hope that the initial rollout of the vaccines, once approved, might occur more quickly than anticipated. By providing a head’s up to states, they can begin putting in place the necessary protocols for this initial delivery.
The ACIP has announced it will hold additional virtual meetings beginning next week to identify priority groups for successive staggered deliveries of the vaccine. These groups, as identified by the presentations at the December 1st viral meeting, include the following categories of recipients: Phase 1b “Essential workers” in diverse sectors including education, food and agriculture, utilities, police, firefighters, corrections officers and transportation and Phase 1c “Adults with high risk medical conditions.”
As defined in the CDC interim playbook, Phase 2 would include “critical populations” and some members of the general population. Phase 3 would include “critical populations” not previously included in Phase 2 and the rest of the general population. The precise identity of the recommended “critical populations” in Phases 2 and 3 has yet to be identified. The interim playbook suggests that included among such “critical populations” would be people at increased risk of acquiring or transmitting COVID-19, including people from racial and ethnic minority groups, from tribal communities, incarcerated/detained in correctional facilities, experiencing homelessness or attending colleges and universities and other congregate settings. Other potential critical populations could include people who are under- or un- insured; with disabilities or who have limited access to routine vaccination services, including people living in rural communities. The beginning of a new phase would be based on the availability of vaccines to meet the anticipated higher demand.
This recognition of the need to step up the finalization processes for state, local and tribal guidelines is a welcome development. Any delay in finalizing the order of access guidelines for the remaining phases will undoubtedly be amplified by the time required for their local implementation. This will inevitably create further delays in the actual public vaccination of the general public which we can ill afford given the increasing mortality rates.
Creating a Transparent Vaccine Roll-Out
A concerted public information campaign would undoubtedly strengthen the credibility of public health officials during this critical phase. The first step – tell the public the truth about the vaccines. Public health experts already admit that any of the vaccines will most likely give the patient mild symptoms, such as fevers, body aches and fatigue. In addition to being unpleasant, unless people are made aware of this possibility; there is a strong likelihood that many will believe the vaccine was ineffective, or worse, gave them a mild case of the virus. Since all vaccines moving through the FDA approval system require two doses, there is a real threat that patients won’t take the second dose without adequate warnings of acceptable post-vaccination symptoms.
The initial roll out of the vaccine must be accompanied by absolute transparency from all involved parties – drug companies and their representatives, public health officials and agencies, and COVID-19 task forces, commissions and advisory councils. Regulations should be quickly established that impose fines and an obligation for corrective advertising on those who fail to make accurate, transparent statements about efficacy, realistic distribution timetables, or potential adverse effects of the vaccines, including acceptable symptoms post-vaccination. These fines should be large enough to counteract any perceived economic benefits such half-truths could provide.
Using Transparency to Repair Broken Supply Chains
Transparency also includes disclosing fully the bases for determining who receives the vaccine, in what order or priority, during what realistically-estimated time frame, and how the inevitable supply chain issues will be resolved. The order of rollout posted by Operation Warp Speed (OWS) contains no detailed explanation of how the vaccines will actually be rolled out or how the special challenges in delivering the vaccines in a rapid and effective manner have been anticipated and will be met. Such lack of detail is even more problematic given that the states will bear the burden of actually delivering the vaccines to their inhabitants. We already know from the debacle of the roll out of PPE’s during the early stages of the pandemic that U.S. distribution decisions were less than even-handed. There is no guarantee on the face of the OWS framework that similar problems will not arise again, particularly once distribution is extended into the more numerous and more skeptical general population.
Fortunately, some of those gaps were just filled yesterday, December 1st, by the CDC’s Advisory Committee for Immunization Practices recommendation to begin Phase 1a with front line health care workers and elderly residents in assisted living facilities. Remaining gaps in defining both the recipients and timing of their phased deliveries, however, need to be quickly and transparently filled.
The task of simply delivering sufficient doses of a vaccine for all patients in need is a herculean task. But as we learned from earlier testing protocols, it takes more than the vaccine itself to ensure an effective rollout. We already know that both the Pfizer and Moderna vaccines need to be stored in special refrigeration units at -70ºC and -20 ºC, respectively. Without a sufficient number of refrigeration units, it won’t matter how many viable doses are created. However, there are additional supply chain issues related to the actual tools for delivery of the vaccine beyond refrigeration. These include swabs, needles and syringes, alcohol pads, vaccination cards, limited PPE for vaccinators, as well as conversion of flu clinics and COVID-19 testing clinics to vaccine clinics, and the always difficult question of the equitable rollout of limited doses to the public. We have already suffered delays in COVID testing due to similar supply chain breaks. We need to quickly translate those hard-earned lessons to vaccine distribution to avoid similar problems.
Price Transparency Still Matters
Unlike COVID treatments, current pricing for the three vaccines appears relatively reasonably based. At least as currently reported, Pfizer’s vaccine is currently priced, per dose, at $19.50, Moderna’s at $15 to $37 and AstraZeneca’s at $4. But there is no guarantee that prices will remain so low. To the contrary, these low prices were part of negotiated deals with the U.S. Government for delivery of specified amounts. Those initial orders won’t fill even current U.S. needs. There is no indication these price limits will remain in place once the initial orders are filled.
It will take time for the vaccines to be delivered to enough of the population to have a cognizable impact on the spread of the Corona Virus. In the meantime, we need to be certain that treatments for the virus are more readily available than they have been at present. Some of the most effective treatments for COVID-19 remain not only largely undersupplied, but wildly expensive. For example, when President Trump tested positive, he was given an antibiotic cocktail provided by Regeneron Antibiotics, that has been used to successfully treat other wealthy members of the Republican party. The U.S. government had reportedly paid $450 million for 300,000 vials by the end of January. It has also paid Lilly $375 million for 300,000 vials of its antibody equivalent bamlanivimab. Given that over 300,000 new cases that are serious enough to require such treatments reportedly arise each week, the two combined fall far below what is required to rapidly and effectively treat even a small percentage of the patients who need it. And it is clearly not being distributed on socially equitable terms. We need effective, reasonably priced, readily accessible treatments for everyone while we wait for vaccines to take effect.
We have all learned the painful truth that relief delayed during a pandemic results in tragic human loss. We need to establish a transparent system now to repair the broken public confidence in our public health system and ensure that the benefits of an effective vaccine are rapidly and fully available to all who need it. Our lives depend on it.