Pfizer announced Monday that its COVID-19 Vaccine demonstrated more than 90% effectiveness and reported no serious side effects in the early trial: this is exciting outcome data that will enable the company to seek an emergency authorization if the next two weeks of safety data support it. But establishing that the vaccine is safe and effective is a preliminary step in a complex process of vaccine production, distribution and delivery. Even in the most optimistic of circumstances, we need to continue to support social distancing behaviors and personal protective gear. Please do not discard your masks!
The vaccine trials focus on safety and efficacy in reducing the vaccine’s morbidity and mortality. They do not show how this affects infectiousness. As noted in the NASEM publication, Framework for Equitable Allocation of COVID-19 Vaccine, “The ongoing COVID-19 vaccine trials are not designed to estimate the impact of the vaccine candidates on transmission and evidence of the vaccines’ actual impact on transmission might not be available for some time after FDA approval.” ( Section S-6)6. In other words: it may protect the individual, but it is not clear the impact on the mass spread of the disease, and thus the control of the pandemic.
At the core of efforts to develop a vaccination program lies trust: the need to restore and expand the public’s belief in the trustworthiness of scientific and public health authorities. Erosion of this trust in vaccination research and vaccination began well before COVID-19, but it has certainly gotten worse during this pandemic. This is a critical issue that must be addressed, because there is widespread skepticism. Social issues such as pervasive racism and discrimination, medical mistrust, inequity of access to care have contributed, but so has the fact that the whole topic of Covid has been politically polarized. As noted by Danchin et al, “To build vaccine confidence in general practice, governments need to invest in understanding the factors that will influence COVID-19 vaccine acceptance and plan to co-design strategies with communities to optimize uptake when these vaccines become available”. And, even if the vaccine is somehow made available to all, accepting and getting vaccinated is, in fact, a behavior. It is a personal choice. The development and availability of a safe and sufficiently efficacious vaccine will not ensure vaccine impact in the real world.
Some Practical Concerns: Storage, and Equitable Access
The Pfizer vaccine is much more difficult to ship and store than any other routine vaccines: It is administered in two doses given 28 days apart and storage requires temperatures of minus 100 degrees Fahrenheit. At this time, the plan is to deliver them in dry ice boxes holding 1,000 to 5,000 doses. Once opened, the box can be used for five days but can’t be opened more than twice a day. The vaccine can also survive in a refrigerator for five days but can’t be refrozen if unused.
Obviously, the more people that get this vaccine, in theory, the safer the global community becomes. Vaccine initiatives are public health programs. But think about it: to administer 1,000 doses within the five days required per box opened, it necessitates a large hospital system or mass vaccination centers. It could potentially rule out sending the vaccine to providers with small patient populations and doctors’ offices in cities. Smaller towns, rural areas and Indigenous communities on reservations could be disproportionately excluded because of the struggle to administer that many doses quickly or to maintain them at ultracold temperatures.
Furthermore, the federal program will deliver the vaccines to the states, but the states will be responsible for a plan to distribute them to those deemed the most needy. ProPublica obtained preliminary plans issued by 47 states (Hawaii, Pennsylvania and Minnesota say they’re still working on theirs). This report says that “Examples of the state-specific challenges include: Washington state’s Health Department does not have its own warehouse that can store the Pfizer vaccine at a cold enough temperature. Arizona expects the Pfizer vaccine cannot be handled by the state’s rural communities and tribal lands. North Dakota and Oregon aren’t sure how to take care of migrant workers. Kansas’ plan appears to mistakenly assume shipments will be far smaller than 1,000 doses. Georgia’s Public Health Department is relying on local districts and counties to work out their own details.”
Impact on People’s Behavior:
The danger is also the impact of the vaccine on social behavior. The availability of a vaccine may decrease people’s fear about Covid, and lead them to relax their protective behaviors. It also may result in school and public authorities prematurely lifting restrictions or reducing enforcement of such policies, again potentially leading to continued outbreaks of infection. [Note that currently there is no pediatric Covid vaccine in trials- please see our previous blog on Pediatric Covid Vaccine]. Everyone’s desire to return to pre-COVID-19 lifestyles make it essential, therefore, that public health authorities and health professionals begin now to communicate with patients and the public about the fact that behavioral mitigation strategies will continue to be critical even in the context of an approved vaccine.
Mass immunization is a multilayered process, involving public communication campaigns, equipment, staffing and training of vaccine providers and ensuring that the vaccine administration sites won’t actually contribute to the spread. And then the determination of who would be the first to receive the vaccine. The CDC advised state and local health authorities to prioritize health care workers, then move on to other essential workers and at-risk populations such as nursing home residents. Access would expand to the general public only as more doses available. But other populations to consider are teachers and other school employees who are in contact with vast numbers of children, a vector for spread of the virus that has potentially huge impact on containment of the pandemic.
And state by state differences also are at issue. According to the ProPublica report: “North Dakota wants hospitals to document how they decided whom to vaccinate first. Maryland is prioritizing people in jails and prisons (where sharing close quarters has led to severe outbreaks), but states like Idaho and Mississippi have scheduled them for later. Arkansas, which has a large chicken industry, considers meatpacking workers to be essential. Oklahoma is prioritizing its long-term care population. Some states stressed communities of color, which have been disproportionately sickened and killed by the virus. “We are currently in the midst of a social justice movement across the county,” Kentucky’s plan notes.”
CDC Director Robert Redfield has said Congress will need to provide up to $6 billion for vaccine distribution, but funding negotiations stalled ahead of the election. To date, the federal government has allocated 3% of that amount, $200 million, to the states to immunize the nation. Much of the implementation will spill into the next administration. President-elect Joe Biden is actively working on strategy but as of now, access to the White House is being blocked by the incumbent administration.
The many uncertainties about COVID-19, about the efficacy and safety of candidate vaccines, and about the duration of vaccine-induced immunity make it particularly important that we remember that COVID-19 potential vaccines will not replace the need for continued vigilance for some time to come. The development and availability of SARS-CoV-2 vaccines are sources of hope in the battle against the COVID-19 pandemic, but they are just one piece of the strategy needed to succeed. For now, with so many issues still unresolved, and with the recent dramatic increase in Covid cases, please wear [and wash, and reuse] your mask.