Commentary paper authored by me, Kelly Lynn Moore and John Lloyd "Logistical challenges for potential SARS-CoV-2 vaccine and a call to research institutions, developers and manufacturers" is now available online in VACCINE journal.
In the absence of specific treatment or an effective vaccine, the SARS-CoV epidemic was brought to an end through public health tools like isolation, quarantine, physical distancing, and containment measures within eight months in 2003. Despite similarities between SARS-CoV and SARS-CoV-2 (and with recognition of differences such as trajectories, infectious period, transmissibility, clinical spectrum, and community spread) similar public health measures were only able to slow the spread of COVID-19, suppressing the peak and providing health systems much needed time to scale up for effective response. Much debated herd immunity is far from being an exit strategy for the world since it may result in an intolerable global death toll. Currently, the availability of a safe and effective vaccine against SARS-CoV-2 is considered essential to the pandemic exit strategy with non-pharmaceutical interventions to be continued until the vaccine is made available globally. When a coronavirus vaccine arrives in sufficient quantity, a new marathon will commence for storage, distribution, and vaccination of every person on this planet who needs it.
Developing, manufacturing, and approving a quality vaccine is not enough to ensure quality throughout the product’s lifecycle since vaccines spend considerable periods at country level storage facilities, as well as being transported between warehouses, and all service points regardless whether they are used routinely or in a campaign. To ensure the quality of vaccines, countries require robust storage, transport systems, and well-organized service points staffed with trained workforce for effective vaccine management. To achieve the goal of immunizing the world’s population safely with an effective vaccine in the shortest possible time, the vaccine must be prequalified to meet WHO biological standards governing safety and efficacy. Also, two critical factors will optimize and determine the successful conclusion of the goal. First, the presentation of the vaccine product should be simple to prepare and safe to administer with minimum manipulation. Second, country distribution systems should be safe and efficient. Both of these factors require historic amounts of cooperation between the vaccine manufacturers, country immunization programs, and international stakeholders. It should be kept in mind that resource-limited countries have far greater experience than industrialized countries in organizing mass vaccination events throughout the country.
Temperatures of storage and transport are recorded at each stage of distribution and for each refrigeration device. In addition, for the health professionals to interpret the cumulative exposure of vaccines to heat and time, Vaccine Vial Monitor (VVM) labels are attached to each vial. These devices provide a simple visual reference to the viability of the vial of vaccine throughout distribution to the point of use. VVMs warn users not to use vaccines that have been damaged any stage of distribution from manufacture until the vaccine is used. At manufacture of the vaccine, the appropriate VVM label is assigned to the vaccine to match the accelerated stability data at 25 C and 37 C. An appropriate VVM attached to the SARS-CoV-2 vaccine permits evaluation of the effect of time and temperature at all levels to ensure quality. Furthermore, VVM will prevent wastage and facilitate outreach to remote populations. Today, a total of 230 vaccine presentations out of 246 WHO prequalified vaccines are shipped with VVM.
The authors call research institutions, developers and manu- facturers of SARS-CoV-2 vaccines to make publicly available
detailed information of the temperature stability and target product profile (vaccine presentation details) even before clinical trials are completed, so that all potential time-temperature indicator developers have ample time to produce necessary devices/tools, and countries start planning for successful management of vaccine receipt, storage, distribution, and country-wide vaccinations. Authors also recognize the efforts of WHO for establishing a new global coalition to accelerate the development, production and equitable access to new COVID-19 diagnostics, therapeutics and vaccines.
Today, there is need for commitments on global unity to make vaccines equitably available everywhere. WHO has a critical role in this and world leaders should join WHO in calling for fair distribution of the SARS-CoV-2 vaccines when available.