Gearing up for distribution of Covid-19 vaccine
Desperate times call for desperate measures. Covid-19 is arguably the most challenging period worldwide and for India in the recent history……
By Dr Harvinder Popli/ Meenu Grover Sharma
Right from generating awareness to mask-up, wash hands and maintain social distancing, to managing steep fall of economy and its gradual revival, to gearing up the healthcare system for test-trace-rehabilitate to an unimaginable extent, to increasing the capacity of testing laboratories and to becoming self-reliant in manufacturing PPE kits for healthcare workers, the struggle has been nothing less than monumental.
The speed, at which the biopharmaceutical industry, well-supported by the regulatory agencies around the world, has been able to successfully develop highly effective and safe vaccines for this deadly disease, is nothing short of a miracle. As a bonus we have not just one but 2-3 option already available and several more in the pipeline which hopefully will be ready for commercialization soon.
Globally there are 203 vaccine candidates in development of which over 85 are in clinical development already. Recently, Pfizer/ BioNtech and Moderna got emergency use authorization in the US and the roll out of public vaccination has already started. Other vaccines such as Sputnik-V and few Chinese candidates such as those from Sinopharm, Sinovac and Cansino have been in limited/early use in Russia and China respectively. In India, about 8 candidates are in development in collaboration with Indian companies of which one Covishield (Serum Institute of India) has also applied for emergency use approval. Additionally, Pfizer has also applied for emergency use approval in India.
The benefit of having multiple options available is not just in having a choice, but also the fact that for fulfilling the demand of global populations, manufacturing at multiple sites with multiple processes would be advantageous where just one facility would have been quite inadequate. Ensuring that the right people get the right vaccine at the right time is a formidable challenge given the population size, disparity in access to modern healthcare and the costs involved in procuring, distribution and administration of the vaccine, especially because the immunization programs have traditionally been planned for infants/children and never targeted vaccinating adults at such a massive extent and the required pace.
Identification of at-risk populations for Prioritization
Planning for efficient distribution of vaccine and identification of vulnerable populations is quite a challenge in a country like India where we do not have a well-developed health information system. While it is obvious that healthcare workers and frontline workers would get priority in getting vaccinated, followed by at-risk age-groups and those with comorbid conditions, robust data to transparently implement this sequence is lacking in our system.
Also, there might be the challenge of political patronage and the so-called VIPs and VIP-recommended people jumping-the-queue at the detriment of those who need the protection the most- the extent to which we can curtail this phenomenon will have a significant impact on overall success of the population vaccination program against COVID19. MoHFW has announced the aim to vaccinate 30 crore most vulnerable people by August 2021, which will be the phase 1 of mass adult vaccination program, the first of its kind.
Uptake, Follow-up and Monitoring to EnsureComprehensive Vaccination
The unique requirement of two doses for most vaccine candidates, 14-21 days apart, poses another challenge of execution. Ensuring that the identified populations show up or healthcare workers reach them on the day of the second dose is another layer of unique challenge that will require micro-planning and impeccable implementation. Healthcare workers will need to track who received which vaccine and when, to ensure people are protected.
Additionally, with social media abuzz with half-baked information on efficacy, novelty of mechanism and most importantly, safety anecdotes, there is also an increasing concern about confidence of general public in these vaccines ‘developed so rapidly’ with implicit doubts on these being really safe and effective – which might impact uptake. Documentation of vaccination, tracking and investigation of any safety events will be essential components of monitoring to boost confidence and improve voluntary uptake.
Storage Conditions & Logistic Challenges
Pfizer’s vaccine needs to be storage at -70 degree Celsius, a condition not commonly available in the existent pharma/vaccine supply chains and a dauting task to maintain this condition throughout the supply chain to the actual point of vaccination. Other candidates such as Moderna vaccine require lesschallenging conditions but still cold-chain requirement is likely to be a given for most candidates. India’s cold chain vaccine distribution network is operated through four government medical store depots (GMSDs) in Karnal, Mumbai, Chennai and Kolkata, which procure vaccines from manufacturers. 53 state vaccine stores get their supplies either from these GMSDs or directly from manufacturers. The state vaccine stores then distribute the vaccines to regional, district and sub-district level cold chain points via insulated vans. India currently has about 28,000 cold chain points, 76,000 cold chain equipment, 55,000 cold chain handlers and 2.5 million health workers as part of its vaccine logistic network, used for universal immunization program catering to immunization of children.
India’s vaccine management has improved in recent years thanks to a real-time supply chain management system known as Vaccine Intelligence Network (eVIN). But still the infrastructure is greatly inadequate and will require massive scaling up of the capacities at a breakneck speed to achieve the unprecedented goal of achieving vaccination of the entire population, without faltering on its key goal of regular immunization of newborns.
Theft, Diversion and Black-marketing Risk
At least initially, when the supplies will be limited and demand much higher, there is a risk of diversion of stocks to black-markets and profiteering at the expense of vulnerable populations. Despite strict requirements put in place for drugs such as remdesivir, sporadic instances of black-marketing at exorbitant prices were noticed in the initial periods of limited supply. Stronger safeguards need to be put in place to avoid such practices as also prevent spurious vaccines entering the supply chain. Robust oversight mechanisms need to be put in place before vaccination roll out and technology-based approaches need to be adopted.
Operational Planning in India: Election Model to be followed for Vaccine roll-out
National Expert Group on Vaccine Administration for COVID19 (NEGVAC) was constituted on August 7, 2020 to provide guidance on prioritization of population, selection of vaccine, procurement and inventory management and vaccine delivery and tracking mechanisms. NEGVAC has recommended that roll out of vaccination should be carried out on the lines of the execution of elections in the country. A digital platform for COVID19 vaccine delivery (CoWIN) will be used for vaccine distribution and management through electronic beneficiary registration. The system will be integrated with Aadhar/UHID for authentication, Digilocker for document verification and Safevac system for AEFI reporting. There will be an easy to use mobile app for recording vaccination data.
Session allocation to the beneficiaries will be done through the CoWIN platform. A five-member team at the registration site will authenticate/check documents, check registration status and vaccinate the registered beneficiary. The arrangement will be same as that seen at the polling booth during elections. SMS notification of particular dose with next date and time for subsequent dose will be communicated to the beneficiary along with a digital certificate with a QR code.
While the challenge is mammoth and our existing resources grossly inadequate, there is hope that with lessons learned during the last one year of capacity building and the use of digital technology, India will rise to the occasion and successfully vaccinate most vulnerable population by August 2021 and entire population by the end of next year. Significant manufacturing strength in vaccines will aid India achieve not just universal access for its own population but extend to other nations of the world as well.
(The authors are from Delhi Pharmaceutical Science and Research University (DPSRU), New Delhi