Covid-19 Vaccine: No Silver Bullet
Indian drug regulator Wednesday deferred a decision to give accelerated approval to any of the Covid-19 vaccine candidates.
Though three firms — the US headquartered MNC Pfizer; Pune-based Serum Institute of India (SII) making AstraZeneca-Oxford University vaccine, and the Hyderabad-based Bharat Biotech India Ltd (BBIL) — have ap plied for early approval for their vaccine candidates to the Drug Controller General of India (DCGI), only the two Indian firms presented their data before the Subject Expert Committee (SEC) appointed by the regulator.
It is understood the review is still on and the companies may be asked for more data. The predicament of the experts is understandable. In all three cases, there are large data gaps. While BBIL’s Covaxin is still undergoing Phase-III trials, SII, though has completed Phase-II/III trials, does not have the efficacy data. Pfizer may have efficacy data, but that comes from another country not from India.
The Central Drugs Standard Control Organisation (CDSCO) therefore, cannot be faulted for hesitating on ‘emergency use approval’. While India needs to vaccinate large sections of its population at the earliest, any serious lapse in safety and efficacy in the initial stages can derail the entire vaccination effort by turning the public mood against the initiative.
An article on the Astra Zeneca vaccine, published by Lancet Tuesday, observes that while its efficacy is about 70 per cent overall, there needs to be more clarity on whether the worldwide trials have established its effectiveness and safety in elderly populations.
India’s vaccine roll-out plan: India’s vaccine roll-out plan is to vaccinate 30 crore Indians including one crore healthcare workers and two crore frontline corona warriors such as police and armed forces personnel, and municipality workers. People above 50 as well as those suffering from co-morbidities would also be in this priority group.
Global challenges
Sooner rather than later, approvals will come, even as more data becomes available. But even if the vaccines are as effective in the real world as they look in clinical trials, Sam Fazeli (senior pharmaceuticals analyst for Bloomberg Intelligence and director of research for EMEA) says “they can’t change the course of the pandemic overnight, and may not be able to entirely stop the spread of the virus. We need reinforcements.
“It will take months for Covid-19 vaccines to reach a large enough percentage of the population to create “herd immunity” — and that’s assuming they win the public’s trust and the vaccination effort goes smoothly. Manufacturing enough doses may not be as easy as the headline deals with various countries suggest. There are also questions around how long immunity to Covid-19 may last. And vaccines may come up short in the really frail or elderly, especially those with preexisting conditions. Worst of all, the virus may mutate around our vaccines and start re-infecting people. That’s one reason public health officials have called for continued social distancing and masks even after the vaccination effort is in full force.”
The good news however, is “there are several promising therapies in use and more in development. But the biggest game-changers are still months away.”
Challenges for India
For a country the size of India, the staggering numbers to be vaccinated poses huge challenge in terms of logistics, infrastructure and crowd management. Another issue, write K Rajeshwari (Associate Professor) and Praveen Ram (PGDM aspirant, Great Lakes Institute of Management) “is the two-shot requirement of the vaccine process — this means that the public will need to travel twice to the vaccine location. The third and possibly the biggest problem is that of cold storage requirements.”
Vaccines from Pfizer or Moderna require a storage temperature of -70 degrees centigrade and -20 degrees centigrade, respectively, which is almost impossible in the Indian conditions (particularly the former). Vaccines from Sputnik V and AstraZeneca require to be stored at -18 degrees centigrade and 2-8 degrees centigrade respectively. The latter can be handled relatively easily as these are the temperature ranges around which the Polio vaccine is stored.
Delaying will lead to the mutation of the virus: Also, “the final protocol in terms of priority segments (frontline health workers, senior citizens, those with co-morbidities, pregnant women) is not clear…..Delaying to vaccinate the rest will lead to the mutation of the virus, thereby rendering the future inoculation of the vast majority ineffective. Therefore, the government needs to use as many vaccines as possible in the fastest time.”
Partnership with private sector: Combining “A disruptive and comprehensive distribution system that combines government infrastructure and the private sector’s efficiency is called for.”
Gagandeep Kang (Professor, Christian Medical College, Vellore) cites additional challenges.
Ability to purchase vaccines: “If vaccines that will not be used for national immunisation programmes are given limited or full approval, the ability to purchase vaccines will differentiate sections of society between those with purchased access and those who must wait for the government to provide vaccines. This situation already exists for many vaccines, such as influenza or chickenpox where vaccines are available in the private sector. Open and transparent discussions about the role of the private sector and access to vaccines are essential for a clearer picture of what lies ahead.”
Supply-chain management: It is understood India could have access to 1.6 billion doses of vaccines by the end of 2021. “There are significant challenges to getting these doses to where they are needed. The WHO has six rights of supply-chain management for immunisation, which are right product, right quantity, right condition, right place, right time and right cost. Making sure that all of these logistics are in place requires permutations of product packed volume, temperature for transport and storage, location of supply and delivery, cycle for vaccination and restocking. Availability of refrigerated transport, security of transport, opportunities for pilferage and replacement with fake products are all very real concerns for which preparation is necessary.”
Training vaccinators: In addition India “will need to train vaccinators, have additional supplies needed for immunisations, prepare for immunisation sessions and establish systems for waste disposal. And all that, as we develop and use methods to identify and track individuals who need the vaccine.
Prioritisation lists: “India does not have an adult immunisation programme beyond the tetanus/diphtheria vaccination for pregnant women. Hence, in the prioritisation lists that have been announced, identifying and reaching all priority groups will be a challenge. States have been asked to list public and private health care workers, and this is feasible and being done.
“However, moving beyond health care workers and other essential workers, however defined, to the elderly and those with co-morbidities as indicated in official announcements will be difficult and there is a need to prepare for falsified documents and fraud.”
Communication the benefits of the vaccine to the public is crucial. The positive is that India has “experience with strengthening immunisation and with the conduct of campaigns, particularly in the last decade.”
