The success of combating Covid-19 will depend on profound monitoring of vaccine quality, rollout, among other key aspects, writes Dr Saurabh Kumar Banerjee, Dean & Associate Professor, School of Pharmaceutical Management, at IIHMR University, Jaipur Rajasthan.
Access to Covid-19 Vaccine
The dreaded malicious Coronavirus Disease 2019 (COVID-19) which has engulfed the entire globe has devastated the whole human generations will keep on haunting for many decades to come. As of February 14, 2021, according to the WHO, Covid-19 dashboard 10,904,940 confirmed cases and 155,642 deaths have been reported in India.
To cope with a pandemic of this magnitude an efficient and effective healthcare delivery model is required which could serve the general population. Access to essential medicines and Vaccines are a strong indicator of a robust health system and is of vital significance in the attainment of the health outcome of the population. In context to Covid-19 pandemic, the present piece of writing is an attempt to share some important developments for availability, affordability, and quality of Covid-19 vaccine in the country.
Availability of Covid-19 Vaccines
One basis question which is apprehended by the public is where will be the Covid-19 vaccine available to them and who are the anticipated beneficiaries? The MOHFW GOI has formulated a very meticulously designed document,
‘Covid-19 vaccines – Operational Guidelines’ for undertaking the herculean task of the world largest vaccination drive in India which was kicked on January 16, 2021.
The introduction of Covid-19 vaccine in the country will be in a phased manner and the overall guidance will be provided by the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC). The major beneficiaries in the first phase will be healthcare workers, frontline workers, and the population at higher risk and it is anticipated to cover a population of 30 crores. The healthcare workers comprise of the people who are rendering their services to the nation in various government and private healthcare settings namely ANMs, ASHAs, medical officers, paramedical staff, nurses and supervisors, support staff, students. The frontline workers comprise of personnel’s working in the Ministry of Defence, the Ministry of Home Affairs, the Ministry of Housing and Urban Affairs and state government personnel. Since the population in the higher age group and suffering from commodities are more prone to Covid-19 infection, the age group of >50 years will also be prioritized for Covid-19 vaccination.
The GOI is using a Co-WIN (COVID-19 Vaccine Intelligence network) application for managing the rollout of the Covid-19 vaccine in the country. The Covid-19 vaccines will be administered at designated session sites. The session sites have been categorized as fixed session site which includes health facility either the government or private having the availability of a medical officer/doctor and outreach session site which are sites other than health facilities such as schools, community halls, marriage places, etc.
Affordability of Covid-19 Vaccines
Affordability is another important factor which affects access to a pharmaceutical product such as a Covid-19 vaccine. If the medicine/vaccine is not affordable, the population affected by the diseased condition will not be able to afford it and will be devoid of its benefits. In a mammoth country like India making the Covid-19 vaccine affordable to the target beneficiary is indeed a challenging task but with the active involvement of many government departmental bodies and collaboration with the private pharmaceutical organization, India is moving steadily and progressively.
Two vaccines have received the emergency use authorization by Drug Controller General of India, namely Oxford-AstraZeneca Covishield which is being manufactured by Serum Institute of India, Pune, and Covaxin by Bharat Biotech International Ltd, Hyderabad developed in collaboration with ICMR and NIV, Pune.
The Indian Government is providing vaccination to the targeted beneficiary free of cost, which means there is no financial liability on their part which is indeed a laudable step towards access to Covid-19 vaccine. The Covishield costs to government Rs 200 (taxes extra) and the Covaxin around Rs 295 for a single dose. A goodwill gesture from Bharat Biotech in terms of providing 1.65 million free doses of Covaxin has certainly helped the Government financially and has aided in making the vaccines affordable to the beneficiaries.
Quality of Covid-19 Vaccines
The quality of the Covid-19 vaccine is another very important determinant which must be satisfied as the vaccines are produced using bacteria, viruses, or genetically modified organism, hence they should have the ability to treat or prevent the disease without them causing the harm. Safety and efficacy are the two yardsticks which are evaluated for accessing the quality of a vaccine.
The efficacy of Covishield has been evaluated in the clinical trials conducted worldwide and it is stated that it would be 90 to 95 percent effective if the two doses are given at an interval of two to three months. As far as the safety of Covishield is concerned the results of the clinical trials are encouraging and no peculiar or unusual side effects have been observed so far in three of its three stepped trials.
Covaxin which is India first indigenously developed Covid-19 vaccine got a remarkable breakthrough in terms of its Phase-I clinical trial data published in Lancet Infectious Diseases. According to Lancet Covaxin was found to be well tolerated in all the dose groups and there were no vaccine-related severe adverse drug events. The phase-III clinical trials of Covaxin are going on and as per the CMD of Bharat Biotech, the efficacy data is expected to be released by March 2021.
As of Feb 15, 2021, India has reached a phenomenal number of over 80 Lakh population inoculated in one of the largest ever immunization drive in the world which truly speaks of the efficient and effective healthcare delivery system but close monitoring in terms of availability, affordability and quality of the Covid-19 vaccine will be crucial for fighting this dreaded monster in days to come for the Indian population.
Disclaimer: The information has been collated from different sources and is already out in the public domain.