While Covid-19 pandemic made gods and godmen retreat, scientists worked in their labs in silence. Usually, vaccine development takes about 10 years, but we already have three vaccines that have received the go ahead from national regulatory authorities – developed by Moderna, Pfizer, and AstraZeneca. According to the FDA, the Moderna vaccine is 94.1% effective in preventing symptomatic cases. The Pfizer vaccine has claimed 95% effectiveness, while AstraZeneca’s Oxford vaccine has 90 efficacy.
The World Health Organization (WHO) compiles the COVID-19 candidate vaccine database with detailed information on vaccine under development. According to WHO’s COVID-19 candidate vaccine landscape, the platforms used for Vaccine manufacturing are protein subunit, viral vector (non-replicating), DNA, inactivated virus, RNA, viral vector (replicating), virus-like particle, VVr+ antigen presenting cells, live attenuated virus, and VVnr+ antigen presenting cells.
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Russia and China are also launching their vaccines. Beijing-based pharmaceutical company Sinovac is testing the CoronaVac vaccine, by using the traditional vaccine manufacturing strategy of using the inactivated virus. The Moderna and Pfizer vaccines are mRNA vaccines, a new approach towards vaccine manufacturing. However, none have yet received WHO pre-qualification (PQ) authorisation. The Pfizer vaccine has already received approval from several countries including the US, UK and Bahrain.
Vaccination protects against several diseases such as polio, tetanus, the flu (influenza), hepatitis A, hepatitis B, rubella, HIB, whooping cough, pneumococcal disease, rotavirus, mumps, chickenpox and diphtheria.
Ensuring the safety and quality of vaccines and health products is the responsibility of national regulatory authorities. However, many developing countries and WHO member states lack regulatory capacity. WHO provides a quasi-regulatory pre-qualification service to identify health products – including affordable generics that are acceptable for use in UN-funded health programmes. And, since 1987, WHO prequalifies vaccines.
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The efficacy and safety results of the five vaccine candidates have been reported through press releases. But only one (AstraZeneca) has published the results in a peer-reviewed journal. As per WHO data, 61 COVID-19 vaccine candidates are currently under development. The Oxford vaccine and Sinovac, the Chinese vaccine, can be stored in a standard refrigerator at 2-8 degrees Celsius. Moderna’s vaccine must be stored at -20C and Pfizer’s at -70C. Sinovac and the Oxford-AstraZeneca vaccine will be useful for developing countries that might not have the infrastructure to store large amounts of vaccine at low temperatures.
Nations ready mass vaccination plans
Many countries, including France, Germany, Italy, Austria, Portugal and Spain, are planning to begin mass vaccinations, starting with health workers. The US, Britain, Switzerland, Serbia and China have already started mass vaccination. Argentina is immunising its citizens with the Russian Sputnik V vaccine. Turkey has gone in for China’s Sinovac vaccine and preliminary tests on 7,371 volunteers show that the vaccine is 91.25% effective, although phase III tests are still in progress. China’s Sinovac coronavirus vaccine will be administered in the United Arab Emirates, Bahrain and Singapore. As per the news report, Sinovac has secured deals with Turkey, Brazil and Chile.
Even before the regulators approve the Covid-19 vaccines, the Indian government and many state governments are getting ready for the rollout of COVID-19 vaccines across the country. According to media reports, the Oxford vaccine Covishield is likely to become the first vaccine to get the nod in India. However, the recruitment of trial participants for Phase III clinical evaluation of AZD1222 vaccine has been suspended due to suspected unexpected serious adverse reaction (SUSAR) at the University of Oxford sponsored Phase2/3 study. The study will be on hold until Russian MOH approves the vaccine.
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According to Press Information Bureau reports, the government has taken various efforts to roll out the vaccine. Development of the specialised apps to monitor and register for vaccination, training modules for special training, logistics, vaccine storage facilities, and the priority list of recipients are being readied.
India prepares for Covid vaccine rollout
As part of efforts to strengthen the public health capacity for the COVID-19 vaccine rollout, detailed training modules have been developed. As the vaccine administrators play an essential role in the vaccination process, trainers and those who shall administer the vaccine have been prioritised across various states.
The training is targeted to different categories of vaccine handlers and administrators including medical officers, vaccinators, alternate vaccinators, cold chain handlers, supervisors, data managers, ASHA coordinators and all others involved in the implementation process at different levels. The Union health ministry has developed an exclusive digital platform, an application called CoWin, for real-time monitoring of Covid-19 vaccine delivery, recording data and for people to get themselves registered for vaccination.
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The training includes operational aspects such as the organisation of vaccination sessions, use of Co-WIN IT platform for the management of the vaccination process, deployment of HR Cold chain preparedness, management of adverse events, communications and intersectoral coordination, biomedical waste management and infection prevention protocols.
When Covid-19 became a public health challenge, the government came out with an app Aarogya Setu to keep track of the coronavirus infections. The Aarogya Setu app was launched in April, which has over 10 crore registered users. However, now, the government has decided to develop another App, CoWin-20, as the Covid-19 vaccination programme tool. The Co-WIN app is primarily to help agencies track the distribution of vaccine and enable citizens to register for vaccination.
The primary objective of the CoWin-20 app is to help agencies keep track of Covid-19 vaccination programme and allow citizens to apply for vaccine shots. CoWin-20 app is divided into five modules. These are the administrator module, registration module, vaccination module, beneficiary acknowledgement module, and report module.
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According to Maharashtra health minister Rajesh Tope Maharashtra can start mass Covid-19 vaccination from January if the Centre’s authorisation comes by the end of this month. “Bharat Biotech and Serum Institute have applied for vaccination authorisation. If the central government gives authorisation by the end of December, the state government can start vaccination by January,” he said.
In Mumbai, Healthcare workers would get vaccinated on priority. The Brihanmumbai Municipal Corporation (BMC) said it had uploaded the data of nearly 80,000 employees on CoWin, for priority vaccination. These employees will be vaccinated first.
The Centre plans a dry run for the Covid-19 immunisation drive in four states in early January. The dry run will be done in two districts and five different settings such as district hospitals, community health centres or primary healthcare centres, urban sites, private health facility and rural outreach. The dry run will help assess the readiness of the mechanism laid out for the Covid-19 inoculation drive.
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As per PIB reports, 2,360 participants were trained during the national level training of trainers. This includes state immunisation officers, cold chain officers, IEC officials and development partners. According to the PIB, the state level training was completed with more than 7,000 district level trainees. In 681 districts, (49,604 trainees) medical officers’ training on operational guidelines is also completed. Vaccination team training was completed in 1399 out of 17831 blocks, planning units. It is ongoing in other blocks.
To facilitate queries on COVID-19 vaccination and Co-WIN portal related queries, national 1075 and State 104 Phone Helpline capacity has also been strengthened. To assess the planned activities’ readiness, a dry run is planned in four states; Andhra Pradesh, Assam, Gujarat, Punjab considering the geographical locations.
Each State will plan it in two districts and preferably in different settings; district hospital, CHC/PHC, urban site, private health facility, rural outreach etc. This will exercise enable end-to-end mobilization and testing of COVID-19 vaccination process (except the Vaccine) and check the usage of Co-WIN in the field environment, the linkages between planning, implementation and reporting mechanisms and identify challenges and guideway forward before actual implementation including improvements that may be required in the envisaged process.
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The trial run will also provide hands-on experience to programme managers at various levels. It will include activities from the necessary data entries in Co-WIN to vaccine receipt & allocation to the deployment of team members, mock drill of session sites with test beneficiaries to reporting and evening meeting. This will also include testing for cold storage and transportation arrangements for COVID19 Vaccine, Management of crowd at the session sites with proper physical distancing.
In Maharashtra, the BMC has done extensive preparations for the storage and distribution of the vaccine. An area of 5,000-square-feet on the first floor of a building at Kanjurmarg in S Division for Covid-19 vaccination will be known as Regional Vaccine Store (RVS) only for the centralised vaccine storage.
Meanwhile, an ideal immunisation centre for vaccination is being developed at Cooper Hospital in Mumbai to be replicated in other centres. Additional centres will also be set up for frontline workers as per the availability of second phase vaccination.
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In case of adverse vaccine events, adequate facilities have been made available at suburban hospitals and medical colleges. The existing committee will be expanded to include cardiologists, nephrologists and respiratory specialists to strengthen the mechanism for monitoring such incidents.
Instructions for collecting data on leading workers have been received from staff in the public health, sanitation, waste management, frontline engineers, drivers, BEST staff, cemetery staff and maintenance departments.
The dry run will focus on Management of Adverse Events Following Immunisation (AEFI), adherence and management of infection control practices at the session site. The mock drill will include concurrent monitoring and review at the block and district levels, and preparation of feedback shared with the state and Union health ministries. A detailed checklist has been prepared by the Union health ministry and shared with the four states to guide them in the dry run.
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The National Expert Group on Vaccine Administration of COVID-19 (NEGVAC) has recommended three prioritised population groups including healthcare workers (HCWs), about 1 crore, frontline workers (FLWs) about 2 crore, and prioritised age group (about 27 crore).
Covid19 vaccines are temperature sensitive and need to be stored at a specific temperature. The present cold chain system can store an additional quantity of Covid-19 vaccines required for the first 3 crore prioritised population. According to data from ClinicalTrials.gov (Identifier# NCT04540393), the vaccine beneficiaries will receive 2 doses of AZD1222; the first dose will be administered on day 1 and the second dose on day 29. The route of administration of vaccine is through Intramuscular injection.
Based on the evidence and data, experts believe that getting a COVID-19 vaccine may help you get seriously ill even if you get COVID-19. Vaccinating oneself may also protect people around them, particularly people at increased risk for severe illness from COVID-19.
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Will corona vaccine hit other vaccinations?
Covid19 vaccine rollout should not be at the expense of other vaccinations. The disruptions caused by the COVID-19 pandemic have a devastating impact on routine vaccination programs. The delays in immunisation campaigns could increase infectious diseases such as polio, measles, and human papillomavirus. The pandemic is overstretching the healthcare sectors and countries with limited capacity to deal with significant outbreaks are at breaking point. According to WHO, more than 116 million infants was vaccinated in 2019, and still, more than 13 million children miss vaccination around the world and that the number could have increased due to COVID-19.
A robust follow-up programme on the long-term protection and the side effects of Covid-19 must be part of the rollout programme. To ensure the vaccination programme’s integrity, there should be a rapid mechanism to examine each claim of side effects of the vaccination and a protocol to compensate such claims.
The Covid-19 vaccine rollout must strengthen the overall healthcare system. The revived momentum also should extend our efforts to ensure universal health coverage. This is also an opportunity to develop a new vision for the nation’s health and rollout a “health first” approach to rebuild the post Covid-19 society.
(Dr Joe Thomas is associate dean, faculty of sustainability studies, and head, School of Public Health, MIT World Peace University, Pune.)
References
WHO Pre Qualificcation
https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_31-3_Prequalification.pdf?ua=1
Sinovac Vaccine CoronaVac
https://www.daily-sun.com/post/522723/Sinovac:-What-do-we-know-about-Chinas-Covid19-vaccine
WHO Landscape of Covid19 Vaccines
https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
US FDA Clinical Trial Registry
https://clinicaltrials.gov/ct2/show/NCT04540393
GOI Frequently Asked Questions on COVID-19 Vaccine
https://www.mohfw.gov.in/pdf/FAQsonCOVID19VaccineDecember2020.pdf
Dr Joe Thomas is Professor of Public Health, Institute of Health and Management, Victoria, Australia. Opinions expressed in this article are personal.