India has launched its long-awaited vaccination programme on 16 January 2021 to protect its countrymen against the novel coronavirus that invaded and shocked the whole world throughout the bygone year of 2020. In the first two days, over three lakh people in various states were vaccinated, and barring a few cases of the alleged reactions the efficacy of which is yet to be established, nothing untoward has occurred so far despite too much criticism and hullabaloo raised by the opposition political parties, and their sympathetic media and intellectuals/professionals. Two vaccine candidates which have been approved by the Drug Controller General of India (DCGI) for the “emergency use” are Covishield and Covaxin.
Covishield is one of the few frontline vaccines in the world which has been developed by the University of Oxford in UK in collaboration with AstraZeneca, a multinational pharmaceutical company, and is manufactured by the Pune based Serum Institute of India under licence production. On the other hand, Covaxin is purely indigenous in nature developed and produced by Hyderabad based Bharat Biotech company. Both the vaccines have been approved by the India’s national drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), as suitable for the emergency use and, unlike Pfizer-BioTech and Moderna vaccines of US origin, both the vaccines can be stored on normal refrigerator temperature and their lower cost makes it ideal for mass production and vaccination in developing countries.
Why Emergency Use Became Necessary?
Ever since its invasion on the world populace, the coronavirus has not shown any symbol of respite with its characteristic uniform trend worldwide. Throughout the world and more particularly in the Western Europe and US, the pandemic had shown a constant upward trend since March 2020; then a dip was noticed among almost all badly affected countries during July-September giving some hope to mankind. But from October 2020, the entire Europe and Americas have been seized with a fresh wave of virus spread even with the reports of new variants occurring supposedly deadlier than the original one. The worst affected countries in the second wave are the US, UK, Brazil, Mexico, Russia, France, Germany, Spain, Italy, and many more developed countries of the West. In some countries like US, UK and Brazil, the number of the daily reported cases has shown phenomenal increase in the recent past.
Among the Asian countries, China and India have the largest population occupying first two places in the world chart with over 1.35 billion each, the Chinese population being marginally more. Strangely, while nearly 218 big and small countries and territories across the world have been severely affected from the virus with significant number of human casualties, but in China it has remained largely localized in Wuhan despite the country being the most populous with about thirteen cities having from ten to thirty million population. In terms of the number of people affected, India stands only next to US, and in terms of human casualties, it has suffered with over 15e thousand deaths so far with only US and Brazil being ahead on this notorious parameter. Due to rigorous measures and strict discipline, the virus remained in control in initial months but once relaxation was allowed, the rate of infections grew phenomenally from June onwards, peaked in November 2020 and on a declining trend now.
Although the number of new Covid-19 patients reported daily is now on decline in India except two states of Kerala and Maharashtra; however, learning from the experience of US and many European countries, the possibility of yet another fresh wave cannot be ruled out. Also considering the population of the country and rather inadequate medical care facilities compared to the developed countries of West, the second Coronavirus wave, if it occurs, would certainly be more dangerous and disastrous for the country. Hence the need for taking all possible measures including emergency vaccination to prevent the further escalation of the virus in the country. As the trend of the virus spread has been very erratic so far without showing any signs of the disease subsiding its own, the world at large and India have pinned their hope on the ongoing vaccination programme for the large target population and, accordingly, countries have endeavoured to accelerate vaccine development and its emergent use.
Currently, nearly fifty vaccine candidates are under various stages of development and testing worldwide; however, four vaccine candidates viz. Moderna, Pfizer-BioTech, Oxford-AstraZeneca and Sputnik V were leading ones under phase 3 trials towards the end of previous year. Of these, first two vaccines have been developed by Moderna Inc., a US based Biotech company, and Pfizer Inc. and BioTech American multinational pharmaceutical corporations, respectively. The Oxford-AstraZeneca has been developed by the University of Oxford in collaboration with AstraZeneca in UK while Sputnik V is the Russian vaccine named after its Sputnik satellite series. India has been working on its own vaccine named Covaxin under the aegis of Bharat Biotech and the Indian Council of Medical Research (ICMR). Considering the emergent requirement of the huge Indian population, the Indian authorities appear to have decided to conclude phase 3 trials, and go for mass production, distribution and use of Covaxin along with simultaneous licence production and end use of the Oxford-AstraZeneca by the Pune based Serum Institute under the trade name Covishield.
The sceptics and critics, particularly the Indian opposition political parties, have criticized the government move of the emergency commencement of the vaccination programme in mid-January 2021 allegedly without properly conducting and evaluating the final phase testing and trials. The Government would for sure be interested for early launch of the vaccination drive but testing and evaluation is carried out by the scientists and doctors, and production and distribution cannot be commenced without the regulatory approval. Hence there is a reasonable ground to believe that the DCGI has approved Covishield and Covaxin for the emergency use in India when they have reasonably assured themselves of its safe application on the target population. Also considering the risk of a second coronavirus wave worldwide, it appears a wise move to pre-empt such risk through an urgent response rather than resorting to a reactive damage control when the virus strikes back with full vigour again.
Vaccines’ Fact Sheet and Cautions
Two producers, Hyderabad based Bharat Biotech and Pune based Serum Institute of India have nearly simultaneously released their fact sheets and frequently asked questions (FAQs) to answer common queries and doubts about the vaccines before use. Such details include the benefits and possible risks of these vaccines for use against the novel coronavirus. The Bharat Biotech, while reiterating its faith and confidence in the vaccine, has mentioned that the efficacy of Covaxin is yet to finally establish as the clinical trial for the phase 3 are still underway. Needles to mention that the most other vaccines work on the normal antigen-antibody reaction concept in the human body and Covishield and Covaxin are no exception. all beneficiaries are expected to reveal certain health information before taking a vaccine shot.
The indigenous Covaxin is injected into the deltoid muscle of the upper arm and is expected to generate immunity after admission of two doses with a gap of four weeks. The vaccine producing company has assured that there is absolutely no fear of getting Covid-19 due to Covaxin vaccination. Some people may have side effects which could vary from one to a combination of the following symptoms: Injection site pain, swelling, redness, itching; stiffness and/or weakness in the upper injection arm; body ache and headache; fever, malaise and weakness; also, in some cases rashes, nausea and vomiting. Some people may have severe allergic reaction too but this would be in very rare cases. Such symptoms in vaccine beneficiaries may include difficulty in breathing, rashes all over the body, swelling on face and throat, a fast hear beat, and dizziness and weakness.
As already mentioned earlier, Covishield is the trade name given to the Oxford-AstraZeneca vaccine produced under licence by the Serum Institute of India and approved by the Indian drug regulators for the emergency uses. This too comprises of two separate doses, the second one to be administered four to six weeks after the first dose. However, any person reporting a severe allergic reaction to the first dose of the vaccine, would not be given the second shot. The company is hopeful that people would develop immunity for the Covid-19 disease after about four weeks of the second shot.
The common side effects of the Covishield may include one or a combination of symptoms such as tenderness, pain, redness, warmth, itching, and swelling or bruising at the injection site; fatigue, headache, and chills or feeling feverish; nausea or vomiting; muscle ache and/or joint pain. People may also experience a lump at the injection site and flu-like symptoms with high fever, runny nose, sore throat, cough and even chills. In rare cases, some people might experience dizziness, loss of appetite, abdominal pain, enlarged lymph nodes and excessive sweating with rashes or itchy skin.
Among other precautions and restrictions, the beneficiaries have been advised to disclose their medical condition and avoid taking vaccine shots in the following circumstances:
- The person has allergies of any kind such as on account of a drug, food or any vaccine;
- The person already has fever;
- The person has previous bleeding disorders or is on a blood thinner;
- If the lady is already pregnant, or have any such plan, or already breast feeding;
- If the person has previously received another Covid-19 vaccine;\
- If the person is immunocompromised or using a medicine that affects immune system;
- The person has any other serious health issues in vaccinator’s opinion.
Basic Facts About India’s COVID-19 Vaccination Programme
The Indian vaccination programme kick started with the first dose being administered to a sanitation worker at the All-India Institute of Medical Sciences in New Delhi along with the Prime Minister ‘s nationally televised speech on 16 January 2021. In the aforesaid launch, the Indian health workers and support staff have been targeted for priority vaccination in the initial phase. As of now and as per available information, the Indian Government has tentatively planned to vaccinate about 300 million people. The recipients would include about 30 million doctors, nurses, health workers and other front-line support workers such as police, sanitation and municipal staff in the initial phase. This would be followed by nearly 270 million people that either fall in the age group of over fifty years or have illnesses making them vulnerable to the Covid-19 disease. As India is also the home of the world’s vaccine producers with the biggest immunization programmes, the aforesaid feat may be tough but not beyond the achievable goals.
In about a week’s time since commencement of the drive, nearly 1.39 million people have received first shot without any major complication or serious side effects. Side effects have been reported in a small segment with minimal symptoms. The vaccination programme undertaken would be the world’s largest known such campaign as such information from the Communist China are never truly revealed and the third largest populous country US has nearly as much total population (330 million). Some western and wealthier countries including US and UK had already started giving vaccine shots to their citizens from the later part of December 2020 mostly opting for Pfizer-BioTech and Moderna vaccines. The Indian move to take care of it’s health workers first, appears reasonable and laudable as they are the ones who have been under tremendous stress and risk ever since coronavirus made its entry and stronghold in the country in March 2020.
Indian regulators had approved the emergency use of two vaccines on 4 January 2012: Covishield, the vaccine developed by the Oxford University in collaboration with the UK-based drug company AstraZeneca, and produced by the Serum Institute of India under licence; and Covaxin, indigenously developed and produced by an Indian company Bharat Biotech in collaboration with ICMR. Unlike the US produced Pfizer-BioTech and Moderna which require special arrangement for the storage and safe keep, both these vaccines are easy to handle and can be safely stored at the normal refrigerator temperature; thus, they are less expensive and suitable for the developing and populous country like India. During the next ten days, shipments were dispatched through cargo planes to different Indian cities to simultaneously start the vaccination programme on 16 January.
The aforesaid 300 million target appears to be inadequate for India’s over 1.25 billion population that may change based on exposure and experience later on. The government appears to have aimed at inoculation of about hundred people in each of about three thousand vaccination centres across the country. Even this target might undergo change based on the needs, resources and constraints. The factors in India’s favour are its indigenous potential and capacity of vaccine production, distribution and inoculation while the limiting factors have been the sheer number of Covid-19 patients over 10 million so far, only next to US, and number deaths over 152 thousand, only next to US and Brazil. On global basis, total number of coronavirus patients so far has been over 98.76 million and deaths 2.1 million.
However, it is not only opposition politicians but some experts too who have expressed apprehension about India’s vaccination programme. For instance, one director of a rural hospital in Maharashtra, remarked that the government has taken decisions in a hurry to be populist that might not be in the best interest of the common man. According to him, the regulatory approval was hasty and not backed by science. At least one state health minister is also on record to have opposed the move. Similarly, some doctors at the Ram Manohar Lohia Hospital in Delhi were also reported to have given preferential choice for the Covishield, instead of the indigenous Covaxin, as they appeared apprehensive about the lack of the complete trial of the latter vaccine candidate. Notwithstanding such scepticism and dissenting voices, people in general have shown tremendous zeal and response to the ongoing vaccination campaign.
While striking a balance between its own requirements and helping other developing countries, India has planned the supply of Covishield and Covaxin vaccines to its neighbouring countries including Nepal, Bhutan, Bangladesh, Myanmar and Maldives, and certain consignments already released, while regulatory clearances from Sri Lanka, Afghanistan and Mauritius are awaited. India’s credentials as vaccines producing hub are already established and with the reports of the Indian vaccines showing minimal side-effects, demand from a score of many other countries is pouring in for the supply of both the vaccine candidates.
The World Vaccination Scenario
Dozens of the wealthy nations of the West and oil rich Islamic countries had already commenced their vaccination programmes in the later half of December 2020. Pfizer-BioTech and Moderna Covid-19 vaccines developed by two pharmaceutical companies of US have mostly found favour in these countries and, as per reports, the majority of the vaccine doses produced by these companies have been earmarked and diverted to them. On their part, the World Health Organization appears to lag behind struggling for the money, vaccines and logistics for their UN backed COVAX project for the organized development, production and distribution of reliable vaccine doses to less resourceful and needy developing countries.
Currently, Pfizer-BioTech, Moderna, Sputnik V and some Chinese vaccines are being administered to people world over. Of these, Pfizer has taken a lead over the rest vaccine candidates and currently over two dozen countries including UK, Argentina, Belarus, Belgium, Chile, Costa Rica, Croatia, Cyprus, The Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Kuwait, Malta, Mexico, Oman, Poland, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Switzerland and Singapore are using it alone or in combination with some other vaccine. As usual, only little is known about the communist countries but Russia is stated to have already commenced its inoculation programme with the Russian vaccine Sputnik V since September 2020. Turkey is using the Chinese Sinovac vaccine for its emergency programme and the United Arab Emirates is using both American Pfizer and Chinese Sinopharm vaccines.
The US has been the worst victim of the coronavirus both in terms of the total number of cases over 25 million as well as deaths more than 424 thousand. Both the Pfizer-BioTech and Moderna vaccines were approved by the US authorities in December and the vaccinations had started on 14 December 2020 and nearly 18.4 million shots have been given as on 22 January 2021. Another North American country Canada too has gone ahead with the same two vaccines with effect from 14 December 2020. According to the global data collected and reported by Bloomberg, more than 56.7 million vaccine shots have been administered in 52 countries as on 22 January 2021.
Updates on Leading Questions & Queries
Some of the intriguing questions and queries are still bothering concerned authorities and common populace as well in the countries where vaccination programme has been undertaken. Some more important ones include if the vaccination would provide a long-term protection as also whether vaccine shots of two different make can be taken. Then in a country like India, people are also apprehensive about the vaccination rendering them sterile and impotent.
About the long-term protection, the WHO has opined that it would be too early to say if COVID-19 vaccines would indeed provide any long-term protection. According to them, additional research is needed to answer this query. However, the world body appears to be hopeful as the available data about the people recovered from the Covid-19 disease suggest that most of them develop an immune response which shall provide protection against reinfection at least for some period. However, how strong the immune response is and how long it is likely to last is yet to be determined.
As per available reports, currently five vaccine candidates have been released for the global use. The majority countries are currently using either Pfizer or Moderna, or both, produced by US based multinational pharmaceutical companies. Russia has been using Sputnik V for the last four months and as per available reports, countries like Argentina, Belarus, Serbia and Hungary have approved it for their domestic use. Also, Russia has now filed for registration of its vaccine in the European Union. Oxford-AstraGeneca is already in use of the UK, South Africa, and India. The position of Indian Covaxin is already explained in an earlier paragraph. Most likely due to suspect role of the communist nation in coronavirus spread, the Chinese vaccines have not generated desired global interest yet Turkey and some Islamic countries have entered into arrangement for taking Chinese vaccines.
While the national regulatory authorities of the respective nations have authorized the use of various vaccines, any of these vaccines have not received a nod from the WHO as yet. However, none of the countries have approved or advised the use of two different vaccines on the same individual. As the most vaccine candidates prescribe two shots at a certain interval, each person would be compulsorily required to take the second dose of the same vaccine.
As the apprehensions about the sterility and impotency due to vaccine use is more of a country specific based on rumour mongering and ill-conceived notions, the Indian Union Health Minister Harsh Vardhan has personally clarified in an appeal on 14 January about the absence of any scientific evidence to suggest that the Covid-19 vaccine could cause infertility in either men or women. He also stressed that infertility is not known to occur as a result of Covid-19 disease either and people must believe only official channels of communication of the government to get correct information about Covid-19.
To understand why different types of vaccines should not be mixed or simultaneously used, the following information about how different vaccines are being developed and work, may be useful:
- Inactivated or weakened virus vaccines that use a form of the virus that has been inactivated or weakened so it doesn’t cause disease, but still generates an immune response. India’s indigenously developed Covaxin falls in this category.
- Viral vector vaccines that use a virus that has been genetically engineered so that it can’t cause disease, but produces coronavirus proteins to safely generate an immune response. UK’s Oxford-AstraGeneca and Russia’s Sputnik V come under this category.
- RNA and/or DNA vaccines, a cutting-edge approach that uses genetically engineered RNA or DNA to generate a protein that itself safely prompts an immune response. The Pfizer-BioTech and Moderna of US are mRNA-based vaccines.
- Protein-based vaccines, which use harmless fragments of proteins or protein shells that mimic the COVID-19 virus to safely generate an immune response.
Thus, scientists around the world are developing potential vaccines for COVID-19 with different approach and technology. Though the ultimate aim of all vaccines is to teach the body’s immune system to safely recognize and block the virus that causes COVID-19 but the immune response of different vaccines might vary in each case. Hence only their separate use is advisable.
Opposition Questions Timing and Efficacy of Vaccine Use
Perhaps India is the only country in the world where a sizeable section of politicians, mediapersons and intellectuals seek opportunity for self nearly in all situations, be it the normal circumstances, disputes with the neighbours, external aggression and enemy attacks, or even the current pandemic badly affecting the economy and health of the entire nation. This trend has become more vicious and sharper after the present NDA Government came in power in 2014 and repeated its grasp on governance and power with a massive mandate in 2019 General Elections. The unfortunate and regrettable part is that these sceptics and critics use such tactics without discretion and do not spare even the issues directly linked to the public health or other cause.
So, it is not surprising that as soon as the India’s drug regulator approved Oxford-AstraGeneca Covishield and indigenous Covaxin for the restricted emergency use, the prominent leaders (I’m avoiding names) of India’s grand old party now in opposition started questioning the Government’s motive and moves firing salvos on almost every aspect of the vaccination programme. It is true that both the vaccines have been approved for use pending final words on their efficacy and application but even UK’s approval to Oxford vaccine came under somewhat similar circumstances well before India’s nod for this vaccine candidate. Similarly, other Western vaccine candidates too had to sum up final phase quickly to enable majority nations to approve vaccination of their population as an emergency measure.
The serious concerns raised by the main opposition party leaders include nearly all aspects of the vaccine, development, approval, production, distribution and end use. According to one leader, the grant of approval to Bharat Biotech’s Covid-19 vaccine for the restricted use was premature and can prove dangerous. The phase 3 trials have not been completed and the data on safety and efficacy has not been reviewed. He called upon the Health Ministry to explain why the mandatory protocols were dispensed with. In another statement, similar concerns about the global efficacy and final trials in UK about the Oxford-AstraGeneca vaccine were also raised with insistence that the facts about the government-to-government agreement shall be revealed in public domain. Here the issue regarding the price difference between the same vaccine in India and Belgium was also raised besides the inter-se comparison of Covishield and Covaxin cost.
The opposition party also opposed the Government’s plan to allow the export of two vaccines to the neighbouring countries. A party spokesman held that the Government should not allow export of vaccines till the entire population of the country is immunized. Yet another leader questioned if all the underprivileged and poor people of the country will receive free shots of these vaccines. Opportunism and confusion climaxed when a little later after the regulatory approval of the vaccines, the party appeared in a reconciliatory mood when a formal statement was issued that the party had full belief on the scientific community and scientists. Similar scepticism and criticism also came from some regional parties, e-periodicals, news magazines and media blitz, with one leader of a political party denying use of vaccines linking them to the ruling Bhartiya Janata Party.
Conclusion
The aforesaid paradox, influence of such elements and media bias in India could be understood from the following simple illustration. The Indian states of Uttar Pradesh and Kerala have population of over 230 million and 34 million, and are ruled by the Bhartiya Janata Party and Communist Party (Marxist), respectively. Initially, Kerala had a low count of Covid-19 patients and the local and national media had all praise and glorification of the Kerala leadership and more particularly their Health Minister. Uttar Pradesh, despite being one of the largest and most populous state, stands at the seventh slot in the overall national tally of coronavirus cases while Kerala being one of the smallest and less populated states occupies the fourth slot, where the virus spread has gone beyond control now with 6753 new cases reported as against only 303 in Uttar Pradesh on 22 January 2021. By all counts, Uttar Pradesh has been among the most well managed states during the pandemic, Nonetheless, one would seldom find any appreciation in media for the political leadership of Uttar Pradesh or now criticism for Kerala leadership for the current mismanagement.
The opposition parties and their sympathetic media and intellectuals’ move to question and embarrass the efforts of the Central Government by creating wild theories, and consequent panic and confusion among the people is not justified by any means. It is true that in every parliamentary democracy, the important role of opposition is to point out and criticise the shortcomings of the government. But such criticism shall be a constructive criticism on the policies and programmes and not indiscriminate with ill-motive by creating confusion and fear among the people just to garner cheap popularity and political mileage. Let there be no doubt that the extraordinary situations need extraordinary remedial measures. Therefore, to overcome a difficult situation, a calculated risk shall also be taken if it is so warranted. Almost entire world fraternity has taken such calculated risk by allowing emergency use of Covid-19 vaccines for their population.
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