Corona Vaccination in India : Some Pros and Cons

The Vaccination against Covid19 has started in many countries by now...more than five dozen or so. UK took the lead in extending Emergency Use Authorisation (EUA) first to Pfizer Vaccine on 02 Dec 20 and started vaccinating their population from 08 Dec 20. Thereafter, FDA of USA accorded EUA to their Pfizer on 11 Dec 20 followed by Moderna on 18 Dec 20. All these approvals were accorded while the vaccines were still in phase-3 trials…some at the threshold of completing some past half-way. It was noticeable that all these vaccines during their phase-2 trials had to be stopped temporarily for investigating the serious side-effects encountered. Hence, all of these vaccines needed more data in its phase-3 trials in order to overcome their shortcomings. UK's own Oxford-AstraZeneca was granted EUA on 30 Dec 20 by their Deptt of Health and entered the vaccination program along with the other two. On 29 Jan 21, European Medical Authority (EMA) too have accorded EUA to the Oxford AstraZeneca claiming 60% efficacy.

India too has many vaccine candidates in phase-3 trials. Of these Covishield of Serum Institute of India (SII) and Covaxin of Bharat Biotech Limited are worthy of mention. Covishield uses the same Virus seeds in preparing the vaccine that is used by the Oxford-AstraZeneca, but following largely own procedures in the R&D. As a result, any significant side-effects faced by Oxford AstraZeneca had some impact on the Covishield too. On the other hand, the Covaxin was purely developed indigenously by Bharat Biotech with the assistance of NIV Pune who provided the virus seed and the ICMR guiding thru’ the procedures. Fortunately, this vaccine did not have any major side-effects during the phase-1 or phase-2 trials. In the initial few thousands of phase-3 trials too, this vaccine did not have any major side-effect.

After the Oxford-AstraZeneca applied for the EUA in the UK, Covishield of Serum Institute (SII) of India and Covaxin by Bharat Biotech Ltd (BBL) too applied for the EUA on 10 Dec 20. Both of them had started their phase-3 trials. However, Drug Controller General of India (DCGI), an independent organisation, sought more data and documents from both of them that reportedly pertained to the details of immunogenicity and side-effects during phase-2 and phase-3 trials. SII provided the phase-2 and part of phase-3 records but BBL provided their phase-2 records as the phase-3 trials were in the preliminary stage only. It is worth mentioning here that there is very little difference between phase-2 and ph-3 trials. Both immunogenicity and side-effects are calculated in both trials. Hence, based on a reasonably strong immunogenicity and fewer side-effects, both vaccines candidates were called to make final presentation to the expert committee on 01 Jan 21. Satisfied with the further inputs and explanations, the Expert group recommended both vaccine candidates for EUA that was accorded on 02 Jan 21 by the DCGI. It was a huge achievement for the Indian R&D on vaccines.

After the Indian govt announced EUA as above, the political bigots in the country could not digest the govt effort rendered through the Covid Task force and started the smear-campaign. Every Tom, Dick and Harry, be it Manoj Tiwari, Digvijay or even learned Tharoor...all started challenging the Expert Group recommendations. Some ignorant like Akhilesh Yadav called it a BJP vaccine. It was so unfortunate that these politician’s disrespect the doctors and scientists in the R&D of the Vaccines, the Expert Group and the Institution of the DCGI. However, both the Expert Group members and the DCGI has no iota of doubt in their decision hence, the smear-campaign of the ill-intentioned opposition politicians slowly faded away. Meanwhile Novovax and Janseen of USA are at the verge of getting EUA with the former claiming 92.5% efficacy incl that against the newer mutants. However, these claims are seemingly based on the commercial reasons than any credible scientific facts. Russian Sputnik-V too being tried out by Dr Reddy’s lab is likely to be applying for the EUA. Indian firm Zydus Cadila developing indigenous DNA-based vaccine, ZyCov-Da, at its facility in the city of Ahmedabad is in Ph-3 trials and likely be approaching for the EUA sooner than later.

Modi govt announced of the initiation of the vaccination from 16 Jan 21. The entire population has been divided in the various priority groups. The phase-1 vaccination is meant for all ‘Corona Warriors’ and the Front-line workers that number about 3 Cr people. This constitutes the doctors, nurses and other health workers. This is followed by the police, Armed Forces and the other Front-line workers who have to come out of the Lock-down measures and expose themselves to the Corona Virus almost daily. This will be followed by the Second phase of the Vaccination that will include people >50 yrs and also those below 50 yrs but having co-morbidities. It will constitute about 27 Cr people who will have to register themselves on a specially designed mobile App "CoWin" that will be available for download towards the end of Phase-1 vaccination. The App will inform the date and nearest place of the vaccination to the registered people. Phase-1 vaccination plan is free for the priority group all over the country. However, the cost-bearing of next phases have not yet been worked out. In all probability, it will be a cost-sharing by the State Govts and the Centre. The pace of the vaccination is far from satisfactory. In the 13 days, a total of about 33.6 lakh Covid Warriors have got immunised. It is felt that the govt has infrastructures in place that can perform at least 10 lakh of vaccination per day. Reports are also coming that some health workers are unwilling for the vaccination. It was expected as it is totally voluntary. However, it is felt strongly that if the designated groups/people are not coming for vaccination at the date/time, a waiting list could be created of the priority-2 group individuals who could take the vaccination in lieu. Govt must take a call on this otherwise, the target of vaccinating at least 65-67% people can ot be met in the near-foreseeable time period and the nation will remain vulnerable for another wave of Covid19 infection.

The main aim of the vaccination is to provide individual protection to the people as well as generate the herd immunity among the population in order to break the chain of transmission. For Corona, it is expected that almost 65-67% population need to have immunity to break the chain of transmission. If that be so, 89.7 Cr to 92.5 Cr population need to be immunised. Will that be possible? One may wonder. The corona vaccines are contraindicated for pregnant women (10% of all women in child-bearing age). The vaccine is not yet cleared for children and adolescent (<18 yrs forming approx. 23%). The vaccine is optional for only those who volunteer for it. It is a general feeling that about 20-25% people may not come forward for the vaccination as per the mood prevalent today. However, we don’t know if they will change their minds in the weeks and months to come. Under such circumstances, possibly all in the eligible groups of individuals will have to be vaccinated in order to achieve adequate herd immunity.

As the time passes, many questions will keep arising on the vaccination plans. Even before the vaccination drive started in India on 16 Jan 21, questions were already being raised of its efficacy and safety. In the first phase of the vaccination, 'Covid Warriors' have been prioritised. The govt and private hospitals are in the list but what about those who run their own small clinics? They don’t figure in the current list of Covid Warriors. Surely govt will have to make provision for them too. This is just one example. Many such queries are already in public domain; some being listed out here for which clear guidelines will have to be laid down: -

Should the Covid patients be vaccinated?

Should an immunocompromised patient receive the vaccination?

Should the adolescent and children on whom the Ph-3 trial have not been carried out, be vaccinated?

How many booster doses will be required if Covid19 infections continue in a nation?

What are the delayed sequele of the vaccination?

Will the vaccine be effective against the newer variants of the Corona?

Pros of the Vaccination. The strongest point in favour of the vaccination is that the individuals will get immunity and will be protected from any serious consequences of the Covid19. This wil surely reduce both morbidity and mortality of Covid19 as well as reduce the burden on the healthcare services of the nations. The other aim and objective of the vaccination is to achieve the ‘herd immunity’ to break the chain of transmission in the society. This larger aim in the national interest can be achieve only if people come forward for the vaccination.

Cons of the vaccination. In USA and Britain, many subjects receiving both Pfizer and Moderna vaccination have reported moderate to severe adverse reactions. Some had to get admitted to the hospital and one-odd have even died. In India too, mild symptoms of local inflammation at the injection site have been reported in the form of mild redness, pain, swelling and mild fever too. Three subjects have died after few days of vaccination by heart element unrelated to the vaccination. Indian vaccines have fewer side-effects. Nonetheless, the apprehensions are there but less. There are however, many questions in the minds of the people some of which can be answered but many not…at least at this time. They include the followings: -

Could the vaccine be injected to children & adolescents <18 yrs and elderly >55 yrs age as those age groups were not included in the Ph-3 trials? Report released by the MS, CMC Vellore dated 11 Jan 21 indicates so. It is felt that those above 55 yrs of age who are clearly at the higher risks of Covid19, could be vaccinated with inferences drawn from the study. Many may also feel it reasonable enough to vaccinate the children above 12 yrs of age. However, these are “inferences drawn” and not the actual studies. Since children <12 yrs may need a smaller dose, they are nor recommended to be vaccinated. As such they are not at higher risks of Covid19.

What if immunity is not adequate? There could be Covid19 infection in spite of vaccination. However, the severity of such vaccination will be less. Chances of them spreading infections to others are remote.

What if another variant of virus mutate? This is a genuine question in everyone’s mind. The scientists as yet, do not have a clear answer. There are hypothetical postulations that the vaccines against the Corona Virus should be effective against the Spanish, UK or the African variants of the Viruses. The same are the expectation for the vaccines against the German variant detected a couple of days back.We don’t know if altogether a different mutant strain of Virus will strike us in the coming weeks and months. There are claims and counterclaims about the efficacy of one or other vaccine candidates against the mutant strains of the virus but there are no confirmatory data. These claims are driven more for commercial considerations than the scientific proof. In general, it is expected that most if not all vaccines available as on the date, are also effective against the mutant strains though with somewhat lesser efficacies.

Will all vaccines be equally effective as a “booster dose” among the subjects who have recovered from Covid19? We don’t know with precision. We also know that all Covid19 patients have varying level of antibodies. Whether the particular Vaccine candidate will boost an identical antibody response, we don’t know. It is expected that all vaccines having whole SARS nCoV2 virion, attenuated or killed, should have identical antibody response and serve as a perfect booster dose for them. What about the others? Will other vaccine candidates require two doses in Covid19 recovered patients too? The scientists will have to find the answer.

Could the Vaccine cause serious antigen-antibody reactions among the Covid19 patients who have recovered from the infection? We don’t know for sure. Same is the answer for them who have received the convalescent serum of the Covid19 subjects after their recovery. Theoretically many of the ‘Corona Warriors’ are expected to have suffered asymptomatic and undetected Covid19. They may be having Corona antibodies in their blood. Such people, if given vaccine, could theoretically develop an Antigen-Antibody reactions of various grades incl that of anaphylaxis. Here, we may draw inferences from the Oxford-AstraZeneca Vaccination among the British for over 2 weeks now, where no serious antigen-antibody reactions have been reported. Hence, theoretical assumption of higher or serious antigen-antibody reactions appears to be unfounded. Indian roll-out of the vaccination will throw more light on this aspect.

The Indian vaccination program is massive. In the initial few days only, enough data is available about the safety of the vaccines…esp among the frontline workers, many of whom may have varying levels of Corona antigen in their blood. They are theoretically expected to manifest more allergic reactions. The next groups of the recipients of the vaccines that will incorporate the elderly and those having co-morbidities, and later... the general population, who are likely to have much less of the allergic manifestation as compared to the frontline workers.

While the vaccines are coming to the market, commercial rivalries too are on. China is understood to be running a smear campaign against the Indian vaccines esp in Africa. On the other hand, Indian Govt is trying to fulfil its obligations to provide the vaccines in the neighbourhood…to Nepal, Bangladesh, Sri Lanka, Maldives Seychelles Islands and Afghanistan. PM Modi had made a commitment in the UNGA of providing the vaccine to the world and stands firm on it. DG, WHO Dr Tedros has warned of vaccines not being available to the smaller and poorer nations. India is trying to do its best to fulfil the obligations.