click here to read All India Peoples Science Network (AIPSN) Position Paper (English)

click here to read Hindi version of Position Paper 

On Second Wave of Covid-19 Pandemic in India

14 Apr 2021

click here to read the short statement (English) based on the position paper

click here to read the short statement (Hindi) based on the position paper 

Click here to read short statement in Odia

India is well and truly into a brutal second wave of the Covid-19 pandemic. Daily cases are skyrocketing to unprecedented heights, and are now the highest of all countries, while total cases have taken India to second place worldwide overtaking badly hit Brazil. For the sixth day, India had record numbers of daily cases over 1 lakh, reaching 1, 61,736 new cases on 13 April, far higher than the  record high of 97,894 new daily cases on 16 September 2020 during the first wave.  Going by current trends, India is likely to reach even higher daily case rates, with these new highs prevailing for a prolonged period, unless strong and effective steps are urgently taken. Mortality and hospitalization rates are on the rise dangerously in parts of the country and show a worrying trend overall.

Accept responsibility; don’t blame the people and States

A very belated high-level meeting at the PMO a week ago “emphasized that the reasons for the sharper rise in cases could be mainly attributed to the severe decline in compliance of Covid-appropriate behavior primarily in terms of use of masks and maintaining ‘2 Gaj ki Doori’ [two yards distance], pandemic fatigue and lack of effective implementation of containment measures at the field level.” This analysis blaming the people and the States for this crisis, and repetition of the same charge by other high officials, is disingenuous, hypocritical and even dangerous, serving only to enable the Centre to evade responsibility for the present situation and give itself an excuse for future inaction or failure. It is evident even to a casual observer that broad sections of the people all over the country have become extremely lax as regards masking, maintaining physical distancing and avoiding crowded spaces especially indoors. However, this begs the question: what was the Government doing to tackle this and prevent the inevitable consequences of a second wave, and did not the Government itself encourage this laxity?

As public health experts have pointed out, the period when cases were sharply declining reaching a trough or low point of 9,121 on 15 February, provided the best opportunity to attack the virus through vigorous containment and mitigation actions including expanded vaccinations, but the Government lowered its guard and missed this chance. Meanwhile, encouraged by signals  from the Centre, authorities everywhere relaxed all restrictions, with offices, cinemas, restaurants, malls, passenger airlines and public transport all functioning at full capacity virtually in a pre-pandemic “life as usual” mode. Learning from the first wave, it is important that measures are taken through a partnership between the Centre and States, with the Centre providing evidence-based guidelines and financial as well as other assistance, with the Centre not making efforts to shift blame to States while withholding essential supplies and co-operation on many fronts.

Experience of different countries has repeatedly underlined the importance of continued vigilance and ensuring Covid-appropriate behavior during periods of declining cases. However, the Government itself suggested, through its National Covid Supermodel, that cases in India had peaked by October 2020 and would be under control by February 2021, and led to widespread lowering of guard. Even today, in the midst of this dangerous second wave, huge crowds are attending potentially super-spreader events such as the massive gatherings at the Mahakumbh Mela, and packed rallies and road shows during the State elections frequently addressed by the topmost Government leaders who are themselves responsible for Covid-19 control measures. No guidelines have been issued, no efforts at enforcement of Covid norms are being made, and the few mild public appeals seem like a mere a formality. It would appear there is no pandemic in India!

Additional epidemiological data and further analysis is required to arrive at any firm conclusions as to reasons behind this second wave, and precautions required to be taken in the future.

Understand role of variants, expand gene sequencing

There is considerable discussion, albeit so far without adequate evidence or data, about one particular reason that may be contributing to this second wave, namely Sars Cov2 virus variants which may be more infectious, or deadlier, or even provide a “vaccine escape” i.e. being resistant to vaccine-induced immunity. It is well known that viruses mutate to combat increasing immunity in the host population due either to widespread prior infections or vaccination. The major internationally known variant strains or lineages are the so-called UK variant (B.1.1.7), which ravaged Britain and has now emerged as a dominant strain in the US and may even lead to more deaths, the South African variant (B.1.351) and the Brazilian variant (P.1.). All these variants have been observed in India. Of around 10,787 samples from 18 Indian states analyzed by labs involved with the Indian SARS-CoV-2 Consortium on Genomics (INSACOG), 771 variant cases were detected comprising 736 UK (336 in Punjab alone), 34 South African and 1 Brazilian variant. Maharashtra has shown a worryingly large number of cases (202 of the above sample) with a “double mutation” (E484Q and L452R), now assigned a distinct lineage B.1.617.

However, insufficient information is available as of now to draw any firm conclusions about the impact of these variants. Also, not enough is known about the efficacy of different vaccines in protecting against these variants, although some available information suggests that the Oxford-AstraZeneca or Covishield vaccine provides good protection from the UK variant but not from the South African variant. INSACOG has been beset with difficulties and only 7,664 samples – less than 1% of the total positive samples since January 2021 through March 18, 2021 – have been sequenced. It is important that India significantly expands genetic testing across the country and correlates findings with epidemiological data in order to obtain a better understanding of the dangers posed by these variants. There is therefore need for more laboratory and field studies regarding the efficacy of Covishield, Covaxin and other vaccines likely to be used with respect to these variants.

Increase testing, tracing and surveillance

It is important to note that the main public health response to the present second wave, irrespective of these variants and other factors, remains broadly the same as was advocated earlier, but learning from missteps and experience during the first wave.  India needs to vigorously test, trace, isolate and treat infected persons, besides putting in place decentralized, locally relevant and evidence-based surveillance and containment strategies. Test positivity rate in the first wave was highest at around 12.7% on 20 July 2020, about 8.7% at the case load peak around 20 September 2020 and was at its lowest at 1.6% on 15 February 2021. Today all-India average test positivity rate is high at 11.4% on 12 April 2021 showing inadequate testing, and rising continuously. Testing needs to be ramped up significantly, with emphasis on RT-PCR tests, so as to uncover infections more quickly. At the same time, testing needs to be strategic, targeting contacts of positive cases and symptomatic cases in clusters identified through community surveillance and contact tracing.

Contact tracing was the weakest aspect of the response by governments at the Centre and most States during the first wave, with the Aarogya Setu App proving to be ineffective, and badly needs to be strengthened now. Tracing all contacts quickly, testing and then isolating them if infected, is essential for quick containment of the spread of the disease, along with community-level surveillance measures to identify potential hot spots. Decentralized evidence-based approaches with community participation would be most effective. All available human resources need to be mobilized for this, going beyond health workers and the police who may have enough on their hands, and tapping NDRF, home guards, educated youth and other volunteers, and civil society organizations, all with proper training for the purpose. Data relating to contacts traced, tested and isolated should also be included in daily reporting dashboards of State governments along with cases, tests, deaths etc, since this would act as a monitoring mechanism as well as motivation to perform better.

Address Vaccine shortage & Equity

There is a seriously mistaken tendency among authorities, and also some commentators, to look to vaccines as a silver bullet to tackle the pandemic and bring this second wave to an end. India is currently vaccinating an average of 3-4 million persons per day and has so far administered around 85 million doses. While this may look good in absolute numbers, especially for a developing country, India’s vaccinations per capita rank well below the global average. Many States are also complaining of shortages in vaccine supply from the Centre.

It also needs to be emphasized that India will take at least another 55 days at present rates to administer at least one dose to the original target of 300 million persons for this phase, not counting the additional recipients due to inclusion of all above the age of 45 years in the eligible group. That still leaves a huge gap of several hundreds of millions of doses requiring to be administered even if those under 18 years are not counted. Clearly, India cannot just wait for vaccinations to be completed and must press on urgently and effectively now with the public health measures discussed above.

There is much information available, albeit scattered and mostly anecdotal at present that a class divide is emerging in India’s vaccination drive, in cities as well as in many rural areas in the country. Those missing out on vaccinations say they do not know where vaccines are being administered, how to get vaccinated, how to enroll for vaccinations, that they do not have smart phones etc. These deficiencies need to be urgently rectified by suitable modifications in the vaccination strategy, especially by taking the vaccines to eligible populations at community level and conducting widespread communication campaigns on the vaccination drive. Continuing vaccine hesitancy also needs to be overcome.

The weakness in vaccinating health workers and frontline workers, the first in the eligibility queue, also needs to be overcome urgently. Reports suggest that around one-third of health workers have not been vaccinated, for whatever reason. Having noticed some misuse of the priority facility for health workers, the Government has recently closed the enrollment of health workers for vaccination. Instead of taking punitive action against health workers by closing their enrollment for vaccination, Government should rectify the enrollment system and block loopholes, while actively persuading health workers to get vaccinated.

Scale-up Vaccine production and availability

These vaccine numbers show that, quite apart from complaints by several States about vaccine shortages and lack of timely supplies from the Centre, requirement for vaccines is currently greater than supply and likely to remain so over the next few months. According to reports, Serum Institute of India (SII) is producing around 21.6 lakh doses of Covishield daily or 648 lakh (64.8 million) doses per month. Bharat Biotech is manufacturing around 1.6 lakh doses of Covaxin daily (4.8 million doses per month). The total production is therefore enough only for 23 lakh doses daily, much below even current vaccination rates, leave alone an expanded vaccination drive. Therefore the Government needs to urgently take steps to boost manufacturing capacity. For instance, both the above manufacturers have requested the Government to finance expansion of production significantly and quickly. SII has said it could ramp up production of Covishield to 200 million doses per month if such financing is made available, and. Bharat Biotech says they could scale up production of Covaxin to around 7 times current levels or to about 33.6 million doses per month.

All those who are clamoring for on-demand vaccinations for the entire adult population should keep these supply chain constraints in mind. At the same time, the suggestion from several hospitals and doctors that those between 18 and 45 with serious co-morbidities should also be brought within the eligibility criteria for vaccinations need consideration.

At the same time, the Government should also take several other steps to ramp up availability of vaccines. At the time of writing, the Russian Sputnik-V vaccine, which has a proven high efficacy against the SARS Cov2 virus and has also undergone bridging trials in India, has been given emergency use approval by DCGI after a prolonged wait while being repeatedly asked for additional data. This contrasts sharply with the rapid pace with which Bharat Biotech’s Covaxin was approved, without even waiting for efficacy data. This is not to argue for similarly cutting of corners for Sputnik-V or other vaccines, but Government should help to expedite the process. Sputnik-V is not prohibitively expensive, unlike the Pfizer and Moderna vaccines, and can be stored in ordinary refrigerators in powder form, and can therefore form an important part of India’s vaccination programme. Russia Direct Investment Fund (RDIF) has also tied up with 6 Indian vaccine manufacturing companies to together produce around 650 million doses. However, since this production in India will take time, Sputnik V will initially be fully imported from Russia. Again, at the time of writing, Government has decided to invite those vaccines approved by WHO and by regulators in the US, Europe and Japan to apply for approval in India without having to undergo bridging trials, stating that close watch would initially be kept on safety aspects before large-scale roll out.

Care should be taken to ensure that modalities of import, pricing and distribution are designed in such a manner as to not accentuate the present class divide in vaccine access, and that a dual-access does not emerge where the well-off have ready access to a wide variety of vaccines through private facilities by virtue of their ability to pay higher prices, while the poor struggle to access vaccines due to lack of paying ability and poor access to information.

Address Licensing/ IP issues

It is unfortunate that despite this good track record of assisting the global vaccination effort despite high , India has not pushed back on high-income countries such as in the US and in EU countries who have hoarded vaccines at the cost of other especially poorer countries.

India recently participated in a Meeting of the Indo-Pacific Quad grouping comprising the US, Australia, Japan and India. Among other things, the Meeting discussed a major Quad role in enhancing vaccine supplies for the Indo-Pacific region through an agreement under which the US would provide vaccine know-how and share financing with Japan, India would take responsibility for manufacture and Australia would handle logistics for supply of 1000 million doses to the region by end of 2022. Unfortunately, India did not use the occasion to raise the issue forcefully with the US, merely stating afterwards that the matter is sensitive and is being discussed with the US bilaterally. India must push the US strenuously in this regard; otherwise the “strategic partnership” would mean little.

India and South Africa also moved a proposal to the WTO in October 2020 calling for suspension of intellectual property rules and other obstructions to sharing of know-how especially to developing countries to enable the latter to manufacture vaccines, medicines and other medical products and hence to more rapidly bring the Covid-19 pandemic under control at least cost to their people. Regrettably, but true to form of the global North, the high-income countries notably the US, UK and EU blocked the proposal. In this case too, India did not actively pursue this proposal, which had the backing of the developing countries, either bilaterally with the US and other developed countries or in multi-lateral fora, revealing a possible lack of courage and determination to take on the leaders of global capitalism.

However, this demand by India points to another measure the Government could take in India so as to ramp up production of vaccines in India. The Covaxin vaccine was developed by the National Institute of Virology in Pune, a laboratory under the Indian Council of Medical Research, and productionized by the Hyderabad-based Bharat Biotech who put it into production.  It is suggested that the Government take the initiative to work out arrangements for licensing other Indian manufacturers to produce Covaxin so as to augment total supply of this vaccine. Established public sector enterprises such as the Haffkine Bio-Pharmaceutical Corporation Limited, Maharashtra should also be included in this endeavor, putting aside the blind ideological opposition of the ruling dispensation to PSUs.

There is no compulsion to allow Bharat Biotech to retain a monopoly over the know-how for this vaccine, especially during this dangerous second wave of the pandemic, just as India had joined South Africa to demand that vaccine developers and manufacturers in the developed countries give up their monopoly rights.

Oppose misguided vaccine nationalism

In this connection, there is a wholly misconceived campaign being mounted, including by some political parties and sections of the media, that India should stop commercial and aid-based exports of vaccines so as to prioritize domestic needs. Even before this, the Government had imposed some restrictions on exports potentially undoing the goodwill earned earlier by free supply of vaccine to friendly developing countries and by its substantial contribution to the international Covax facility to supply vaccines to lower income countries. India has exported around 64.5 million vaccine doses, mostly of Covishield, since January 2021. Of this, 10.5 million were free supplies to developing countries and UN peace-keeping forces, 18.2 million to Covax, and 35.8 million were commercial exports, again including under contractual agreements with AstraZeneca which has licensed the manufacture of Covishield in India. Notably, India has hugely benefited from the transfer of technology from Oxford AstraZeneca to SII of a vaccine whose price has been deliberately kept low so as to benefit other developing countries. Supplies to Covax too are contracted and manufacturers like SII have received substantial advance funding under the Covax programme, so these actually should not be stopped or delayed, although reports are that India has slowed down supplies to Covax and also under its aid programme, causing anxiety among these recipients.

It should also be noted that India has received back around one-third of its supplies to Covax, since India too is a beneficiary country, and largest recipient, under Covax! The free vaccine supplies amounts to just 3 days of vaccination in India at present rates, and even the commercial exports are equivalent to only about 10 days’ supply for vaccination in India. Therefore, stopping exports will not provide much relief from the demand-supply gap India is facing. Further, China and India are almost the only countries that are working to assist the global vaccination effort especially in developing and low-income countries, and it would be cruel and immoral to weaken or close down this endeavor in an extremely selfish display of vaccine nationalism, and that too for very little benefit. This is a record to be proud of not condemned. The point again is that what India needs to do now is to ramp up vaccine production by existing manufacturers, and by quickly approving the production and deployment of several other vaccines that are in the pipeline.

It is precisely this kind of vaccine nationalism and related crass commercialism practiced by the US which is one of the major factors preventing SII, Biological-E (licensed to manufacture the Johnson & Johnson vaccine in India) and other vaccine manufacturers in India to scale up production. These manufacturers depend on various raw materials and intermediates such as specialized bags, filters, cell culture media, single-use tubing and special chemicals from the US, which has imposed an export ban on all vaccine-related materials under its Defence Production Act. If India were to similarly restrict exports, it would have no moral authority to demand opening up of exports by the US or others.

For clarifications contact:

D.Raghunandan 9810098621; T. Sundararaman 9987438253; S. Krishnaswamy 9442158638

P.Rajamanickam, General Secretary, AIPSN gsaipsn@gmail.com, 9442915101 @gsaipsn

click here for pdf of English version AIPSNStatement-VaccineApprovals-6Jan2021

On Hasty Regulatory Approvals in India for Covid-19 Vaccines

6 Jan 2021

India’s regulatory authority for medical products, the Central Drug Standards Control Organization (CDSCO), gave  “restricted emergency approval” on 2^nd January 2020 for two Covid-19 Vaccines, namely Serum Institute of India (SII)’s “Covishield” being manufactured in India under technology transfer from Oxford University-Astra Zeneca, and the indigenous “Covaxin” developed by Bharat Biotech in collaboration with ICMR/National Institute of Virology.

AIPSN salutes the efforts of Indian scientists, research institutions and vaccine manufacturers in bringing to the forefront indigenous vaccines like Covaxin in less than a year, with some other candidates just a few months behind. As and when these vaccines meet the threshold requirements for at least 50% efficacy, AIPSN will join other citizens in hailing this triumph and India’s contribution to the global battle against the Covid-19 pandemic.

Tragically, the Government and CDSCO have together seriously damaged these hopes, and also undermined confidence in Covaxin and other vaccines against Covid-19, in particular concerning Covaxin, due to lack of evidence and unsatisfactory scientific basis, non-transparency and concerns around possible political pressure.

SII’s Covishield was approved on the basis of Phase-III clinical trials data from Brazil and the UK, and the approval granted by the UK’s Medical & Healthcare Regulatory Agency (MHRA) based on 70.4% efficacy revealed by the related published data despite some remaining grey areas relating to varying dosages. CDSCO approval for SII’s Covishield could have awaited results from on-going Phase-III trials and bridge studies in India to demonstrate efficacy and bio-equivalence.  However, given the UK approval the approval by CDSCO, although not ideal, may be understandable. Questions still remain, however, about the Health Ministry’s announcement of an extended gap of up to 12 weeks between the first and second doses, whereas the SEC is understood to have recommended the original protocol of 28-days.

The approval for Bharat Biotech’s Covaxin raises more serious questions. The SEC had called for additional data from Phase-III trials, but appears to have been pressured overnight into reconsidering its decision and giving approval the next day, albeit hedged in by many conditions. CDSCO’s Statement shows that the approval is based only on Phase-I and Phase-II data on safety and immune response, but without any efficacy data from Phase-III trials. Top-ranking officials of the Government and ICMR have been strenuously defending this decision by stressing safety and arguing, without any evidence, that the design of Covaxin might make it more effective against the new UK mutation.  The opinion of ICMR, a co-developer of Covaxin, reflects possible bias and a conflict of interest, besides adding to perceptions of pressure on the regulator.

The serious doubts of the SEC on Covaxin are reflected in the CDSCO’s statement saying SII’s Covishield is approved “for restricted use in emergency situation subject to certain regulatory conditions” whereas, in contrast, approval for Bharat Biotech-ICMR’s Covaxin is given with numerous conditions such as “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains (emphasis added).”

True to form, the Government is steamrolling the decision, and attacking all critics, including many leading Indian scientists, as opponents of Indian science who should instead be upholding “national pride” over the indigenously developed vaccine. This achievement will indeed be hailed as a major Indian scientific achievement once efficacy data are released but, by this hasty approval without evidence, the Government has shot itself in the foot. Whatever prestige India may gain abroad for an indigenously-developed vaccine will be outweighed by the damage caused to the credibility of Covaxin in particular, and of Indian science, research and regulatory institutions.

In light of the above, the AIPSN calls for:

1. Re-consideration of approval for Covaxin till efficacy data is available or, at least, strict adherence to conditions specified in the CDSCO order implying no roll-out of Covaxin for mass vaccination. 
2. Phase-III efficacy trials for both vaccines continue without extraneous pressure and the data published at the earliest
3. No vaccine or Covid-19 related drug be released for commercial use in the private sector until regular approval as per protocols (as distinct from emergency use authorization) are obtained.

For clarifications contact:

Sundararaman 99874388253 D. Raghunandan 9810098621 S.Krishnaswamy 9442158638

Rajamanickam, General Secretary, AIPSN gsaipsn@gmail.com, 9442915101 @gsaipsn

click here to see the English pdf of AIPSNPositionPaper-Vaccine-Politics16Dec2020

Click here to see the Hindi pdf of AIPSN position paper

Click here to see Tamil pdf of AIPSN position paper

Fog over Covid-19 Vaccines in India

All-India Peoples Science Network (AIPSN) Position Paper

16 Dec 2020

Many new developments have come about in recent weeks regarding Vaccines against Covid19 both internationally and in India. These have raised some optimism, but also several concerns about vaccine politics, undue commercial influence and other extraneous factors playing out around the world and, specifically, in India. This Position Paper focuses chiefly on India, within the global context, whereas international dimensions have been dealt with in a separate Statement and the Indian response to EUA for vaccines was highlighted in another Statement.

AIPSN calls for a science-based, equitable and rigorously conceived nation-wide policy in India for development, manufacture and deployment of vaccines in a free, universal vaccination strategy against Covid-19 as discussed below.

1. Context and Status

Accelerated development and deployment of a safe and effective vaccine is crucial to combat the rampaging Covid-19 pandemic to protect individuals and enable full and safe re-opening of the economy and society. Access to free vaccination is essential for people’s right to life and health, since the disease has a significant burden of preventable morbidity or serious illness and mortality or deaths. Though the proportion of infected persons who get serious disease is low, in absolute numbers the number of persons who are at risk is unacceptably high. Free vaccination is also necessary since it is low-income working people who have paid the maximum social costs of the lock-down and disruption of the economy, and because vaccine development has mostly been done with public funds. At the same time, a nationwide vaccination programme is a challenge and raises crucial questions including with regard to the preparedness of the public health system in India to deliver this without compromising other essential health services.

Internationally, some leading vaccine candidates have, in recent weeks, declared high levels of efficacy or effectiveness based on preliminary results from on-going Phase-3 clinical trials. US-German Pfizer-BioNTech and US-based Moderna have both declared efficacy of above 90% for their two-dose  vaccines and applied for Emergency Use Authorization (EUA) in the US and Conditional Marketing Agreement (CMA) in EU. Both these vaccines are relatively expensive (at around USD 40 (Pfizer) and USD 70 (Moderna) for two doses) and, importantly, require very low temperature cold chains, adding to the costs and delivery challenges for India and other developing countries. At the time of writing, Pfizer has obtained a global first EUA in the UK and subsequently in Bahrain, Canada, and US.

UK-based Oxford University-Astra Zeneca, which is partnering with the world’s largest vaccine manufacture Pune-based Serum Institute of India (SII), for mass production of its vaccine, has claimed average 70% efficacy across different modes and 90% efficacy at specific dosages. This double-dose vaccine is expected to be relatively inexpensive at around USD 6 and, significantly, can be stored at ordinary refrigerator temperatures, making delivery easier in India and other developing countries. SII has publicly claimed that it would be supplying around 300 million doses for India by mid-2021.

Russia’s RDIF-Gamaleya Institute too has declared effectiveness of over 90% for its “experimental” Sputnik-V vaccine. The powdered version requires storage at refrigerator-like temperatures, while the liquid version has to be at -18 deg C. The vaccine is expected to cost about USD 20 for 2 doses. This vaccine is undergoing Phase-3 trials in different countries including India and is to be manufactured by Hetero Biopharma in Hyderabad.

China’s Sinovac is being deployed widely in China and also in Brazil, and is gearing up for global supply when regulatory approvals are obtained, with a price tag internationally of around USD 60 for two doses and also requiring only refrigerator-like temperatures. Again at the time of writing, another China-origin vaccine from Sinopharm has been declared by the UAE as having 86% efficacy in Phase-3 trials in that country where it had been given EUA in September for front-line workers, but data from the trials are still not public.

These developments represent a significant achievement for science and medical research, because these promising results, however limited and preliminary have been attained in less than a year from the outbreak of the Covid-19 disease compared to the normally expected several years for vaccine development.

However, detailed data related to all these vaccine trials have not yet been published or peer-reviewed, which would bring out additional and important information such as effectiveness in different age-groups and segments of the population, prevention or reduction of severe illness and deaths, prevention of transmission, duration of immunity or protection etc. These properties may vary for different vaccines and may influence choices for deployment. Other vaccine candidates too are at various stages of clinical trials, and may similarly also obtain EUA over the next 3-6 months.

Therefore, questions have already been raised about how scientific, rigorous or transparent these EUAs have been. Both “vaccine nationalism” and commercial interests are known to be deeply involved, apart from panic response by governments in the face of failures to control the pandemic, as evidenced by pronouncements of government spokespersons in many countries including in India. The sharp rise of concerned company values in stock markets could also be contributing to the haste in these announcements.

In India, several indigenously developed vaccine candidates have also come to the forefront in recent weeks. Leading candidates are from ICMR/NIV-Bharat Biotech in Hyderabad, Zydus Cadilla in Ahmadabad and Gennova in Pune. There are already undergoing, or soon to start, Phase-3 trials and are expected to become available in early to mid-2021. Some other promising indigenous candidates are a few months behind. The Gennova vaccine, co-developed with HDT Biotech of the US and supported through seed funding by Department of Biotechnology (DBT), which has also supported indigenous development of some other vaccines, has recently received approval to start Phase-1 and 2 clinical human trials in India. This vaccine is of particular importance for future scientific and medical research in India since it is the first indigenous development of an mRNA (messenger RNA) vaccine, using a technology that may also be very useful for new-generation pharmaceuticals for treatment of infectious diseases and cancers.

After the Prime Minister’s recent visits to and meetings with several of these companies to encourage them in their efforts, he is reported to have also instructed the regulatory agencies to facilitate the expedited approvals process. It is important that data from clinical trials for all these candidates are scientifically assessed without “vaccine nationalism,” pressure from political or commercial interests, cronyism or favoritism and also meet high standards of efficacy and safety, especially since high efficacy percentages have  been announced by  leading international candidates.

2. Need for transparent, science-based trials and approvals

In this context, extraneous considerations do appear to be creating untoward interference in scientific processes involved in vaccine trials, assessments and expedited or emergency approvals with implications for deployment as well. There are indications, covered in the media and supported by several experts, that ongoing clinical trials for vaccine candidates are “designed to succeed” in several ways.

It may be recalled that the Director General, Indian Council for Medical Research (ICMR) had, earlier this year, written to all hospitals where clinical trials were underway demanding that they expedite results by 15^th August this year, clearly to enable a grand announcement from the Red Fort. Fortunately, a massive outcry by scientists, medical professionals and civil society organizations brought about a retreat from this blatant attempt at pressurization. However, the danger remains in many ways.

Thresholds for efficacy or effectiveness (i.e. the percentage of infections the vaccine prevents), different aspects of efficacy as discussed earlier, as well as the sample size required for grant of EUA, may be lowered to enable vaccine candidates to more easily pass the test. While anxiety to roll-out an indigenous vaccine quickly through EUA is understandable for several reasons, it is crucial that clinical trials and assessments of results are, and continue to be, conducted transparently by scientific-medical Data Review Boards independent of political and bureaucratic influence, and results be made public and, when completed Phase-3 trials, be published and subject to peer review. This is essential to build global and domestic public confidence in Indian-origin vaccines.

In this context, it is a matter of considerable satisfaction that the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organization (DSCCO), at its meeting on 9^th December 2020, has kept pending its consideration on the applications for Emergency Use Authorization (EUA) of Covid-19 Vaccines by SII and Bharat Biotech, and has asked for additional information. The regulatory agency Drugs Controller General of India (DGCI) was to have decided on grant of EUA based on SEC’s recommendations. The SEC has, at least for now, rightly asserted its responsibility for scientific assessment of Covid vaccine candidates independent of political, bureaucratic or commercial interests.

The SEC decision has come against the background of considerable pressure from different levels of government, such as several recent public statements by the Health Secretary, Dr.V.K.Paul of Niti Aayog heading the National Task Force on Covid-19, and by DG ICMR. These officials pushed for a quick grant of EUA for these and other applicants, rather than respecting due process and scientific evaluation of data relating to safety and efficacy.

Urgency for approval and deployment of vaccines is no doubt important, but not at the cost of safety or potential impact in tackling the pandemic. More robust data would be available soon, providing opportunity to “hasten slowly”.  Self-reliance and encouraging indigenous research and manufacturing industry too are important, but sloppy or unscientific decision-making relating to public health will only damage the reputation of Indian science and regulatory processes, far outweighing any brownie points gained by rolling-out vaccination a few weeks early. Problematic EUA approval may also add to existing vaccine skepticism or hesitancy among the public.

The SEC and DCGI should therefore fearlessly conduct a thorough scientific assessment of available early data from Phase-3 trials in India or abroad, resisting pressure from different quarters. SEC/DCGI should also release the data based on which any recommendation is made so as to enhance transparency and secure the confidence of the scientific and medical community in India and internationally. This is especially crucial if India is to contribute to the global fight against the Covid-19 pandemic through its indigenously developed and manufactured vaccines. While granting EUA, it is also important to set up extensive surveillance of the vaccination programme, and to continue with rigorous Phase-III trials and peer review and publication of its data.

It must be also understood that, at this stage of development of different vaccines, it is not clear whether each vaccine is efficient at preventing infection, as distinct from preventing serious disease or mortality. It is also important to know whether infection can spread from persons administered specific vaccines, and the duration for which each vaccine protects persons. These specificities need to be taken into account for decisions on deployment. These unknowns at the present stage and the need to find answers them underline the necessity for continuation of clinical trials involving the larger numbers of enrolled volunteers, extensive post-vaccination surveillance and, importantly, continuing with all other public health measures of disease prevention and epidemic management.

The reputation of India’s science, vaccine manufacturing industry and regulatory institutions depends heavily on such unbiased, rigorous and science-based assessments, since India could potentially emerge, now or in the future, as a major exporter of low-cost indigenously developed vaccines especially to other developing countries.

3. Free and Transparent Vaccine deployment strategy

Ruling parties in different States are making promises of free vaccines to all, especially in the run-up to State elections. The nation needs a science-based and nationwide policy on vaccine deployment to be implemented by States with additional measures if desired, keeping in mind, the phased availability of different vaccines. The National Task Force on Covid-19 headed by Dr.V.K.Paul of Niti Aayog recently announced a prioritization roadmap proposing to initially vaccinate health care workers, other frontline workers, security personnel and those above 50 years of age and persons with co-morbidities, amounting to an estimated 300 million persons, starting perhaps in March 2021.

A clear, well reasoned and long term vaccination roadmap is required, especially keeping in mind the different indigenous vaccines set to obtain regulatory approval in the near future.  The policy needs to more definitively identify those included in the category of “frontline workers,” how senior citizens and those with co-morbidities would be enumerated, address phase-wise coverage of the rest of the population especially children and young adults not mentioned so far but whose immunization against Covid is necessary for early and much-needed resumption of safe and regular in-person education. It is also important to specify which categories of the population, such as infants or the elderly, would be immunized using which vaccine, depending on the efficacy characteristics of available vaccines.

The Prime Minister in his televised address to the nation on October 20 assured that the government seeks to ensure “delivery of the vaccine to every citizen.” However, the Health Secretary in the presence of DG ICMR stated categorically that the government has never committed to universal vaccination which was in fact not necessary since  the need is only to break the chain of transmission and obtain ‘herd immunity,’ and therefore the government may not vaccinate the entire population. It would, however, be extremely difficult to decide which sections to leave out of the vaccination programme and explain such a decision, since this would raise serious apprehensions of discrimination or injustice on different grounds.

Further, although achieving a threshold level of herd immunity (loosely estimated at 60% of the population) could prevent epidemic spread, the disease would still remain endemic in the country especially in population sub-groups, with significant numbers developing the disease and more limited outbreaks continuing in different parts of the country. Similar phenomena are seen in diseases like measles and diphtheria. The more skewed the demographic characteristics of the persons immunized, the less would be the braking effect of herd immunity.

In the Indian context, equity as a value and principle demands that those least able to practice social distancing, because of working and living conditions, need it most. All things considered universal vaccination may be the best option to prevent arbitrariness, real or perceived discrimination and emergence of a black market, besides enabling more robust and sustainable disease control.

A danger is that many Vaccine manufacturers in India and other corporate interests are already lobbying for the Government to allow delivery of vaccines by the private health sector at market prices to those who can afford to pay, as was done in Covid Tests and Hospital charges. Such a vaccine deployment strategy would, however, completely undermine equity and divert precious vaccine doses to privileged paying sections away from the vast poor underprivileged masses, and would also distort government procurement and equitable vaccination.

It is therefore essential that the Government of India announces a clear and transparent vaccination programme including a categorical and binding commitment to a programme of free universal vaccination with a fair and transparent policy of phase-wise prioritization for different segments of the population so as to ensure access to most vulnerable segments and marginalized sections.

4. Obstacles to domestic manufacturing and deployment

            There is much confusion regarding the Indian government’s participation in COVAX, the newly created global institution under the Global Vaccine Initiative (GAVI) and WHO. COVAX is funded by donor countries, corporate philanthropy notably the Gates Foundation and Wellcome Trust, as well as the 10% down payment from self-funded participating countries. COVAX has provided financing to different vaccine developers and manufacturers in exchange for a proportion of vaccines produced, all through confidential agreements. COVAX also has agreements with participating countries to provide upto 20% of their vaccine requirement, for the duration of the agreement period which is now only till end-2021, with special arrangements for lower income countries. On the other hand, rich countries with 13% of the world’s population have already purchased over 50% of the world’s scheduled vaccine production and many other such bilateral agreements have been signed.

In this context, several Indian vaccine manufacturers who have agreements to manufacture leading vaccines developed elsewhere, would be bound by confidential agreements made with COVAX and also with their corporate partners as regards prices and supply schedules. Voluntary licenses granted by vaccine developers to Indian manufacturers prevent the latter from transferring the technology to other Indian companies or from exporting to countries not covered by COVAX.  It would therefore be difficult for Indian vaccine manufacturers to scale-up vaccine production and supply to the levels required by India.

Government of India needs to work out how to overcome this problem. It is recommended that any agreements India signs with COVAX should be within an improved framework and its governance made more multilateral and democratic with a greater role for WHO, and removal of corporate influence. Government should also make public to the Indian people the terms and conditions of agreements with COVAX.

The government should urgently evolve and implement measures for scaling up manufacture of the most appropriate vaccines for our needs, through support to existing  manufacturing units in private sector to expand their capacity and by encouraging public sector manufacture in this area irrespective of the vaccine being indigenously developed or licensed from international pharmaceuticals.

5. Strengthen the public health system

Finally it should be emphasized that the vaccination programme will require massive strengthening and mobilization of the public health system in India including for follow-up, monitoring of side-effects and efficacy. The capacity of current cold chain infrastructure is only about 50% of what is required even for the existing package of immunization. The human resources gaps are also huge. Procuring, storing and distributing and administering vaccines to close to 800 million more persons, even if phased is going to require considerable expansion of cold chains equipment, infrastructure, refrigerated transport vehicles, and  skilled human resources at the field level.

Therefore any plan for vaccine deployment, must also make a firm and quantified commitment to increased financing of the public health system. In the absence of such a commitment, the vaccination programme will suffer and other essential health services including child immunization would also be undermined by large scale diversion of existing public health resources.

6. AIPSN Demands

The Government of India needs to urgently undertake the following so as to ensure a safe, effective and free universal vaccination programme against Covid-19:

1. Scrupulously monitor Phase-3 clinical trials for all indigenously developed vaccines and, after robust and independent scientific assessment of efficacy with peer review of trial results, grant Emergency Use Authorization within a definitive deadline within which such approvals can be applied for;
2. Rapidly scale up manufacturing capacity by recruiting and re-tooling both public sector as well as private sector manufacturing units for both internationally and indigenously developed vaccines;
3. Ensure transparency of agreements that Indian manufacturers have signed or may sign with COVAX/GAVI and Corporates. These may require further arrangements for systematic transfer of technology from international vaccine developers to Indian manufacturers to enable effective and rapid scaling-up manufacture and deployment in India;
4. Make public the basis of approval, including evidence reviewed, provide details of the protocol, process and timelines followed in investigating any reported severe adverse events (SAEs);
5. Make public the Government’s stand on indemnifying vaccine manufacturers;
6. Actively advocate and lobby for declaration of all vaccines developed worldwide as global public goods and, if patents remain an obstacle, take steps to use compulsory licensing if necessary;
7. Bring out a white paper on the system and related costs for vaccine procurement and delivery, along with details of the expansion of public health infrastructure and human resources that would go with it;
8. Set up a Parliamentary Committee to oversee the implementation of the Covid-19 Vaccination programme in an effective, timely and equitable manner and a broad based Advisory Committee including representation of the scientific community and civil society organizations.

For clarifications contact:

P.Rajamanickam 9442915101;T.Sundararaman 99874388253;D. Raghunandan 9810098621