All India Peoples’ Science network (AIPSN)

27 May 2021

 click here to see the pdf with endorsements received till 31May 

click here to see the letters in EPW Vol. 56, Issue No. 23, 05 Jun, 2021 carrying the endorsement

Urgently Expand Public and Private Sector Production along with related R&D

to meet India’s Vaccine Requirements

 Need for New Strategies

With the present Indian population of over 130 crores, the number of vaccines required to immunise the entire population would be about 310 crore doses (3.1 billion doses)  or 218.5 crore doses for the 18+ adult population, allowing about 15% process losses. This is not an easy task.  However,  the Indian people need to know why India, a pioneer in large-scale vaccine production even before the current pandemic and a major exporter of vaccines, has to rely on just two private domestic manufacturers, Serum Institute of India (SII) and Bharat Biotech, to produce Covid-19 vaccines, a constraint that is painfully obvious today.

India, now, has a number of public and private sector units that can make a contribution to the expansion of local production of vaccines. Presently two vaccines namely COVISHIELD of Serum Research Institute (SII), Pune and COVAXIN of Bharat Biotech (BB), Hyderabad are available for supply in India. Technology for COVAXIN is fully home grown, through collaboration between BB and the National Institute of Virology (NIV), a public sector R&D institute under the Indian Council of Medical Research (ICMR), itself an agency of the Ministry of Health and Family Welfare. The central government is therefore entitled to make use of march-in-rights available to supporting government entities, as tacitly accepted by BB in extending technology transfer to 3 public-sector vaccine Units.

Up to the 2000s, 80% of India’s vaccines for the Universal Immunization Programme were sourced from the public sector. Today, 90% are sourced from the private sector, that too at a higher cost. Brazil, Cuba and China are using public sector companies and institutes to undertake integrated R&D and production operations to vaccinate their populations and export to developing countries to meet their requirements. In contrast, India has neglected its public sector units. India has a large number of a few decades old facilities as well as new facilities equipped with appropriate modern infrastructure. The central and state governments should be making full use of all these facilities to expand local production of COVID vaccines.  Presently India has eleven public sector units. Some are almost ready to go into production. The government has taken some initial steps in the direction of using a few selected units. Integrated Vaccine Complex at Chengalpattu, whose construction was completed as recently as 2016, needs just one hundred crores and some handholding to start the domestic production of COVID vaccines.

There are a number of private sector units which can also contribute to the domestic production of COVID vaccines, , such as Biological E.,  Hyderabad, Panacea Biotech,  Solan etc. In addition to vaccine manufacturing companies, there are also companies that manufacture biologics that have the capacity to be repurposed for manufacture of vaccines. Already, Dr. Reddy’s Lab and at least five biologics have teamed up with Russia to procure the Sputnik-V Vaccines in the country. In all, there are close to thirty units which can be involved in the production of COVID vaccines. Such expanded manufacture in India would enable meeting domestic requirements as well as international obligations to which India, in particular SII, is committed having also accepted advance payments. Procurement of already approved vaccines from abroad by private sector units is also an option.

While the private sector is itself getting ample albeit highly belated funding from the government, the public sector is still not getting requisite support. Only recently some relatively small government grants have been given for manufacture of Covaxin under license to state owned companies such as Indian Immunologicals Ltd. Hyderabad, Bharat Immunologicals and Biologicals Corporation Ltd, Bulandhshahar, to and Haffkine Institute, a Maharashtra state PSU as called for by its Chief Minister. SII cannot by itself transfer technologies since it is itself making Covishield under license from AstraZeneca, it can certainly be nudged to sub-contract work to other Units. Both SII and Bharat Biotech could be appropriately persuaded to handhold these other units as one way of paying back their own long-standing obligations to the public sector and the Indian state.

Specific suggestions for the government to announce a policy to urgently ramp up domestic production of vaccines and improve related R&D are as follows:

1. The existing public sector undertakings and state owned enterprises be revived and assisted to ramp up vaccine production.
2. The use of the Integrated Vaccine Complex at Chengalpattu be handed over to TamilNadu Government with clear provisions allowing the state governments, public sector undertakings and state owned enterprises for contractual manufacturing of Covid vaccines using the facility.
3. Compulsory licenses or appropriate legislation be issued where required to enable interested parties for production of COVID 19 vaccines.
4. The conventionally used march-in-rights available to the Govt of India/ICMR be used to ensure technology transfer and handholding by Bharat Biotech to PSUs, SOEs and other Units to enable them produce vaccines for domestic use.
5. Indian companies that are planning to manufacture Sputnik V be assisted, as required, for scaling up.
6. SII, AstraZeneca and Novavax be persuaded to expand manufacturing in India through joint ventures or other collaborations with suitable public and private sector entities both for domestic use and export especially for the Covax facility.
7. Research on new vaccine development strategies and development of multiple vaccines be enabled and encouraged across research laboratories, public sector and private sector institutions. Genomic surveillance be increased appreciably and linked to viral efficacy and epidemiological studies, so that vaccines are constantly checked for efficacy against variants of concern enabling collaborative modification across manufacturers, as required, especially in view of emerging variants and for different demographics such as children.

We the following scientists, academicians, doctors endorse the above statement:

(endorsements received till 31 May 2021)

 click here for Statement On Government’s Phase-3 Vaccine Strategy 

                                                                     21 Apr 2021           

 Government unmasked: Abdicates vaccination responsibility

click here to see the press Statement

After a Meeting chaired by the Prime Minister, the Central Government announced on 19 April 2021 a “liberalized and accelerated” strategy for Phase-3 of India’s vaccination drive against the Covid-19 disease to take effect from 1 May 2021. On the face of it, the new strategy appears to meet demands of several stakeholders viz, for opening up the vaccination drive to all above the age of 18, to permit private institutions and State governments to directly acquire 50% of total vaccine production from manufacturers at unregulated prices set by the latter, grant State governments the liberty to tailor vaccination roll-out as per local needs, and provide additional finances to the two Indian Covid-19 vaccine manufacturers for scaling up production. Government has claimed that the new strategy aims to ensure that “maximum numbers of Indians are able to get the vaccine in the shortest possible of time: PM (sic).”

AIPSN welcomes the financial assistance, even though belated, extended to Serum Institute of India (SII) (Rs.3, 000 Crores) and Bharat Biotech (BB) (Rs.1500 Crores) against future supplies, to enable them to scale-up production. This measure should have been taken at the very start of the vaccination drive instead of the meager advance then given against limited orders, which would have significantly reduced the time that will now be required to make available greater volumes of vaccine. Regrettably, adequate financial support for the several PSU vaccine manufacturers presently lying idle due to ideological bias of the Government was not announced simultaneously.  This blinkered view had also led to the PSUs not even being called for discussions or consultations or being involved in non-vaccine related activities that are needed for the Covid-19 pandemic management. Now after the second wave disaster the Government wakes up to call up upon PSUs to make oxygen cylinders, bed manufacturing etc. What prevented the Government from involving the PSUs last year itself to ensure sufficient vaccine and non-vaccine materials are available when needed?

All other aspects of the new strategy, however, are highly counter-productive. By surrendering 50% of vaccine availability to the open market including for procurement by States and private hospitals, the Central government has at one stroke abdicated its responsibility for the vaccination drive and will henceforth freely blame States for any inadequacies. The strategy will pit States against each other in dog-eat-dog competition. A similar policy at early stages of the pandemic in early 2020 regarding procurement of test kits and PPEs failed miserably, forcing the Centre to centralize procurement. Only Central procurement and distribution can ensure reasonably equitable access by all States.

Opening up vaccine procurement and administration to private health facilities, corporates and other institutions at market prices will encourage price gouging and a black market in vaccine doses. It will also adversely impact the on-going vaccination programme which will henceforth have only 50% of the earlier vaccine supply, and with only government hospitals continuing free vaccinations with the empanelled private hospitals compelled to buy vaccines at market prices which will result in higher vaccination charges impacting the middle classes. This dual system can be expected to open the doors to all kinds of manipulation, favoritism and malpractices.

Privatizing 50% of vaccinations will also undoubtedly exacerbate inequities in vaccinations, in favor of urban, rich and well-connected sections of society.

No other major country, including the most market friendly nations, has adopted a vaccination strategy of this kind, precisely for the reasons enumerated here.

Even the seemingly welcome strategy of expanding the eligibility criteria to everyone above 18 years of age, without first increasing vaccine supply, may prove to be problematic in practice, at a time when there is acute vaccine shortage even for the currently eligible and more vulnerable 45+ population. Increased demand without matching supply will only increase problems in the inoculation drive which may in turn fuel vaccine hesitancy. The assertion in the new policy that enlarging the eligible population because “a good amount of coverage of vulnerable groups is expected by 30th April,” is belied by the facts.

The new strategy is not a win-win solution as propagated. Corporates, private health care institutions and the well-off will win, while the poor and the middle class will lose big time. 

AIPSN calls for rolling back of this new strategy and for a recalibrated fully public funded and universal vaccination programme, backed by adequate government support for vaccine manufacturers including PSUs.

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 All India Peoples Science Network (AIPSN) Statement (English)

click here to read the AIPSN Statement in Hindi

Click here for the statement in Odia

On Second Wave of Covid-19 Pandemic in India

14 Apr 2021

click here to read the Position paper (English) on which this statement is based. 

click here for the Position paper (Hindi) 

click here for the signed AIPSN Statement

This AIPSN Statement is based on the position paper on the Second Wave of Covid-19 Pandemic in India. India is well and truly into a brutal second wave of the Covid-19 pandemic.

            Accept responsibility; don’t blame the people and States  : A belated high-level meeting at the PMO blamed the people and the States for this crisis. This serves only to enable the Centre to evade responsibility for the present situation and give itself an excuse for future inaction or failure. 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. 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, that Sars Cov2 virus variants which may be more infectious, or deadlier, or even provide a “vaccine escape,” are responsible for the second wave. Limited gene sequencing so far has thrown up concerning data regarding possible extensive presence of the UK variant (B.1.117) and the Indian double-variant lineage (B.1.617). However, insufficient information is available to draw any firm conclusions about the impact of these variants. Significantly expanded gene sequencing across the country, and correlating findings with epidemiological data, is necessary to obtain a better understanding of the dangers posed and to work out containment and mitigation strategies addressing these variants.

            Increase testing, tracing and surveillance:  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. Testing needs to be ramped up significantly with emphasis on RT-PCR tests so as to uncover infections more quickly. 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. Decentralized evidence-based approaches with community participation would be most effective.

            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’s vaccinations per capita rank well below the global average. Many States are also complaining of shortages in vaccine supply from the Centre. 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. These deficiencies need to be urgently rectified 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.

            Scale-up Vaccine production and availability:  Total production by Serum Institute of India (SII) and Bharat Biotech, while high by the former is below even current vaccination rates, leave alone an expanded vaccination drive. Therefore the Government needs to urgently take steps to boost manufacturing capacity. At the same time, the Government should also take several other steps to ramp up availability of other vaccines. The Russian Sputnik-V vaccine has finally been given emergency use approval by DCGI. Sputnik-V is not prohibitively expensive, can be stored in ordinary refrigerators in powder form, and can therefore form an important part of India’s vaccination programme. The Government has now decided to also invite other vaccines approved by WHO and by regulators in the US, Europe and Japan to apply for approval in India. 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 scenario 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. Both SII and Bharat Biotech have requested financial support from the Government to enable additional manufacturing capacities. These funds should be urgently provided so as to augment indigenous production, which may take another few months to fructify.

            Address Licensing/ IP issues: Covaxin vaccine was developed by the National Institute of Virology in Pune, a laboratory under the Indian Council of Medical Research, and the Hyderabad-based Bharat Biotech put it into production.  The Government must 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: 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. 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!

China and India are amongst the few 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.

It should also be noted that 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. It is unfortunate that despite this good track record of assisting the global vaccination effort, 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.

For clarifications contact:

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

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

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