Wuhan Coronavirus Resource Thread

Mort Walker · Post by **Mort Walker** » 19 Apr 2021 20:52

Uttam wrote:Lots of policy updates today:

Everyone above the age of 18 to be eligible to get vaccine from May 1, says govt

Vaccine manufacturers empowered to release up to 50% of their supply to state governments and in the open market at a pre-declared price.

This means GoI is confident of supply issues being resolved by sometime in the month of May. Certainly a positive development. From anecdotal reports, from what I can tell, the demand for vaccines is nearly twice of what is available. Maybe 5-6 million doses/day.

putnanja · Post by **putnanja** » 19 Apr 2021 20:54

The vaccine manufacturers can sell up to 50% directly to state govt and others. So, central govt is keeping 50% for its program and allowing remaining 50% to be sold to state govts or open market

Bart S · Post by **Bart S** » 19 Apr 2021 21:17

hnair wrote:
Bart S wrote:

This is not true, plain and simple. People under 45 are flatly being denied the vaccine despite very valid justification existing, citing GOI rules. If they are being vaccinated somewhere, that would be a rare exception and only by somebody who follows basic common sense and is brave enough to break the idiotic rules.
In Trivandrum, as part of some past work I did, I have some insight into a central institution that does good work on differently abled and autistic children. They have a priority list which they send to State health dept for pre-approval and they usually approve it pronto due to the danda of central govt. Heard same process for severe juvenile diabetics and onco/cardio patients from another central govt institute. All of them got their shots along with the first wave of older folks. Btw, this has got nothing to do with state govt, although the state will announce it later. Most of the central institutes for specialized treatment seem to have this protocol.

Like I said, this might be an exception rather that the rule. I have personally asked, on behalf of a vulnerable family member and was turned down repeatedly, by multiple doctors (who empathized but said that nothing could be done due to GOI regulations and requirements to register), at one of the largest hospitals in Chennai which is itself a major vaccination center.

I too have heard of Chennai corporation PHCs vaccinating all comers (perhaps with surplus medicines for the day) but it's hard to rely on such and difficult to tell if it is just a rumor or something definitive.

In any case the need of the day is GOI regulations allowing specific categories of vulnerable people to be vaccinated irrespective of age. The numbers of such people are so small that it is not going to impact the vaccination drive negatively in any way.

Mollick.R · Post by **Mollick.R** » 19 Apr 2021 21:28

No further news about this one..............

30,000 volunteers, 60 sites — India’s 3rd Covid vaccine candidate ZYCoV-D set for final trials
HIMANI CHANDNA 6 January, 2021 2:23 pm IST

Zydus Cadila chief Pankaj Patel says ZYCoV-D is easy to store, transport and inject. It can also be produced in large quantities, in a ten-dose vial format.
New Delhi: Ahmedabad-based drug and vaccine maker Zydus Cadila is all set to roll out the Phase III trial of its Covid-19 vaccine, ZYCoV-D, at over 60 clinical trial sites with 30,000 participants.

The clinical trial is expected to start this month. The company expects the results of its indigenously-developed vaccine to be out by the end of March or early April.

On Sunday, the Drugs Controller General of India (DCGI) granted “conditional approval” to two vaccine candidates — Oxford-AstraZeneca’s Covid vaccine Covishield, manufactured in India by the Pune-based Serum Institute of India, and Hyderabad-based Bharat Biotech’s Covaxin.

Zydus vaccine was the third candidate in India to get the nod to conduct Phase III clinical trials.

“At around 60 plus sites, we are targeting to administer doses to 30,000 volunteers, and we believe that we can accomplish this in the next 2-3 months so by the first quarter or by the end of March, we could potentially have the efficacy results coming out,” Pankaj Patel, chairman of Zydus Cadila, told ThePrint in an exclusive interview.

A maker of hydroxychloroquine and remdesivir, which registered a turnover of over Rs 14,253 crore in 2019-20, Zydus Cadila claims that its vaccine is easy to store, transport and inject. It can also be produced in large quantities, in an exclusive ten-dose vial format, which will help in manufacturing large quantities quickly.

https://theprint.in/health/30000-volunt ... ls/580367/

Mollick.R · Post by **Mollick.R** » 19 Apr 2021 21:29

Another article.........

ZyCoV-D will hit markets in May-June
Interview/ Pankaj Patel, chairman, Zydus group
By Nandini Oza March 28, 2021 16:45 IST

VACCINES HAVE BEEN a ray of hope in a world ravaged by Covid-19. While India has started mass production of two vaccines—Covishield by Serum Institute of India and Covaxin by Bharat Biotech—a third one, ZyCoV-D by Zydus Cadila, is undergoing trials. Pankaj Patel, chairman of Zydus Group, says the DNA plasmid platform vaccine is expected to hit the market by May-June. Excerpts from an interview:

When did Zydus decide to make a Covid-19 vaccine?

Somewhere in February 2020, we decided to develop a Covid vaccine. We realised that there could be a pandemic. We had experience making a vaccine for H1N1.

When is ZyCoV-D expected in the market?

Currently, we are undergoing phase III study. We have to complete the dosing and then wait for 150 symptomatic Covid patients; then we unlock and come out with efficacy data. Our guesstimate is that we should be completing the trial in May. ZyCoV-D will be in the market between May and June.

Are you not going in for emergency use approval?

In any case, approval will happen for emergency use. As a serious pharmaceutical company, we will have to complete the trial and then go for emergency use.

Will the vaccine be exported?

Yes, if the government allows. We do have a lot of requests from various countries. We would like to supply them, depending upon the government’s view at that time. Currently, it is allowing export. So, we will be exporting.

What will be the price of the vaccine?

It will not cost more than the current vaccines.

Has the company lost the advantage of being the first mover?

I do not think there is a race here. We need good science and a good product for the people of India; it should be safe and efficacious at a reasonable price.

Why are there so many concerns about the side effects of Covid vaccines?

It is a communication issue. Many people have been reading articles, news reports. There is a lot of unsubstantiated and false data floating around. It creates apprehensions. Fears can be allayed through education. We did not find any side effects in our phase II trials.

How many people were covered under phase I and phase II trials?

One thousand.

How will ZyCoV-D be different from the two vaccines approved in India?

Ours is a totally different platform compared with the current vaccines that have been approved in India and abroad. We have a DNA plasmid platform vaccine. This vaccine is given intradermally. It does not go deep inside the body. There is a specific device through which it is administered. It is needle-free, painless administering. People will not suffer side effects that are being seen in other vaccines.

Should Covid-19 vaccination be made compulsory in India?

No, I do not think it will be a great idea to make anything compulsory. It should be voluntary. Increased education will allay the fears of people.

What is the investment that has gone into the manufacturing of ZyCoV-D?

We have put up a manufacturing unit, we have done development and trials. In all, we are estimating (an outlay of) around Rs500 crore. Initially, we will produce 100 million doses and scale up to 250 million doses.

Should people be compensated for the side effects of vaccines?

Vaccines always have some side effects, minor or major. The regulator and the governments in order to simply support the vaccination have taken the responsibility for compensation through a kind of a normative method and the companies are required to support. That is a global practice. In India, we currently do not have any practice.

https://www.theweek.in/theweek/specials ... -june.html

Mollick.R · Post by **Mollick.R** » 19 Apr 2021 22:03

Good writeup

EXPLAINED | Why government's funding of 3 PSEs won't raise overall vaccine production anytime soon

SUBHAYAN CHAKRABORTY APRIL 19, 2021 / 05:57 PM IST
The Centre's plan to increase Covaxin production 6-7 times by August-September, relies on the premise that manufacturing can be quickly ramped up at government owned biomedical companies. But apart from the absence of a biosafety level 3 facility which usually takes a year to be constructed, the lack of support infrastructure, rushed deadlines and massive need for investment also threaten to push the deadline further back.

Amid spiralling Coronavirus cases across the country, Centre announced financial support to three government owned biopharmaceutical institutions to bulk up the production of Covaxin on April 16.

The government also announced that it will provide Rs 65 crore to the only manufacturer of the vaccine currently, Hyderabad-based Bharat Biotech International.

As a deadly second wave continues to grip the country, an acute shortage of vaccines have become evident nationwide. With domestic production remaining stagnant, the government last week announced fast track approval would be provided to all foreign-made vaccines which have already received emergency approval from pharma regulatory bodies in the United States, Japan, European Union, United Kingdom and the World Health Organization.

But as reported by Moneycontrol, the process remains long and the number of steps to vet the vaccines or the requirements for them to be commercially sold has not been reduced. Senior officials say talks with foreign vaccine makers are slowly just beginning and it will be a while for any foreign vaccine to hit the market commercially.

By providing funds to Bharat Biotech and three other public sector government companies, the Centre hopes to raise Covaxin production from the current level of around a crore doses per month to 6-7 crore doses per month by July-August and hopefully 10 crore doses per month by September.

Also, with the pandemic expanding rapidly, the government did not have much choice. "Given the current circumstances, the latest plan was one of the few options open to the government apart from allowing state governments to directly import vaccines from abroad or radically redistribute vaccine doses, rationing them," a senior official said.

Why can't Bharat Biotech ramp up production with government support ?

The government allocation of Rs 65 crore was provided to Bharat Biotech officially for the purpose of quickly opening and starting the manufacturing vaccine doses at a new repurposed facility in Bangalore. This was, however, less than half of the Rs 150 crore officially sought by the company, Rs 75 crore each for its facilities at Hyderabad and Bengaluru.

Since the beginning of the vaccination exercise, the firm has been under huge pressure from the government to push up production, owing to it's vaccine being fully indigenous. However, the relatively small size of it's manufacturing operations have often prompted the company to try to temper the Centre's expectations.

The company is also suffering from a shortage of a chemical compound , referred to as an adjutant which is crucial to the vaccine manufacturing process. Media reports suggest the compound is imported from a Kansas, United States based company but supplies have run low over the past few months.
Both officials and industry insiders accept that the 10 crore monthly Covaxin production target remains a steep challenge. Under such circumstances, the government believes latest plan offers India a backup to ramp up domestic capabilities while also upgrade existing infrastructure at multiple government biopharmaceutical facilities.

Haffkine Biopharmaceutical Corporation, Mumbai

While the Mumbai based Haffkine Institute has informed the government it will take atleast a year to begin production, the government has asked it to begin in next 6-months. One of the oldest biomedical research institutes in the country, Haffkine is a public sector undertaking under the Maharashtra government.

The 122-year old institute had developed a number of critical jabs such as the anti-rabies serum, anti-venom serum, oral polio vaccine but has fallen on hard times due to consistent government apathy. A significant overhaul of infrastructure, including new facilities for a virology laboratory have to be built now.

But the key challenge that the institute faces is the construction of a biosafety level-3 (BSL-3) facility, which is absolutely crucial to contain the virus in the event of an accident. Sandeep Rathod, CEO of Haffkine had recently said a brick-and-mortar BSL-111 facility normally takes three years to get completed. But the institute is looking to create a makeshift one and get requisite permissions within the next 6-months.

Bharat Immunologicals and Biologicals Limited (BIBCOL), Bulandshahr

Operating under the central Department of Biotechnology, BIBCOLs principal mission is to save the lives of millions of children from avoidable disability, through polio vaccination.

While the public sector enterprise remains the pioneer in the field of polio vaccines with a more than 60 percent market share in India, the latest objective entrusted to it requires significant investment to build facilities from scratch, the company has said. The lack of a biosafety level-3 facility compounds the problem.

Officials say BIBCOL is currently engaged in manufacturing of various biological, pharmaceutical and food products. It had been quickly roped in by the centre last year to manufacture formulations of Vitamin C and Zinc tablets as the Covid-19 pandemic was breaking out.

Indian Immunologicals Limited (IIL), Hyderabad

The best placed lab to produce the Covid-19 vaccine quickly, IIL already operates one of the largest vaccine manufacturing plants in the world. But the plant is solely geared towards producing veterinary vaccines for animals, most importantly cows.

Set up under the National Dairy Development Board, IIL is the market leader in veterinary and human biologicals in India, manufacturing over 150 plus products. While the company produces significant number of pediatric and rabies vaccines as well, the government has to pump in enough investments to create a similar size plant for Covid-19 vaccine manufacturing.

However, officials say that given the company is based in Hyderabad, it has access to the private sector vaccine manufacturing ecosystem and can quickly source material from abroad to construct a new plant and biosafety level-3 facility.

So, what does this mean for total vaccine production in India and the pace of vaccination nationwide?

Overall, Covaxin reportedly makes up for only 10 percent of the 12.38 crore vaccine doses administered in India till now. The rest are Covishield, 6-7 crore doses of which can be produced currently by Pune-based Serum Institute of India (SII). As a result, India's vaccination efforts will still remain more dependent on the SII's fortunes in the short to medium term, experts say.

Why did the government suddenly allow public sector enterprises to manufacture Covaxin ?

https://www.moneycontrol.com/news/busin ... 87271.html

Suraj · Post by **Suraj** » 19 Apr 2021 22:47

3.1 million vaccinations on Monday to 8pm. Total 126.9 million.

https://www.pib.gov.in/PressReleasePage ... ID=1712763

Mort Walker · Post by **Mort Walker** » 19 Apr 2021 22:53

Looks like average will be about 3 million/day with maximum of 100 million/month. Hopefully it all ramps up to 5-6 million/day by end of May.

Atmavik · Post by **Atmavik** » 19 Apr 2021 22:55

there is definite shortage of vaccine in hyderabad. my parents second dose is delayed by a week and were told today to wait another two days for covisheild supply

vijayk · Post by **vijayk** » 19 Apr 2021 23:10

Mollick.R wrote:Good writeup

EXPLAINED | Why government's funding of 3 PSEs won't raise overall vaccine production anytime soon

Amid spiralling Coronavirus cases across the country, Centre announced financial support to three government owned biopharmaceutical institutions to bulk up the production of Covaxin on April 16.

The government also announced that it will provide Rs 65 crore to the only manufacturer of the vaccine currently, Hyderabad-based Bharat Biotech International.

As a deadly second wave continues to grip the country, an acute shortage of vaccines have become evident nationwide. With domestic production remaining stagnant, the government last week announced fast track approval would be provided to all foreign-made vaccines which have already received emergency approval from pharma regulatory bodies in the United States, Japan, European Union, United Kingdom and the World Health Organization.

why are we penny-pinching?
Is it time to worry about 85 cr?

This is what I read in a paper this weekend ...

In this novel study, over 945,500 genomic files from NCBI Genbank and GISAID were analyzed and more than 28,000 unique variants in the Surface Glycoprotein (Spike Protein), 930 unique mutations in the Resource Binding Domains, 300 unique mutations in the Resource Binding Motifs, and 13 unique variants in the key residues of the Spike Protein that interact with human ACE2 receptors.

Locations of mutations in these key regions of spike protein were identified to determine their effect on the efficacy of the vaccines and therapeutics. In this first-of-its-kind study, information for all the variants was programmatically searched in the
published and pre-print literature and social media platforms such as Twitter and Reddit, and the results were tabulated for each variant. Statistics about the variants suggested that about 80% of the variants are yet to be researched and 70% of them are yet to be acknowledged on social media

Mollick.R · Post by **Mollick.R** » 19 Apr 2021 23:23

Govt gives ‘advance’ of around Rs 4,500 crore to Serum Institute of India, Bharat Biotech
ARUP ROYCHOUDHURY APRIL 19, 2021 / 09:19 PM IST

“The Finance Ministry today has relaxed the general financial rules and permitted the Ministry of Health to pay, if they so wish, to make advance payment to vaccine suppliers, without a bank guarantee. I believe the Health Ministry is already doing so,” a top official told Moneycontrol

The central government, on April 19, approved an advance of around Rs 3,000 crore to Serum Institute of India, and around Rs 1,500 crore to Bharat Biotech, Moneycontrol has learnt from a top government official.

The amount was an advance for the supply of Covishield and Covaxin by the respective companies over the next 2-3 months, the official confirmed. There were reports earlier that the amounts had been given as a grant.

“The government is not in the practice of giving grants to profit companies. There was a proposal that they should be given an advance payment for vaccines that they will be supplying over the next 2-3 months,” the official said. In doing so, the centre has relaxed its own general financial rules.

Under the General Financial Rules of the central government, specifically rule 172, such huge advances are not given to contractors or for-profit companies without the latter furnishing a bank guarantee or collateral.

“The Finance Ministry today has relaxed the general financial rules and permitted the Ministry of Health to pay, if they so wish, to make advance payment to vaccine suppliers, without the bank guarantee. I believe the Health Ministry is already doing so,” the official said.

The person added that this was done keeping in mind the need for vaccines from across the country.

This move comes days after the centre announced financial support to three state-owned owned biopharmaceutical institutions to bulk up the production of Covaxin, and that it will provide Rs 65 crore to the only manufacturer of the vaccine currently, Hyderabad-based Bharat Biotech International.

The manufacturer of Covishield, Pune-based Serum Institute, which is the world’s largest vaccine maker, had sought a financial aid of Rs 3,000 crore two weeks ago to ramp up production.

https://www.moneycontrol.com/news/trend ... 89591.html

Uttam · Post by **Uttam** » 19 Apr 2021 23:26

Covid: In both waves, 70% of patients above 40 years, says ICMR chief

More than 70 percent of Covid-19 patients over 40 years of age in both the waves and older population continues to be more vulnerable to the infection, the Centre said on Monday.

Addressing media, ICMR Director General Balram Bhargava said there is no difference in deaths between first and second wave among hospitalised patients, while the oxygen requirement is higher in second wave and ventilator requirement is not higher in the second wave.

Prevalence of shortness of breath is slightly higher in the second wave of Covid-19 but sore throat and dry cough and other symptoms were higher in the first wave, the Centre said on Monday.

"No difference in deaths between first and second wave among hospitalised patients. About 54.5 percent patients require oxygen in second wave against 41.5 percent in the first wave," he said.

Suraj · Post by **Suraj** » 19 Apr 2021 23:41

The moneycontrol article is poorly written. Here's what the Govt has done:
Finance minister approves advance payment of Rs.4567 crore to SII and Bharat Biotech
Rs.3000 cr to SII
Rs.1567 cr to Bharat Biotech

The Rs.65 cr was the grant to BB's under construction Bangalore facility to speed up readiness.

The new policy is here:
Government of India announces a Liberalised and Accelerated Phase 3 Strategy of Covid-19 Vaccination from 1st May

Nalla Baalu · Post by **Nalla Baalu** » 19 Apr 2021 23:57

Atmavik wrote:there is definite shortage of vaccine in hyderabad. my parents second dose is delayed by a week and were told today to wait another two days for covisheild supply

My parents got their first dose early March and had their second dose scheduled for first week of Apr. Then there was a chatter about potential enhanced immunity with gap between doses prolonged to 6 weeks. Given lukewarm response from Hyderabadis in March, they had no way to anticipate shortage, and decided to wait two additional weeks. In second week, second wave surge became apparent to everyone and tika utsav happened as well. They got 'repu - ellundi' (tomorrow or day after) responses from local hospital starting Apr 8th, indicating demand exceeding supply (or supply getting diverted by hoarders or black-marketeers). Early last week, they walked-in to couple of hospitals without luck. They managed to get them on Fri after walking-in and waiting for 3 hours at Yashoda Hospital @ Nalgonda X Roads.

vijayk · Post by **vijayk** » 20 Apr 2021 00:07

Suraj wrote:The moneycontrol article is poorly written. Here's what the Govt has done:
Finance minister approves advance payment of Rs.4567 crore to SII and Bharat Biotech
Rs.3000 cr to SII
Rs.1567 cr to Bharat Biotech

The Rs.65 cr was the grant to BB's under construction Bangalore facility to speed up readiness.

The new policy is here:
Government of India announces a Liberalised and Accelerated Phase 3 Strategy of Covid-19 Vaccination from 1st May

Good news ...

What about Sputnik? When will this be statrting?

We need to vaccinate 1cr per week if possible ramp it up to 2 cr

nam · Post by **nam** » 20 Apr 2021 00:11

We are already doing 2.1 crore per week. Average of 3m per day. 21m per week.

The ideal would be 5m/35m per week. Then on to 10m per day.

sudeepj · Post by **sudeepj** » 20 Apr 2021 00:27

For the ZyCov vaccine phase III, we should consider doing challenge trials to speed up the validation. This is the worst calamity to have struck India since at least the Bangladesh war. The UK is similarly doing challenge trials with the new so called double mutant strain that is getting prevalent in India.

Challenge trials, as the name sounds, is selecting (compensated) volunteers, vaccinating them, and exposing them to a set dose of the pathogen and quickly validating if the vaccine works or not. There is risk of life and limb to the volunteers, but the weeks and months shaved off the vaccine development timeline can help save tens of thousands of lives.

https://www.telegraph.co.uk/global-heal ... ccinating/

Uttam · Post by **Uttam** » 20 Apr 2021 00:32

sudeepj wrote:For the ZyCov vaccine phase III, we should consider doing challenge trials to speed up the validation. This is the worst calamity to have struck India since at least the Bangladesh war. The UK is similarly doing challenge trials with the new so called double mutant strain that is getting prevalent in India.

Challenge trials, as the name sounds, is selecting (compensated) volunteers, vaccinating them, and exposing them to a set dose of the pathogen and quickly validating if the vaccine works or not. There is risk of life and limb to the volunteers, but the weeks and months shaved off the vaccine development timeline can help save tens of thousands of lives.

https://www.telegraph.co.uk/global-heal ... ccinating/

Given the widespread prevalence of COVID in India, I don't think a challenge trial is needed for ZyCov-D. Whether challenge trial or normal trial, there are trial protocols that require data to be collected after some minimum number of days elapsed after the person is given vaccine/placebo. Usually, the delay is caused by the lack of prevalence of infection, so that not enough people are infected in the vaccine/placebo group to compile and analyze results. That wouldn't be the case in India.

vijayk · Post by **vijayk** » 20 Apr 2021 00:37

nam wrote:We are already doing 2.1 crore per week. Average of 3m per day. 21m per week.

The ideal would be 5m/35m per week. Then on to 10m per day.

sorry ... I meant 1 cr per day ...

4 infections in my close family after the first dose. They are OK as of now.

The interesting thing is spouses are not infected. May be vaccine is preventing the spread. Just anecdotal. Not a comprehensive study

Uttam · Post by **Uttam** » 20 Apr 2021 01:41

https://www.timesnownews.com/india/arti ... nce/747118

Multinational pharma giant Johnson & Johnson has applied to India's drug regulator seeking permission to conduct phase-3 clinical trial of its single-dose COVID-19 vaccine in India as well as import licence, sources said.

Raja · Post by **Raja** » 20 Apr 2021 01:45

durairaaj wrote: I am glad peple in the policy making bodies are not like you.

Err I really hope they are making their decisions based on data and not random whatsapp demands. The govt. is likely expecting a boost on supply side by the end of the month and based on the data that they have collected (which is lot more than what we have) made the calculation that they can continue to vaccinate the high risk population at an accelerated pace while vaccinating the expanded group on the side. So far, I have no reason to doubt that. If the supply side is not sorted out leading to a lack in coverage of high risk population, then we are likely to face issues well into 2022.

Do keep in mind that there is very much a chance that we need to vaccinate everyone again in 9-12 months (which would again call for prioritization). We also have very little evidence on how well the vaccines prevent transmission of disease (not just serious symptoms), something that your theory heavily relies on.

Kakkaji · Post by **Kakkaji** » 20 Apr 2021 01:52

Folks:

Please read carefully the entire Press Release put out by the Health Ministry. Every line is a hit to the boundary, with some sixers included:

Government of India announces a Liberalised and Accelerated Phase 3 Strategy of Covid-19 Vaccination from 1st May

Government has been working hard from over a year to ensure that maximum numbers of Indians are able to get the vaccine in the shortest possible of time: PM

Several important decisions taken in a meeting chaired by Prime Minister

Pricing, Procurement, Eligibility and Administration of vaccines being made flexible in Phase 3 of the World’s Largest Vaccination drive

All stakeholders given flexibility to customise to local needs

Everyone above the age of 18 to be eligible to get vaccine against Covid-19

Vaccine manufacturers incentivized to further scale up their production, as well as attract new national and international players

Vaccine manufacturers empowered to release up to 50% of their supply to State Govts. and in the open market at a pre-declared price

States empowered to procure additional vaccine doses directly from the manufacturers, as well as open up vaccination to any category of people above the age of 18 for the same

GoI Vaccination drive to continue as before, providing free vaccination for essential and priority populations as defined earlier i.e HCWs, FLWs and population above 45 years

Posted On: 19 APR 2021 7:12PM by PIB Delhi

In a meeting chaired by PM Narendra Modi, an important decision of allowing vaccination to everyone above the age of 18 from 1st May has been taken. PM said that the Government has been working hard from over a year to ensure that maximum numbers of Indians are able to get the vaccine in the shortest possible of time. He added that India is vaccinating people at world record pace& we will continue this with even greater momentum.

India’s National Covid-19 Vaccination Strategy has been built on a systematic and strategic end-to-end approach, proactively building capacity across R&D, Manufacturing and Administration since April 2020. While pushing for scale and speed, it has simultaneously been anchored in the stability necessary to sustainably execute the World’s Largest Vaccination Drive.

India’s approach has been built on scientific and epidemiological pillars, guided by Global Best Practices, SoPs of WHO as well as our India’s foremost experts in the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC).

India has been following a dynamic mapping model based on availability of vaccines & coverage of vulnerable priority groups to take decisions of when to open up vaccinations to other age-groups. A good amount of coverage of vulnerable groups is expected by 30th April.

Phase-I of the National Covid-19 Vaccination Strategy was launched on 16th January 2021, prioritizing protection for our protectors, our Health Care Workers (HCWs) and Front Line Workers (FLWs). As systems and processes stabilized, Phase-II was initiated from 1st March 2021 and 1st April 2021, focusing on protecting our most vulnerable i.e. all people above 45 years of age, accounting for more than 80% Covid mortality in the country. The private sector was also roped in to augment capacity.

As per PM Modi’s directions, Government of India has proactively engaged and coordinated with stakeholders across the spectrum, from research institutes to national and international manufacturers, global regulators etc. The strength of India’s private sector vaccine manufacturing capability has been strategically empowered through unprecedented decisive steps, from facilitating public-private collaborative research, trials and product development, to targeted public grants and far-reaching governance reforms in India’s regulatory system. Government of According to PM Modi’s instructions, India is in regular touch with each manufacturer, including having sent multiple inter-ministerial teams on site, to understand each one’s requirements and provide proactive and customized support in the form of grants, advance payments, more sites for production, etc to ramp up vaccine production.

This has resulted in Emergency Use Authorisation being granted to two indigenously manufactured vaccines (Serum Institute of India and Bharat Biotech), and a third vaccine (Sputnik) that while presently manufactured abroad will eventually be manufactured in India.

Government of India has roped in the private sector in the vaccination drive right from the beginning. Now, as capabilities and processes have stabilized, the public as well as private sector has the experience and confidence to rapidly scale up.

In its Phase-III, the National Vaccine Strategy aims at liberalised vaccine pricing and scaling up of vaccine coverage. This would augment vaccine production as well as availability, incentivising vaccine manufacturers to rapidly ramp up their production as well as attract new vaccine manufacturers, domestic and international. It would also make pricing, procurement, eligibility and administration of vaccines open and flexible, allowing all stakeholders the flexibility to customise to local needs and dynamics.

The main elements of the Liberalised and Accelerated Phase 3 Strategy of the National Covid-19 Vaccination program that would come in effect from 1st May 2021, are as follows:-

(i) Vaccine manufacturers would supply 50% of their monthly Central Drugs Laboratory (CDL) released doses to Govt. of India and would be free to supply the remaining 50% doses to State Govts. and in the open market (hereinafter referred to as other than Govt. of India channel).

(ii) Manufacturers would transparently make an advance declaration of the price for 50% supply that would be available to State Govts. and in open market, before 1st May 2021. Based on this price, State governments, private hospitals, industrial establishments etc would be able to procure vaccine doses from the manufacturers. Private Hospitals would have to procure their supplies of Covid-19 vaccine exclusively from the 50% supply earmarked for other than Govt. of India channel. Private Vaccination providers shall transparently declare their self-set vaccination price. The eligibility through this channel would be opened up to all adults, i.e. everyone above the age of 18.

(iii) Vaccination shall continue as before in Govt. of India vaccination centres, provided free of cost to the eligible population as defined earlier i.e. Health Care Workers (HCWs), Front Line Workers (FLWs) and all people above 45 years of age.

(iv) All vaccination (through Govt. of India and Other than Govt. of India channel) would be part of the National Vaccination Programme, and mandated to follow all protocol such as being captured on CoWIN platform, linked to AEFI reporting and all other prescribed norms. Stocks and price per vaccination applicable in all vaccination centres will also have to be reported real-time.

(v) The division of vaccine supply 50% to Govt. of India and 50% to other than Govt. of India channel would be applicable uniformly across for all vaccines manufactured in the country. However Government of India will allow the imported fully ready to use vaccines to be entirely utilized in the other than Govt. of India channel.

(vi) Govt. of India, from its share, will allocate vaccines to States/UTs based on the criteria of extent of infection (number of active Covid cases) & performance (speed of administration). Wastage of vaccine will also be considered in this criteria and will affect the criteria negatively. Based on the above criteria, State-wise quota would be decided and communicated to the States adequately in advance.

(vii) Second dose of all existing priority groups i.e. HCWs, FLWs and population above 45 years, wherever it has become due, would be given priority, for which a specific and focused strategy would be communicated to all stakeholders.

(viii) This policy would come into effect from 1st May 2021 and will be reviewed from time to time.

*****

As the last line says, the policy is subject to review from time to time.

It will take a month or two to establish the price and supply in the 'Other than Government Channel". By that time, a substantial percentage of the avove 45 people would have been vaccinated in the "Government Channel". I think that the GoI will then open the "Government Channel" to the people from 18-45 who are below the poverty line.

I doubt that the individual states like Maharashtra will procure much from the open market. They will let the GoI and the private hospitals do the heavy lifting for them, while continuing to whine all the same.

In any case, most of the recent whines have been addressed by today's Press Release.

Suraj · Post by **Suraj** » 20 Apr 2021 02:30

vijayk wrote:
nam wrote:We are already doing 2.1 crore per week. Average of 3m per day. 21m per week.

The ideal would be 5m/35m per week. Then on to 10m per day.
sorry ... I meant 1 cr per day ...

4 infections in my close family after the first dose. They are OK as of now.

The interesting thing is spouses are not infected. May be vaccine is preventing the spread. Just anecdotal. Not a comprehensive study

CDC has updated its statements on the topic a few times, partly because their first explanations were not clear. But essentially:
1. If you're vaccinated you may or may not still get Covid.
2. Your chances of hospitalization and death are nearly eliminated.
3. You ability to transmit the illness is almost non existent.

Get vaccinated. You may still get the virus, but current data indicates you'll neither spread it nor will you be in danger.

Kakkaji · Post by **Kakkaji** » 20 Apr 2021 02:39

States allowed to use 50 per cent Disaster Response Fund to curb pandemic surge

The Centre has allowed states to use 50% of the State Disaster Response Fund (SDRF) for the financial year to contain the Covid-19 surge. The special onetime measure will have to be “in conformity with approved items and norms in the financial year 2021-22,” a communication by the home ministry to states and union territories on Monday said.

SDRF can be used to buy ventilators, air purifiers, oxygen generation, storage, strengthening ambulance services, quarantine, sample collection and screening suspected patients. It can also be used for temporary accommodation, food, clothing, medical care, quarantine camps or for cluster containment operations.

vijayk · Post by **vijayk** » 20 Apr 2021 02:42

Please stop your WA fwd nonsense. Next time will be a summary ban.

Anujan · Post by **Anujan** » 20 Apr 2021 02:58

Uttam wrote:https://www.timesnownews.com/india/arti ... nce/747118

Multinational pharma giant Johnson & Johnson has applied to India's drug regulator seeking permission to conduct phase-3 clinical trial of its single-dose COVID-19 vaccine in India as well as import licence, sources said.

If costs are reasonable, I think J&J vaccine could be a game changer.

It is single shot, refrigerator stored. Mobile vans with ice boxes can vaccinate in rural areas.

Suraj · Post by **Suraj** » 20 Apr 2021 03:08

The price setting mechanism for the Other Than GoI channel is nice. It compels manufacturers to announce bids openly ahead of time, which means everyone knows who is charging how much and what is the availability.

Anujan · Post by **Anujan** » 20 Apr 2021 03:10

But I'm afraid that states are going to fight it out among themselves for supplies.

IndraD · Post by **IndraD** » 20 Apr 2021 03:11

J&J already have been given approval on 13 April for phase 3 trial

IndraD · Post by **IndraD** » 20 Apr 2021 03:17

https://www.reuters.com/business/health ... ce=twitter
India hopeful U.S. will soon end curbs on vaccine raw materials export - govt sources

Suraj · Post by **Suraj** » 20 Apr 2021 03:20

Anujan wrote:But I'm afraid that states are going to fight it out among themselves for supplies.

Like the proverbial dog that chased the car, that's literally what they were asking for. Now that they have it dropped on their laps, the argument has done a 180 degree change to 'failure of federal government, abdicating responsibility and leaving states with no guidance'.

Half the stock will continue to be available exactly the same way it is now, via the GOI channel. Remaining half can be procured at the openly listed prices by state and private entities.

Now a poor person will obviously go for the free Modi-shot. The onus of managing the other half is entirely on states instead, whether its funding, distribution, or prioritization.

Really nice Dhoni behind the stumps move by the central govt here.

Uttam · Post by **Uttam** » 20 Apr 2021 03:24

Suraj wrote:
Now a poor person will obviously go for the free Modi-shot. The onus of managing the other half is entirely on states instead, whether its funding, distribution, or prioritization.

Just a correction, a poor person who is 45 or above will go for the free Modi-shot. Let's see how states will manage vaccination for poor who are younger than 45.

Suraj · Post by **Suraj** » 20 Apr 2021 03:34

Yes, thanks for the correction - Centre continues to maintain the >45 prioritization but states are free to open up to anyone over 18 starting May 1.

I think this is a great move because the center has effectively given the states literally everything they asked for:
1. Eligibility expanded to over 18 (but entirely up to the state to implement that)
2. Companies allowed to set prices (but bid against each other)
3. States can procure directly 50% of stock cleared by Q&A at NCL (up to them to pay for it)

Kakkaji · Post by **Kakkaji** » 20 Apr 2021 03:34

Anujan wrote:But I'm afraid that states are going to fight it out among themselves for supplies.

I predict that most of the states that are whining 'shortage of vaccine' are going to whine about 'shortage of funds' now. I don't think they will buy much. They will leave it to the private hospitals in their states to do the buying and administering of vaccines.

Besides, I don't think there will be any auction or bidding for the 'Other than GoI' channel. The applicable sentence in the Press Release is:

(ii)Manufacturers would transparently make an advance declaration of the price for 50% supply that would be available to State Govts. and in open market, before 1st May 2021.

I read this to mean that the manufacturers will have to decide on a price for sale and declare it publicly just like manufacturers of other products declare their MRP.

The private hospitals will also have to declare their price publicly for administering a shot.

With 3 vaccines already approved, and more on the way, there is enough competition to restrain the prices.

IIRC Poonawalla had mentioned in an interview that he considered a private market 'fair and reasonable' price for his Covishield would be near Rs 1,000 per dose.

Let us see where the prices end up in the market.

Suraj · Post by **Suraj** » 20 Apr 2021 03:46

The great thing about this policy - and why it's gotten immediate angry response - is that it accepts every demand that the states made of the center recently, but makes the states do all of it.

1. The center said ok you asked for 18+ eligibility. Fine here Im going to announce that from May 1 18+ are eligible... for the state's share. The centrally distributed stock will continue to be for >45, with priority for 2nd dose people.
2. Companies - you wanted to sell at open prices ? Ok go ahead. First you need to announce your prices ahead of time and then all entities can decide whether to buy your product.
3. Allow states to order directly / Fine, they can have it. They are responsible for procurement and distribution.

Frankly the center should allow an opt out clause. Any state that doesn't want to do this, they can opt out and let center manage 100% of their share. A lot of states will quickly find it's easier to yell at Dilli than manage something this complex themselves.

disha · Post by **disha** » 20 Apr 2021 04:13

This is a very hard hitting article clearly highlighting the chicanery of the Vaccine Vultures aligned against India

https://www.news18.com/news/opinion/man ... 56852.html

How many on this forum knew that Chattisgarh has several thousands of Covaxin lying idle because it is not approved by it? Just because it is "BJP"s vaccine!

If this was not enough, Bhupesh Baghel, Chief Minister of Congress-ruled Chhattisgarh, went a step further. He became perhaps the only serving head of a government to incite his own people against a vaccine developed by his own countrymen. His health minister, TS Singh Deo, issued a fiat that he would not allow the use of Covaxin in his state. Thousands of doses are lying unused in the state while it battles the second wave of the virus and lags behind the national average in inoculating citizens

Kakkaji · Post by **Kakkaji** » 20 Apr 2021 04:22

Sputnik V vaccine 98% effective against Covid-19: Russian scientists

Russian scientists have found the Sputnik V vaccine 97.6 per cent effective against Covid-19 in a “real-world” assessment based on data from 3.8 million people, Moscow's Gamaleya Institute and the Russian Direct Investment Fund said on Monday.

The new effectiveness rate is higher than the 91.6 per cent rate outlined in results from a large-scale trial of Sputnik V that was published in The Lancet medical journal earlier this year, and compares favourably with data on the effectiveness of other Covid vaccines.

The new data was based on 3.8 million Russians who received both a first shot and a booster shot as part of the national roll-out of Sputnik V.

venkat_kv · Post by **venkat_kv** » 20 Apr 2021 06:38

vijayk wrote:
Mollick.R wrote:Good writeup

EXPLAINED | Why government's funding of 3 PSEs won't raise overall vaccine production anytime soon

Amid spiralling Coronavirus cases across the country, Centre announced financial support to three government owned biopharmaceutical institutions to bulk up the production of Covaxin on April 16.

The government also announced that it will provide Rs 65 crore to the only manufacturer of the vaccine currently, Hyderabad-based Bharat Biotech International.

As a deadly second wave continues to grip the country, an acute shortage of vaccines have become evident nationwide. With domestic production remaining stagnant, the government last week announced fast track approval would be provided to all foreign-made vaccines which have already received emergency approval from pharma regulatory bodies in the United States, Japan, European Union, United Kingdom and the World Health Organization.

vijayk wrote: why are we penny-pinching?
Is it time to worry about 85 cr?

Vijayk saar,
its 65 crore for only Bangalore facility. in an earlier report it was stated that Bharat Biotech had asked for 150crores for two facilities of Hyderabad and Bangalore (that comes to 75 apiece). It means instead of 75 requested for bangalore facility the govt has sanctioned 65crores which is quite close. maybe the rest will be given as and when required.

venkat_kv · Post by **venkat_kv** » 20 Apr 2021 06:58

Let me share my family's personal experience regarding the vaccination drive.

My father is a diabetic and is regularly taking medicines to keep it under control. Last year he contracted covid when he went to submit some bills in a govt office in Hyderabad. This office had multiple departments in one building and a week later they shut down the whole building to do sanitization/ covid clean up measures in the building. the neighboring department/floor had a case of covid breakout spreading it to mutiple govt employees in the whole building.

My father felt the symptoms in a couple of days after coming back and self isolated and got tested. the testing staff did contact tracing and also got my mom tested and she reported negative. after a couple of week they repeated the tests and both my parents tested negative. this was last year when contact tracing was in full swing.

Fast forward this year and my parents got all sort of whatapp forwards discouraging them from taking vaccines with some videos talking about doctors from scandanavian countries fearmongering as experts. their local doctor also asked them to wait saying most of the health professionals are in wait and watch mode and can get vaccinated later if they choose. After the PM started the vaccine drive by getting vaccinated i urged them strongly to get the vaccine in case if they have to travel abroad as the cases in US were also not that low (though the local media here seems to have gone completely silent about it).

they got a covishield in the first week of march and got their second dose in the first week of April. Both sides the websites were a dud and they kind of had to use walk-in (for second dose) and help of a relative to make the booking (for the first dose). My father had soreness for a day or two and my mom didn't feel anything.

My father tested positive for covid after a week of the second dose and my mom was negative. He didn't show any symptoms and decided to get tested again a couple of times in two different centres. The first one gave him a positive whle the reamining two gave him negative. My mom was a negative through out. Don't know what to make of the results anymore. all these testing happened within a week of each other.
I don't know what to make of these results for now, just happy that they don't seem to show any symptoms.

disha · Post by **disha** » 20 Apr 2021 07:16

Just want to point out that ZyCov-D is also a game changer vaccine if it gets through Phase-III.

It will be the first DNA vaccine in the world approved for human use. This is an altogether new technology platform and similar to the other moonshot vaccine mRNA.

Again if ZyCov-D comes through as phase 3, the celebration on this thread should be no lesser than the lungi dance that accompanies launch of an SSBN or GSLV Mk2/3 or Mangalyaan. Since India will be the only country in the world with a working DNA vaccine approved for humans.

To read up on ZyCov-D : https://www.news-medical.net/news/20210 ... uesys.aspx

To read up on DNA Vaccine: https://weekly.biotechprimer.com/dna-va ... explained/

PS: I do hope that the success of ZyCov-D is announced on 10/11 May 2021 and the first shipments are made on 18th May 2021 and the general public starts getting vaccines on 26th May 2021.