Wuhan Coronavirus Resource Thread

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krisna
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Re: Wuhan Coronavirus Resource Thread

Postby krisna » 11 Jun 2021 04:55




Thank you Suraj,
have read your other articles also. All your articles are wonderful write up with facts.
please continue your good work.
will do my part in sending across social media group.

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Re: Wuhan Coronavirus Resource Thread

Postby krisna » 11 Jun 2021 05:24

From Business today article on Biological E company and its 3 vaccines
Biological E currently makes eight World Health Organization (WHO) pre-qualified vaccines for tetanus, measles and rubella, pentavalent vaccines and snake anti-venom, and sells to over 100 countries. The company was started by Dr DVK Raju and G.A.N. Raju in 1953 as India's first biological products company manufacturing liver extracts and anti-coagulants.

It launched a biotechnology division (now Vaccines and Biologics Division) and commenced large-scale production of DPT vaccines as early as 1962. It also pioneered anti-blood clotting drug Heparin production in India. During 1960s and 1970s, Biological E developed formulations in cough and digestive enzymes, anti-tetanus serum, anti-TB drugs, TT and DTP vaccines, besides working as a contract manufacturer to GlaxoSmithKline. From 2008, it also started making pentavalent (DTP Hib HepB) vaccines. In 1964, Evans Medicals, a UK-based pharma company which later merged with Glaxo SmithKline, acquired 40 per cent stake in the company. This was subsequently bought back by the promoters in 1995.



Only other vaccine maker other than serum institute of India to have a Billion vaccines per year
Within a week of those two deals, Biological E acquired Akorn India, a subsidiary of Akorn Inc., USA, primarily to access the facilities at Akorn India's Paonta Sahib Plant in Himachal Pradesh for commercial scale manufacturing of vaccines. The sterile injectable manufacturing facility has 39,000 square metres of built-up area spread over a 14-acre campus with an annual capacity for about 135 million units, with the potential for immediate expansion of a further 30 million units.The acquisition helped Biological E create a potential overall manufacturing capacity of over 1 billion doses per annum if required, when its vaccines are ready for production. No other Indian vaccine makers has a capacity to make over a billion doses of vaccines, except the Serum Institute of India, which has a capacity of 1.6 billion doses a year and is further expanding it by nearly another 1 billion doses.


It has 3 vaccines in its portfolio-- only company in the world with its own 2 vaccines along with another licensed

1) Corbevax vaccine
By November, Biological E initiated phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI). The vaccine candidate included an antigen in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, along with Dynavax's advanced adjuvant CpG 1018, to boost the immune response to produce more antibodies and longer lasting immunity.The company's COVID-19 vaccine candidate is based on classical vaccine technology of a protein antigen, SARS-CoV-2 spike protein, adsorbed to the adjuvant Alhydrogel (Alum), in combination with another approved adjuvant, CpG 1018. It uses proven recombinant-protein technology and a safe agent to stimulate an immune response in cells. The trials were done in about 360 healthy subjects in the age group of 18-65 years with two doses, and a interval of 28 days between the doses. The results were to be made available by February 2021.Soon CEPI (Coalition for Epidemic Preparedness Innovations), which works with the WHO's Covax Alliance to ensure equitable distribution of vaccines for low-income countries, collaborated for further development with a funding of $5 million for scaling up vaccine manufacturing, and assurance on additional funding to potentially enable production of 100 million doses in 2021. The candidate also received seed funding from Department of Biotechnology, Government of India.

In mid-April, 2021, the vaccine candidate got approval from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC) to start phase III clinical trials following successful completion of previous stage trials. Phase III clinical study is to be conducted at 15 sites across India in about 1,268 healthy subjects in the age group of 18 to 80 years, and plans are to conduct a larger global phase III study. The company plans to start the trials soon, and produce 75 million to 80 million doses per month from August, say sources.


GOI has contracted for about 30 crores of this vaccine, released about 1500 crores(30% of total) for now . remaining will be paid later.
This vaccine expected to be the cheapest .

2) MRNA vaccine-- 3rd vaccine after pfizer and moderna

With the latest deal with Providence, the Candaian company will provide necessary technology transfer for Biological E to manufacture mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses. Biological E will be responsible for all clinical development and regulatory activities for the mRNA vaccine in India and other jurisdictions licensed by Biological E.


3) Johnson vaccine single dose for quad allaince which is being talked about-- Biological E expected to manufcature in excess of 600 million if all goes well.

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Re: Wuhan Coronavirus Resource Thread

Postby krisna » 11 Jun 2021 05:27

Thru PM CAREs fund and covid Suraksha mission, plans are for at least 5-6 vaccines to be manufactured in India.

direct involvement seems to be in Covaxin and Corbevax vaccines.

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Re: Wuhan Coronavirus Resource Thread

Postby Kakkaji » 11 Jun 2021 07:10

Key corporates’ workplace jabs take a chunk of city vaccination

A significant percentage of vaccinations carried out in some of India’s biggest cities are of employees of large corporates — mostly in the service sector but some from manufacturing as well — and their families, official data analysed by The Indian Express show.

The service economy hubs of Mumbai, Bengaluru, Pune, Hyderabad, Gurgaon, Noida, and Chennai, had conducted approximately 20.36 lakh vaccinations at the workplace — which was more than 12 per cent of the total vaccinations carried out in India’s top seven metros.

The large share of workplace vaccinations by big corporates in total vaccinations in cities is significant in light of the fact that private hospitals — with which corporates typically tie up — will continue to get 25 per cent of the country’s total vaccine pie even after the government’s new vaccination policy comes into force on June 21.

Three significant trends in India’s mass vaccination programme emerge from the data.

One, the data show that the workplace vaccination policy has accelerated inoculation at these top firms, which contribute significantly to the country’s GDP. At the same time, this success underlines the need for the Centre, which takes over the bulk of vaccine procurement from June 21, to devise a similar policy for those in the unorganised sector, and for vulnerable sections of the population.

Two, at a time when vaccines are in short supply, these large companies have been able to dip into the 25 per cent bucket for the open market easily, due to their financial position and the fact that they are based mostly in the big cities. This again, spotlights the need for the Centre to target specific categories for vaccination from the 75 per cent doses that it will now control.

Three, the data show that a section of the population which already has access to quality healthcare is getting extra protection from aggressive and targeted vaccination on priority. A strategy is needed to similarly target those with limited access to quality health care, which is critical to ward off a potential third wave of coronavirus infections.

Among the top workplace vaccinators in the country, according to available data are:

* IT services: TCS has carried out 69,170 vaccinations at its campuses in Mumbai, Bengaluru, Pune, Chennai, Noida and Gurgaon; Infosys has conducted 28,493 vaccinations in Pune, Chennai, Hyderabad, and Gurgaon; HCL has administered 9,979 shots in Noida; Cognizant, 7,371; Microsoft, 3,163, and Google, 873 vaccinations.

* Consulting firms: Ernst & Young, 26,406 vaccinations in Gurgaon, Mumbai, Chennai; Boston Consulting Group, 25,899 in Mumbai and Gurgaon; Deloitte, 16,844 in Mumbai, Hyderabad, Gurgaon, and Pune; Pricewaterhouse Coopers, 14,788 in Mumbai and Gurgaon; JP Morgan, 1,590; McKinsey, 1,560; and Barclays Global Service,1,826.

* Automobiles: The top workplace vaccinators include Maruti Suzuki (22,472 shots); Tata Motors (11,316); Skoda-Volkswagen (7,090); Mahindra (6,091); Honda (2,130); Mercedes Benz (1,186); and BMW (542).

* Manufacturing: Centum Electronics (48,313); Godrej Industries (9,791); John Deere (6,194); Tata Projects Limited (5,061).

* E-commerce: Amazon has conducted 22,431 vaccinations; Zomato, 11,683 at its campuses in Noida and Gurgaon.

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Re: Wuhan Coronavirus Resource Thread

Postby Suraj » 11 Jun 2021 07:19

Thanks krisna! Also I forgot to acknowledge the nice set of data arshyam posted earlier, along with AmberGs data references . It’s really good to be data driven and derive insights from that instead of being swayed by the constant posturing from the press . Narratives as they say . The real narrative will be built on data .

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Re: Wuhan Coronavirus Resource Thread

Postby Zynda » 11 Jun 2021 13:21

UK is worrying that Delta variant may cause 4th wave...I think UK has not started vaccinating people below 25...not sure the demographic distribution there but if its anything like India, young folks being sizeable...that is a cause for concern. UK has vaccinated 50-60% adults (> 25) with at least 1 shot of vaccine and hence were planning on significant opening up by end of June (read the exact day being June 21st which the press termed as "freedom day").

Even in Ontario, Canada, they are speeding up 2nd shots as Delta variant has been spotted. Even in US, states where vaccination rates or adoption are slow, hospital cases due to Covid are rising. SF is a first major city in US where herd immunity may have reached. I think CA still has mask mandate but it will be interesting to see if cases will be low going forward.

I am thinking if the virus is one step ahead of vaccines, even if we have achieve "herd immunity" would it be helpful? Probably yes in terms of reducing hospitalisations and deaths, thus reducing the burden on healthcare infrastructure but still a lot of people may end up falling sick. Perhaps newer Covid drugs can help along with vaccination (one Canadian company was claiming its nasal spray being effective in stopping the replication of virus)...

Israel will be another case to watch out for. Recently, Israel has removed indoor mask mandate as well (around 80%+ of their adults have received vaccination)...

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Re: Wuhan Coronavirus Resource Thread

Postby arshyam » 11 Jun 2021 17:56

Suraj-san, thanks for the kind words.

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Re: Wuhan Coronavirus Resource Thread

Postby Uttam » 11 Jun 2021 21:11

day 147 https://www.pib.gov.in/PressReleasePage.aspx?PRID=1726346
day 146 https://www.pib.gov.in/PressReleseDetail.aspx?PRID=1726063

The country has administered cumulatively more than 24.93 Cr Vaccine Doses as per the 7 pm provision report today


Day 147 - day 146 = 24.93 Cr - 24.58 = 35 lacs.


There will probably be another 3 lacs tonight. 25 crores are within reach.

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Re: Wuhan Coronavirus Resource Thread

Postby Suraj » 11 Jun 2021 21:15

You beat me to it. Guess you were busy refreshing pib.gov.in for the past half an hour :rotfl:

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Re: Wuhan Coronavirus Resource Thread

Postby Uttam » 11 Jun 2021 21:39

Suraj wrote:You beat me to it. Guess you were busy refreshing pib.gov.in for the past half an hour :rotfl:

Now that's a race I am willing to run :rotfl:

The 7-day average is over 31 lacs now. Over 15% population have received at least a single dose. (Source: https://www.covid19india.org/).

Looking at India's population pyramid, 26.6% population is below 20. That means, over 20% of the population above the age of 20 has received at least one dose.

Q: How long will it take to vaccinate everybody above 20 with at least one dose?
There are about 1.03 billion people in this age group. Of these, 20% have received one dose.
Assuming 80% of all doses in the near future will be the first dose only (currently, 90% of all doses are first doses).
Then the following table gives an idea of how long it will take to vaccinate everybody above 20 with at least one dose

Code: Select all

daily rate (in million)      days
3   -   219
4   -   164
5   -   132
6   -   110
7   -   94
8   -   82
9   -   73
10   -   66

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Re: Wuhan Coronavirus Resource Thread

Postby Y I Patel » 11 Jun 2021 23:51

Suraj- thank you for yet another superbly researched and articulated publication!

Your article makes me speak out loud what I have been thinking lately: if I were a Modi-hater with a modicum of ability to think ahead, I would be tearing my hair out that he took away the state’s’ responsibility for vaccine procurement just when the new wave of production is going to be available.

What will happen is that now the center will get full and justly deserved credit when the vaccinations pick up pace.

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Re: Wuhan Coronavirus Resource Thread

Postby Prasad » 12 Jun 2021 00:14

Uttam,
the above 18 figure is approx 934 million.

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Re: Wuhan Coronavirus Resource Thread

Postby Uttam » 12 Jun 2021 00:21

Prasad wrote:Uttam,
the above 18 figure is approx 934 million.


Ok, then the number of days will drop by another 10%.
Thanks,

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Re: Wuhan Coronavirus Resource Thread

Postby vijayk » 12 Jun 2021 01:23

Zynda wrote:UK is worrying that Delta variant may cause 4th wave...I think UK has not started vaccinating people below 25...not sure the demographic distribution there but if its anything like India, young folks being sizeable...that is a cause for concern. UK has vaccinated 50-60% adults (> 25) with at least 1 shot of vaccine and hence were planning on significant opening up by end of June (read the exact day being June 21st which the press termed as "freedom day").

Even in Ontario, Canada, they are speeding up 2nd shots as Delta variant has been spotted. Even in US, states where vaccination rates or adoption are slow, hospital cases due to Covid are rising. SF is a first major city in US where herd immunity may have reached. I think CA still has mask mandate but it will be interesting to see if cases will be low going forward.

I am thinking if the virus is one step ahead of vaccines, even if we have achieve "herd immunity" would it be helpful? Probably yes in terms of reducing hospitalisations and deaths, thus reducing the burden on healthcare infrastructure but still a lot of people may end up falling sick. Perhaps newer Covid drugs can help along with vaccination (one Canadian company was claiming its nasal spray being effective in stopping the replication of virus)...

Israel will be another case to watch out for. Recently, Israel has removed indoor mask mandate as well (around 80%+ of their adults have received vaccination)...


Hope they reduce Covishield timing to 6 weeks now that supply is going up

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Re: Wuhan Coronavirus Resource Thread

Postby vijayk » 12 Jun 2021 01:57

I am wondering if we need an agile response team for COVID-19 handling. IT folks know Agile process. For non-IT folks, Agile is a dynamically responding project management where requirements change frequently but handled thru regular co-ordination between customer and the product development teams.

1. We need dynamic strategies to handle oxygen/ventilator needs of each district
2. Similar need to manage medicinal requirements.
3. Vaccine per state/district management based on each state status.Some states may attract using rice distribution and some others might offer 500 Rs cash.
4. UP is lagging pretty bad in vaccination. We need to bring it up with rest of India percentage wise

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Re: Wuhan Coronavirus Resource Thread

Postby Suraj » 12 Jun 2021 02:00

Y I Patel wrote:Suraj- thank you for yet another superbly researched and articulated publication!

Your article makes me speak out loud what I have been thinking lately: if I were a Modi-hater with a modicum of ability to think ahead, I would be tearing my hair out that he took away the state’s’ responsibility for vaccine procurement just when the new wave of production is going to be available.

What will happen is that now the center will get full and justly deserved credit when the vaccinations pick up pace.

Yes that has been apparent for a while, at least to me 8) I expected the policy to end by the end of his month but was off by a week - it ends June 21 .

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Re: Wuhan Coronavirus Resource Thread

Postby IndraD » 12 Jun 2021 02:07

https://www.dailymail.co.uk/news/articl ... ailymailus
CDC calls urgent meeting to investigate 226 cases of heart inflammation in teen boys after having Pfizer or Moderna shots - just one week Israel reported a link and other health regulators launch probes

not one or two they have caused over 800 heart inflammation in teens

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Re: Wuhan Coronavirus Resource Thread

Postby Jay » 12 Jun 2021 02:35

IndraD wrote:
not one or two they have caused over 800 heart inflammation in teens


800 cases in how many of the vaccinated candidates and the severity of this inflammation is important. Hopefully this is nothing too severe to cause the vaccination rates to come down.

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Re: Wuhan Coronavirus Resource Thread

Postby Jay » 12 Jun 2021 02:38

Y I Patel wrote:What will happen is that now the center will get full and justly deserved credit when the vaccinations pick up pace.



Along with the Vaccine drive, my wish is for the Modi govt launch a PR campaign to make this step visible to everybody, especially the opposition. Govt should GO BIG on this and claim the prize, no half measures.

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Re: Wuhan Coronavirus Resource Thread

Postby IndraD » 12 Jun 2021 02:41

Jay wrote:
IndraD wrote:
not one or two they have caused over 800 heart inflammation in teens


800 cases in how many of the vaccinated candidates and the severity of this inflammation is important. Hopefully this is nothing too severe to cause the vaccination rates to come down.

sir oxford was denied approval in US for 22 blood clots in 20 million doses in UK

here is full report https://www.theepochtimes.com/nearly-80 ... witter.com Nearly 800 Reports of Heart Inflammation After COVID-19 Vaccination in US

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Re: Wuhan Coronavirus Resource Thread

Postby IndraD » 12 Jun 2021 02:43

Covaxin to apply for full US approval https://www.hindustantimes.com/india-ne ... 47266.html
Covaxin’s US approval delayed over data, Bharat Biotech’s partner to file for full approval
Ocugen, which has partnered with Bharat Biotech to produce Covaxin for US market, said it will now seek full approval for the shot.
By hindustantimes.com | Written by Karan Manral | Edited by Meenakshi Ray, New Delhi

Bharat Biotech’s partner for Covaxin in the US has said it will no longer seek an emergency use authorisation for its Covid-19 vaccine candidate and will file for a full approval of the shot after the Food and Drug Administration (FDA) asked for additional information and data. Ocugen, which has partnered with Bharat Biotech to produce Covaxin for the US market, said the decision was based on a recommendation from the country's top public health regulator.


"The FDA provided feedback to Ocugen regarding the Master File submitted previously and recommended that we pursue a BLA submission instead of an EUA application for the vaccine candidate and requested additional information and data," Ocugen, which has partnered with Bharat Biotech to produce Covaxin for the US market, said in a statement to the New York Stock Exchange (NYSE).

As a result of this, Ocugen said, it would no longer pursue a EUA application and would instead aim to file for full approval of the shot and go for a Biological License Application (BLA)—the full approval for a vaccine shot. The firm added that it expects data from an additional clinical trial to be required for a full-use application.

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Re: Wuhan Coronavirus Resource Thread

Postby SandeepA » 12 Jun 2021 04:39

While the new infections is now under 1L per day what is worrying is that deaths have not come down as fast even after the usual lag from infections. Its hovering at 4K a day even now. By now the deaths should have gone below the 500 mark given that medical facilities are less stressed and the vaccine (delivered to 15% population) is supposed to be saving lives. Infact Worldometer shows that for the first time the deathrate has crawled up from a low of 1.26 on May 29th to 1.29 today.
We seem to be obsessing over the vaccines but is it saving lives? I'm not a vaccine sceptic, just worried if we are missing something here

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Re: Wuhan Coronavirus Resource Thread

Postby Kakkaji » 12 Jun 2021 05:46

Important news, but behind paywall:

Pfizer, Moderna jabs may not be part of India's free vaccination drive

Pfizer and Moderna Covid-19 vaccines are unlikely to be included in India’s public free immunisation drive for all adults above 18 years of age, but the government will facilitate procurement of the two vaccines, people aware of the matter said

The high cost of the two vaccines is likely to act as a deterrent for bulk procurement and inclusion in the public immunisation drive, they said.

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Re: Wuhan Coronavirus Resource Thread

Postby srai » 12 Jun 2021 06:44

SandeepA wrote:While the new infections is now under 1L per day what is worrying is that deaths have not come down as fast even after the usual lag from infections. Its hovering at 4K a day even now. By now the deaths should have gone below the 500 mark given that medical facilities are less stressed and the vaccine (delivered to 15% population) is supposed to be saving lives. Infact Worldometer shows that for the first time the deathrate has crawled up from a low of 1.26 on May 29th to 1.29 today.
We seem to be obsessing over the vaccines but is it saving lives? I'm not a vaccine sceptic, just worried if we are missing something here

At the peak, COVID-19 deaths were undercounted; maybe significantly. True tally will come out at some point. I think Bihar recently corrected their daily tally by almost double.

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Re: Wuhan Coronavirus Resource Thread

Postby Amber G. » 12 Jun 2021 07:48

Meanwhile this is the kind of news - behind the scenes I find encouraging..
From IIT Kanpur:
>>
More than 500 PSA oxygen plants have been/are being set up at various hospital locations across the country by the Government. These plants require skilled manpower to operate and maintain. Currently, there is an acute shortage of trained technical manpower to manage these plants, so the Department of Mechanical Engineering,
at IITKanpur, has designed a week long online training course on PSA Oxygen Generation Plant – Operation and Maintenance.

About 100 nominated trainers from MoSDE were trained. These master trainers will, in turn, train the operators and technicians to work on the Oxygen generation plants. The course details, for those engineers who may be interested can be found at the in house Teaching-Learning module - (https://outreach.iitk.ac.in)

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Re: Wuhan Coronavirus Resource Thread

Postby Suraj » 12 Jun 2021 09:49

Kakkaji wrote:Important news, but behind paywall:
Pfizer, Moderna jabs may not be part of India's free vaccination drive
Pfizer and Moderna Covid-19 vaccines are unlikely to be included in India’s public free immunisation drive for all adults above 18 years of age, but the government will facilitate procurement of the two vaccines, people aware of the matter said

The high cost of the two vaccines is likely to act as a deterrent for bulk procurement and inclusion in the public immunisation drive, they said.

This has always been the case. Neither of them have ever been intended to be part of public procurement, but any private hospital that wants to import them - or any other vaccine that has cleared Indian procedures - can do so. The whole purpose of facilitating private procurement is that if any such entity wants to procure high cost options, the regulatory processes enable that clearly. This is better than just blindly preventing it, but also ensures that without the government's bargaining power, they'll never be cheap as such.

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Re: Wuhan Coronavirus Resource Thread

Postby Amber G. » 12 Jun 2021 11:36

Another example of excellent work done behind the limelight. It would be nice if some one did a story about this.

Allow me to share this excellent and informative interview/chat of Vinit Saxena CEO of Sepragen.
(Really worth watching - for those who are interested, Hope some main-stream media does a story.



Vinit Saxena is American Indian - IIT Kanpur, UC Berkeley alum- CEO of Sepragen which manufacture equipments for vaccine manufacturers around the world including Pfizer, Moderna and Serum India


Recently, Sepragen quickly made custom equipment for Serum Inst India in a record time of 14 weeks which will enable to ramp up the output from 40 million doses per month to 200 million doses shortly.

Very impressive story - Hope to write something about it to be shared more broadly but this chat is quite informative.
https://youtu.be/TVxyIbwu2dQ

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Re: Wuhan Coronavirus Resource Thread

Postby Amber G. » 12 Jun 2021 11:44

The high cost of the two [Pfizer, Moderna] vaccines is likely to act as a deterrent for bulk procurement and inclusion in the public immunisation drive


The price of these may come down, as there is lot of work going on to make the manufacturing process much more cost effective -- Not only in manufacturing but also making it so that it does not require cold storage.

For example, Sepragen (see my previous post) is working with some innovations. So is some very serious work going on in other institutes/companies.

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Re: Wuhan Coronavirus Resource Thread

Postby Suraj » 12 Jun 2021 13:17

Pfizer is headed the other way on pricing:
Pfizer eyes higher prices for COVID-19 vaccine after the pandemic wanes: exec, analyst
Pfizer execs discuss hiking vaccine price after pandemic wanes

Pfizer is in this foremost as a profit-maximizing entity, and everything from their indemnity demand to pricing is tied to maximizing profit.

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Re: Wuhan Coronavirus Resource Thread

Postby IndraD » 12 Jun 2021 20:52

Image

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Re: Wuhan Coronavirus Resource Thread

Postby Kakkaji » 12 Jun 2021 22:19

Bharat Biotech shares elaborate data of all research studies of Covaxin

India's first indigenous COVID-19 vaccine manufacturer- Bharat Biotech on Saturday shared comprehensive data of all research studies of Covaxin. As per the company release, the complete data for Phase I and II, and partial data for Phase III trials of Covaxin have been thoroughly scrutinised by the regulators in India.

Covaxin, a whole-virion inactivated coronavirus vaccine, is the first and only product to have published any data from human clinical trials in India, Bharat Biotech said.

The full data from studies on Covaxin’s neutralisation of variants are already published at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine, the release added

It is the first and only product to have published any data from human clinical trials in India. Covaxin is the only product to have any data on emerging variants and it is also the first and only COVID-19 vaccine to have efficacy data in Indian populations, Bharat Biotech said in a statement. In vaccine development, preclinical studies involve the testing of vaccine candidates in laboratory animals.

"The published studies are widely cited for the rigour and breadth that Bharat Biotech brings to its clinical trials. Currently, data from both efficacy and safety follow-up of Covaxin's Phase III trial is being analyzed and compiled. Upholding its uncompromising commitment to integrity, the company will make Phase III trials data from the final analysis public soon," read the statement.

The company said that the full data from studies on Covaxin's neutralization of variants are already published at "bioRxiv", Clinical Infectious Diseases, and Journal of Travel Medicine. "The study on the neutralisation of Beta and Delta variants (B.1.351 and B.1.617.2 respectively) and the study on B1.1.28 variant, at Journal of Travel Medicine, while the studies on B.1.617 variant and Alpha variant (B.1.1.7) are published at Clinical Infectious Disease, and Journal of Travel Medicine respectively.

Bharat Biotech completed three preclinical studies, which are published in Cellpress, a peer-reviewed journal. The studies on Covaxin's Phase I (done to assess a vaccine's safety, immune response and to determine right dosage), and Phase II clinical trial (carried out to assess the safety and the ability of the vaccine to generate an immune response) are published by the peer-reviewed journal- the "Lancet-Infectious Diseases", read the statement.

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Re: Wuhan Coronavirus Resource Thread

Postby Kakkaji » 12 Jun 2021 22:33

Ex-ICMR DG clears the air on Covaxin's phase-3 trial data and delay in WHO approval

Dr NK Ganguly, Scientist & Former DG, ICMR throws light on why the US Food and Drug Administration denied Emergency Use Authorisation (EUA) to Bharat Biotech's Covaxin and what is causing the delay in getting approval from World Health Organisation (WHO). Edited excerpts:

Tamanna Inamdar: About all the questions around Covaxin and if I were to compress them-- they come down to why is the phase three trial data not out yet. In March was when the phase three trial was supposed to have ended. In April, we saw a press release with interim results. Now the company says we will put out the data in July, today in the health ministry briefing we are told it will be out in seven to eight days. Why all this mystery over the phase three trial data? ..

Dr NK Ganguly: Actually, it was foolish to apply to US FDA for approval because even in the emergency authorisation vaccine guidelines, you have to complete phase three and wait for two months for safety data and this was a huge concession. Normally, you have to wait for six months. They did not do it, then to put in an application was a foolish step. The second thing was-- that the phase three trial itself changed shape because Indian regulators gave the approval since we needed a vaccine and perhaps our main aim was to vaccinate the largest population, they looked at the phase two data and gave them a trial mode approval.

This trial mode approval was massed in a very different jargon but trial mode approval meant that there was no competitor group now. The group which was given the vaccine --they knew that what they were getting and they had to sign an informed consent form. So, I do not know what kind of phase three data which we will have and whether we can call it a phase three data and then some of things---we will not know what is its efficacy because the end point for most of vaccine trials at that time was freedom from disease, it was not freedom from virus that much, it was freedom from disease. It was not lean to antibody levels because the antibody level was not made an end point and it was thought that we may have a little bit of virus in our nasopharynx and our throat which will perhaps be okay because some of the data from Pfizer and others came-- where we knew that they will not transmit and we now know that asymptomatic also benefit from the better vaccines.

What they should have done after the approval, they should have completed the trial atleast in a larger population-- this was a mistake because vaccines are for the world, vaccines are not for your own country and most of the vaccine trials are done in multiple countries. Some of those guys who did this kind of thing in China and Russia --they put in their population but they were clever enough to do it in Russia, Brazil, South Africa, UAE, Bahrain--so they collected different ethnic population, global data and in those countries, they went through the complete process of the approval. By the time they applied for WHO for pre-qualification approval or other approval, the Chinese vaccine guys have got that WHO pre-qualification approval, the four of them have got it now. This shortcut was a big mistake and this should not have been resorted to.

As far as your other question that whether the students will get vaccine certification or not, if it is not an approved vaccine, WHO has the prequalified vaccine for an international approval stamp. So if it is not WHO prequalified vaccine, you are not going to get that benefit.

Tamanna Inamdar: All of us want to know whether it safe to take Covaxin, in fact there is one school of thought which thinks Covaxin is a superior platform because it is a long trusted platform, what is your view on this, is Covaxin safe, is it okay to take and will it eventually get WHO approval?

Actually, they had this platform for a long period but because of their first vaccine, the rotavirus vaccine was in the Vero cell under virus replication. Dr Bhan has helped them a lot and lot of people, Roger Glass, Dr Harry Greenberg, many people have helped them in getting the cell lines right and growing the virus. So, there is not much technology over here, you grow the virus in a standardised cell form and then kill it and then give it as a vaccine and when it works but it has some limit-- that is why people were also using various platforms that, whether the Adeno platform, Newcastle disease virus platform, whether the different platforms were creating the ones which are safer and tested one like messenger RNA which was for 10 years- 15 years on the making. So, these were the platforms which went in, the main problem in virus vaccine is the trust and utter transparency and exposing it with the virus

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Re: Wuhan Coronavirus Resource Thread

Postby vijayk » 12 Jun 2021 22:35

They better release the third phase results. A lot of folks (Indians) who diss on India on every thing are using FDA rejection saying it is all fraud.

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Re: Wuhan Coronavirus Resource Thread

Postby Kakkaji » 12 Jun 2021 22:39

Bharat Biotech to conduct Covaxin clinical trials in US

Hyderabad-based Bharat Biotech said on Friday that it will be carrying out a clinical trial in the US to support the marketing application for Covaxin in that country. The company didn’t disclose details regarding the possible number of participants or whether it would be a local bridging trial, among other details.

On Thursday the US partner for Bharat Biotech’s Covid-19 vaccine, Ocugen, said that it would pursue submission of a Biologics License Application (BLA) for the jab, instead of seeking Emergency Use Authorisation (EUA) as originally planned.

Analysts say this means that subject to regulatory approvals, it could take longer for Covaxin to be launched in the US. Submission of a BLA represents the pursuit of full approval for the vaccine, rather than a provisional approval under an EUA

“The USFDA had earlier communicated that no new EUAs will be approved for Covid vaccines,” Bharat Biotech said in a statement. “All applications have to follow the BLA process, which is the standard process for vaccines. No vaccine manufactured or developed in India has ever received EUA or full licensure from the USFDA.”

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Re: Wuhan Coronavirus Resource Thread

Postby Kakkaji » 12 Jun 2021 22:55

Day 148 https://pib.gov.in/PressReleasePage.aspx?PRID=1726653
Day 147 https://www.pib.gov.in/PressReleasePage.aspx?PRID=1726346


India crosses a major landmark with Cumulative Vaccine Coverage of 25 Cr

India also crosses the historic landmark of 20 crore first doses administered


Day 148 - day 147 = 25.29 cr - 24.93 Cr = 36 lacs.

putnanja
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Re: Wuhan Coronavirus Resource Thread

Postby putnanja » 12 Jun 2021 23:02

vijayk wrote:They better release the third phase results. A lot of folks (Indians) who diss on India on every thing are using FDA rejection saying it is all fraud.


I think someone needs to point out to those people that even Astra Zenica's vaccine (covishield) hasn't gotten FDA's approval yet for emergency authorization. They are still working on it.

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Re: Wuhan Coronavirus Resource Thread

Postby a_bharat » 13 Jun 2021 08:59

Kakkaji wrote:Bharat Biotech to conduct Covaxin clinical trials in US

Hyderabad-based Bharat Biotech said on Friday that it will be carrying out a clinical trial in the US to support the marketing application for Covaxin in that country. The company didn’t disclose details regarding the possible number of participants or whether it would be a local bridging trial, among other details.



Why does Bharat Biotech even bother to enter the US market? To me it seems like a futile exercise: waste of money and resources and might also lead to big legal risks.

There must be a strong business reason. Anybody understands what it is?

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Re: Wuhan Coronavirus Resource Thread

Postby arshyam » 13 Jun 2021 09:44

FDA certification helps with smaller markets that don't have their own certification system, or simply give approval based on FDA's.

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Re: Wuhan Coronavirus Resource Thread

Postby Suraj » 13 Jun 2021 10:34

It is not Bharat Biotech but Ocugen that’s trying . The FDA - probably under Pfizer/Moderna pressure - has effectively ended the EUA program and no vaccine has been given US EUA lately . Not AZ, not Novavax and not Covaxin. All are required to file the BLA instead.

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Re: Wuhan Coronavirus Resource Thread

Postby srai » 13 Jun 2021 13:16

a_bharat wrote:


Why does Bharat Biotech even bother to enter the US market? To me it seems like a futile exercise: waste of money and resources and might also lead to big legal risks.

There must be a strong business reason. Anybody understands what it is?


COVID-19 vaccine booster shots are going to be required annually. Long-term US market. Plus, generally speaking FDA approval seen as a “gold-standard”; win public perception battle, open up many more doors.


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