Wuhan Coronavirus Resource Thread

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Mort Walker
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Re: Wuhan Coronavirus Resource Thread

Post by Mort Walker »

^^^I think it has been repeated here and other places multiple times, that getting the vaccine doesn’t mean you can’t get Covid. It means your probability of getting very sick and dying is significantly reduced.
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Re: Wuhan Coronavirus Resource Thread

Post by vijayk »

Image
Prof Shamika Ravi @ShamikaRavi
#COVID19India And finally, the growth rate of active cases falls below zero (-0.1%).
ManSingh
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Re: Wuhan Coronavirus Resource Thread

Post by ManSingh »

Mort Walker wrote:^^^I think it has been repeated here and other places multiple times, that getting the vaccine doesn’t mean you can’t get Covid. It means your probability of getting very sick and dying is significantly reduced.
If this is a reply to my post, I was praising covaxin in that the disease was mild due to vaccination. Edited my post.
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Re: Wuhan Coronavirus Resource Thread

Post by Najunamar »

ManSingh wrote:
Mort Walker wrote:^^^I think it has been repeated here and other places multiple times, that getting the vaccine doesn’t mean you can’t get Covid. It means your probability of getting very sick and dying is significantly reduced.
If this is a reply to my post, I was praising covaxin in that the disease was mild due to vaccination. Edited my post.
ManSinghji, your point that did not jell with me was "twitter-esque-debate" thinking the objection was to Dr. Kang raising questions - I belive the distrust (for me) comes from the selective questioning of only Indian vaccine efforts. Perhaps they are all above board but when we see political bias clouding all other shrill rants in SM by the same folks for me at least the burden of proof rests on such folks - I don't buy this "holier-than-thou" routine.
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Re: Wuhan Coronavirus Resource Thread

Post by Suraj »

ManSingh wrote:
disha wrote:
ManSingh'ji, because of vaccine hesitancy people died. Are you supporting death of people? Instead of accusing this forum members of dragging this forum to "twitter-esque level of debate", why do not you think about people who died thanks to Kang and others.

If you think the rest of forum members are dragging this forum down, I have a request for you. Can you please list here all the people who seeded vaccine hesitancy? First you list those people. Then please defend them. I think it might foster some non-twitteresque debate
With all due respect, not sure how my post came across to you.

Yes vaccine hesitancy does kill. At a personal example, when I was searching for the answer about getting my folks vaccinated or not, I did ask around for the same question. At that point covid-19 spread was low. I can tell you that what I came across was a cacophony of one side calling the vaccine "Modi vaccine" and the other side "anti-nationals". Ultimately we did get covaxin shots almost at the end of the clinical trial mode and it did save the day ( parents got covid-19 a month later ).

Questions will be asked when a novel process is being followed. Even the best of the data scientists I know wasn't sure how this was being approached. A clinical trial is not a phase-3 though I understand the risk pay-off. Its best not to counter it with arguments (above)like "she was paid-off well by Pfizer" which you can read in the previous posts. This is what I meant by a twitter-esque debate and we hear this far too often. A technical counter or another formal explanation is more than sufficient.
A professional who cares about the professional approach to medical care would use a professional path to voice her objections. Please point to a medrxiv or biorxiv upload by her on this topic at least . Doesn’t have to be peer reviewed and all - it just has to be a professional path.

Do we hear the efficacy of malaria and TB care being discussed in Times of India ? No, so why does Covid testing protocol criticism in The Hindu need to receive carefully considered non-Twitter like replies ?

If this is a serious matter requiring serious thought then Dr Kang should use serious professional paths instead of MSM, then people will take her seriously. She’s called names because that’s what happens when you do that. In comparison the SUTRA model authors have a publication , not to mention Dr Vidyasagar and Dr Agarwal are math/CS legends - the latter won the Godel prize for the AKS Primality Test.
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Re: Wuhan Coronavirus Resource Thread

Post by yensoy »

vijayk wrote:Image
Prof Shamika Ravi @ShamikaRavi
#COVID19India And finally, the growth rate of active cases falls below zero (-0.1%).
The graph indicates that we should have had a lockdown in March/April itself to cap the growth in cases. Presumably a national lockdown because this is the aggregate across the country, but maybe some states were faring worse than others.

There is also a kink in November, presumably a week or so after Diwali, might have come about due to shopping and other social activities of the festival season.
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Re: Wuhan Coronavirus Resource Thread

Post by Kakkaji »

People are quoting too many different numbers on allocation of vaccines from all over. So, here I am posting the official PIB Release on it:

Update on COVID Vaccine Allocation
Union Government to supply nearly 192 lakh of COVID vaccines to States/UTs, Free of Cost, during the Fortnight of 16th-31st May

The allocation of Govt. of India supplies to the State/UT is decided on the consumption pattern and beneficiary load for 2nd doses during the upcoming fortnight. During the 16th-31st May 2021 fortnight, 191.99 lakh doses of Covishield and Covaxin will be supplied to the States and UTs, free of cost. This will include 162.5 lakh of Covishield and 29.49 lakh of Covaxin.

The delivery schedule for this allocation will be shared in advance. States have been requested to direct the concerned officials to ensure rational and judicious utilization of allocated doses and minimize the vaccine wastage.

The basic objective behind informing the States/UTs in advance of the quantum of free vaccine doses to be made available from Govt of India for 15 days is to ensure that they prepare effective plans for judicious and optimum utilisation of these free vaccine doses which are meant for the age group 45 and above, and for HCWs and FLWs. In the previous fortnight i.e. 1st-15th May, 2021, a total quantum of more than 1.7 crore vaccine doses has been made available by the Union Government to States, free of cost.

In addition, a total quantum of more than 4.39 crore doses was also available for direct procurement by the States as well as private hospitals in the month of May 2021.
IMHO the period from April 1st through May 15th was the one with maximum shortage of vaccines, and that period is now over.

From now on, we should see a steady increase in vaccine supply and daily doses administered.

From July-August, it would be a situation where more doses will be available than the system's daily capacity to administer them.

JMT
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Re: Wuhan Coronavirus Resource Thread

Post by vijayk »

Kakkaji wrote:People are quoting too many different numbers on allocation of vaccines from all over. So, here I am posting the official PIB Release on it:

Update on COVID Vaccine Allocation
Union Government to supply nearly 192 lakh of COVID vaccines to States/UTs, Free of Cost, during the Fortnight of 16th-31st May

The allocation of Govt. of India supplies to the State/UT is decided on the consumption pattern and beneficiary load for 2nd doses during the upcoming fortnight. During the 16th-31st May 2021 fortnight, 191.99 lakh doses of Covishield and Covaxin will be supplied to the States and UTs, free of cost. This will include 162.5 lakh of Covishield and 29.49 lakh of Covaxin.

The delivery schedule for this allocation will be shared in advance. States have been requested to direct the concerned officials to ensure rational and judicious utilization of allocated doses and minimize the vaccine wastage.

The basic objective behind informing the States/UTs in advance of the quantum of free vaccine doses to be made available from Govt of India for 15 days is to ensure that they prepare effective plans for judicious and optimum utilisation of these free vaccine doses which are meant for the age group 45 and above, and for HCWs and FLWs. In the previous fortnight i.e. 1st-15th May, 2021, a total quantum of more than 1.7 crore vaccine doses has been made available by the Union Government to States, free of cost.

In addition, a total quantum of more than 4.39 crore doses was also available for direct procurement by the States as well as private hospitals in the month of May 2021.
IMHO the period from April 1st through May 15th was the one with maximum shortage of vaccines, and that period is now over.

From now on, we should see a steady increase in vaccine supply and daily doses administered.

From July-August, it would be a situation where more doses will be available than the system's daily capacity to administer them.

JMT
Thanks
chetak
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

X posted from the political thread

WTH does CDC have to do with India and why is ANI propagating this crap

we desperately need the masks to stay on and the need to keep social distance is paramount.

this is very wrong.

Some fully vaccinated individuals have died of covid much after their vaccinations.

many others have become infected with covid even after two doses.

@ANI · 20h

Fully vaccinated individuals can resume activities without wearing a mask or staying 6 feet apart: US Centers for Disease Control and Prevention (CDC)
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Re: Wuhan Coronavirus Resource Thread

Post by Amber G. »

Mort Walker wrote:^^^I think it has been repeated here and other places multiple times, that getting the vaccine doesn’t mean you can’t get Covid. It means your probability of getting very sick and dying is significantly reduced.
I saw some statistics from Cleveland Clinic - 99.7% of their covid patients are from the unvaccinated group.
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Re: Wuhan Coronavirus Resource Thread

Post by Mort Walker »

US CDC actions Inherently tied to politics and to force equity markets reactions. Around 1/3 of eligible population has been vaccinated in the US. Lots of vaccine sitting around.
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

Image via@SuchitraElla
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

Gap between two doses of #Covishield Vaccine extended from 6-8 weeks to 12-16 weeks based on recommendation of #COVID19 Working Group.

https://pib.gov.in/PressReleseDetail.aspx?PRID=1718308
4:40 PM · May 13, 2021

Image via@MoHFW_INDIA
Kakkaji
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Re: Wuhan Coronavirus Resource Thread

Post by Kakkaji »

Today's official vaccination numbers:

COVID-19 Vaccination Update- Day 119
India crosses a major landmark with more than 18 Cr Cumulative Vaccination Coverage

Over 3.25 lakh beneficiaries of age group 18-44 Vaccinated today till 8 pm

More than 10.79 lakh vaccine doses administered today


India has crossed a significant landmark in its fight against COVID19 pandemic today. The cumulative number of COVID19 vaccine doses administered in the country has crossed 18 Cr. The cumulative number of COVID-19 vaccine doses administered in the country stands at 18,04,29,261 as per the 8 pm provisional report today.

3,25,071 beneficiaries of the age group 18-44 years received their first dose of COVID vaccine today and cumulatively 42,55,362 across 32 States/UTs since the start of Phase-3 of the vaccination drive.

As on Day-119 of the vaccination drive (14th May, 2021), total 10,79,759 vaccine doses were given. 6,16,781 beneficiaries were vaccinated for 1st dose and 4,62,978 beneficiaries received 2nd dose of vaccine as per the provisional report till 8 P.M.
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Re: Wuhan Coronavirus Resource Thread

Post by Rudradev »

VickyAvinash wrote:
Sir, with your permission, may I use above post/information on social media? Lot of people spreading lies, very few countering them.
Yes, please feel free to share.
Suraj
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Re: Wuhan Coronavirus Resource Thread

Post by Suraj »

chetak wrote:
Gap between two doses of #Covishield Vaccine extended from 6-8 weeks to 12-16 weeks based on recommendation of #COVID19 Working Group.

https://pib.gov.in/PressReleseDetail.aspx?PRID=1718308
4:40 PM · May 13, 2021

Image via@MoHFW_INDIA
I'm glad to see this - what I posted a few weeks ago: article
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Re: Wuhan Coronavirus Resource Thread

Post by Kakkaji »

Dr Reddy’s announces soft launch of Sputnik V in India, imported doses priced at Rs 948 and 5% GST
Indian generic drug giant Dr Reddy’s Laboratories on Friday announced the soft launch of the Russian vaccine for Covid-19 Sputnik V in the Indian market.

The Hyderabad headquartered pharmaceutical company has also announced that the first dose of the vaccine was administered in Hyderabad.
Looks like this one is going to go mostly to private hospitals. At Rs 1,000 for vaccine + maybe Rs 200 for service charges, it will come to around Rs 1,200 per dose administered.

How many people do you think will be able to afford it for themselves and their family.
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

^^^^^^^
@Suraj

good show on your extremely well written articles

well done.
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Re: Wuhan Coronavirus Resource Thread

Post by Kakkaji »

Sputnik V’s first jab administered in Hyderabad: Here’s how much imported corona vaccine would cost in India
Drug firm Dr Reddy’s Laboratories on Friday said it has launched COVID vaccine Sputnik V in the Indian market with the first dose being administered in Hyderabad, as part of a limited pilot.

The company said the imported doses of the vaccine are presently priced at a maximum retail price of Rs 948, with 5 per cent GST per dose, amounting to Rs 995.4 per dose.

“The imported doses of the vaccine are presently priced at an MRP of Rs 948 + 5 per cent GST per dose, with the possibility of a lower price point when local supply begins,” Dr Reddy’s Laboratories said in a statement.

The first consignment of imported doses of the Sputnik V vaccine landed in India on May 1, and received regulatory clearance from the Central Drugs Laboratory, Kasauli, on May 13, 2021, it added.

Further consignments of imported doses are expected over the upcoming months. Subsequently, supply of the Sputnik V vaccine will commence from Indian manufacturing partners,” it added.

The Hyderabad-based firm said that it will work closely with stakeholders in the government and private sector in India to ensure the widest possible reach of the Sputnik V vaccine, as part of the national inoculation effort.
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Re: Wuhan Coronavirus Resource Thread

Post by Kakkaji »

Vaccination suspended in Mumbai for two days due to cyclone warning
The Mumbai civic body on Friday decided to suspend its COVID-19 vaccination drive for the next two days in view of the warning about cyclone Tauktae.

There would be no inoculation on May 15 and 16, the Brihanmumbai Municipal Corporation tweeted.
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Re: Wuhan Coronavirus Resource Thread

Post by Kakkaji »

Dr. Reddy's Laboratories to get 36 million doses of Sputnik V vaccine in next few months
Indian drugmaker Dr. Reddy's Laboratories Ltd said on Friday it expects to get 36 million doses of Sputnik V COVID-19 vaccine in the next couple of months under its contract with Russia's sovereign wealth fund.

"We are in discussions with the Russian Direct Investment Fund (RDIF) to import the vaccine towards the end of May," a senior Dr. Reddy's executive said on a post-earnings press conference.

"Our total commitment contracted from RDIF is 250 million doses, of which the initial 15%-20% is expected through imports," the executive, M V Ramana, added.

The company expects to use the doses to vaccinate 125 million people in the next 8-12 months.
I think this vaccine is the gap filling import for the lean months of June and July that the policymakers had in mind when they announced the liberalized imports for Phase 3.
Suraj
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Re: Wuhan Coronavirus Resource Thread

Post by Suraj »

chetak wrote:^^^^^^^
@Suraj

good show on your extremely well written articles

well done.
They just published my latest one:
How To Bulk Order Vaccines (And How Not To)
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Re: Wuhan Coronavirus Resource Thread

Post by Atmavik »

Mexico cites Russia’s Sputnik vaccine production problems

https://apnews.com/article/europe-russi ... 0ef583e5f0

Sputnik is unusual among coronavirus vaccines in that the two doses are different and not interchangeable.

The Russian vaccine uses a modified version of the common cold-causing adenovirus to carry genes for the spike protein in the coronavirus as a way to prime the body to react if COVID-19 comes along.

That is a similar technology to the vaccine developed by AstraZeneca and Oxford University. But unlike AstraZeneca’s two-dose vaccine, the Russian approach uses a slightly different adenovirus for the second booster shot.
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Re: Wuhan Coronavirus Resource Thread

Post by vijayk »

https://www.wired.com/story/the-teeny-t ... ovid-kill/
The 60-Year-Old Scientific Screwup That Helped Covid Kill
All pandemic long, scientists brawled over how the virus spreads. Droplets! No, aerosols! At the heart of the fight was a teensy error with huge consequences.
Now, though, the WHO’s advisers seemed to be saying those same laws didn’t apply to virus-laced respiratory particles. To them, the word airborne only applied to particles smaller than 5 microns. Trapped in their group-specific jargon, the two camps on Zoom literally couldn’t understand one another.
Whenever a sick person hacks, bacteria and viruses spray out like bullets from a gun, quickly falling and sticking to any surface within a blast radius of 3 to 6 feet. If these droplets alight on a nose or mouth (or on a hand that then touches the face), they can cause an infection. Only a few diseases were thought to break this droplet rule. Measles and tuberculosis transmit a different way; they’re described as “airborne.” Those pathogens travel inside aerosols, microscopic particles that can stay suspended for hours and travel longer distances. They can spread when contagious people simply breathe.
By this definition, any infectious particle smaller than 5 microns in diameter is an aerosol; anything bigger is a droplet. The more she looked, the more she found that number. The WHO and the US Centers for Disease Control and Prevention also listed 5 microns as the fulcrum on which the droplet-aerosol dichotomy toggled.
To her, it seemed to foreshadow the idea of a droplet-aerosol dichotomy, but one that should have pivoted around 100 microns, not 5.
One of them showed the trajectory of a 5-micron particle released from the height of the average person’s mouth. It went farther than 6 feet—hundreds of feet farther. A few weeks later, speaking to an audience at Harvard Medical School, Fauci admitted that the 5-micron distinction was wrong—and had been for years. “Bottom line is, there is much more aerosol than we thought,” he said. (Fauci declined to be interviewed for this story.)
But Marr was paying attention. She couldn’t help but note the timing. She, Li, and two other aerosol scientists had just published an editorial in The BMJ, a top medical journal, entitled “Covid-19 Has Redefined Airborne Transmission.” For once, she hadn’t had to beg; the journal’s editors came to her. And her team had finally posted their paper on the origins of the 5-micron error to a public preprint server.

In early May, the CDC made similar changes to its Covid-19 guidance, now placing the inhalation of aerosols at the top of its list of how the disease spreads. Again though, no news conference, no press release. But Marr, of course, noticed. That evening, she got in her car to pick up her daughter from gymnastics. She was alone with her thoughts for the first time all day. As she waited at a red light, she suddenly burst into tears. Not sobbing, but unable to stop the hot stream of tears pouring down her face. Tears of exhaustion, and relief, but also triumph. Finally, she thought, they’re getting it right, because of what we’ve done.
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Re: Wuhan Coronavirus Resource Thread

Post by sanjayc »

From a published paper:
Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial

Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial Restricted access to data hampers trust in research. Access to data underpinning study findings is imperative to check and confirm the findings claimed. It is even more serious if there are apparent errors and numerical inconsistencies in the statistics and results presented.

Regrettably, this seems to be what is happening in the case of the Sputnik V phase 3 trial.1 Several experts3,4 found problematic data in the published phase 1/2 results.2 We have made multiple independent requests for access to the raw dataset, but these were never answered. Despite publicly denying some problems, formal corrections were made to the Article,2 thus addressing some concerns.5 Notwithstanding the previous issues and lack of transparency, the interim results from the phase 3 trial of the Sputnik V vaccine1 again raise serious concerns.

We have a serious concern regarding the availability of the data from which the investigators draw their conclusions. The investigators state that data will not be shared before the trial is completed, and then only by approval of stakeholders, including a so-called security department. Data sharing is one of the cornerstones of research integrity; it should not be conditional and should follow the FAIR principles. The second concern pertains to the trial protocol, as already described in an open letter by the Russian Society for Evidence-Based Medicine.3 The Sputnik V investigators mention that three interim analyses were added to the study on Nov 5, 2020,1 but this change was not recorded on ClinicalTrials.gov (NCT04530396).
Unfortunately, the full study protocol has not been made publicly available, so the rationale behind this change or the type I error rate adjustment, if any, is not known. According to the ClinicalTrials.gov record NCT04530396, the primary outcome was changed on Sept 17, 2020. Initially, the primary outcome was to be assessed after the first dose, but the evaluation was postponed to after the second dose.
The presented primary result (efficacy of 91·6%) is dependent on this change, but the reasons for the change have not been made public. Moreover, the latest ClinicalTrials. gov record (Jan 22, 2021) defines the primary outcome inconsistently: “Primary Outcome Measures: percentage of trial subjects...after the first dose...based on the percentage...after the second dose”. Besides these protocol amendments, the definition of the primary outcome is unclear in the Article,1 where it says that when COVID-19 was suspected, participants were assessed with “COVID-19 diagnostic protocols, including PCR testing”. Here, we lack some crucial information, such as the clinical parameters determining suspected COVID-19, what diagnostic protocols were used, when the PCR testing was done, what specific method was used, or how many amplification cycles were used.

The way cases of suspected COVID-19 were defined could have led to bias in PCR testing used to assess the number of confirmed COVID-19 cases, which is crucial for the efficacy determination. A final point of concern about the study protocol relates to the enrolment and randomisation of patients. According to the trial profile in figure 1 of the Article,1 35 963 individuals were screened and 21 977 individuals were randomised. The ClinicalTrials.gov record for NCT04530396 ( Jan 20, 2021) mentions that 33 758 patients were enrolled. We would expect that this last figure should be equal to either the number of participants screened or randomised. Moreover, there is no information about what caused the exclusion of 13986 participants, as per the trial profile. The third concern relates to the data reported and numerical results. We found the following data inconsistencies: (1) in figure 2 of the Article,1 data for the vaccinated group on day 20 refer to more individuals than at day 10, as if there was either information missing for 100 participants at day 10, or participants were enrolled after day 10 (figure 2 was formally corrected on Feb 20, 2021, but the correction statement did not state the reasons leading to such correction); and (2) in table S1 of the appendix,1 the number of participants reported for the different vaccinated age cohorts do not add up to the reported total (n=338 vs n=342). With such inconsistencies, we question the accuracy of the reported data.

A very peculiar result of the major subgroup analysis of the primary outcome caught our attention. The vaccine efficacy was said to be high for all age groups. The reported percentages were 91·9% in the 18–30-year age group, 90·0% in the 31–40-year age group, 91·3% in the 41–50-year age group, 92·7% in the 51–60-year age group, and 91·8% in participants older than 60 years. We checked the homogeneity of vaccine efficacy across age groups (interaction tests): the p value of the Taroneadjusted Breslow-Day test was 0·9963, and the p value of a non-asymptotic test was 0·9956,6 indicating a very low probability of observing a homogeneity this good if the actual homogeneity is perfect. By applying 18 other homogeneity tests (six in table 1, seven in table S6, six in table 2 of the Article1 ), we could not find other major abnormality in the overall distribution of p values (appendix). We also found some highly coincidental results reported in table S3 of the appendix. In particular, two upper confidence limit values for two different distributions (placebo group at baseline for unstimulated and antigen-stimulated measures) both equal 0·708. Of course, this is possible, but we call once more for access to the data from which the statistics originate for close scrutiny.

In line with our earlier concerns with the phase 1/2 results4 and the substandard reporting of the phase 3 interim results,1 we invite the investigators once more to make publicly available the data on which their analyses rely. Access to the protocol, its amendments, and the individual patient records is paramount, as much for clarification as for open discussion of all the issues. We also invite the Editors of The Lancet to clarify the consequences of further denying access to the data needed for assessing the results presented, should the authors still deny it.
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Re: Wuhan Coronavirus Resource Thread

Post by vijayk »

Image

A friend in Vizag (doctor) posted it ...Looks like some limited quantity is released

Being manufactured from Jan 2021?
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Re: Wuhan Coronavirus Resource Thread

Post by Mort Walker »

Suraj wrote:
chetak wrote:^^^^^^^
@Suraj

good show on your extremely well written articles

well done.
They just published my latest one:
How To Bulk Order Vaccines (And How Not To)
Congratulations. A concise and well written article that quickly shows the data. It appears the GoI got this right despite all the hand-wringing in the irresponsible press; and the US got it right with OWS.
Suraj
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Re: Wuhan Coronavirus Resource Thread

Post by Suraj »

Agree with you, Mort. Comparing US to EU, the former did a much better job so far. India followed a similar approach but only constrained by far less monetary resources. Both faced initial production ramp up problems but both are scaling up now.
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Re: Wuhan Coronavirus Resource Thread

Post by Pratyush »

Kakkaji wrote:Dr Reddy’s announces soft launch of Sputnik V in India, imported doses priced at Rs 948 and 5% GST

Looks like this one is going to go mostly to private hospitals. At Rs 1,000 for vaccine + maybe Rs 200 for service charges, it will come to around Rs 1,200 per dose administered.

How many people do you think will be able to afford it for themselves and their family.
Most of the Middle class can afford this vaccine. Dr Reddy's had plans for 900 Million doses over the next 12 months. Lets see if this can be done.
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Re: Wuhan Coronavirus Resource Thread

Post by Pratyush »

Suraj wrote: They just published my latest one:
How To Bulk Order Vaccines (And How Not To)

Nicely done.

If you don't have an exclusivity agreement with Swarajya. Would you have any objections to publishing to The Print.

SG keeps on harping about inviting people for articles to publish.

This might just be the opening that is required.
chetak
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

Another vaccine being developed in India, and this time it is an mRNA-based vaccine just like pfizer's and moderna's Covid-19 vaccines
Messenger RNA, or mRNA, technology has been under development for years, but Pfizer's and Moderna's Covid-19 vaccines are the first time mRNA has been cleared for use in humans. The mRNA-based Covid vaccine works by tricking the body to produce a harmless piece of the virus, triggering an immune response
.


HGCO19 vaccine candidate: Gennova starts enrolment for Phase 1/2 human clinical trials



HGCO19 vaccine candidate: Gennova starts enrolment for Phase 1/2 human clinical trials



HGCO19 vaccine candidate: Gennova starts enrolment for Phase 1/2 human clinical trials

Our Bureau New Delhi
April 13, 2021

The DBT said it has approved additional funding towards clinical studies of the country’s first of its kind’ mRNA-based Covid-19 vaccine


The Department of Biotechnology (DBT) in Ministry of Science & Technology has announced that it has approved additional funding towards clinical studies of India’s ‘first of its kind’ mRNA-based Covid-19 vaccine - HGCO19.

This vaccine has been developed by Pune-based biotechnology company Gennova Biopharmaceuticals Ltd.

This funding has been awarded under the ‘Mission Covid Suraksha- The Indian Covid-19 Vaccine Development Mission’ by DBT’s dedicated Mission Implementation Unit at Biotechnology Research Assistance Council (BIRAC) after multiple rounds of evaluation of all the applications that were submitted in response to the ‘Request for Expression of Interest’, an official release said.

DBT has been hand-holding Gennova’s right from the start and has facilitated establishing Gennova’s mRNA-based next-generation vaccine manufacturing platform by providing seed funding for the development of HGCO19.

Gennova, in collaboration with HDT Biotech Corporation, USA, has developed the Covid-19 mRNA vaccine – HGCO19.

Renu Swarup, Secretary, DBT, and Chairperson, BIRAC, said, “At the onset of Covid-19, DBT backed many vaccine development programs, including the mRNA-based Covid-19 vaccine. A year back, this was a new technology and never used for vaccine manufacturing in India. However, believing in the potential of this technology, DBT provided seed funding to Gennova to develop this technology platform amenable to scale-up and production. We are very proud that India’s first mRNA-based Covid-19 vaccine is going to the clinics.”

She also said that DBT is committed to fostering technological innovation in biotechnology in India.


Speaking on the development, CEO of Gennova Biopharmaceuticals Ltd, Sanjay Singh, said, “We conducted all required safety assessments of the HGCO19 as per well-defined norms and regulations before the start of the human clinical trial designed to establish the safety and efficacy of the HGCO19. Today, the problem of the SARS-CoV2 illness and the associated appearance of new variants made this disease a moving target. We believe the mRNA-based cutting-edge technology will play an important role in evolving effective solutions.”

Gennova has initiated the process to enrol healthy volunteers for the Phase I/II clinical trials, the release added.

HGCO19 has already demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models. The neutralising antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of Covid-19.

Gennova has completed two preclinical toxicity studies as per the Drugs and Cosmetics (Ninth Amendment) Rules-2019 to establish the safety of the vaccine candidate and got regulatory clearance from the Review Committee on Genetic Manipulation and office of the Drugs Controller General of India, Central Drugs Standard Control Organization to conduct clinical trials.

mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. They are highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm.


Published on April 13, 2021
Raja
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Re: Wuhan Coronavirus Resource Thread

Post by Raja »

I wonder what is their schedule. Hopefully, they can speed up their trials while we have an abundance of covid cases making it easier to find volunteers. Do we know what are the storage requirements with this vaccination?

If mRNA vaccines are the future, we will have to make investments in cold storage infrastructure.
Suraj
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Re: Wuhan Coronavirus Resource Thread

Post by Suraj »

Please read the Gennova page HGCO19 mRNA candidate
Their current statement is that it is stable at regular 2-8C temps.
nandakumar
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Re: Wuhan Coronavirus Resource Thread

Post by nandakumar »

Pratyush wrote:
Suraj wrote: They just published my latest one:
How To Bulk Order Vaccines (And How Not To)

Nicely done.

If you don't have an exclusivity agreement with Swarajya. Would you have any objections to publishing to The Print.

SG keeps on harping about inviting people for articles to publish.

This might just be the opening that is required.
I feel it would not be fair to Swarajya. Its credentials are more in tune with BRF objectives. Print clearly draws financial support from entities that have an agenda of their own. Of course ultimately it is for Suraj to decide!
chetak
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

Raja wrote:I wonder what is their schedule. Hopefully, they can speed up their trials while we have an abundance of covid cases making it easier to find volunteers. Do we know what are the storage requirements with this vaccination?

If mRNA vaccines are the future, we will have to make investments in cold storage infrastructure.
It is an Indian made vaccine so it will/should cater to mostly Indian conditions as well as conditions in the poorer areas of the globe.

So it may be logical to expect that extremes in storage, transportation and delivery conditions may not be like those applicable to pfizer or moderna vaccines.

But at the same time it has an ameriki collaborator to cater to so pricing may not be to the liking of our "gimme free, gimme free" woke brethren.


typically the moderna vaccine will arrive frozen between -50°C and -15°C (-58°F and 5°F).

and vaccine vials may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 30 days before vials are punctured.


so, let's hope that the necessity of such extreme freezing conditions is relaxed and made more benign by design.

To create a special countrywide cold chain infrastructure (-50°C and -15°C (-58°F and 5°F)) for just one vaccine is simply not viable for us
chetak
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

Suraj wrote:Please read the Gennova page HGCO19 mRNA candidate
Their current statement is that it is stable at regular 2-8C temps.
does it arrive from the factory at this temp ( 2-8 degrees celsius) or is it applicable only for a limited storage period after being shipped from the factory at a much colder temp
chetak
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

nandakumar wrote:
Pratyush wrote:

Nicely done.

If you don't have an exclusivity agreement with Swarajya. Would you have any objections to publishing to The Print.

SG keeps on harping about inviting people for articles to publish.

This might just be the opening that is required.
I feel it would not be fair to Swarajya. Its credentials are more in tune with BRF objectives. Print clearly draws financial support from entities that have an agenda of their own. Of course ultimately it is for Suraj to decide!
or OpIndia which is dharmic friendly too
Suraj
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Re: Wuhan Coronavirus Resource Thread

Post by Suraj »

nandakumar wrote:
Pratyush wrote:

Nicely done.

If you don't have an exclusivity agreement with Swarajya. Would you have any objections to publishing to The Print.

SG keeps on harping about inviting people for articles to publish.

This might just be the opening that is required.
I feel it would not be fair to Swarajya. Its credentials are more in tune with BRF objectives. Print clearly draws financial support from entities that have an agenda of their own. Of course ultimately it is for Suraj to decide!
I doubt SG likes me after this:
https://twitter.com/surajbrf/status/137 ... 93605?s=21

chetak: JEM thinks I’m too boring for Opindia . You are probably a better choice :rotfl:
Pratyush
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Re: Wuhan Coronavirus Resource Thread

Post by Pratyush »

Suraj,

No harm in sending him the article, he would either publish the piece or he won't.

If he does, it's a win and we should take it.

If not then it just proves what we already know. No loss to us.

But it should not be at the expense of your relationship with Swarajya.
chetak
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Re: Wuhan Coronavirus Resource Thread

Post by chetak »

BB is going to open another plant at Malur in Kolar district of KAR

looks like BB has hit a massive expansion jackpot being in the right country at the right time

states are falling over to offer land to these companies, including in bengal by mumtaz bano, though one doubts very much if anyone in their right minds would want to set up shop there

"Covaxin vaccine-manufacturing plant of Bharat Biotech will be established at the earliest in Malur Industrial Area of neighbouring Kolar district," Narayan, who is the IT-BT Minister and heads the State Covid task force, said in a statement

Bharat Biotech setting up vaccine unit in Karnataka: Deputy CM
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