Will @MoHFW_INDIA or @CDSCO_INDIA_INF put out an explanatory note to deal with all the questions about the differences in approval for
a) @SerumInstIndia's #Covishield
b) @BharatBiotech's #Covaxin
pib.gov.in/PressReleseDet…
For Covishield:
"restricted emergency use of vaccine, subject to multiple regulatory conditionalities"
For Covaxin
"restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains
One interpretation of the Covaxin approval is that it is essentially approval to continue their phase 3 trial. In which case, what's new?
Then, a day later, i.e. today we learn: pib.gov.in/PressReleseDet…
This press release says, of Covaxin, "The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date."
The 22,500 can't have been 'vaccinated' this was a placebo study so half must have got the placebo. Be that as it may, we know from Bharat Bioptech's press release of 16 Nov, that they started their Phase 3 trial in Mid Nov. bharatbiotech.com/images/press/B…
We further @BharatBiotech's press release on 22 Dec "announced successful recruitment of 13,000
volunteers..." see this link,
bharatbiotech.com/images/press/c…
So here's the Question: when did 13,000 volunteers recruited as of 22 Dec turn into 22,500 (out of a target 26,000) by the time @CDSCO_INDIA_INF's expert committee looked at the data.

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More from @GorwayGlobal

3 Jan
Memo
Re Bharat Biotech Covaxin.
1. We have a rregulatory approval process that approves vaccines on the basis of data demonstrating safety and efficacy.
2. The trustworthiness of this process is shown when approval is NOT granted in the absence of such data.
Memo (continued)
3. We trust a licensed vaccine not because it has been approved by the regulator.
We trust it when the regulator and the manufacturer are open and transparent with the data on which the approval is based.
4. We should no more accept an opaque regulatory process that we would accept a kangaroo court that delivers its verdict in a closed court.
Read 8 tweets
2 Dec 20
The one great genius of the #Hindutva #RightWing in India is their capture of the mind of the average Hindu. That there was a time when Hindu civilisation was the greatest, when India was a land of milk and honey, that India's decline in fortune was entirely the fault
Of marauding foreigners -mostly Islamic, but latterly European (but they are white-skinned and probably Aryan, so let's not be hard on them); that therefore by association, anything Islamic is bad and must be rooted out of India. They have further convinced the Hindu mind that
All we need to do to return to the pole position we once enjoyed in the world, is to return to anything that is Ancient. Hence, Sanskrit, Ayurveda, social structures based on caste, outmoded gender roles, an imagined vegetarianism, cow-worship, cow-pathy.
Read 10 tweets
1 Dec 20
A thread.
After the #PunjabFarmers protesting at the #ModiGovt's AgriMarket bills complained that the mainstream media TV were either ignoring them or mischievously showing them in a bad light, lets look at how the World's press is reporting it.
Londo's @guardian first. On 30 Nov they carried this big story:
The story reported:
Read 14 tweets
19 Nov 20
A shocking account of blunderbuss over-treatment in #India. First-hand report. Read full thread.
Case Report:
90 y old Female; Diabetes; early signs of dementia; non-ambulatory; incontinent; hypertension; Anemia (Hb 7.1) cared for by family; recent UTI.
BAMS Dr. Trtng
Recent crisis: rapid onset of vomiting, delirium, insomnia, agitation and hallucination. distressing for patient (pulling out IV cannula) and for family.
Here's the treatment: Plus 5 daily iron infusions for anaemia (IV Orofer)
Questions
1. Qutipin is Quetiapine. Atypical antipsychotics are useful in short bursts to control agitation and mania but Risperodone would have been a better choice.
2. IV Zofar is Ondansetron - that is a strong centrally acting anti-emetic usually used in chemotherapy
Read 6 tweets
18 Nov 20
103 years ago this day on 19 Nov 1917 (the same year in which John F Kennedy was born), in Allahabad, India (now known as Prayagraj), a daughter was born to the most illustrious political families of the time
#IndiraGandhi became India's First woman PM
#JFK became the 35th #POTUS
The #FarRight remember Indira Gandhi for the #Emergency she declared in 1975 - the suspension of Constitutionally guaranteed civil rights. But not because they are champions of citizens' rights and freedoms. On the contrary they are taking away our rights and freedoms silently
The liberal secular left remembers Indira Gandhi's Emergency because the experience taught them the value of Constitutionally-guaranteed #Rights and #Freedoms.
Read 5 tweets
18 Nov 20
Patients - ordinary people worried about having to be admitted and pay mega-bucks for treatment should they become really ill - are an important driver for #COVID19 #Overtreatment. They expect a treatment that will prevent deterioration, they want a pill - any pill.
In this situation if you say "no drug has been shown to delay deterioration, Steroids reduce the risk of death if given to those needing oxygen or on ventilators" the patient will think you are ignorant and look elsewhere. You're a Doctor! Do Something!! Prescribe something!!!
OTOH, If you say, "i've treated hundreds and most have never needed oxygen let alone admission to an ICU", then the patient will do what you ask. Get a CT scan? sure (a commission for you) do an MRI? (sure, this Dr is good, he can spell MRI in full; another kickback)
Read 6 tweets

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