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सिद्धार्थ Profile picture
सिद्धार्थ
@das_seed
Quantum Information Theory, Asst Prof @iiit_hyderabad | Member at All India Drug Action Network (AIDAN). Live life with no regrets.
Jul 2, 2021 • 21 tweets • 11 min read
Phase 3 trial results for COVAXIN (a double-blind, randomised, placebo-controlled trial). Thread.

medrxiv.org/content/10.110… 2 July 2021.

1. Vaccine efficacy against

● Symptomatic COVID19+ve: 77.8% (95% CI: 65.2–86.4) w/ 130 cases (24 COVAXIN, 106 placebo) Image ● Severe symptomatic COVID-19+ve: 93·4% (57·1–99·8) w/ 16 cases (1 COVAXIN, 15 placebo)

● Symptomatic COVID19+ve in age 18–59 yrs: 79·4% (66–88·2) w/ 109 cases (19 COVAXIN, 90 placebo)

● Asymptomatic COVID19+ve: 63·6% (29🤔–82·4) w/ 47(?) cases (13 COVAXIN+33 placebo=46🤦) ImageImage
Jul 2, 2021 • 6 tweets • 7 min read
Based on recommendations from NTAGI, @MoHFW_INDIA on 2 July 2021 approved the vaccination of pregnant women against COVID-19.

Decision allows pregnant women to make an informed choice on taking COVID vaccination.

Decision communicated to the states/UTs.
pib.gov.in/PressReleasePa… FAQ by @MoHFW_INDIA circulated among designated health practitioners before approval to allow COVID19 vaccination in pregnant women.

NTAGI had recommended studies to monitor safety of COVID19 vaccine in pregnant to be put in place immediately. Any update?
Jul 2, 2021 • 8 tweets • 7 min read
Should Indians be concerned about commercial COVAXIN deals by @BharatBiotech?

@ICMRDELHI & @BharatBiotech have MoU on COVAXIN and also share Intellectual Property rights.

ICMR gets 5% on net sales of COVAXIN as royalty from BBIL.

Partial COVAXIN trials & mfg support from Indian govt.

Not to forget super-extraordinary regulatory authorization to COVAXIN w/o Phase 3 trial data that allowed BBIL to opened door for early sales of COVAXIN in India & some other nations.

During early days, COVAXIN consignments only had BBIL's logo but not of ICMR.
Jul 1, 2021 • 26 tweets • 16 min read
What do we know about ZyCoV-D, a plasmid DNA vaccine candidate against symptomatic COVID19 by Zydus Cadila? Thread.

1. Results of pre-clinical studies on animals before July 2020 put in public domain in 2021:
biorxiv.org/content/10.110… 26 Jan 2021
biorxiv.org/content/10.110… 3 Feb 2021 2. Permission granted by DCGI on 2 Jun 2021 to initiate human trials adaptive Phases I & II.

Safety profile of 7 days after 1st dose of ZyCoV-D needed to be reviewed by DSMB & CDSCO before go ahead for Phase 2.

Some issues w/ these permissions are:
a) ZyCoV-D needs 3 doses for
May 24, 2021 • 17 tweets • 8 min read
A short note on dosing regimen of COVISHIELD for complete vaccination.

We've 3 different set of trials:

1. UK/Brazil trials
This trial was open-label, w/ scandalous error in dosing regimen ("half-dose" error), had multiple major amendments in protocol when trial was undergoing Image w/ minimum gap b/w 2 doses set to be 4 weeks.

COVISHIELD was initially supposed to be a single dose vaccine, but in middle of trial they realized that booster dose was required for higher efficacy compared to just single dose.

In the process, due to mfg/supply delay, intended Image
Apr 11, 2021 • 16 tweets • 12 min read
A thread on recent updates (24 March- 9 April 2021) on Vaxzevria, a COVID19 vaccine mfg by AstraZeneca (called COVISHIELD if the same product is mfg by @SerumInstIndia).

1. Summary of productcharacteristics updated by @AstraZeneca after @EU_Commission's decision. Importantly, ImageImageImage a) Thromobocytopenia is listed as common (≥1/100 to <1/10) adverse reaction

b) Thrombosis in combination w/ thrombocytopenia is listed as very rare (<1/10,000) adverse reaction

c) Currently available trial data do not allow an estimate of vaccine efficacy in 55+ yrs age group. Image
Mar 18, 2021 • 24 tweets • 15 min read
Pause of AZD1222 vaccine by some EU countries (Germany, Denmark, etc.) when UK has not raised any concerns, is relevant for India because > 85% of vaccine currently being admin in India is COVISHIELD (SII's AZD1222).

Thread on safety data from MHRA,UK

\1
Up to 28 Feb 2021:

1st doses of COVID19 vaccines administered by UK

- 10.7 million of BNT162b2

- 9.7 million of AZD1222

& ~ 0.8 million 2nd doses mostly of BNT162b2.

AEFIs reported via Yellow card:

- 94809 of BNT162b2

- 201622 of AZD1222

- 843 unspecified

\2 Image
Feb 17, 2021 • 9 tweets • 8 min read
💉ZyCoV-D, DNA plasmid based COVID19 vaccine candidate by Zydus Cadila.

Event-based phase III, double-blind RCT to evaluate efficacy, safety & immunogenicity, ctri.nic.in/Clinicaltrials…

👉Sample size: 28216

👉For age ≥12 yrs

👉No. of events: 158

\1
ImageImage 👉Primary obj: efficacy of ZyCoV-D in prevention of virologically confirmed symptomatic COVID19 cases vs placebo (Day 70 to 364)

Dose: 0.2 ml (0.1ml in each arms) w/ Pharmacjet; Upper arm; frequency: single time @ days 0, 28, 56; Intradermal

No. of sites regd: 43 till date

\2 Image
Sep 25, 2020 • 22 tweets • 24 min read
How can medical insurance companies NOT trick their customers!

Guidelines on handling of claims reported under Corona Virus: irdai.gov.in/ADMINCMS/cms/w…

(Images from thread below by @AnooBhu)

ImageImageImage Ashraya Hospital, Chikmagalur, Karnataka

Bill splitting:

Doctor's visit charges alone is ~₹2 lakhs.

Separate hefty charges for COVID ICU, oxygen, NIV, etc.

Hospital admit: 24.08.20, discharge: 11.09.20

@malini_aisola @RemaNagarajan @inayat_s_kakar

Image
Jul 13, 2020 • 31 tweets • 24 min read
Restricted Use of #Itolizumab for CRS in moderate to severe ARDS patients due to #COVID19. No peer-review.

❗️Phase III clinical trial exempted, to go for Phase IV.

Wordings of SEC meeting & Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, have similar tone. 👇 To understand how HUGE scientific rationale can be, check her discussion w/ @SadhguruJV, a repeat offender. She speaks on DATA as well.

Both spewed lot of misinformation & judgement that could endanger public health & lives.

Jul 10, 2020 • 15 tweets • 9 min read
🚩What is community transmission? Is India under community transmission?
⚠️What are implications of community transmission? Why is @MoHFW_INDIA denying it?
🧐What are possible consequences if there's declaration of community transmission? How will it help public? (thread)\1 @WHO's definition of community transmission allows govts to announce/deny community transmission based on their agenda. Maybe vague but @MoHFW_INDIA is NOT in position to defend its denial. "COMMUNITY TRANSMISSION" is officially used in @MoHFW_INDIA's critical policy/rules. \2
Jul 6, 2020 • 5 tweets • 2 min read
🚩Unprecedented time demands pertinent questions.

IMO, we are often not asking questions appropriate to priority.

e.g.,

1. Ask about quality, quantity, delivery status of medical devices (PPE, N95 masks, ventilators, sanitizers, etc.). NOT price even if its via #PMCARES. \1 Lives are getting lost due to delay, low quality, shortage while disease keeps spreading. You need to save healthcare workers else who will take care of patients even if we keep adding beds.

Money NOT an issue, have $2250 million loan from World Bank+ AIIB alone for COVID18.\2
Jun 29, 2020 • 14 tweets • 12 min read
📋CLINICAL MANAGEMENT PROTOCOL: COVID-19 by GoI, @MoHFW_INDIA provides guidance to #COVID19 medicare and mgmt units all over India.

❗️Essential to be FACT-based, well-INFORMED, UPDATED.

⚠️Sadly, its not well-informed or fact-based. Needs URGENT UPDATE/REVISION now. e.g., 👇 Image ❗️Some MISINFORMATION based on outdated @WHO's surveillance guidelines & info (~March '20).

❗️Ignored information post mid-March from EU, USA, India though these form major % of total cases.

❗️ECOLOGICAL FALLACY.

❗️Systematic CALLOUSNESS.
\2 Image
Jun 4, 2020 • 4 tweets • 2 min read
⚠️Public health @ risk: Misinformation by @PMOIndia @NITIAayog @ICMRDELHI

❗️COMMUNITY TRANSMISSION on.
❗️UTTERLY LIMITED test capacity & medical facility.
❗️NO ESTIMATE FOR % ASYMPTOMATIC, not in India and not for global popn!
❗️still EARLY stage. \1 ❗️PRE-SYMPTOMATIC ≠ ASYMPTOMATIC.
❗️Pre-symptomatic can be EXTREMELY contagious as symptomatic ones.
❗️ECOLOGICAL FALLACY is BLUNDER.
❗️Self-ISOLATION/QUARANTINE when suspicious of exposure to infection is MUST. \2
May 30, 2020 • 15 tweets • 6 min read
❗️What're some of India's elite COVID19 calculators (@NITIAayog, @ICMRDELHI, majority of media) getting wrong? Here are some monumental blunders in elementary analysis of numbers related to COVID19 cases in India.
Rule 1: If facts are misrepresented, analysis will be wrong! /1 1. An ecological fallacy: 1st, we keep/kept deducing about the spread of infection in India by inferring global data (avg.).
Same at level of India, focused on average rather than local level data barring few states/districts. Need extensive analysis of data at local level. \2
May 8, 2020 • 10 tweets • 5 min read
A thread. Even tax invoices (TI) sent to Ketto by @BosonMachines (BM) look cooked up (to misuse public donations?). Boson Machines have multiple major inconsistencies in their official letter (OL), dated April 30, to Ketto. Multiple self-contradictory points by Boson Machines. \1 A/c to OL: Rate per Face Shield (FS) is INR 120/- before April 14. After April 14, the rate was reduced to INR 75/- for FS from other vendors. Changing the design and manufacturing process FS price was reduced to INR 60/-.

Why huge price variations within a few days??? \2
May 3, 2020 • 47 tweets • 27 min read
#COVID19. Thread. How some individuals and/or groups are using adversity of pandemic probably for their selfish interests at cost of others' health/money/trust, with a case brought in light by @KushaKapila. Suspicion was raised by documents in ketto.org/fundraiser/hel… /1 Kusha said Boson Machines (BM) provided her with letter from a doc in LTMGH & LTMMC, Mumbai & claimed it to be approval for their face shield. This letter was meant to be letter of certification that face shield has passed the test/criteria. /2