Share this page!

Enter URL or ID to Unroll

You can paste full URL like: https://x.com/threadreaderapp/status/1644127596119195649
or just the ID like: 1644127596119195649

How to get URL link on X (Twitter) App

  1. On the Twitter thread, click on or icon on the bottom
  2. Click again on or Share Via icon
  3. Click on Copy Link to Tweet
  4. Paste it above and click "Unroll Thread"!
  5. More info at Twitter Help
सिद्धार्थ Profile picture
@das_seed
Jul 2, 2021 • 8 tweets • 7 min read • Read on X
Scrolly
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.
However, there're COVAXIN consignments featuring logos of both developers, ICMR & BBIL, from March.

Commercial supply of 2 lakh COVAXIN doses to Mauritius on 19 March had logos of ICMR & BBIL w/ sign of #VaccineMaitri by Indian govt.

Was ICMR logo because of int'l shipment? No.
There're COVAXIN consignments supplied w/n India during March w/ logos of both developers, BBIL & ICMR.

No rationale to why logo of ICMR initially not included. As ICMR is co-developer, its logo should continue to feature in COVAXIN consignments, right?

Well, not sure what unfolded but there are consignments being supplied in May which don't have logo of ICMR.

There's also augmentation of mfg capacity for COVAXIN production under Mission COVID Suraksha by Indian govt. 3 PSUs identified to support BBIL.
Even boxes of vials don't contain logo of ICMR (left pic tweeted by @SuchitraElla, 21 June '21)

COVAXIN development & mfg partially supported by Govt.

Commercial deals also facilitated by Govt.

COVID19 vaccines are public good.

Bizarre for Govt & media to be mute spectator.
🤦‍♀️On 21 May 2021, @SuchitraElla said

a) @BharatBiotech reached out to ICMR-NIV only for SARS-CoV-2 strain. There was no technology transfer.

b) From there, it was developed in-house, completely funded in-house & taken through all testing, animal, toxicology & human testing &
everything was done as per int'l norm & protocols of drug development/discovery.

c) ICMR-NIV, ICMR & BBIL have collaborated on trials in large animals (monkeys, hamsters).

🤨On 2 July 2021, Phase 3 trial paper mentions only BBIL as developer of COVAXIN.

• • •

Missing some Tweet in this thread? You can try to force a refresh
　

Keep Current with सिद्धार्थ

सिद्धार्थ Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @das_seed

सिद्धार्थ Profile picture
Jul 2, 2021
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
2. Vaccine efficacy against symptomatic COVID19+ve

● B.1.617.2 (Delta): 65·2% (33·1–83·0) w/ 50 cases (13 COVAXIN, 37 placebo)

● B.1.617.1 (Kappa): 90·1% (30·4–99·8) w/ 11 cases (1 COVAXIN, 10 placebo)

3. Total 79 variants (VOIs or VOCs) detected in 130 cases analyzed for Image
Read 21 tweets
सिद्धार्थ Profile picture
Jul 2, 2021
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?
@MoHFW_INDIA says that pregnant woman opting for vaccination can get COVID19 vaccinated available in India any time during pregnancy.🤦‍♀️

(Not all vaccines have same safety profile. NTAGI had noted concerns along w/ recommendation to allow COVID19 vaccination for pregnant).
Read 6 tweets
सिद्धार्थ Profile picture
Jul 1, 2021
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
completion (at day 0, day 28, day 56).

b) Vaccine candidate platform/tech is new for humans. 7 days for such a new vaccine candidate is too short period for monitoring. SAEs could occur based on dosages as well & some type of events may take longer to manifest.

c) Phase I trial
Read 26 tweets
सिद्धार्थ Profile picture
May 24, 2021
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
interval of 4 weeks was not achieved & got prolonged.

Attached are intended & extrapolated sub-group analysis that was carried out by PIs as part of protocol, w/ different dosing levels & intervals.

*extrapolated analyses were not part of protocol hypothesis but in response to ImageImage
Read 17 tweets
सिद्धार्थ Profile picture
Apr 11, 2021
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
d) Asks healthcare professionals to be on alert for signs & symptoms of thromboembolism &/or thrombocytopenia. Instructs vaccinated people to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain ImageImage
Read 16 tweets
सिद्धार्थ Profile picture
Mar 18, 2021
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
Up to Feb 28, 2021 in UK:

~10.1 million received Pfizer/BioNTech's mRNA vaccine, whereas 9.7 million received AZ/Oxford vaccine

Deaths reported via Yellow card:

- 251* of BNT162b2

- 275* of AZD1222

- 6 unspecified

% of deaths in vaccine recipients: AZD1222 > BNT162b2

\3 ImageImageImage
Read 24 tweets

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Don't want to be a Premium member but still want to support us?

Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal

Or Donate anonymously using crypto!

Ethereum

0xfe58350B80634f60Fa6Dc149a72b4DFbc17D341E copy

Bitcoin

3ATGMxNzCUFzxpMCHL5sWSt4DVtS8UqXpi copy

Thank you for your support!

Follow Us!

Send Email!

:(