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https://twitter.com/das_seed/status/1408712113321820164

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@das_seed

2 Jul

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)

● 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🤦)

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

Read 15 tweets

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@das_seed

2 Jul

@BharatBiotech

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

https://twitter.com/ShobhanSaxena/status/1410741584979644419

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.

Read 8 tweets

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@das_seed

1 Jul

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

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@das_seed

24 May

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

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

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

Read 17 tweets

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@das_seed

11 Apr

@SerumInstIndia

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,

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.

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

Read 16 tweets

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@das_seed

18 Mar

https://twitter.com/kakape/status/1372315648894844940

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

https://twitter.com/kakape/status/1372315648894844940

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

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

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