Discover and read the best of Twitter Threads about #Covaxin

Most recents (24)

NASAL VACCINES: To explain nasal vaccines, we have to explain the immune system first.
IgA is an antibody that helps attack the pathogen and exists in mucosal surfaces (like nose/mouth)
IgG is an antibody that is in the bloodstream
bbc.com/news/world-asi…
Cellular immunity is fantastic, redundant (so even if one cell line down in immunocompromised, have other), generated by either vaccine or infection; Comprised of
T cells- so in breadth from vax - works even across spike protein with its mutations
And the 2nd type of cell produced by vaccines or infection -B cell- amazing thing about B cells is that - if see omicron or one of its subvariants in future- they make antibodies adapted to that variant or subvariant (aided by T cells); adaptive immunity
Read 15 tweets
INDIA: Went through BA2.75 in June-July with mild rises in cases & not severe disease; same with XBB so far because cellular immunity works against variants & lots of immunity in India (they have 8 vaccines available for their population including #covaxin- whole virus vaccine)
These subvariants are not more severe per WHO - all of them are the milder Omicron types & although antibodies from vaccines don't work as well, the T and B cell immunity from vaccines (or prior infection) work against these subvariants
www3.nhk.or.jp/nhkworld/en/ne…
If we go through how cellular immunity works, we will understand why we are in such a different place with the pandemic in 2022 than 2020 (IHME model predicts 75% of planet has been infected with COVID + vaccination rising & saved many from delta/omicron)
medscape.com/viewarticle/98…
Read 5 tweets
GREAT NEWS / BREAKING

First phase III #Covid19 #intranasal #vaccine data released.

IT LOOKS VERY GOOD!

@BharatBiotech s intranasal #iNCOVACC has a 45% higher antibody titer than their intramuscular #Covaxin.

And it shows a satisfactory immune response against Omicron BA.5.
2

Source: @BharatBiotech just published the pack insert for the intranasal vaccine:
bharatbiotech.com/images/incovac… (p. 7)

This is from their updated their website for #iNCOVACC:
bharatbiotech.com/intranasal-vac…

H/T to @Pdr_US for alerting me to that change and the new documents!
3

That @BharatBiotech published a vaccine pack insert and a summary of product characteristics (SMPC) shows to me that they are very far along in the release process.

The primary course vaccine has been authorized in India, we are still waiting on authorization of booster use.
Read 12 tweets
Today was the first appearance of India’s #DCGI on a public platform after the WHO suspended the supply of #BharatBiotech’s #Covaxin to UN due to quality issues it found in its manufacturing practises, in March this year (1/n)
It was at @CPR_India dialogues series where the discussion was happening about regulation of various health aspects in India. I asked him ( at 1.01.20) since WHO had already submitted the inspection report; also the Bharat Biotech’s corrective plan and
WHO’s rejection of it, would he divulge the key findings of both reports (submitted in Apr and Jul) and since this was the issue of larger public interest, would he like to put these reports in public domain?
Read 12 tweets
Pfizer and BioNTech/ Moderna Submit Application to U.S. FDA for EUA of Omicron BA.4/BA.5-Adapted Bivalent Vaccine- both the Moderna & Pfizer boosters have BA4/BA5 subvariants + old strain (latter gone in world). FDA asked for clinical
pfizer.com/news/press-rel…
data for BA1-original strain bivalent but that is not this vaccine- this is BA4/BA5 + OG bivalent where pre-clinical data & manufacturing data requested: assumedly means antibody titers (we previously had data in mice; this EUA may have human data)
medscape.com/viewarticle/97…
Like other variants & subvariants, BA4/BA5 more evasive of antibodies but not of cellular immunity- latter mediates protection from severe disease. Getting high boost of BA5/BA4 directed antibodies may prevent even mild infection while higher Image
Read 9 tweets
Though #BharatBiotech is now waiting to launch an all new intranasal vaccine against #Covid_19 pending regulator's nod, its problems with #Covaxin are still far from over ever since #WHO suspended its supply for UN agencies in April (1/n) science.thewire.in/health/exclusi…
It's 4 months into suspension already but WHO is still not satisfied with company's good manufacturing practises (GMPs), it told me last Friday, sharing its assessment of corrective and preventive action (CAPA) plan submitted by company in June. Here's what the WHO exactly said:
"In summary, based on the said CAPA response, the manufacturing site for Covaxin is still considered to be operating at an unacceptable level of compliance with WHO Good Manufacturing Practices for Pharmaceutical Products guidelines,"
Read 13 tweets
Breakthrough infection by SARS-CoV-2 Delta and Omicron variants elicited immune response comparable to mRNA booster vaccination academic.oup.com/jid/advance-ar…
Adds to other studies showing an infection after vaccination serves as a booster of the immune response (of antibodies, T and B cells) like this one from Yale and others in the thread below:
mdlinx.com/news/booster-a…
Other studies here:
T CELLS: In fact, this important paper shows that any exposure (breakthrough infection) or any booster after vaccination actually broadens and diversifies the T cell memory repertoire (e.g. expands your immune response).
nature.com/articles/s4159…
Read 6 tweets
There are many problems with #Covaxin #vaccine, contrary to the article tweeted multiple times at me.
In April @WHO blocked it because science.org/content/articl…
The company's study offered no antibody info on placebo users to compare efficacy of vax to medrxiv.org/content/10.110…
MORE
2/
Exportation from India was halted on April 2 after @WHO discovered manufacturing contamination mail.google.com/mail/u/0/#sear…
An Indian study found 2-dose #Covaxin only 47% effective against #SARSCoV2 despite manufacturer claim of 93%. doi.org/10.1016/S1473-…
BUT...
MORE
3/
#Covaxin can be stored at 47 degrees F, unlike the super-cold required for mRNA vaccines. That's a big plus.
Still, head-on-head independent comparisons of #COVID19 #vaccines against #Omicron found the Bharat-made Covaxin performed poorly.
nature.com/articles/d4158…
MORE
Read 6 tweets
The #WHO on April 2 issued a statement saying the supply of #Covaxin to UN agencies had been suspended due to "deficiencies in good manufacturing practices". There were not mny details. In an email, they have now told @TheWireScience the following : science.thewire.in/health/who-cov… (1/n)
"Problems were detected in some parts of the manufacturing process. SOME CHANGES WERE MADE after the emergency-use license was granted but were not submitted to the national drug regulator and WHO for evaluation and validation."
The WHO still didn't specify what were those changes. Whether those changes were related to increase the yield, or on the front of raw materials or due to some other reason--we don't know. A GMP expert said major changes, if done post approval, have to be informed.
Read 10 tweets
“ a Chinese National Health Commission (NHC) document showed that the Chinese COVID-19 vaccines had caused leukaemia”

(Sinovac & Sinopharm)

timesnownews.com/world/chinese-…
Read 62 tweets
Great article Science on cellular immunity, may help US on booster strategy "much focus in.. immunity surveillance has been on role of neutralizing antibodies..less emphasis on understanding role of T cells, memory B cells and non-neutralizing antibodies"
science.org/doi/10.1126/sc…
"Mounting evidence (I would argue we have known about T cells for long time!) suggests T-cell contributions to the host immune response are required for early, broad, and durable protection from SARS-CoV-2, especially in the setting of new variants of concern"; T cells provide
durable protection Want T cells across whole virus? Give whole virus vaccine. "Because Covaxin shows immune system the entire virus, the vaccine elicits a broad immunologic response not only against spike, but also against the receptor-binding domain, the
medpagetoday.com/opinion/second…
Read 26 tweets
There was no risk from the virus but the vaccine is causing multiple damages. Parents have to unite and say no to schools and authorities else the madness will not stop. #leaveourkidsalone
@Swamy39 @mansukhmandviya Image
Are we going to normalise heart attacks in kids and attribute the same to exam stress? @PMOIndia @MoHFW_INDIA @pbhushan1 @Swamy39 @mansukhmandviya
Stop this vaccination drive immediately! ImageImage
Read 12 tweets
Join our webinar on #COVID19 #Vaccination & Adolescents, today

Speakers:

Senior Advisor to Govt. of Maharashtra and @UNICEF on Child Health, Dr. Mrudula Phadke

&

Prof. Praveen Kumar
Lady Hardinge Medical College, Delhi,

Live From ⏰ 11 AM

🎥
📡Live Now📡

Webinar on #COVID19 #Vaccination & Adolescents

Speakers:

Senior Advisor to Govt. of Maharashtra and @UNICEF on Child Health, Dr. Mrudula Phadke

&

Prof. Praveen Kumar
Lady Hardinge Medical College, Delhi,

Join live 🎥
Govt. is doing its best to provide right information about #COVID19 #Pandemic to public

The purpose of this webinar on 'COVID-19 Vaccination & Adolescents' is to address the concerns of parents regarding ongoing #Vaccination for adolescents:

- ADG @PIBMumbai
Read 18 tweets
[BREAKING] In a 100 CRORE defamation case filed by BHARAT BIOTECH, Andhra Court ordered taking down of 14 articles on @thewire_in and restrained

1)THE WIRE
2) Siddharth Vardarajan
3) SR Bhatia
4) M.K. Venu &others

From publishing DEFAMATORY articles relating to @BharatBiotech
Bharat Biotech represented by Senior Advocate Vivek Reddy argued that The Wire had published articles which contained false allegations against Bharat Biotech and COVAXIN with a MALICIOUS intent to undermine the reputation of Bharat Biotech. @BharatBiotech @kvivekreddy #COVAXIN
Bharat Biotech had sued the following defendants
Read 4 tweets
The story of #Mild #Omicron Part 1
Long Thread -Story of 8 countries
Italy- Deaths due to Omicron have been higher than Delta by miles and almost reaching prevaccination levels .Vaccines were released around end December- Early January in most countries #OmicronIsNotMild ctd)
Ctd2)Denmark is second country- Again the Delta was decimated by the vaccines BUT with the Omicron the deaths have reached almost pre vaccine deaths #OmicronIsNotMild, #Omicron, #OmicronVariant , Also the Danes like others opened up after reaching good vaccination levels .
Ctd3) Country 3- Canada -Here too #Omicron crossed the deaths due to Delta by miles , reaching number of deaths before vaccination, in fact overshooting that number
#OmicronIsNotMild , needless to say the Canadians are fed up because it is #Mild in the media
Read 12 tweets
💡We need to consider this vaccine—a whole virus traditional one that may add more protection versus variants (watch the🎥 why) & mRNA-vaccine-hesitant folks can be comfortable with. ➡️The FDA should honestly authorize #COVAXIN—EUA app submitted & waiting.
2) Notably, unlike a single target spike protein vaccine line mRNA ones or the adenovirus (J&J and AstraZeneca) ones, an inactivated whole virus traditional vaccine has multiple protein targets for which the body can “learn” to build recognition and immunity if spike is mutated.
3) P.s. I own **zero** stocks in COVAXIN makers. I’ve never traded their stock.
Read 6 tweets
🚨🚨🚨
Basti, UP | 7 students faint after their vaccination | rushed by ambulance to PHC | referred to dist hospital as situation is not improving
m.up.punjabkesari.in/uttar-pradesh/…
Chattisgarh, village Lalpur | 12th standard girl died the same evening she was jabbed
Chattisgarh, Rajnandgaon | 17 YO took ill and started vomiting hours after #Covaxin shot | rushed to local PHC and then referred to civil hospital | died on the way
google.com/amp/s/www.naid…
Read 5 tweets
More than 40 lakh teenagers in the 15-18 age group received their first dose of #Covid19 vaccines on Monday. Some concerns were raised about ‘expired’ #Covaxin being administered to this younger group, leading to the Health Ministry issuing a clarification.
The Ministry described these claims as “false and misleading” and said these were based on “incomplete information”. It pointed out that the shelf life of #Covaxin, the only vaccine being given to the people below 18 years of age, had been extended: indianexpress.com/article/india/…
The Health Ministry said the shelf life of #vaccines is extended by the national regulator, Central Drugs Standard Control Organisation, or CDSCO, based on a comprehensive analysis and examination of stability study data furnished by the vaccine manufacturers.
Read 8 tweets
The SmPC (Summary of Product Characteristics) for #Covaxin (see the link to Bharat Biotech's website here: bharatbiotech.com/images/covaxin…
has not been updated since the #EUA was granted for use in the 12-18 year age group. It still says (page 1):
"COVAXIN® is indicated for active immunization against SARS-CoV-2 Virus infection for age ≥18years."

The SmPC is a legal document that is part of the approval process. On the question of expiry date, it says:(page 10),
"6.3 Shelf life
The expiry date of COVAXIN® is indicated on the label and carton of the vaccine. Do not use the
vaccine after the expiration date shown on the label and carton of the vaccine."
Read 5 tweets
India on Monday reported 33,750 fresh #Covid19 cases and 123 deaths. According to the Union Ministry of Health, the #Omicron tally in the country has reached 1,700, of which 639 have recovered or been discharged. Image
Meanwhile, Covid vaccination for teenagers, aged between 15 to 18 years, began today. The Union Health Ministry had announced that Bharat Biotech’s #Covaxin will be the one that will be administered to eligible children — in two doses 28 days apart.

📸Amit Chakravarty Image
A 17-year-old became the first one to get the #COVID19 jab at the PCMC hospital in Pune's Kasarwadi as vaccination of those between 15 to 18 years began at 10.20 am.
Live updates: bit.ly/3eHP1rN

📸Express photo Image
Read 12 tweets
The approvals, the authorisations, the announcements go hand in hand. Now the #Covaxin bhakts will line up to get their children p0!s0ned. ImageImage
I am sensing the 15-18 age range to change soon to 12-18. 12-15 applicable to children with comorbidities...😥
Maharashtra is perhaps receiving special incentives ??? Image
Read 10 tweets
💡[Whisper]… there is actually a proven vaccine for kids age 2-4 that is *CURRENTLY UNDER REVIEW* at the @US_FDA with an EUA app submitted on November 5th—but FDA has not moved yet on approval meeting. ➡️Why is the media not talking about this? #COVAXIN ir.ocugen.com/news-releases/…
2) COVAXIN™ (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines.
3) The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India.
Read 8 tweets
Antibodies wane (major line of defense in nasal passage); may be more susceptible to mild re-infections (omicron); enduring immunity of T cells, ability of B cells to kick in, produce adaptive antibodies toward variants protects against severe disease
leaps.org/how-long-do-co…
Because Omicron variant is latest, we have to examine whether T cells from vaccine or prior infection work well against it and this paper shows us they do! From NIAID & other institutions. Literally only ONE T cell epitope affected by the 32 mutations
biorxiv.org/content/10.110…
"Virtually all individuals with existing anti-SARS-CoV-2 CD8+ T-cell responses should recognize Omicron". This study done in recovered but work in "vaccinees has demonstrated a strong CD4+ and CD8+ T-cell responses suggesting that similar trends" will be seen among vaccinated
Read 36 tweets
🆕 WHO has granted emergency use listing (EUL) to #COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of #COVID19.
The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the #Covaxin vaccine meets WHO standards for protection against #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used 🌍.
#Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. #COVID19
Read 9 tweets

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