Breaking news: WHO is likely to give Emergency Use Listing for Indian Covid vaccine COVAXIN

 

Indian Bharath Biotech's CCOVID-19 vaccine COVAXIN is likely to get the WHO's EUL.  Indians and folks from other countries vaccinated with COVAXIN will be allowed to travel to international destinations. This will enable India to export to many more countries.

This will join COVAXIN join six others already having this listing-AstraZeneca-Oxford, Moderna, Johnson and Johnson, Pfizer-BioNTech, Sinopharm, and Sinovac.


https://www.usheadlinesnews.com/covid-19-vaccine-who-approval-for-covaxin-expected-this-week/

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Breaking news: COVAXIN Reports on phase 3 trial

 COVAXIN: Phase 3 Interim Report

On 3rd July 2021 Bharath Biotech based in India's Genome Valley announced their Phase 3 interim results of Covid vaccine BBV152(COVAXIN). The pdf link describes some details. 

The bulleted highlights are as follows:

"

•  Data from 25,800 participants, received vaccine or placebo in a 1:1 ratio showed that

the vaccine candidate was well tolerated.

•   COVAXIN® demonstrated 81% interim efficacy in preventing COVID-19 in those without

prior infection after the second dose.

•   Clinical trial to continue through to final analysis at 130 confirmed cases in order to

gather further data and evaluate the efficacy of COVAXIN in additional secondary

study endpoints.

"

One of the key points to note;

"The inclusion of the Algel-IMDG adjuvant enhances T-cell immune responses to COVID-19, leading to long-term protection"

Vaccine distribution status:

4 billion doses distributed worldwide so far.

More here on Bharath Biotech:

http://www.bharatbiotech.com/

https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf

What is an adjuvant?

In immunology, an adjuvant is a substance that increases or modulates the immune response to a vaccine. The word "adjuvant" comes from the Latin word adiuvare, meaning to help or aid. Wikipedia

https://www.nih.gov/news-events/news-releases/adjuvant-developed-nih-funding-enhances-efficacy-indias-covid-19-vaccine

More on NIH related information in quotes:

"The adjuvant used in COVAXIN, Alhydroxiquim-II, was discovered and tested in the laboratory by the biotech company ViroVax LLC of Lawrence, Kansas with support exclusively from the NIAID Adjuvant Development Program. The adjuvant comprises a small molecule attached in a unique way to Alhydrogel, a substance frequently called alum that is the most commonly used adjuvant in vaccines for people. Alhydroxiquim-II travels to lymph nodes, where the small molecule detaches from alum and activates two cellular receptors. These receptors, TLR7 and TLR8, play a vital role in the immune response to viruses. Alhydroxiquim-II is the first adjuvant in an authorized vaccine against an infectious disease to activate TLR7 and TLR8. In addition, the alum in Alhydroxiquim-II stimulates the immune system to search for an invading pathogen."

https://www.financialexpress.com/lifestyle/health/covaxin-to-use-virovaxs-adjuvant-alhydroxiquim-ii-to-boost-immune-response/2098284/

About ViroVax:

"Dr. Sunil David founded (an alumnus of the Indian Institute of Science, Bengaluru)) ViroVax, LLC in 2019 in Lawrence, KS.  ViroVax is a biotechnology company focused on the research and development of vaccines, adjuvants, and therapeutics to protect and treat people from infectious diseases, including Zika, West Nile, Dengue, and SARS-CoV-2.

Breaking News: A second Indian vaccine against Covid-19 Wuhan virus is seeking emergency Use authorization in India

 

The Ahmedabad based Zydus Cadilla's vaccine (ZyCoV-D) is the second indigenous vaccine against Covid-19 Wuhan virus. The company will be seeing emergency authorization in India soon. The Phase 3 study had more than 28,000 volunteers.


ZyCoV-D will be the world's first DNA Plasmid-based vaccine. Another feature of this vaccine is that it is administered without using a needle but via skin. It requires 3 doses for complete effectiveness.

More here:
COVID-19 Vaccine: Zydus Cadila to seek emergency authorization for ZyCoV-D vaccine next week (jagranjosh.com)

India is presently administering Covaxin, Covishied and Sputnik V. Pfizer and Moderna are also likely to enter the picture soon.

Politics and economics of vaccine distribution

 There is a lot of politics and economics involved in the distribution of the Covid vaccine. Based on the availability of the vaccine, the future looks dismal for the have-nots. They say it takes 11 years for Africa to reach herd immunity. 

Africans suffering for 11 years is a blot on our collective shared feeling. We really should be ashamed. The quick answer is to remove barriers to producing vaccines based on politics. 

It remains for the future to determine how many lives would have been saved in India if Biden had not put restrictions on vaccine raw materials; if China had given full cooperation to the WHO fact finding team, and all religions for not cooperating with congregations and defying social distancing, and for political rallies (Trump, Modi, etc.), and activism groups for their agenda (BLM, etc.). They did not give a damn for the Covid virus's virulence.

Here is some nice summarizing of the vaccine path for India and Vaccine economics.

Regarding the Indian vaccine COVAXIN

 There is a great deal of interest from many countries. It has shown 81% efficiency in those who were not infected after 2 doses. It has demonstrated that its antibodies can neutralize the UK variant.It is similar to SinoVac's CoronaVac.

Download fact sheet here: https://www.bharatbiotech.com/images/covaxin/covaxin-fact-sheet.pdf

The following countries have lined up for the supply:

Mongolia

Sri Lanka

Philippines

Bahrain

Oman

Maldives 

Mauritius

As to how much does it cost. Here is a quote from this site: https://www.bmj.com/content/373/bmj.n997

"Each dose of Covaxin costs 295 rupees (£2.93 versus £19-£28 for the Moderna vaccine11 and £26.70 for the Pfizer/BioNTech12). Moreover, Bharat Biotech is providing the first 1.65 million doses at no cost to the government. This makes the Indian vaccine the cheapest purchased by any country in the world at 206 rupees per shot for the 5.5 million doses the government currently has on order. The government has capped the price of the vaccine sold in the private market, with private hospitals able to charge up to 250 rupees.13"

Looks like there are too many angles to this pricing question:

Profits before people? Vaccine diplomacy: Why is Modi govt losing out globally? - Kashmir Times

Breaking News: Novavax trials in India

 

Trump administration backed the NOVAVAX vaccine as one of the six vaccines in Operation Warp Speed. Operation Warp Speed provided $1.75B funding for this company. 

Novavax has matured and it is being tested in a trial in the US and Mexico with about 16,000 to 30,000 participants. Moderna and Pfizer vaccines have already been used in millions of vaccinations in the USA. The AstraZeneca vaccine has also been used in vaccinating millions in the UK and elsewhere. AstraZeneca vaccine manufactured by the Serum Institue in India has been shipped to many countries under a UN program.

Performance-wise, Novavax has 95.6% efficacy against the original strain, a reduced 85.6% against the UK variant but much less % efficiency (49.4%) against the South African variant.

https://www.ndtv.com/world-news/novavax-covid-vaccine-highly-effective-but-not-against-south-africa-variant-2359680

Serum Institute in India will be producing the Novavax vaccine.

The Novavax as well as the Nasally delivered Bharath Biotech's weakened virus has approval for clinical testing.

https://www.business-standard.com/article/current-affairs/more-covid-19-vaccine-candidates-get-approval-for-clinical-trials-in-india-121020502044_1.html

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A note on COVID-19 variants, old and new

  A number of COVID-19 variants have appeared, first time in many parts of the world but seems to be spreading to other countries. Increased travel and relaxing will only promote spreading virus variants and controlling the virus spread will be difficult. 

Here is an image of collated information from various sources (obviously incomplete) across the Internet.

 

Here is a list of variants identified by MAKO laboratories.

Here are some links that you may be interested in (the titles are in bold):

 

Covid-19: The E484K mutation and the risks it poses

https://www.bmj.com/content/372/bmj.n359

Covid-19: Novavax vaccine efficacy is 86% against UK variant and 60% against South African variant

https://www.bmj.com/content/372/bmj.n296

Scientists In US' Oregon Find B.1.1.7 Variant With 'E484K', Mutation Also Found In India

https://www.republicworld.com/world-news/rest-of-the-world-news/scientists-in-us-oregon-find-b-dot-11-dot-7-variant-with-e484k-mutation-also-found-in-india.html

Another New Coronavirus Variant Now Detected In 13 Countries (B.1.125)

https://www.republicworld.com/world-news/global-event-news/another-new-coronavirus-variant-now-detected-in-13-countries.html

There is also a new variant from India, the Indian variant:

The Indian variant is given the designationB.1.617 which has two mutations, E$*$Q and L452R

https://www.firstcoastnews.com/video/news/local/double-mutant-covid-19-variant-first-discovered-in-india-now-found-in-the-us/77-176b256f-35df-4931-923a-0fb5cd527678?jwsource=cl

More here:

https://www.wsj.com/articles/indian-covid-19-variant-found-in-u-s-across-globe-as-foreign-help-arrives-11619545081

One has to be careful as this variant according to Indian scientists evade immune response:

https://www.reuters.com/world/india/indian-scientists-flag-virus-mutations-that-could-evade-immune-response-2021-05-01/

Vaccination in Brazil is broiled in controversies

 Brazil is one of the countries hard-hit by the coronavirus. It has not reached a plateau or, decreasing. This is what it looks like from a Google search,

This certainly does not look good. Brazil, through its well-known Butantan Institute, is conducting a Phase-3 study of the Sinovac vaccine, https://www.cnbc.com/2021/01/13/chinas-sinovac-vaccine-reportedly-50point4percent-effective-in-brazilian-trial.html.

The study says that the vaccine is 50.4% although earlier it was claimed to have 75% effectiveness. The side effects, if any, were mild and lasted a short time. With 50.4%, it barely meets the threshold for approval. 

Barring this effectiveness number, the Sinovac vaccine is cheaper and can be store in a refrigerator. The Sinovac vaccine is also under trial in Turkey, Indonesia.

This is news on Reuters some 3 days ago regarding the Sinovac use in Brazil. Note that this is the result of a small study.:

https://www.reuters.com/article/us-health-coronavirus-vaccine-sinovac/sinovac-vaccine-may-not-trigger-sufficient-antibody-response-to-brazil-variant-study-idUSKBN2AX0KK

There are also reports of misappropriation of vaccines that may carry 12-year imprisonment.

https://www.theguardian.com/global-development/2021/feb/18/brazil-fake-covid-vaccinations-allegations

There is a gap between the have and have-nots in Brazil which is perhaps more prominent than in other places. Now, it appears the rich are trying to arrange their own supply of vaccines through private clinics according to this;

https://apnews.com/article/brazil-wealthy-coronavirus-vaccine-c1e157ac56985dcb6f3931f31a1c3ff6

Brazil will also be producing its own vaccine.

https://agenciabrasil.ebc.com.br/en/saude/noticia/2021-03/governors-want-speedy-sputnik-v-production-brazil

Brazil is also planning to buy India's locally developed vaccine, Covaxin.  There appear to be some objections from concerned people that the vaccine has not completed the Phase 3 studies. Perhaps they are not aware of the latest results:

https://www.bbc.com/news/world-asia-india-55748124

The following image is from the above link:

Breaking news: COVAXIN getting ready for nasal delivery

The COVAXIN vaccine developed by Bharath Biotech is now getting ready to try the nasal variant, which according to Dr. Gillurkar from a site chosen to monitor COVAXI vaccine efficacy. As COVAXIN is whole-virion inactivated, it targets all parts of the virus and makes it more effective.

Source: Gillurkar's Hospital- Facebook

The nasal variant in a Phase I and Phase II study will start at Dr. Gillurkar's Hospital in Nagpur, India. The injectable variant Phase I and Phase II studies were completed at this hospital. According to Dr. Gillurkar, "We are all set to host the trials for nasal Covaxine in next two weeks. Enough scientific evidences are available that vaccines given through nasal route are more effective than injected ones". 

The other advantages of nasal route are no brainer. It will drive the cost so far down that it may emerge as the most preferred. Let us all look forward to it.

Read more at:

http://timesofindia.indiatimes.com/articleshow/80127595.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst "


Also read:

https://www.msn.com/en-in/health/medical/covaxin-controversy-doctors-in-trial-sites-chosen-by-icmr-say-human-trials-cant-be-fast-forwarded-anticipate-6-month-observation-period/ar-BB16oNfo

Covaxin, the Indian Vaccine for COVID-19 uses a traditional technique for vaccine development

 

https://www.bharatbiotech.com/covaxin.html

"U.S. biopharmaceutical firm Ocugen and Bharat Biotech have signed a binding letter of intent (LOI) to co-develop India’s COVID-19 vaccine candidate Covaxin for the United States market.....

----------

Covaxin offers a vaccine candidate that is different from other options currently available in the U.S. market with potentially broader coverage against multiple protein antigens of the virus,” said Harvey Rubin of the University of Pennsylvania and a member of Ocugen’s Vaccine Scientific Advisory Board."

The above extracted from:

https://www.thehindu.com/business/bharat-biotech-ocugen-to-take-covaxin-to-us/article33397081.ece

New Covid-19 Vaccine Update

Few more have entered the vaccine race to end the scourge.  Here is an update extracted from the link provided. The highlighting is added.

More here:
                              https://tinyurl.com/y9qjt4re

Indian Corona Virus Vaccine "COVAXIN" gets approved in India for Phase I and Phase II

India's regulator, Central Drugs Standard Control Organization has approved Bharat Biotech India to conduct human clinical trials for its 'COVAXIN'.  Phase I and Phase II trials start in July 2020

Bharath Biotech in collaboration with the Indian Council of Medical Research's(ICMR) National Institute of Virology(NIV)

Others in the queue:

Zydus Cadilla

Serum Institute of India

Panacea Biotec

More here: http://bitly.ws/8V7B