Why can’t this Texas-born COVID-19 vaccine break into the U.S. market?

[Elderberry]

Texas Tribune by Karen Brooks Harper Oct. 19, 2021

It’s cheap, easy to make and in demand overseas. So why can’t this Texas-born COVID-19 vaccine break into the U.S. market?

A Houston vaccine team would like a U.S. distributor but for now focuses its efforts abroad to inoculate those in countries where COVID-19 variants surface more quickly.

The day before COVID-19 claimed its first Texas victim in 2020, Dr. Peter Hotez was a guest on the popular Austin-based podcast “The Drive.”

After 10 years of research into coronavirus vaccines, Hotez and his Houston team needed an infusion of cash to build on their past work and make a vaccine that could, as Hotez told listeners then, “rescue the world” from the deadly emerging coronavirus pandemic.

“You’d think that people would be pretty eager to support us to move this forward, but so far it hasn’t happened,” the Houston pediatrician and vaccine scientist told the host, Dr. Peter Attia, on March 14, 2020.

By the following week, major cities in Texas began to shut down to avoid widespread community outbreaks.

But Hotez’s plea worked. The donations started coming in support of efforts in the deadly new pandemic at the Baylor College of Medicine at the Texas Children’s Hospital Center for Vaccine Development, co-directed by Hotez and Dr. Maria Elena Bottazzi in Houston — both of whom are celebrated pioneers in the area of vaccines for neglected tropical diseases like chagas and schistosomiasis.

Among the gifts was a $1 million infusion of cash in May 2020 by the philanthropic arm of Texas-based Tito’s Handmade Vodka, whose director of global impact and research, Sarah Everett, was tuned in when Hotez asked for help in reviving their research.

“We decided that somebody should help restart that work immediately,” Everett said.

Now, nearly 18 months later, the Houston team’s vaccine, called Corbevax by its maker in India, is cheap, has no patent, can be made by many vaccine producers globally — including those in low- and middle-income countries — and is poised to receive approval for widespread global use.

The Indian government has promised the biopharmaceutical company Biological E Limited, which is making the vaccine in that country, that it will buy 300 million doses with the potential for more.

A halal version of the vaccine, for use in Islamic countries because it doesn’t contain animal-based ingredients, is also about to start clinical trials in Indonesia.

And later this year, the company hopes the vaccine will be endorsed by the World Health Organization for use globally, which could open the doors to quicker authorization in several countries that need it.

But here in the United States, this “truly Texas vaccine,” as its creators like to call it, has no home.

More: https://www.texastribune.org/2021/10/19/texas-covid-19-vaccine-peter-hotez/

[Ghost Bear]

... the Houston team’s vaccine, called Corbevax by its maker in India, is cheap, has no patent, can be made by many vaccine producers globally — including those in low- and middle-income countries ...

And that explains why the vaccine has no interest in the developed world. It won't make huge profits for Big Pharma companies.

[Bigun]

And that explains why the vaccine has no interest in the developed world. It won't make huge profits for Big Pharma companies.

B I N G O ! ! !

Ladies and gentlemen, we have a winner here!

[Polly Ticks]

And that explains why the vaccine has no interest in the developed world. It won't make huge profits for Big Pharma companies.

Exactly right.


Also,

... the Houston team’s vaccine, called Corbevax by its maker in India, is cheap, has no patent, can be made by many vaccine producers globally — including those in low- and middle-income countries ...

I think @corbe maybe should be worried about hidden messages.
 

[PeteS in CA]

Well, maybe it's a Big Bogey Pharma conspiracy. Or maybe it has to do with being some 9 months behind in starting testing, https://www.biologicale.com/news.html :

BIOLOGICAL E. LIMITED STARTS PHASE I/II CLINICAL TRIAL OF ITS COVID-19 VACCINE CANDIDATE
Hyderabad (India), November 16, 2020: Biological E. Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston, TX, today announced that BE has initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI).

The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax’s advanced adjuvant CpG 1018.

BIOLOGICAL E. LIMITED GETS CDSCO NOD TO START PHASE III CLINICAL TRIAL OF ITS COVID-19 VACCINE CANDIDATE
Successfully Completes Phase I/II Clinical Trial
Results are Highly Positive and Promising

Hyderabad (India), April 24, 2021: Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced that it has successfully completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC).

BE started the Phase I/II Clinical Trial of its COVID-19 Vaccine Candidate in the second week of November 2020. Its candidate includes an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s (Nasdaq: DVAX) advanced adjuvant CpG 1018TM. The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the Phase I/II Clinical Trials and also for the upcoming Phase III trial of this vaccine candidate.

By way of contrast, the first Phase 1 injection for Moderna happened in March, 2020, and for Pfizer in April, 2020. And while the Indian company began its Phase 1 testing in November 2020, Moderna and Pfizer had met the endpoint goals of their Phase 3 testing, and received Emergency Use Authorization in December, 2020. By the time the Indian company began their Phase 3 testing, Moderna's and Pfizer's vaccines had been in use in the US for 4 months. Also, the Indian company appears to have done and be doing all of its testing in India, not working at all with the US FDA.

So the real answer to the Texas Tribune's question is simple. The Indian vaccine is very late to the market, to the degree of not yet having completed its Phase 3 endpoint goals, and the company has chosen not to test in the US or work with the FDA. Also, the Indian company's News webpage makes no mention of their vaccine being in production nor authorized for use in India.

Sorry, no Big Bogey Pharma conspiracy here.

[corbe]

Exactly right.


Also, I think @corbe maybe should be worried about hidden messages.
 

   Funny you should bring that up this afternoon @Polly Ticks I haven't had a cold/flu in 40 years BUT Covid hit me hard last night (not vaccinated) and the dumb azz that gave it to me will line up for his booster next week when it is available. He also took a Greyhound from San Antonio to Dallas last weekend for a job, which he didn't get. Just out of rehab and I'm trying to encourage him to not give up.  Only the second time I've been out of bed today.  I'm pissed at being so sick and will give my natural immunity through the weekend to kick this $hit.  The only comorbidtalities (sic) I have is heavy smoker and heavy drinker, oh yea, I smile and laugh a lot. 

[Polly Ticks]

   Funny you should bring that up this afternoon @Polly Ticks I haven't had a cold/flu in 40 years BUT Covid hit me hard last night (not vaccinated) and the dumb azz that gave it to me will line up for his booster next week when it is available. He also took a Greyhound from San Antonio to Dallas last weekend for a job, which he didn't get. Just out of rehab and I'm trying to encourage him to not give up.  Only the second time I've been out of bed today.  I'm pissed at being so sick and will give my natural immunity through the weekend to kick this $hit.  The only comorbidtalities (sic) I have is heavy smoker and heavy drinker, oh yea, I smile and laugh a lot.

Oh no!  I'm sorry to hear it and hope you feel better soon, @corbe
Might want to hit the over-the-counter remedies in the meantime ... zinc and Mucinex and what not.  (Is it @Smokin Joe that has the list of OTC stuff that is supposed help?)
Prayers up for you, and also for your friend fresh out of rehab.

[Ghost Bear]

By way of contrast, the first Phase 1 injection for Moderna happened in March, 2020, and for Pfizer in April, 2020.

So, you're saying that Moderna had a potential vaccine start testing in the same month that the pandemic was recognized as a pandemic, and Pfizer had their potential vaccine ready to start testing a month later.

Sorry, no Big Bogey Pharma conspiracy here.

Sure, sure. 

[PeteS in CA]

So, you're saying that Moderna had a potential vaccine start testing in the same month that the pandemic was recognized as a pandemic, and Pfizer had their potential vaccine ready to start testing a month later.

Sure, sure. 

I really have to go over this chronology? So soon?

1. News of the SARS-Cov-2 (as it has come to be known) outbreak was leaked to the world out side of China on December 31, 2019.

2. The DNA sequence was communicated (leaked?) to the world out side of China on January 11, 2020.

IOW, by early January the world knew the SARS-Cov-2 virus was a serious threat to spread worldwide. US government (under Trump's Presidency) responded proportionally:

January 4, 2020 - CDC Director Robert Redfield offers to send technical experts to China: https://www.washingtonpost.com/politics/2020/04/03/how-much-pressure-did-trump-put-china-access-concerning-coronavirus/ (behind paywall)

January 6, 2020 - CDC issued a Level 1 travel notice for Wuhan, China; https://afludiary.blogspot.com/2020/01/cdc-issues-level-1-watch-travel-notice.html

January 8, 2020 - CDC alert to clinicians to ask patients with "severe respiratory illness" whether they had traveled to Wuhan; https://emergency.cdc.gov/han/han00424.asp

January 17, 2020 - The US started screening arriving passengers from China; JFK, SFO, LAX https://www.businessinsider.com/new-disease-virus-china-us-airports-screening-cdc-2020-1 ; O'Hare and Hartsfield-Jackson
January 22, 2020 - https://www.washingtonpost.com/nation/2020/01/21/us-screenings-coronavirus-expanded-airports-atlanta-chicago/

January 20, 2020 - National Institutes of Health working developing a vaccine for coronavirus; https://www.cnn.com/2020/01/20/health/coronavirus-nih-vaccine-development/index.html

January 20, 2020 - CDC activated its emergency operations center; https://emergency.cdc.gov/recentincidents/index.asp?cid=EPR-homepage

January 27, 2020 - US CDC issues highest-level travel health notice, Level 3, recommending that travelers avoid all nonessential travel to China; State Department raises its own travel advisory for all of China to Level 3 of 4, urging U.S. citizens to “reconsider travel”, while retaining its Level 4 travel advisory for Hubei Province; https://www.cdc.gov/media/releases/2020/s0128-travelers-avoid-china.html , https://china.usembassy-china.org.cn/travel-alert-level-4-do-not-travel-to-hubei/

January 29, 2020 - White House announced the formation of the Coronavirus Task Force; https://thehill.com/policy/healthcare/480627-white-house-announces-task-force-to-monitor-coronavirus

January 31, 2020 - Trump declared a public health emergency; https://abcnews.go.com/Health/delta-suspends-us-flights-china-amid-coronavirus/story?id=68666037

January 31, 2020 - State Department raised the travel advisory for China to Level 4, do not travel; https://www.usatoday.com/story/travel/2020/01/31/coronavirus-china-flight-ban-delta-cuts-all-flights-white-house/4620989002/

January 31, 2020 - People entering the US from China forbidden; Announced January 31, effective February 2; https://www.cnn.com/2020/02/02/us/coronavirus-us-travel-restrictions/index.html

Etc., etc., etc., .......

That WHO declared Covid-19 a "Pandemic" on March 11, 2020, https://pubmed.ncbi.nlm.nih.gov/32191675/ , was just a statistical distinction about the degree of spread. What came to be called Covid-19 was spreading worldwide long before that point in time.

That Moderna began developing their vaccine in mid January was a common sense response to a threat - responding early, rather than late, being the common sense. The same applies, obviously, to BioNTech, who developed the vaccine that Pfizer produces and distributes in the US. The same applies to Oxford University, which also started Phase 1 testing of the vaccine AstraZeneca produces and distributes around the world. In the field of Covid treatment, AbCellera (later partnered with Eli Lilly) and Regeneron began working in their monoclonal antibody treatments, with US government assistance, in late January and early February. AbCellera, in particular, was part of a DARPA project to develop a platform for early development of treatments for potential epidemics.

I don't know why Baylor University was so late in starting development of their vaccine - after Moderna and Pfizer were already doing Phase 1 testing with humans - or why Biological E Limited was so late in starting human testing, and only testing in India. I'm just pointing out that the chronology of events answers Texas Tribune's "question". ETA: Partial credit where partial credit is due, if one reads deep enough into the Texas Tribune article one will find general acknowledgement of the chronology I have posted above, in more detail, that Baylor and the Indian company were much later than Moderna and Pfizer (and eve J&J!), and, indirectly, that they didn't work with the US government. Why Texas Tribune buried the obvious answers to their title "question" so deep in their article, I won't guess.

And now I've given chronology that explains why Moderna and Pfizer had their vaccines in human testing very shortly after WHO declared Covid-19 a Pandemic. Again I'll say it, there's no Big Bogey-Pharma conspiracy here, just rational responses to rapidly developing events and the realities of time requirements to do development and testing.

If anyone is interested in how things Covid and Covid vaccines progressed, here are some decent starting points:

https://www.gopbriefingroom.com/index.php/topic,412484.0.html

https://www.gopbriefingroom.com/index.php/topic,412485.0.html

https://www.gopbriefingroom.com/index.php/topic,412910.0.html

https://www.gopbriefingroom.com/index.php/topic,412701.0.html

[Ghost Bear]

I really have to go over this chronology? So soon?

No, you don't... oh, you already did.

Oh well, no conspiracy here. Never mind then. 

[libertybele]

Texas scientists say they have developed a 'game changer' affordable COVID vaccine ignored by US government

A team of Texas-based scientists say they have developed a COVID-19 vaccine using proven technology that is safe, effective, and affordable and will be a "game changer" for poor countries.

The vaccine, called CORBEVAX, was authorized for use in India last month after clinical trials showed promising results. According to NPR, an unpublished study conducted in India found the vaccine was 90% effective in preventing disease caused by the original coronavirus strain and 80% effective against the Delta variant. The vaccine is still being tested against Omicron.

The hope is that this new vaccine can be manufactured and distributed much more cheaply and efficiently than either of the mRNA vaccines produced by Pfizer and Moderna or the viral vector vaccine from Johnson & Johnson.

Peter Hotez and Maria Elena Bottazzi are the medical researchers responsible for developing the vaccine. They began work on what became CORBEVAX around 19 years ago, at George Washington University in Washington, D.C., where they were studying vaccines and treatments for tropical diseases such as schistosomiasis and hookworm, NPR reported.............

https://www.theblaze.com/news/texas-scientists-say-they-have-developed-a-game-changer-affordable-covid-vaccine-ignored-by-us-government

[Hoodat]

"It's cheap, a dollar, dollar-fifty a dose," Hotez said. "You're not going to get less expensive than that."

No wonder the government turned it down.

[Mod2]

Topics merged.