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Here's something that's at once good news and extremely disheartening. Valneva, the only Western pharmaceutical to produce an inactivated virus vaccine for COVID19, today announced they are *starting* their phase 3 trials.
https://valneva.com/press-release/valneva-initiates-phase-3-clinical-trial-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/
https://valneva.com/press-release/valneva-initiates-phase-3-clinical-trial-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/
This comes 2 weeks after Phase 1/2 trials of their vaccine produced excellent results in inducing neutralizing antibodies.
But of course it did, we've known since 2005 that inactivated vaccines against original SARSCoV2 produced nAbs https://www.ft.com/content/bf3e8e9e-a94a-42b4-be11-a11d8d9790ec
But of course it did, we've known since 2005 that inactivated vaccines against original SARSCoV2 produced nAbs https://www.ft.com/content/bf3e8e9e-a94a-42b4-be11-a11d8d9790ec
Sinovac announced and published immunogenicity results from the Phase 2 RCT of their inactivated vaccine for COVID19 in Aug 2020. https://www.medrxiv.org/content/10.1101/2020.07.31.20161216v1.article-info
Pfizer/BioNTech and Moderna announced their immunogenicity Phase 1 results also in Aug 2020.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-share-positive-early-data-lead-mrna
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-share-positive-early-data-lead-mrna
So Valneva, starting Phase 3 now, is a full 8 months behind the first wave of vaccines, and indeed it's been 5 months since the Phase 3 trials of Pfizer/BioNTech and Moderna finished!
Valneva is also behind Bharat Biotech's Covaxin, which announced Phase 1 results in December 2020, and is now one of the two main vaccines being distributed in India (the other one being AZ's Covishield)
What's even weirder: Valneva managed to complete enrollment for a 4000-person Phase 3 vaccine trial in the USA between Dec 2020 and this month — but not for COVID19. Instead it is for chikungunya virus.
https://valneva.com/press-release/valneva-completes-recruitment-for-pivotal-phase-3-trial-of-chikungunya-vaccine-candidate-and-initiates-antibody-persistence-trial/
https://valneva.com/press-release/valneva-completes-recruitment-for-pivotal-phase-3-trial-of-chikungunya-vaccine-candidate-and-initiates-antibody-persistence-trial/
Chikungunya virus is a mosquito-borne virus that infects about 30 people per year in the US, and has an infection fatality rate of 1 in 1000. So... that's about 1 person per 33 years who might die of it in the US.
I read the press release 3x to make sure I wasn't hallucinating, but it's right there:
• dated 2021-04-12, with worldwide COVID19 cases at all-time highs
• a company specializing in infectious disease with significant unmet need
• testing a chikununya virus vax in the US
• dated 2021-04-12, with worldwide COVID19 cases at all-time highs
• a company specializing in infectious disease with significant unmet need
• testing a chikununya virus vax in the US
Words escape me. This is complete lunacy. I'm sure there's some excuse but I don't need to hear it. Sure it was already planned before COVID19 but adapt; take the same clinics recruiting 4000 for your chikununya vaccine and use them to recruit for your COVID19 vaccine.
Or just ice it, spare your company from the embarrassment of admitting they are a year behind on COVID19 vax. Touting the ability to trial 4000 Americans for a vax to prevent 1 death every 33 years, while COVID19 claims thousands of American lives daily, is idiotic.
For those of you who told me Western big pharma didn't need to do inactivated vaccines because they have newer shinier adenovirus and RNA vaccines, I give you: the current state of the world.
Specifically
• RNA vax expensive, harder to distribute
• Adenovirus vax with efficacy at 66-80% and exceedingly rare but scary side effects in healthy people; we'll use them but sure wish there were something without those side effects
• Inactivated vaccines in short supply
• RNA vax expensive, harder to distribute
• Adenovirus vax with efficacy at 66-80% and exceedingly rare but scary side effects in healthy people; we'll use them but sure wish there were something without those side effects
• Inactivated vaccines in short supply
And why are inactivated vaccines in short supply? Because
• India's Bharat and China's Sinovac Sinopharm need to vaccinate the >2B people in their countries first
• Western big pharma snubbed their noses at the old tech
• Valnexa cares more about chikungunya than COVID19
• India's Bharat and China's Sinovac Sinopharm need to vaccinate the >2B people in their countries first
• Western big pharma snubbed their noses at the old tech
• Valnexa cares more about chikungunya than COVID19
Meanwhile Bharat announced today their inactivated vax is 78% effective against symptomatic COVID19 and prevents nearly all severe disease. This is 2nd interim Ph3 look. Same as the 1st interim look a few months ago, and similar to Sinovac & SInopharm. https://in.news.yahoo.com/covaxin-demonstrates-78-efficacy-phase-111200169.html
So that's what happens when big pharma snubs tried and true old tech, and governments don't step in decisively to make sure it gets done. You have fancy solutions that are sometimes a bit too fancy, and you don't get enough of the tried and true stuff for the demands of the world
And finally, in case Valnexa pulls the press release, here it is. It's like something you would read in the Onion, except it's sad, not funny. Because it's real.
Also today, an article on France's other vaccine failures. It suggests innovation isn't supported enough.
But you don't need risky innovation if there are existing proven methods.
France would know: Pasteur followed Jenner's method to make his vaccines https://www.sciencemag.org/news/2021/04/after-coronavirus-vaccine-failures-france-laments-state-its-biomedical-rd
But you don't need risky innovation if there are existing proven methods.
France would know: Pasteur followed Jenner's method to make his vaccines https://www.sciencemag.org/news/2021/04/after-coronavirus-vaccine-failures-france-laments-state-its-biomedical-rd
A search for Pasteur and Jenner brings up this review that also concludes WKV/inactivated vaccines would be Pasteur and Jenner's choice.
They have advantages of comprehensive antigen presentation, their safety, and easy manufacturing/transport/storage. https://www.frontiersin.org/articles/10.3389/fimmu.2020.02173/full
They have advantages of comprehensive antigen presentation, their safety, and easy manufacturing/transport/storage. https://www.frontiersin.org/articles/10.3389/fimmu.2020.02173/full
