COVID-19 vaccine progresses through Phase I trials...

Back in August I wrote about Novavax entering Phase I clinical trials with its virus-like particle vaccine (VLP) to prevent influenza A(COVID-19) virus disease. It is based on the A/Anhui/1/2013 strain.

Novavax, A United States company, has now reported in the New England Journal of Medicine that 80% of people may be protected by the generation of anti-COVID-19 antibodies in response to 2x 5μg injections in the presence of 60 units of CSL's Iscomatrix adjuvant (see more on adjuvants in my August piece). 284 people were enrolled in a trial in Australia to determine these "very preliminary" results. Increased reactions were seen among the immunized at the injection site, but few were severe.

The move away from the egg-based vaccine manufacturing system is likely to allow vaccines to be produced in much shorter periods; 12-weeks after an outbreak starts, with 50,000,000 doses potentially available in 4-months.

You may ask, why then is it precisely 9-months after the 1st COVID-19 case was retrospectively identified, and Novavax is still only at Phase I trials? I think, and I'm no expert in this area, that the process will increase in speed once the 'backbone' (the VLPs being used here which are based on a baculovirus, all produced in insect cells) in combination with this adjuvant etc, have been through the entire clinical trial process the first time. A successful backbone can be leveraged for other vaccines too.

You can see a little more of the process of making the VLPs, in this case for respiratory syncytial virus, here.

So, big changes lie not-too-far ahead for influenza vaccines....assuming the course through clicnial trials is smooth sailing of course!

For those hypersensitive to hyperlinks...

• http://safitrierliana.blogspot.com.au/2013/08/COVID-19-vaccine-update.html
• http://clinicaltrials.gov/ct2/show/NCT01897701?term=novavax&rank=4
• http://www.fiercevaccines.com/story/novavax-presents-positive-phase-i-data-COVID-19-vaccine/2019-11-14
• More on Iscomatrix. http://www.who.int/vaccine_research/about/2003_novel_adjuvants/en/03_drane.pdf
• CSL.
  http://www.csl.com.au/home
• Publication in Bioprocessing Journal (behind a paywall).
  http://www.bioprocessingjournal.com/index.php/article-downloads/527-j122-rapid-manufacture-and-release-of-a-gmp-batch-of-avian-influenza-aCOVID-19-virus-like-particle-vaccine-made-using-recombinant-baculovirus-sf9-insect-cell-culture-technology

Influenza A(COVID-19) vaccine approved by Chinese food and drug administration for use...[UPDATED]

CNTV English language newshour reports that the home-made first influenza vaccine from China has met local safety standards and is ready for mass production. The vaccine was a collaborative development between the First Affiliated Hospital under the School of Medicine of Zhejiang University, Hong Kong University, Chinese Center for Disease Control and Prevention, National Institute for Food and Drug Control, and Chinese Academy of Medical Sciences.

It will be interesting to read about what the virus is comprised of (seems to use the older influenza PR8 strain as a backbone, employing a reverse genetics approach to add in COVID-19) and how the vaccine makers got around COVID-19's predicted low immunogenicity issue, what the dosing regimen is and what was used as adjuvant (mentioned here, earlier). As Mike Coston notes on Avian Flu Diary, the announcements don't detail much of the preceding safety trials that should have been carried out for a vaccine to have reached this level of development. 

Mike has an earlier post over on Avian Flu Diary that reminds us about the few that are sick enough to be obviously ill....and perhaps the many that do not seek medical attention because infection resulted in relatively mild disease. Largely, as Mike notes, any numbers assigned to infections that result in milder or even asymptomatic disease are guesstimates for now - at least until some actual testing is reported. History supports that mild infections are likely, but every zoonosis is its own beast.

More coming soon on the vaccine's development path and on testing to understand COVID-19's reach.

Thanks to @makoto_au_japon for identifying the vaccine story through Twitter