Industry Updates Volume 20

SARS-CoV-2: Tougher Variants, New Vaccines, Extended Coverage, Slower Vaccine Rates

• Tougher Variants: The arrival of further Omicron variants BA.4 and BA.5 have resulted in another surge of global infections
• The true extent of the surge is hard to quantify, as there are less testing facilities available, and less interest on the part of the public in testing
  • Epidemiologists consider BA.5 - also referred to as the ‘Ninja’ variant - “The worst version of the virus that we’ve seen”, overtaking the ‘Stealth’ BA.2 version of Omicron
  • BA.5 is also being referenced as a ‘Deltacron’-like variant, given that is is so transmissible and is showing signs of symptoms in the lungs, vs. other Omicron variants affecting mostly the upper respiratory areas only
  • This variant evades immunity from either prior infections or from the initial vaccines in use world-wide over the past 18 months
  • BA.5 is causing > 50% of all U.S. infections, based on late June health data
  • Infections and hospitalizations in the U.S. have doubled from May to June, but with reductions in reportable testing, some experts think the caseloads could be 10X higher
  • Another variant - BA.2.75 - infecting people in India, as the Omicron strain continues to evolve
• Estimates on how widespread these new infections are varies from 5%-30% of the population
• Hospitalization and death rates as a percentage of infections continue to fall
  • This is believed to be driven by the cumulative effect of vaccinations and prior infections, but is not a reduction in the severity of risk in naive (not previously infected/vaccinated) subjects
• Vaccination - even with 3 shots of Pfizer or Moderna - has not stopped most infections
• Countries with older populations appear to be having worse outcomes (Portugal vs South Africa) irrespective of vaccination status (90% vs. only 50%)
  • Good BA.4/BA.5 reference: https://www.nature.com/articles/d41586-022-01730-y
• To combat the BA.5 variant, in early July, China instituted a mandatory vaccination program for selected venues - a first of its kind for China - but then quickly scrapped the program after Chinese citizens strongly criticism of the new policy
• Meanwhile, given the BA.5 variant, China shut down all gambling casinos in Macau for one week
• World Health Organization still considers COVID-19 a global health emergency
• Exhibits 1-2 show the extent of the latest surge, in terms of both (probably under-) reported infections, as well as deaths (right-most portions of the exhibits)
  • Daily caseloads have almost doubled from 477K in early June to 820K in early July
  • Death rates, while down, continue to be non-trivial
  • For example, in the United States, current COVID-19 death rates are still running at 3X-4X the annual death rates from motor vehicle accidents
• New Vaccines - Annual COVID-19 Shots:  Dealing with COVID-19 going forward is - as predicted - beginning to look more like an annual flu shot campaign
• The two challenges: 1) Timing and 2) Which variants to target
• The risk is that targeted variants will be the wrong targets when the vaccine is ready to go
• Pfizer and Moderna have each tested vaccines targeting the initial Omicron strain
  • U.S. has ordered 105 Million doses of these new vaccines from Pfizer
• The FDA is currently deciding which policy to pursue; signals already being sent to expect new versions of the vaccine to be available this fall
  • The independent advisory committee has recommended updating vaccines to include Omicron
  • An Alternate Perspective: "Don't Rush a Change to the COVID-19 Vaccine Composition”: https://www.statnews.com/2022/06/29/fda-dont-rush-to-change-covid-19-vaccine-composition/

• A large study of long COVID-19 was initiated in the U.S.; it will enroll 40,000 test subjects
• Broader Vaccine Coverage, But Declining Vaccine Rates: FDA has now approved Pfizer and Moderna vaccines for children 5 and under
  • Controversial Decision - The sickness/death rates in this age group from COVID-19 have been infinitesimal, and unlike nearly all other childhood vaccines, the protection quickly wanes
• Global vaccine rates have declined, leveling off between 6-9 Million doses/day - in the U.S., the number is down to 150K doses/day
• In many countries with lower vaccination rates, the market has reached saturation due to:
  1) Public resistance to vaccination and 2) Feeling by the general public that the Pandemic is ‘over’ and 3) Reduced prioritization of COVID-19 government vaccination campaigns

Vaccine Industry Updates

• Valneva: https://pubmed.ncbi.nlm.nih.gov/35718205/, Stage 1/2 test results for its WIV vaccine
  • In mid-June Valneva settled with the UK for the the termination of the UK’s Advanced Purchase Agreement (APA) for Valneva’s vaccine
  • In late June, Valneva received full marketing authorization for its vaccine in all 28 EC countries and is also now getting country-specific approvals, e.g., Sweden
  • Also announced an Equity Subscription Agreement with Pfizer, allowing PFE to invest in 8.1% of Valneva’s shares, participate in the development of a vaccine candidate for Lyme disease
• Novavax: 4th vaccine approved in U.S., early June; U.S. ordered 3.2 million doses of this vaccine; will be manufactured by the Serum Institute of India (SII)
  • Novavax’s vaccine already available in 40 other countries
  • As a protein sub-unit vaccine, the Novavax vaccine is targeted as ‘an alternative to MRNA vaccines’, towards the non-vaccinated ‘vaccine hesitant’ skeptics
  • https://www.science.org/content/article/fda-advisers-greenlight-novavax-covid-19-vaccine
• CureVac: filed a patent lawsuit against BioNTech and two of its subsidiaries in Germany for violation of MRNA patents
  • An illustration of the competitive intensity in the Biotech industry over intellectual property protection, especially since CureVac’s MRNA-based COVID-19 vaccine was considered a failure
• QazCovid-in (QazVac): WIV-based vaccine developed in Kazakhstan 
  • https://pubmed.ncbi.nlm.nih.gov/35770251/
• Sinopharm:  In June, reported a test of a Trivalent WIV vaccine in a mouse experiment; the test used the HBO2, Delta and Omicron variants - this is consistent with Refana’s approach
  • https://pubmed.ncbi.nlm.nih.gov/35746564/

Financial Markets

• Biotech stocks have suffered more than the general equity markets in the recent declines
  • BioNTech down 35%; Moderna down 38%; Novavax down 63% over the past six months
  • This compares to 16% drop in Dow Jones;  21% fall in S&P 500; 24% in the NASDAQ
• Contrarian move: ARCH Venture Partners raised U.S. $3 billion to invest in early stage biotech

Post-COVID-19 Economy

• While severely exacerbated by Russia's invasion of the Ukraine, all of the major economic shocks the world is now suffering were already evident/or predicted during the height of the COVID-19 pandemic, i.e.:
  • Disruption to the global supply chain
  • Labor shortages
  • Rampant inflation
  • Social unrest and political polarization
    
    

Refana Update

• Refana's Vaccine Division maintains its interest in three areas:
  • Design of longer-acting protective COVID-19 vaccine boosters using a Trivalent WIV approach
  • Potentially dramatic improvements in the manufacture of WIV vaccines in terms of modularity (which lowers the economies of scale), quality and consistency of production (providing greater predictability and control of yields), and significantly improved unit cost economics
  • The quest to design a single pan-Coronavirus vaccine - also known as a Universal Vaccine - utilizing computational genomics and Artificial Intelligence
• Refana continues to seek non-dilutive funding for the first two areas and is exploring additional funding for the third area
• Exhibit 3 shows the ‘Poster Board’ summary of the Illinois Institute of Technology (IITRI) research paper on the Refana-sponsored Proof-of-Concept WIV Vaccine Test - will be presented at the American Society of Virology (ASV) Conference in Wisconsin - July 16-20, 2022

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Next Update - End of Q3

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Exhibits

Exhibit 1: Cases Per Million People 2022

Exhibit 2: Deaths Per Million People 2022

Exhibit 3: American Society of Virology (ASV) Conference Poster Board - July 2022

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