Industry Updates Volume 21

SARS-Cov-2 Pandemic Mostly, But Not Completely Over

• Omicron variants still rule - no new highly contagious + severe variants have emerged
• Despite Pfizer and Moderna’s regulatory approvals for a bivalent (Omicron BA.5 and the original Wuhan strain) mRNA booster and the release of these vaccines into the U.S. and many other markets, there continues to be many breakthrough infections:
  • Refana aware of many boosted with new vaccines that have then tested COVID-19 positive
  • President Biden and Dr. Albert Bourla, Pfizer’s CEO, have both tested COVID-19 positive twice
• It appears that the sub-variants of the BA.5 Omicron variant are becoming increasingly vaccine resistant, while thankfully not imposing severe illness during an infection
• SARS-CoV-2 not fully settled down - could evolve to other highly contagious + severe variants
• Many signs the world is moving away from treating SARS-CoV-2 as a Global Pandemic:
  • In a recent 60 Minutes (CBS) Interview, President Biden declared that “The Pandemic is over”
  • The WHO also said that the end of the Pandemic is approaching, given that 7-day rolling average global daily caseloads and death rates have dropped to much lower levels
    • Caseloads are currently estimated at -450K on a global basis, ~50K in the U.S.
    • Death rates now estimated at 1,438 per day globally, 450 per day in the U.S. - the lowest levels since March 2020 (but compared to 118 deaths/day from car accidents in the U.S. in 2021, current COVID-19 death rates are still 3.8X more severe than car accidents)
    • Measurements are getting noisy - many agencies have stopped tracking this data
  • Vaccination rates are also much lower: 775K doses/day globally, 45K doses/day in the U.S.
  • However, there are still well over 2 ½-3 Billion people in the world who not vaccinated at ALL
  • Even countries trying to execute a Zero Covid policies are relaxing constraints, for example, China, recently lifted city-wide lockdowns in megacities such as Chengdu.
• Still a common belief in the research community that the world will see future seasonal waves of COVID-19 infections going forward. 

Pandemic After-Effects, Lessons Learned

• A clear long-term impact has emerged with what is now generally referred to as ‘Long Covid’
• Not well understood, Long Covid incorporates a broad range of symptoms and severities
  • Most common symptoms: Shortness of breath, cognitive dysfunction (‘brain fog’), fatigue
  • 200+ additional symptoms have been reported as Long Covid-related, including chest pain, difficulty with speech, anxiety, depression, muscle aches, fever, ongoing loss of smell or taste, and the list goes on
• Significant research is being done now to better understand this situation and how to treat it
• Many ‘SARS-Cov-2 Pandemic Lessons Learned’ are beginning to emerge; for example, the Lancet COVID-19 Commision, who’s key points include:
  • Overall, the global loss of 17.2 Million lives - their estimate - is considered a “profound tragedy and massive global failure on several levels”
  • Much of this was driven by world powers and governments that did not collaborate, act rationally or transparently to control the Pandemic
  • The WHO was cited as being ‘sluggish’ and too cautious - not sounding the alarm bell quickly enough, taking too long to declare a global public health emergency and acting too slowly to recommend the use of masks and to restrict travel to curb the spread of the virus
  • Advocacy of a ‘Global Health Fund’ - aligned with the WHO - to aid disease control, Pandemic preparedness/response and health scale up - recommended funding level is $60 Billion/year
• Given SARS-CoV-2’s migration from Pandemic status, wait to see what reactions and responses will take place for these or similar recommendations to improve Global Pandemic preparation.

Vaccine Industry Updates

• Even more evidence suggesting that Pfizer and Moderna have emerged as the primary duopoly in the Western World for COVID-19 vaccines and boosters, given their recent bivalent booster approvals and current FDA applications to release these vaccines for children
  • A beginning of the expected evolution and transition to the Western world ‘winners’ taking their solutions to periodically-updated vaccine protocols, similar to flu vaccines
• Chinese and Indian vaccine manufacturers will end-up supplying the Rest-of-World
• Meanwhile providers such as Valneva in Europe are moving to next generation vaccine development, given a lack of demand or orders for their approved COVID-19 vaccine
  • VLA stock price in Europe now at ~20% of its 52-week high (i.e., 5.1 € vs. 26 €)
• Other U.S. providers - such as Novavax - also not making progress with their approved vaccine; first-to-market players (i.e., Pfizer, Moderna) clearly winning the vast majority of the profit pool
  • NVAX stock price now at ~8% of its 52-week high (i.e., $20 vs. $250) - too late to the party
• Interestingly, in August, Moderna filed a patent lawsuit against Pfizer/BioNTech for violating Moderna’s mRNA patents filed between 2010-2016, with the following implication:
  • In effect, once this lawsuit gets settled - as they typically do - this locks in both players as a duopoly, making it harder for others to get into the same vaccine markets.

Refana Update

• Beyond participating in the more traditional vaccine development business, Refana has pushed forward on a next generation development for  a Pan-Coronavirus/Universal vaccine
  • Funding application for this approach now in consideration with CEPI (Coalition for Epidemic Preparedness Innovations) via their RFP process - response expected in the next few months
• Refana is also pursuing AI in Medicine applications, consistent with the Company’s original foundation - more to be revealed on these proprietary Projects when they can be discussed.

Next Update - End of Q4

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