Industry Updates Volume 9

​Global Pandemic

• Globally, the pandemic shows no sign of abating as global deaths reach 4 million
• The majority of COVID-19 related deaths have occurred in the past 6 months
  • World-wide COVID-19 death toll in first 6 months of 2021 exceeds total COVID-19 deaths in 2020
  • U.S. passed 600,000 deaths in mid-June
  • Fears that the pandemic in India is spreading to neighbouring countries
  • Brazil passed 500,000 deaths; with severe outbreaks in other Latin American countries, e.g., Columbia, at 100,000 deaths
  • New COVID-19 hot spots have also broken out, for example in Kenya in East Africa
• The ‘common theme’ across these outbreaks and hot spots is the Delta variant, which originated in India; the prediction that "No One Will Be Safe, Until Everyone Is Safe" is becoming reality
  • Delta making substantial inroads, in countries: 1) WIth high vaccination rates (e.g., Israel, the UK); 2) With strong isolation/tracing (e.g., Australia) and 3) Where prior variants dominated (e.g., South Africa, with the Beta variant)
  • Delta variant represents 99% of new infections in the UK and is predicted to reach 90% of all infections in Europe by August
  • Former U.S. FDA Commissioner - now a Director at Pfizer - Dr. Scott Gottlieb predicted that U.S. is two months behind the UK in the penetration of the Delta variant - and to expect  local mini-Pandemics in locales in the U.S. with low vaccination rates (482 U.S. counties have vaccination rates < 25%)
  • The CDC Director pleaded for people to get vaccinated to prevent “Completely avoidable deaths”
• Over 3 Billion vaccine doses administered to date - 40% of those are in China
  • China represents ½ of the 43 Million doses currently being administered per day and 5 countries (China, India, U.S., UK, Brazil) plus the EU accounts for 80% of vaccines administered so far
• The recent G-7 summit started positively, with President Biden's commitment to provide 500 Million doses of the Pfizer-BioNTech vaccine to lower-income countries, and the expectations of total pledges of 1 Billion doses from all the G7 nations
  • Final communique referenced 870 Million doses
  • Duke University reported a real 'new commitment' of only 648 Million doses, when prior, recycled pledges and existing EU schemes were discounted
  • Duke forecasts that it will take well into 2023 to reach even 60% of the target global population globally vs. the 70% considered to be the minimum to be effective.

Industry

• Pfizer-BioNTech and Moderna maintain their market leadership in the West, but there is a loss of lustre to their crown, for several reasons;
  • As new variants diverge further from the original Wuhan strain - which existing vaccines are based on - the amount of antibodies generated in defense by these vaccines falls by up to 80%
  • In Israel, there have been reports of people fully-vaccinated with two doses of Pfizer becoming infected; Israel has re-introduced mask-wearing and extended its travel ban for a further month
  • The side effect of heart myocarditis, caused by the mRNA vaccines in a small percentage of healthy, mostly young males, has been confirmed by the CDC, in more than 300 cases in the U.S.
• On the positive side, this heart side-effect is not as life threatening as the blood clots caused by AstraZeneca and Johnson & Johnson, and also affects a lower percentage
• President Biden chose to provide Pfizer-BioNTech vaccine in the 500 Million dose donation
  • Made it clear that this was an entirely new vaccine order vs. using up substantial pre-paid inventories of AstraZeneca and Johnson & Johnson doses under Operation Warp Speed
  • Perhaps to prevent any allegation that the U.S. passed off 'inferior products' on the 3rd World
• Meanwhile, potential challenges to Pfizer/Moderna's leadership position in mRNA from German start-up CureVac receded, given that the CureVac mRNA trial failed to reach the minimum 50% efficacy hurdle
  • The EU and Germany had already partially pre-paid for 200 Million doses of the CureVac vaccine
• Outside of Europe and North America, the WIV vaccines dominate the market overall, with close to 80% of actual vaccinations in China, India and 70 other countries (Exhibit 1 below)
• Bloomberg recognized this global WIV vaccine leadership position, given the volume of inoculations and number of countries involved with the Chinese Sinovac/Sinopharm vaccines, described as "good enough"
• The Brazilian regulator failed both the Sputnik and Bharat vaccines after manufacturing site inspections
• FDA has ordered the destruction overall of 60-70 Millions doses of both AstraZeneca and Johnson and Johnson vaccines in its ongoing review of troubled Baltimore Production Factory, Emergent BioSolutions
• Novavax announced Trial results of up to 91% efficacy (and as low as 60%, based on other calculations)
  • They delayed their FDA submission by 3 months to September
  • Meanwhile, The Serum Institute of India (SII) announced they will begin manufacturing the vaccine.

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