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6/30/2021

Assessment of Approved COVID-19 Vaccines

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Given the broad and extensive coverage by the media and the scientific literature on how the Pharma/Biotech world is doing in the development and deployment of COVID-19 Vaccines in 2020-2021, Refana decided to take an objective, systematic look at the 'current state' of the approved COVID-19 vaccine world, to assess how these vaccines were doing in the fight against the COVID-19 Pandemic. As a result, this 'White Paper' addresses six key questions:

How are the currently approved COVID-19 vaccines doing overall in the fight against the Pandemic?
How are they doing against the emerging 'Variants of Concern' (Alpha - UK, Beta - South Africa, Gamma - Brazil and Delta - India) vs. the original Wuhan virus?
What are the key side-effects of each approved COVID-19 vaccine
How well are the approved COVID-19 vaccines doing as far as levels and lengths of immunity and the need for further Booster shots?
How have these vaccine manufacturers' done as they transitioned from development to production of their vaccines?
How have other factors - Government-driven vaccine diplomacy, vaccine hoarding/equity issues, and vaccine hesitancy - impacted the roll-out of these approved Vaccines?

Refana summarized its findings in a short-form outline style to make these insights more accessible. Refana have also provided detailed Appendices with more specific info to support the summary outline, plus a detailed listing of all source links to the original articles and research papers that drove the assessment.

This material is not meant to be a detailed scientific review of the approved vaccines, but more of a summary of the ongoing findings related to the approved vaccines with respect to these six key questions, based on the substantial amount of reporting that has been published world-wide during the COVID-19 Pandemic. As such - and as an objective assessment of where things stand - Refana believes this material represents a good consolidated reference document on the current 'State of the Art' for the approved COVID-19 vaccines.

Since this is a highly dynamic situation, Refana is referring to this White Paper as the June 2021 Release V1.0. Refana intends to regularly update this material with the latest info on all approved COVID-19 vaccines on a periodic basis.

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Since this is a highly dynamic situation, Refana is referring to this White Paper as the June 2021 Release V1.0. Refana intends to regularly update this material with the latest info on all approved COVID-19 vaccines on a periodic basis.

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6/29/2021

Industry Updates Volume 9

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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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Assessment of Approved COVID-19 Vaccines

Industry Updates Volume 9

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