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2/5/2021

Industry Updates - Volume 5

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February has seen the news full of stories of virus mutations, increased vaccinations and global inequality. Volume 5 looks at these headlines and more.

Global Pandemic

Infections measured globally passed 100 Million during January, and now stand at 105 Million. New peaks for infections/deaths recorded in many countries worldwide last month.
Two countries with the largest number of confirmed infections - U.S. and India - both saw a fall in the number of new infections in January. In India, this is possibly due to some level of 'herd immunity' being achieved, as 56% of 28,000 people tested in Delhi tested at random to be positive for antibodies.
An important milestone was achieved worldwide, as the number of vaccinations (108 Million) exceeded the number of COVID-19 infections (105 Million) for the first time.
Current Single Dose vaccination rates: Europe - 3.4%, U.S. - 11.2%, UK - 16.5%, Israel - 58.5%.
Increasing concerns on new virus strains from the UK, Brazil, South Africa. South African strain reduces effectiveness of four current vaccines. Could require new vaccine booster shots for adequate protection.
All three leading Western vaccine manufacturers failed to meet production targets and contracted delivery volumes across many countries, by up to 50% in volume and by up to three months in timing
- European Union severely affected - had previously delayed signing agreements while negotiating lower prices; Latest updates from Pfizer more positive.
The EU controversially introduced a new export approval process for delivering EU-manufactured COVID- 19 vaccines outside of the European Community.

Industry News

EMA has approved the Moderna vaccine only manufactured in Europe, given U.S. production issues.
Multiple AstraZeneca updates:
- Despite a bitter public row between AstraZeneca and the European Community, the AstraZeneca/Oxford vaccine was approved for Emergency Use in Europe last week.
- However, lower efficacy of AstraZeneca in older people led multiple countries to not approve it for that population - Germany, Poland, Austria, France, Belgium, Sweden and Italy.
- Leading German newspaper Handelsblatt claims the vaccine is <10% effective in older people.
- Switzerland refused authorization of AstraZeneca vaccine, pending U.S. Stage 3 Trial data.
- Separately, AstraZeneca announced new early results suggesting a single shot of their vaccine rose to a peak of 75% efficacy 12 weeks after inoculation, rising to 83% after a second dose.
  - Better result than the 62% after two shots reported in Stage 3 Trial (4-week dosing interval).
  - Measurement of antibodies however, showed a peak at 28 days with a decline of 33% by 90 days, and a 64% decline by 180 days.
- AstraZeneca excluded hundreds of cases that were PCR positive - but without disease symptoms - to achieve these results; inclusion of all Covid positive cases showed efficacy of only 49%, just below the minimum target set by regulators.
Has become clear that current vaccines are less effective against the South African mutation; Moderna, GSK/Curevac and AstraZeneca all working on new vaccines to counter this new strain.
Merck abandoned its Covid vaccine development efforts, which involved two different protein vaccines; Will concentrate on Covid-19 therapeutics, and will also assist with vaccine manufacturing of Pfizer/BioNTech, as will Sanofi.
Johnson & Johnson reported Stage 3 data for their One-Shot adenovirus vaccine; Roughly as effective as the Two-Shot adenovirus vaccine from AstraZeneca; Results varied by location, with 72% efficacy in the USA: 66% in Latin America, and only 57% in South Africa; Requested FDA Emergency Use Authorization approval, now expected end of February.
Novavax also reported Stage 3 efficacy data at 85% in the UK, only 49% in South Africa.
Fortune magazine pointed out differences in measurement between the American and overseas Stage 3 trials, with the U.S. Trials typically measured three categories, whereas Brazilian Trials measured six. If the 1,529 mild cases ignored in the Pfizer Stage3 trial had been counted, Pfizer’s 95% efficacy reported would be significantly lower.
- However, data from 700,000 actual Two-Shot Pfizer inoculations in Israel gave a 92% effectiveness in the first few weeks.
The Russian Sputnik vaccine, using two different types of adenovirus to achieve a meaningful boost from the second shot, reported efficacy of 92% in a peer-reviewed paper published in the Lancet.
- However, doubts remain, as earlier Trials were not published nor peer-reviewed
- Data in the Stage 3 Trial was 'self-reported', compared to objective scientific tests (PCR, etc.) in other trials
- Also, significant manufacturing challenges for the second shot of the Sputnik vaccine.

Financial News

GSK purchased 10% of the mRNA German company CureVac for $180 Million, committed to developing 'next generation' vaccines to address the Covid mutations.
Novavax’s stock price jumped 210+% in one week - adding almost $9 Billion to the company's market cap - following announcement of it’s vaccine test results, even though the results showed mixed signals in performance; Novavax plans to raise as much as $500 Million, given these test results.
Inovio (INO) commenced a $150 Million cash raise.
Pfizer announced it expected $15 Billion of Covid vaccine sales in 2021.
BioNTec paid a special $600 Million cash dividend to their investors.

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