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2/9/2021

To vaccinate or not to Vaccinate?

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Talking Tachlis Podcast

Talking Tachlis Podcast - interview with Dr. Phillip Schwartz
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Talking Tachlis Podcast · 129. To Vaccinate or Not to Vaccinate? with Dr. Phillip Schwartz
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2/8/2021

Refana CEO Gives Update on COVID-19 Pandemic

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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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