Industry Updates - Volume 2

12/18/2020

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Volume 2 of our Industry Updates sees the second Covid-19 wave still raging and highlights the latest vaccine developments.

Pandemic Stats Update

Second COVID-19 Wave Still Raging

Pandemic data shows strong growth in the frequency (# of infections) and severity (# of deaths) of COVID-19 - both Globally and in the U.S. - from Mid-November to Mid-December:
- # of infections grew 26% around-the-world and 38% in the U.S.
- # of deaths grew 20% around-the-world and also 20% in the U.S.
Surprising growth rates in the last month, on a large base of infections/deaths.

Industry News

Pfizer/BioNTech Vaccine Rollout/Allergic Reactions

Following the granting of Emergency Use Authorizations (EUA) in both the UK and U.S., two severe allergic reactions occurred in the UK, followed by two allergic reactions in Alaska. One severe case of anaphylaxis occurred in Alaska for a person with no history of allergies.

Moderna Approval

Moderna reports 95% efficacy from 14 days after the 2nd shot as the headline, with equal effectiveness across genders, ethnic groups. In the 65 and older group, efficacy fell to 84%.
More severe reactions to first/second Moderna shots than in Pfizer's case. 19% of the placebo group suffered pains from the shot, 84% of the vaccinated group suffered. Of these, one in five (16% overall) had 3rd level severity - i.e., unable to carry on daily activities, going to work and/or needed prescription-only level painkillers. 10+ times the level of the placebo group.
As with Pfizer, a number of cases of Bell's Palsy occurred in vaccinated groups, and in addition, facial swelling in people with dermal injections.
Eleven vaccinated persons got Covid-19 - not severely. One vaccinated person died.
FDA Advisory Committee voted 20-0 (with abstention of the industry rep) to recommend EUA for Moderna from FDA. (Pfizer had four votes against).

Astra Zeneca/Sputnik Discussions

Following the 62% efficacy result for the core Oxford 2 shot design, discussions commenced with Russian vaccine Sputnik, which has a better design - it uses a different adenovirus for the first/second shots (addressing the problem of adenovirus not working the second time).
The Russian vaccine was criticised for inadequate testing and may have manufacturing challenges, which Astra Zeneca could help overcome.

CSL/University of Queensland’s Protein Sub-Unit Based Vaccine Cancelled

Vaccine was promising, with novel technology used to bind spike protein derived from HIV, but it caused false positive HIV results in testing.

Sanofi/GSK Delayed

Following mistakes in the calibration of the level of antigens in their vaccine candidate - leading to poor results - a new formulation and trial is contemplated, prompting a delay of 6-7 months. Could lead to final approval by the end of 2021, vs. original plan to gain approval in May, 2021.

Johnson & Johnson (J&J) One-Shot Adenovirus Vaccine Now up to 45,000 Stage 3 Trial Participants

J&J is expected to report initial results from this Trial in late January, after a one-week delay due to an ‘unexplained illness’.
Two-Shot version is also being tested in Stage 3 Trials by J&J/Janssen.

Valneva Whole Inactivated Virus (WIV) Vaccine Enters Trials

Valneva just commenced Stage 1 Trials in the UK for their WIV vaccine, that would be primarily focused on the UK/Europe once approved.

Finance News

Novavax Executives Sell Shares

The top five executives of Novavax all sold approximately U.S. $5M of shares each at prices of U.S. ~$120 per share over the past eight weeks; 30% below the U.S. $180 peak in August.
Investment analysts suggest this indicates a lack of confidence in their Protein Sub-Unit vaccine.

Gates Provides Funding for Second Wave Covid-19 Vaccines

The Gates Foundation together with Coalition for Epidemic Preparedness Innovations (CEPI) announced their first investment in a next-generation 'Wave 2' vaccine candidate for Covid-19, making a U.S. $10M grant to SK Bioscience of South Korea.

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