Welcome to our first Industry Update, which brings you the latest news in Covid-19 Vaccine Developments and Industry Financial Updates.
Covid-19 Vaccine Developments
Pfizer/BioNTech (Pfizer) achieved Emergency Use Authorization (EUA) in the UK and Canada, and EUA appears imminent in the US.
The Pfizer submission to the FDA reveals a significant issue with side effects during vaccinations. This was mirrored during the very first day of administering the vaccine in the UK, where two health workers suffered anaphylaxis - a very serious and life threatening allergic reaction, leading to a recommendation from the MHRA to stop giving the vaccine to allergic people and to only administer this vaccine in a hospital or clinical setting.
In Stage 3 Trials of the Pfizer vaccine, vaccine recipients suffered 2X-10X more side effects than placebo recipients, including fever, headaches and fatigue, many lasting several days. There were also unexplained increases in lymphadenopathy, Bell's Palsy, and appendicitis among the vaccinated group.
In dramatic contrast to Pfizer, almost the same percentage of parties injected with the Sinovac Whole Inactivated Virus (WIV) vaccine (19%) or placebo (18%) complained, mostly of local pain at the site of the injection only.
The 94% 'headline' efficacy rate for the Pfizer vaccine – which has been widely publicized – is based on measuring those people who had received both doses and after a further time lapse to allow the immunity to become stronger. The raw data however of the full group was 50 vaccinated persons who got COVID-19 compared to 275 on the placebo, which is 82% efficacy. There were four deaths from COVID-19, one among the vaccinated and three among the placebo (66% efficacy). Efficacy against severe Covid-19 disease was measured at 75% (one vaccinated party vs four on placebo).
Pfizer is the most difficult vaccine to administer, not just because of the -70°C cold chain distribution requirement, but also because it needs to be thawed and diluted 3-to-2 with sterile Sodium Chloride 0.9% injection just prior to vaccination; this creates five doses, which then all must be used within 6 hours from the time of dilution.
The Astra Zeneca/Oxford adenovirus-based vaccine received pushback from the FDA and the Indian regulators, following problems with the trials and poor disclosure; nonetheless, it is likely to be approved in the UK next month.
The leading WIV contenders, Sinopharm and Sinovac, which received Emergency Use Approval in China in July 2020, have now vaccinated 1.3 million people in a dozen countries, 5X more than all other vaccines in development world-wide. No reports of serious side effects so far. Use authorizations given in Bahrain and the UAE, imminent in Indonesia. Efficacy of 84% is suggested from a small sample – more extensive results expected from multi-country Stage 3 Trials in weeks.
Industry Financial Valuation Updates
The pure-play Biotech mRNA stock prices have risen by more than 3x in six months. Moderna is now valued at U.S. $61B; BioNTech (which shares the rights 50/50 with Pfizer) at U.S. $31B; the German Curevac at U.S. $23B.
Sinovac raised U.S. $515M for 15% ownership this week valuing the Covid-19 vaccine unit at U.S. $3.4B. This followed the successful completion of Sinovac’s Stage 2 Trials and the commencement of Stage 3. Seven months ago, on completing the animal trials and starting Stage 1 in humans, the company sold 15% for U.S. $15M or a valuation of U.S. $100M. This represents a 34X gain in 7 months.