RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Vaccine headlines continue to pour following V-Day in the U.K., brighter news on the University of Oxford and AstraZeneca (NASDAQ:AZN) jab and the possibility of mandatory vaccinations for New Yorkers.
The latest? China’s state-backed coronavirus vaccine, developed by Sinopharm (OTCPK:SHTDF), was found to have protected 86% of people against COVID-19 in trials conducted on 31,000 volunteers in the UAE.
The vaccine has already been administered to hundreds of thousands of people under emergency authorization in China, but it’s yet to receive public use approval from any drug regulators.
Unlike shots developed from Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) – which have over 94% efficacy – but rely on mRNA and deep freeze facilities, China’s vaccine is based on an inactivated virus and can be transported at normal refrigerated temperatures.
That makes it an attractive option for nations without sophisticated cold-chain infrastructure and developing countries like Indonesia and Pakistan have already signed deals for the vaccine.
Pfizer (PFE -1.5%) and BioNTech (BNTX -3.4%) say documents related to their development of a COVID-19 jab have been “unlawfully accessed” in a cyber attack on Europe’s medicines regulator. No further details were provided.
Both the company said no personal data of trial participants have been compromised and the European Medical Agency “has assured us that the cyber attack will have no impact on the timeline for its review.” They also added that “no BioNTech or Pfizer systems have been breached in connection with this incident”.
The Pfizer-BioNTech jab is among the top contenders in a global race to roll out a vaccine for COVID-19. Under emergency use nod, administration has begun in Britain.
The vaccine is still being reviewed by the European Union, which is expected to complete by Dec. 29.
Canada has become the latest country to approve the COVID-19 vaccine co-developed by Pfizer (PFE) and BioNTech (BNTX). Already approved in the U.K. and Bahrain, the vaccine, code-named BNT162b2, is undergoing the FDA review this week ahead of a potential emergency use authorization in the U.S.
“Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified,” Health Canada said in a statement.
The recommendation for use in people 16 years of age or older, could change as “Pfizer-BioNTech are running further clinical trials on children of all age groups”, it further added.
Pfizer and BioNTech are on track to supply 20 million doses to Canada through 2021, including 249,000 doses scheduled to deliver this month.
Yesterday, Britain kicked off its COVID-19 vaccination campaign giving the Pfizer/BioNTech jab to a 90-year old retired shop clerk.
Moderna (NASDAQ:MRNA), a potential winner in the COVID-19 vaccine race, receives a downgrade from Needham from ‘Buy’ to ‘Hold’ rating.
The company’s COVID-19 jab, MRNA-1273, undergoing review across the world for regulatory approval, is scheduled to face the FDA Advisory Committee meeting next week, potentially leading to an Emergency Use Authorization.
The analyst Alan Carr notes, with the development of the vaccine, “Moderna has made significant progress in 2020 towards validation of its mRNA platform” arguing, the stock, after a +770% YTD gain compared to the +18% rise in the S&P 500 Index, appears ‘fully valued’.
Despite a potential upside from the EUA, Carr believes, the approval will not ‘justify a meaningfully higher price target’, until data emerge on ‘competitor vaccine updates and additional data from other Moderna programs’.
Despite trading -4.27% lower today, the stock has gained more than a fifth in value over the past five days.
Sorrento Therapeutics (SRNE +4.1%) nabs FDA sign-off for its Phase 1 trial for intravenous (IV) STI-2020 (COVI-AMG) that will evaluate the safety, pharmacokinetics and efficacy of a single injection of STI-2020 in healthy volunteers and outpatient COVID-19 patients with mild symptoms.
The company previously announced that STI-2020 demonstrated a complete neutralizing effect at a very low dose in preclinical studies. Sorrento has initiated manufacturing to produce up to 100,000 doses in anticipation of a potential emergency use authorization.
In November, the company filed investigational new drug application for STI-2020.
