On November 9th, Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19. The vaccine has been demonstrated to be 90% effective in participants without prior evidence of SARS-COV-2 infection, based on the first interim analysis conducted on November 8th, by the Data Monitoring Committee (DMC) from the Phase 3 clinical study. Efficacy in this case refers to the likelihood that a coronavirus vaccine injection will work for most people.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication. They estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate will be available by the third week of November. Moderna announced today (November 16th) that analysis of data from its Phase III clinical trial (which is still ongoing) claims that its vaccine may be 94.5% effective a preventing COVD-19. Predictably, markets responded well (BNTX +23.4%) and (PFE +11.5%), in premarket trading on Monday November 9th.
Readers should note that the efficacy numbers will change as the studies continue since these early calculations are based on fewer than 100 cases in each study. The efficacy status of Pfizer/BioNTech and Modern’s vaccines are very encouraging news as there was a concern among global health officials that coronavirus vaccines would match the effectiveness of flu vaccines, which have ranged from 20 to 60% effective in recent years.
And Now Phase III
To put this in perspective lets examine some brief details of a Phase III clinical trial. Phase III trials compare a new drug to the standard-of-care drug. Often, these trials are randomized; the patients are put into treatment groups (called trial arms) by chance to ensure accuracy. There can be more than two treatment groups in phase III trials. Every patient is closely monitored, with the study being paused or stopped early if the side effects of the new drug are severe [ex. Johnson & Johnson (NYSE: JNJ) Phase III trials] or if one group has better results. Phase III clinical trials are often required before the FDA will approve the use of a new drug for the general public.
Canada has reserved access to a total of 414 million doses of COVID-19 vaccines from different sources. Over the course of the pandemic the US government has heavily invested in several vaccine development programs, spending up to $2.1 billion in grants to global pharmaceutical companies. Earlier this year, the US secured 300 million doses of vaccine from AstraZeneca, after signing an agreement worth approximately $1.2 billion
Other companies of note that have a vaccine in Phase 3 trials are University of Oxford/AstraZeneca (NASDAQ: AZN) and Novavax (NASDAQ: NVAX). Over the full course of the month, there we can see that there has been a mixed reaction from the market on Phase III announcements. We will continue to monitor developments, as the race to a vaccine excelerates.
