COVID-19 Vaccine Updates

Hello and welcome back to the Corner. In this issue, I would like to provide some insight as to where we stand with the development and testing of vaccines aimed at preventing infection with COVID-19.

Around the world, scientists and others are racing to develop and test potential vaccine candidates to help prevent infection with COVID-19.  Worldwide, there are many vaccine candidates in various stages of development.  At least four companies, AstraZeneca, Johnson & Johnson, Moderna Therapeutics, and Pfizer have indicated they plan to have products available by the end of 2020 or beginning of 2021.  Other companies have either not determined a potential launch date or do not have enough insight as to when their product(s) may be available.

Of the companies listed above, 3 have received federal funding to complete Phase 3 trials.  Moderna Therapeutics began recruiting patients for trials in July, AstraZeneca (in conjunction with University of Oxford) will begin in August, and Pfizer in September.  Phase 3 clinical trials mean that the vaccine will be given to human volunteers who do not have COVID-19 to evaluate the product(s) for both safety and effectiveness.  At this point, it appears that Moderna Therapeutics will be looking to enroll around 30,000 adult volunteers.

The FDA has issued guidance specific to COVID-19 vaccine candidates.

Along with needing to meet the various regulatory, clinical trial, and documentation requirements for vaccines, a potential candidate must exhibit at least a 50% reduction of infection. 

The candidates would also be required to continue both safety and efficacy monitoring including post-marketing surveillance and data collection.  It should be mentioned that these are the parameters set forth by the FDA at this time and could change based on new information that becomes available either through clinical trials or scientific research.

Based on the above, the outlook is hopeful for one or more vaccine candidates to be available by either late 2020 or early 2021.  As we  push forth through the pandemic the development of a vaccine(s) that can help stop the spread of the virus is critical.  While we continue to explore and find ways to treat people with active infection to avoid complications, vaccine development will only enhance our efforts to flatten the curve.  It will be interesting to follow the developments in a race to find a vaccine; one that is safe, effective, and has the potential to put this behind us.

Thanks again for stopping and continue to stay safe and healthy.