- A second vaccine candidate is applying for FDA approval
- The US has options on enough vaccines for 4X our population if all approved
- Covid-19 deaths & cases are near May levels and counter positive vaccine news
I mentally composed the title of this article as I digested Thanksgiving turkey last Thursday, not knowing how timely it would become. This morning we were all treated to news that Moderna is applying for FDA authorization for its Covid-19 vaccine after receiving promising data over the weekend. This positive news comes as the CDC’s US Covid-19 deaths¹ reporting topped 1,650 per day last week, the highest since mid-May. The combination of peaking viral spread and rapidly evolving vaccine news will set up a tug-of-war that should produce market volatility in the short-term.
Vaccines have leaped some very promising hurdles over the last month, but have more challenges to come. Three vaccine developers, Pfizer, Moderna, and AstraZeneca have released promising efficacy & viral protection data from Phase-3 clinical trials. Moderna’s emergency use authorization application today follows Pfizer’s Nov 20 application. Emergency use authorization, which could be granted by the FDA as early as Dec 10 for Pfizer and Dec 17 for Moderna, will likely allow dosing of health care workers and nursing home residents². Additional trials will be needed for full FDA approval for the rest of the population. Full approval³ for Gilead’s remdesivir therapy for hospitalized patients took 18 weeks after its emergency approval May 1.
The US Dept of Health & Human Services has also funded development with Johnson & Johnson/Janssen, Novavax, GlaxoSmithKline/Sanofi, and Eli Lilly, in exchange for early access to manufactured doses and future options to purchase additional doses. According to data compiled by Duke’s Global Health Innovation Center⁴, the US has advance options on enough vaccines to inoculate our population four times over.
The big questions are, when will these vaccines be delivered and when will our population be vaccinated enough to provide broad protection against the virus, allowing us begin a return to normalcy? Unfortunately, those are two questions that no one can answer today. HHS Secretary Alex Azar estimated⁵ in mid-November that the US could inoculate roughly 20 million people by the end of the year with Pfizer & Moderna vaccines.
All the promising news of vaccine development and supply chain planning for their deployment comes against negative news of elevated viral spread, combined with holiday travel that should lead to increased cases & deaths in coming months. These opposing forces will continue to create market volatility over the short term. While we do not have a crystal ball to predict when the Covid saga will come to an end, we continue to believe that pairing cash flow management with investment allocation discipline is a time-tested formula that will continue to create optimal outcomes.
- CDC, 7-day moving average of daily deaths https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases
- CNN Moderna story https://www.cnn.com/2020/11/30/health/moderna-vaccine-fda-eua-application/index.html
- FDA Use Authorizaiton https://www.fda.gov/drugs/drug-safety-and-availability/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectiveness
- Duke Vaccine Tracker https://launchandscalefaster.org/COVID-19
- Alex Azar Nov 16 CNBC Interview https://www.cnbc.com/2020/11/16/coronavirus-hhs-secretary-azar-says-fda-will-move-as-quickly-as-possible-to-ok-moderna-and-pfizers-vaccines.html