Is it time to sell your bitcoin to buy Moderna stock?
With the news a few days ago that early studies on a SARS-CoV-2 vaccine look promising, the rise in stock price for Moderna made a bunch of people a lot of money. The stock has since taken a bit of a tumble after a STAT news editorial from Helen Branswell threw some cold water on the initial promising results, but it’s still up from a few days ago.
So what gives? How optimistic should we be? Is this a harbinger that Operation Warp Speed is going to create the miracle that lets us just get past this pandemic quickly?
What did the Moderna vaccine study tell us?
Moderna reported preliminary results from a Phase 1 clinical trial. In their study, they gave two different doses of a potential vaccine to healthy people between the ages of 18 and 55.
Moderna reported that all of the participants developed antibodies to SARS-CoV-2, but they don’t give us any type of quantitative information. Their report notes that 8 participants developed neutralizing antibodies - the type of antibodies we want to see in a vaccine - but data for the remainder of patients isn’t available yet.
It’s interesting that they don’t give any real numerical information. All of the “data” reported are qualitative in nature.
As the STAT editorial notes, doctors read a paper by looking at graphs and tables, not going by through the prose. When Moderna just gives us a press release instead of the raw data, the right thing is to view it through a lens of skepticism.
You always remain a little bit more cautious when results aren’t published in peer reviewed journals. It’s not that great quality science needs to be peer reviewed, but when something isn’t published, the right approach to take is one of cautious optimism, not overly credulous acceptance.
Being too excited by non-published data is how a lot of smart people lost millions on Theranos.
Can we pause for a second so I can understand what it means that this is a Phase I trial
Sure. My mistake. I should have gone into this sooner.
Phase 1 trials are to check the safety of a new treatment. They let us know if a treatment is safe enough to check for efficacy.
Phase 2 trials are to see if a drug that has been deemed suitably safe in a Phase 1 trial has efficacy. Until a Phase 2 trial has been done, we make no presumptions regarding therapeutic effect. Phase 2 trials usually test an order of magnitude more patients than Phase 1 trials.
Phase 3 trials let us quantify therapeutic effect. Phase 3 trials usually test an order of magnitude more patients than Phase 2 trials.
Phase 4 trials are post market surveillance trials that test long term effects and help to determine incidence of rare side effects that didn’t have a signal in prior trials.
So back to the Moderna thing. What does it all mean?
The press release put out by Moderna tells us that 8 healthy people between the ages of 18-55 in a phase 1 trial developed SARS-CoV-2 neutralizing antibodies 2 weeks after receiving the vaccine.
They didn’t present the data on patient characteristics or quantified antibody numbers. They didn’t test for the length that neutralizing antibodies persist. They didn’t inoculate the participants with COVID post vaccine or expose them to infected patients.
In order words, we don’t know which types of people developed the antibody response, how long the antibody response lasts, or whether the antibody response protected these people against COVID infection.
We only need a few more things to happen before we can start getting excited about this vaccine. If all ages given the vaccine produce neutralizing antibodies, and if these antibodies persist, and if the persistent antibodies protect against inoculation, then we’re on to something.
After that, we just need to see similarly promising results in the Phase 2 and Phase 3 studies. In other words, we’re not quite where we need to be just yet.
So I guess I’ll leave you with what Dwight Schrute once said: “if onlys and justs were candies and nuts, then everyday would be Erntedankfest.”