Life doesn’t get fully back to normal until we have a COVID vaccine.
Obviously, we’re all waiting anxiously and many of us are rapidly devouring each story about vaccine updates. Every morsel of vaccine news leads to stock price rises and tumbles.
In the past week, there have been a handful of stories that deserve a bit of unpacking that I wanted to cover in this newsletter.
What’s going on with the Moderna vaccine you wrote about earlier?
An earlier newsletter installment covered the hype around a small biotech company named Moderna and their efforts to develop a vaccine.
My conclusion at the time was that the reports from their Phase 1 trial were exciting but pretty far from something to bet on. News broke this week that their planned Phase 3 trial has been delayed and their stock tumbled about 10%.
Moderna is still expected to get their Phase 3 clinical trial of 30,000 patients off the ground this month, but - as with any clinical trial - until we see evidence of effectiveness, it makes sense to proceed with caution. The medical literature is littered with examples of treatments and drugs that seemed promising in the initial phases of investigation that have been relegated to the dustbins of history.
This vaccine remains tantalizing - after all, it did elicit an antibody response in some participants - but if you recall, the only data that we have so far comes from an 8 patient subset.
I’m waiting until the Phase 3 trial to get excited about this.
What about the new Pfizer vaccine?
Pfizer put out promising news - backed up by data! - about Phase 1 and 2 data looking at the safety and antibody response with multiple doses of a SARS-CoV-2 vaccine.
The vaccine was administered to healthy individuals and antibody response was assessed.
From the way the story is being framed in the news, it seems like it’s only a matter of time before this vaccine works and can be distributed. Pfizer is reporting they’re getting 100 million doses ready to be distributed in 2020 with over a billion in 2021.
Of course, it’s really exciting, but the details show that we are still in a very preliminary place. 45 patients were given varying doses of the Pfizer vaccine, which demonstrated a good safety profile as well as an antibody response after about a month.
We’re at the same place here as we are with Moderna - awaiting a Phase 3 trial to see if the antibody response means immunity and effectiveness.
The 2 biggest COVID vaccine challenges
With at least 17 vaccines in the clinical trial pipeline, I really do think it’s only a matter of time before we have a safe, effective vaccine available for SARS-CoV-2.
But even after an effective vaccine is developed, I see 2 major areas of questions/challenges on the horizon.
Logistical challenges - mainly distribution and cost. Who gets it first as production is ramped up? Who pays for the vaccine and how do we get it to everyone?
Trust questions - it’s been jarring to see the backlash to the medical community during this pandemic. I am concerned about the issues that will arise from mistrust in the system. Will enough people be willing to get a vaccine to achieve herd immunity? What if the roll out is bungled or if in the rush to have a vaccine, there is a heterogeneity of effect? What are the downstream consequences for trust in the medical system?
Ultimately, I think that these challenges will be overcome. But I don’t expect it to be easy or quick.
Non-COVID vaccine news, which may ultimately be the biggest vaccine news of all
Some really big news in coronary heart disease came out last week - the potential for a “vaccine” for this non-communicable disease that kills more people than anything else on earth.
Verve Therapeutics is a company founded by Sek Kathiresan, one of the world experts on the genetics of heart disease. I can’t overemphasize what a leader in the field Dr. Kathiresan is, so his leaving an academic research career to found a company trying to cure heart disease is really big news in the medical world.
Verve recently announced that they were able to edit the DNA of monkeys to express genetic variants found in humans who are essentially immune to heart disease. The two genes in question, PCSK9 and ANGPTL3, are worth their own newsletter installments at another time, as is the technology behind DNA editing.
The vision of Dr. Kathiresan and Verve is to prevent heart disease by using DNA editing CRISPR technology to give lifelong “immunity” from heart disease.
We’re much farther away from needing to confront the ethical questions surrounding DNA editing to reduce risk of heart disease than we are from needing to confront the ethical issues surrounding distribution of a COVID vaccine, so I’ll leave that for another day.
At some point, I’ll circle back to these “heart disease genes,” but this is getting a bit long. For now, I wanted to just put it as a quick bullet at the end of a newsletter because it’s fascinating and potentially revolutionary work.
For all the vaccine news, here’s the TL;DR: a lot of excitement, but tons of work to be done.