The institute was created to foster translational studies in health and disease, and integrates the expertise of the disciplines of epidemiology, pharmacology, cell biology, genetics, biochemistry and health economics and informatics across the Rutgers Biomedical and Health Sciences network.
It’s why Panettieri and his team have been part of two trials, one for Moderna and another for Janssen. And it’s why it’s fair to say Panettieri knows what he’s talking about when it comes to vaccines.
ROI-NJ checked in with him Monday, after Moderna reported incredible efficacy results with Phase 3 of its COVID-19 vaccine trial — the second major drug company to report such a result in the past 10 days.
Does the result build on the results of Pfizer‘s trial? Is it better? Is it different? Panettieri provided the answers.
The biggest: Even though Moderna’s announcement came a week after Pfizer, the Moderna result is the more impressive (and more complete) of the two and much closer to completion — which is the day the vaccine becomes available for use.
“The Moderna (trial) has greater validity in that this is the entire data set at this particular point, whereas the Pfizer was a quick look halfway through the study,” he said. “So, (Pfizer) was not a complete data set, while Moderna is.”
And, while Moderna may be closer to the finish line, it is not there yet. The trial is just one step in the process, Panettieri said.
“You might say, why aren’t they just approved — why didn’t they get the emergency utilization authorization?” he asked, and then answered. “(It’s) because they have to follow these individuals for a very specific period of time to be sure there was no adverse effects from the injection.
“Remember, the FDA is all about efficacy and safety. You have to have both sides of the coin before it can be approved. Right now, it looks like they have the efficacy. They just need to get a little more rubber on the road to get to the safety signal.”
Here’s more of the conversation, edited for space and clarity.
ROI-NJ: Talk about the Moderna result and what it means.
Reynold Panettieri: The 30-second soundbite is this: The Moderna trial is the first one to read out that has a full data set. The last patient was enrolled, they followed them, they’re now looking at efficacy after the last patient. And the data is stunning, frankly. It’s a very effective vaccine.
We don’t have all the adverse effects in yet. That’s going to take another month or so before everything is examined closely, but in the execution of the study (was strong), there weren’t a whole lot of issues, there were certainly no stopping points — and the efficacy is fabulous.
ROI: How does this trial and this vaccine compare to the other dozen or so vaccines trials that are out there?
RP: We’ve got two vaccines now, both that have a very similar format (mRNA) that’s much different than that of AstraZeneca, Cambridge or J&J, which is Janssen.
The Moderna and Pfizer are very similar, but there’s a big deal with the Moderna — because, whatever their special sauce is, they were able to not have it be super frozen.
The Pfizer vaccine requires the vaccine to be frozen to minus-80 degrees centigrade; that’s minus-96 Fahrenheit. That’s a logistics problem if you’re going to be injecting globally in areas where there wouldn’t be such freezers available — whereas, the Moderna vaccine is safe for being frozen in a regular freezer and then thawed and used.
Both of these are two doses. There’s an initial immunization, then a booster. That’s different than the J&J vaccine, which is going to be a single dose.
ROI: You used the phrase mRNA. Explain what that means and its importance?
RP: There are different types of vaccine platforms; there are a variety of ways to boost the immunity. Some are by actually giving viral protein. That is not as effective; it doesn’t give a long-lasting benefit. Other approaches actually have a virus. It’s not the Sars-CoV-2 virus (that’s the clinical name for COVID-19), it’s an attenuated virus, meaning it doesn’t cause human problems, but it acts as a carrier that then infects cells and allows the cells to produce a protein that then generates immunity. That’s very similar to Janssen and to AstraZeneca.
But Moderna and Pfizer have an approach where they use the precursor to the protein. That’s called messenger RNA. That is injected into the cell. And then that mRNA is read to generate a protein, which gets secreted by the human cells, and that generates immunity.
So, it’s simply a different mousetrap. But it’s a mousetrap we haven’t used before. The other vaccines have been around tried and true. The other ones have been used for MERS and Ebola. This one is quite a unique platform.
ROI: Of course, there are many more vaccine reports to come. Many others also may show incredible results. Explain why that matters?
RP: We’re going to have a fair number of vaccines with different mechanisms of action. So, that gives us opportunity to figure out what’s the right drug for the right patient at the right time.
ROI: Time. Can you believe it took this little time to get these results? How was that possible — and why isn’t the norm for all vaccine or therapeutic research?
RP: Because it was all-hands on deck. This was an all-out effort. And, truthfully, it is remarkably funded by NIH and by the federal government. There was a lot of money put into it.
The federal government doesn’t necessarily go hands and feet into the water here to support commercial vaccine discovery and development. But, in this case, the gravity of the pandemic certainly pushed people in a direction that it had to be done, it had to be done quickly. It was a gargantuan effort.
ROI: That begs the question: Would we have other discoveries this quickly if the government was so heavily invested? Compare this to the last great national health issue, the HIV crisis that started in the ‘80s? Would more investment allowed us to find a cure?
RP: I think you’re overstating the case. Vaccines have not been very effective in the case of HIV. This is a vaccine that was likely to have high success. HIV was not. There was a lot of fundamental biology that was completely unknown. HIV was a different kettle of fish — much more complicated.
And we do not have a vaccine. We do have effective therapy. Could we have found those therapies faster? Potentially. But there was no guarantee.
ROI: Which brings us back to today. We have invested — and it appears to be paying off. Sum up how important these last two announcements have been?
RP: It’s exciting. It’s a big deal. We weren’t anticipating this coming out until mid-first quarter in 2021. We’re halfway through November and we’re getting signals that are optimistic.
The vaccine is going to be a game-changer.