The co-creators of the mRNA technology used in both Pfizer (PFE)/BioNTech's (BNTX) and Moderna's (MRNA) COVID-19 vaccines are looking into the causes of a low risk of heart inflammation, especially in younger males.
Dr. Katalin Karikó and Dr. Drew Weissman spoke with Yahoo Finance Tuesday, a day they were being awarded for their research from Northwell Health's Feinstein Institutes for Medical Research.
Karikó, a biochemist at University of Pennsylvania and senior vice president at BioNTech, began working on the RNA technology 35 years ago, and struggled to garner academic support. Weissman, a physician and scientist at University of Pennsylvania, joined the research 10 years after she began, and the two worked tirelessly to get mRNA to the point it was — primed and ready for use — at the start of the pandemic.
"Back then, we never imagined that RNA would be used to stop a pandemic, but we knew it had incredible potential," Weissman said, adding that the experience has been a whirlwind.
Photo courtesy of Northwell Health
Karikó said she is amused that the general population can identify the brand of vaccine they are receiving.
"No other medicine people talk about...who made it," she said, but added that because the new technology came to the fore amid a pandemic, there does remain some hesitancy.
"Maybe prior to that, we should have done more work and educated the public so maybe [there would be] less resistance ... against the RNA technology," Karikó said.
To that end, some concerns have arisen from real-world data showing a causal link between the vaccines and heart inflammations, known as myocarditis and pericarditis. Weismann said he and a collaborator will be publishing new findings soon.
"What people have to understand is....if you look at COVID-19, the myocarditis that the disease gives you occurs at about 30 times higher frequency. So, yes, it's true that the vaccine has a rare adverse event of myocarditis, and we and others are trying to understand how it occurs and how to avoid it," Weissman said.
"We're actually working on a paper right now that identifies the mechanism," he added, but declined to drop any hints.
Karikó noted that the low risk is not just associated with the mRNA, but also in Novavax's (NVAX) recombinant protein vaccine as well. (The FDA's advisory committee is meeting Tuesday to discuss that and other data related to the company's emergency use authorization filing.)
A discussion on the topic arose during the FDA's advisory committee meeting Tuesday.
One member of the committee, Dr. Cody Meissner, a vaccine expert and chief of pediatric infectious diseases at Tufts Children's Hospital, emphasized how little is currently known about the link to myocarditis.
"There's been such variation in reports of the rates of myocarditis following administration of these vaccines that I think it's very hard to say that it occurs more frequently...with one vaccine platform than with another," he said.
Dr. Paul Offit, a vaccine expert and director of the Vaccine Education Center at the Children's Hospital of Pennsylvania, said there is an urgent need to understand that cause as the virus is going to be with us for generations.
"So that we can use that knowledge to make safer vaccines for a disease that is going to be with us for decades if not longer," he said.
But, he also noted that with a low risk of adverse events for several vaccines, more understanding is needed. Still, no vaccine will be 100% risk free.
"Everything in medicine is about taking the choice that puts you at lowest risk. Whether that's the surgery you're about to get or medicine you're about to take. There are no risk-free choices," Offit told Yahoo Finance.
Moderna's chief medical officer Dr. Paul Burton, in a separate interview Tuesday with Yahoo Finance, said the risk of myocarditis could have to do with an interaction with the spike protein — which plays a role in the basis of all Covid vaccines — and heart muscle cells.
"We know so much more about myocarditis today than we did a year ago. I do believe that it is the spike protein....that either causes a little bit of direct damage to the heart, or antibodies that are produced that react with the heart cells," Burton said.
Global potential
As global public health experts warn the coronavirus outbreak won't be the last pandemic, lower- and middle-income countries have begun to lay the infrastructure to incorporate mRNA technology for future outbreaks.
That can be seen in recent announcements to open plants in sub-Saharan Africa from BioNTech, Moderna and the Serum Institute of India. Weissman has been working with the World Health Organization as it set up an mRNA hub in South Africa, and worked with Thailand in the spring of 2020 to set up a GMP (good manufacturing practices) manufacturing site.
"I'm continuing to do that worldwide, working with countries, governments, organizations, and to give them the technology to make RNA therapeutics locally. And, to me, that's probably one of the most important things that I do," Weissman said.
When the vaccines were first authorized in the U.S., they faced cold chain barriers for some regions of the world that couldn't handle the ultra-cold storage temperatures required. But since the first batch, that has been addressed.
"The cold chain was purely a speed issue," Weissman said.
Companies "spend a lot of time on how to stabilize, how to ship, how to produce at the highest temperatures possible. For the COVID vaccine, there was such a rush to get them out that they didn't do that," he added.
Karikó noted that the tradeoff to increasing the temperature for storage is a shorter lifespan, compared to when it is kept at ultra-low temperatures.
In addition to addressing the cold chain barrier, raw materials and supplies needed to make mRNA vaccines are now being abundantly produced, compared to the strict supply that existed at the start of the pandemic.
"We never imagined that we would want to make 5 billion or more doses of RNA vaccine," Weissman said.
