Newly released data on how well the Moderna COVID-19 vaccine works in children 6 months to 6 years old brings good news, even if efficacy against infection came in below 45%, the chief medical officer of Moderna said in an exclusive interview with Medscape/WebMD.
"As a dad and a physician, I think the results really are very good news," said Paul Burton, MD, PhD.
The company plans to ask the FDA for emergency use authorization to provide the vaccine to this age group in the coming weeks. Getting this authorization is important, he said, "because there's no other option for these kids right now."
While Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said this week he doesn’t believe another wave of cases is headed this way, Burton also believes it is inevitable in the United States, given the global picture.
"It is remarkable to me that we see these kind of case counts now in Hong Kong, in South Korea, in Denmark, and throughout Europe. Hospitalizations rising in in the United Kingdom and many of these other countries," he said.
The rise in COVID-19 cases in other countries presents an opportunity for vaccine boosting here, particularly for people who have received less effective vaccines, Burton said.
This global picture also raises the likely need for a fourth dose or second booster as vaccines get less effective over time in the U.S. While acknowledging that testing sites, free vaccination clinics, and federal funding are on the decline, he cautioned that it's too early to be complacent and dismantle this infrastructure.
"We've come so far. We've put so much into this to now take our foot off the gas. I think it would be a mistake for public health worldwide," Burton said.
He also answers how Moderna can be both a company that develops lifesaving vaccines and one that reported $18.5 billion in revenue in 2021, what it's like as the CMO of a global vaccine company to wait for top-line research numbers to come in, and what he's most optimistic about regarding mRNA vaccine technology going forward.
This interview has been lightly edited for length and clarity.
Question: Moderna released new datafrom the KidCOVE study showing a robust immune response but vaccine efficacy below 45% for children 6 months to 6 years. How can it be a strong immune reaction and also provide efficacy below 45%?
Burton: If this study was done during Delta predominance, I'm confident we would have seen vaccine effectiveness north of 90%.
When people see our data, everybody expects it to be 95%, 100%. You just have to remember that this was a study done between October and February, really a period of strong Omicron predominance.
What we see in U.K. data, real-world data here, and at other centers around the world is really strong protection, even against Omicron, and in its more severe form. So that's why I think parents can be confident that if they were to give it, it would be safe.
Q: When you say it's effective against a more severe form, are you talking about the BA.2 variant of Omicron?
Burton: That's a great question. Most of the work that has been done has been against BA.1 (the original Omicron strain).
What we have found is that plasma from people that have had Spikevax (the brand name of Moderna’s COVID-19 vaccine) is they are able to neutralize BA.2 about as well as it can do for BA.1. So, I think it probably does translate across these variants … but we'll confirm that as time goes on.
Q: What is your message for parents who are still hesitant to vaccinate their young children?
Burton: Look, COVID, Omicron, whichever variety -- kids are unwell when they get it. It keeps them out of school, and that impacts family life and working life. They act as a reservoir to give it back to older people, or Granny and Granddad, too.
Now is the time, if we really want to continue to try to eradicate COVID, we've got to vaccinate across the age range.
Also, long COVID is a real disease. This is an opportunity to protect kids against that and the long-term sequelae that we really don't understand yet. And I think having to deal with that as a 6-month-old or 6-year-old, that could be important.
Q: Does the effectiveness of Spikevax and other vaccines decrease in an environment where mass mandates have been lifted? What is the interplay between easing of mask restrictions and other measures and the vaccine?
Burton: It's a great question. I was at a meeting this week in Europe and there was a lot of de-masking going on. What have we seen there and in other parts of the world? A definite surge in cases and surging hospitalizations.
The use of public health [protections] like masking, social distancing, hand-washing remain extremely easy and extremely effective. They have to be coupled with vaccination If we really are going to get an endemic phase.
Q: Given that Dr. Fauci and others are more doubtful we will face a big surge from the BA.2 variant, at least in the United States in the near future, why is a fourth dose still necessary?
Burton: We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months. The natural history, from what we're seeing around the world, is that BA.2 is definitely here, it's highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.
While many people got boosted once we heard about Omicron in November December, January, this next wave is coming soon, and I think there will be waning of effectiveness. We need to be prepared for that, so that's why we need the fourth dose.
Q: What's it like to be waiting for the clinical data from KidCOVE to be announced? What's it like at that moment when you're waiting to find out what are the efficacy numbers going to be?
Burton: I have spent my life waiting for statisticians to send me emails with top-line results of studies. I find the same feelings today -- of excitement, trepidation anguish, and sometimes elation -- that I did 20 or more years ago, when I started in this industry.
What I would say is that Spikevax is an unprecedented therapeutic agent for me. I have never had the privilege to work on something that is so effective, does it so safely, and provides so much public health value.
Q: So it's fair to say are a little spoiled?
Burton: I'm spoiled, yes.
Q: There's all obviously some altruism involved with a lifesaving vaccine. But at the same time, Moderna reported $18.5 billion in revenue last year. How do you address the fact that you're doing that kind of business at the same time that you're saving lives? How do you resolve that?
Burton: It's a good question. The simple answer is this: It took Moderna 10 years, a huge amount of work, massive investment to develop a remarkable new therapeutic approach that has delivered just an exceptional vaccine.
We pump huge amounts of money back into development.
We've dosed nearly 550 million people around the world. We've helped to save millions of lives with this platform, and we will continue to. We're in this very fortunate position … where we now have this cash flow that we can pump back into R&D and bring that next wave of amazing therapeutics.
Last year, we had nine programs in development. Now we have 39.
Q: That goes perfectly into my next question: What are you most optimistic about going forward after your company's most recent update?
Burton: I think the ability for us to take multiple different mRNAs and make vaccines against complex proteins. An example is CMV where we put six different mRNAs in; or combining flu and COVID together; or flu, COVID, and RSV. I think that's amazing.
We're also working in rare diseases, such as propionic acidemia. It's a real opportunity there and for other many other diseases.
And in cancer, of course -- and not only therapeutic approaches, but also personalized cancer vaccines.
So this is just the beginning.