Moderna CMO on childhood vaccines, recalls and the next wave of COVID

March 25, 2022 – Recently released data on the effectiveness of the Moderna COVID-19 vaccine in children 6 months to 6 years old brings good news, even though the effectiveness against the infection is less than 45%, said the Moderna’s chief medical officer in an exclusive interview with Medscape/WebMD.

“As a father and a doctor, I think the results are really, really good news,” said Paul Burton, MD, PhD.

The company plans to apply to the FDA for emergency use authorization to provide the vaccine to this age group in the coming weeks. Getting that permission is important, he said, “because there is no other option for these children right now.”

While Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said this week that he doesn’t believe another surge of cases is headed in that direction, Burton also thinks it is. is unavoidable in the United States, given the overall situation.

“It is remarkable to me that we see these kinds of cases now counting in Hong Kong, South Korea, Denmark and all over Europe. Hospitalizations are increasing in the UK and in many of these other countries,” said he declared.

Rising COVID-19 cases in other countries present an opportunity for stronger vaccines here, especially for people who have received less effective vaccines, Burton said.

This overall picture also raises the likely need for a fourth dose or a second booster, as vaccines become less effective over time in the United States. While acknowledging that testing sites, free vaccination clinics and federal funding are dwindling, he cautioned that it’s too early to be complacent and dismantle that infrastructure.

“We’ve come so far. We’ve invested so much in this to now ease off. I think that would be a public health mistake around the world,” Burton said.

He also explains how Moderna can be both a company that develops lifesaving vaccines and a company that reported $18.5 billion in revenue in 2021, what it looks like as the CMO of a company. world of vaccines to await the arrival of leading research figures, and what he is very optimistic about the future of mRNA vaccine technology.

This interview has been lightly edited for length and clarity.

Q: Moderna is out new datafrom the KidCOVE study showing a robust immune response but less than 45% vaccine efficacy for children aged 6 months to 6 years. How can it be a strong immune reaction and also less than 45% efficiency?

Burton: If this study had been done during Delta dominance, I am confident that we would have seen vaccine efficacy north of 90%.

When people see our data, everyone 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 high Omicron prevalence.

What we see in the UK data, the real world data here and in other centers around the world, is really strong protection, even against Omicron, and in its most severe form. That’s why I think parents can be sure that if they gave it away, it would be safe.

Q: When you say it is effective against a more severe form, are you talking about the BA.2 variant of Omicron?

Burton: That’s an excellent question. Most of the work that has been done has been against BA.1 (Omicron’s original strain).

What we’ve found is that plasma from people who’ve had Spikevax (the brand name for Moderna’s COVID-19 vaccine) is able to neutralize BA.2 about as well as it can BA.1. So I think it probably translates into those variants… but we’ll confirm that over time.

Q: What is your message for parents who are still reluctant to vaccinate their young children?

Burton: Look, COVID, Omicron, whatever variety – kids don’t get well when they catch it. This prevents them from going to school, which has an impact on family life and professional life. They act as a reservoir to return it to the elderly, or to grandma and grandpa too.

The time has come, if we really want to keep trying to eradicate COVID, we need to vaccinate the whole age group.

Also, the long COVID is a real disease. This is an opportunity to protect children from this and the long-term sequelae that we don’t yet fully understand. And I think having to deal with that at 6 months or 6 years, that could be important.

Q: Does the effectiveness of Spikevax and other vaccines diminish in an environment where mass mandates have been lifted? What is the interaction between the easing of restrictions on masks and other measures and the vaccine?

Burton: That’s an excellent question. I was at a meeting this week in Europe and there was a lot of unmasking going on. What have we seen there and in other parts of the world? A sharp increase in cases and an increase in hospitalizations.

Public health use [protections] such as masking, social distancing, hand washing remain extremely easy and extremely effective. They must be coupled with vaccination if we really want to have an endemic phase.

Q: Given that Dr. Fauci and others are more doubtful that we will face a large surge of the BA.2 variant, at least in the US in the near future, why is a fourth dose still needed?

Burton: We see a decrease in effectiveness, antibody levels decrease and certainly the effectiveness against Omicron decreases within 3-6 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’re going to have an additional wave of BA.2 here in the United States.

While many people were stimulated once we heard about Omicron in November, December, January, this next wave is coming soon, and I think there will be a drop in effectiveness. We have to be prepared for this, which is why we need the fourth dose.

Q: What’s it like waiting for the KidCOVE clinical data to be announced? What does it look like as you wait to find out what the efficiency numbers will be?

Burton: I’ve spent my life waiting for statisticians to send me emails with the best study results. I find the same feelings today – of excitement, anxiety, worry and sometimes elation – as I did 20 or more years ago when I started in this industry.

What I would say is that Spikevax is for me an unprecedented therapeutic agent. I have never had the privilege of working on something so effective, so safe, and so valuable to public health.

Q: So is it fair to say you’re a bit spoiled?

Burton: I’m spoiled, yes.

Q: There is obviously some altruism involved in a life-saving vaccine. But at the same time, Moderna recorded $18.5 billion in revenue last year. How do you deal with the fact that you’re doing this kind of business while saving lives? How do you solve this?

Burton: It’s a good question. The simple answer is this: It took Moderna 10 years, an enormous amount of work, a massive investment to develop a remarkable new therapeutic approach that delivered nothing but an exceptional vaccine.

We are pouring huge sums of money into development.

We have dosed nearly 550 million people worldwide. We have helped save millions of lives through this platform, and we will continue to do so. We’re in this very lucky position… where we now have this cash flow that we can put back into R&D and bring this next wave of amazing therapies.

Last year we had nine programs in development. We now have 39.

Q: This lines up perfectly with my next question: what are you most optimistic about the future after your company’s latest update?

Burton: I think the ability for us to take several different mRNAs and make vaccines against complex proteins. An example is CMV where we put six different mRNAs; or combining flu and COVID together; or flu, COVID and RSV. I think it’s amazing.

We are also working on rare diseases, such as propionic acidemia. It’s a real opportunity there and for many other diseases.

And in cancer, of course – and not just therapeutic approaches, but also personalized cancer vaccines.

So this is only the beginning.

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