MEG TIRRELL: Well Moderna has looked at its vaccine’s effectiveness against these new variants we’ve been hearing about B117 and B1351, associated with the UK and South Africa, and found that against the B117 UK variant, no discernible difference in the immune response against that variant. Against the South African one, as we have been hearing from experts like Dr. Fauci, there is an impact on the neutralization of the, of that variant with the vaccine and declined by six-fold. That sounds scary but Moderna is saying in this release just now that they still think the antibody levels are high enough to work well against that variant. Nonetheless they do say they are testing both a booster shot of the current vaccine as well as working on a vaccine that could address this variant and moving that into early trials. Now joining us to tell us more about this is Moderna CEO Stephane Bancel. Stephane, thanks for being with us this morning. You know, you guys are the first company I believe to say you are actually working on a new vaccine version to address these variants. Tell us about what you found this morning and the decision to do this.
STEPHANE BANCEL: Good morning Meg and thank you for having us back. So indeed, we announced this morning that we posted last night a manuscript between the NIH team and Moderna, looking at those new variants, especially B117 first found in the UK and B1351 first found in South Africa. The great news with both virus, we see very high level of antibody. With B117 strain from the UK, we basically see the same level of antibody, as we saw in the, in the strain that has been circulating in the US and as shown in the Phase 3 trial leading to the FDA authorization, you know, very high efficacy so we’ve been very good about that strain and as you know, the CDC has said that that strain will become the dominant strain in the US by mouth so that’s a very good thing. For the South African strain, we still see a very high level of antibody, but it is indeed lower than the traditional strain and B117 and so, we believe our vaccine will be protective in the short term. What is unknowable right now is what will happen in six months in twelve months, especially to the elderly because as you know they have a weakened immune system and the immunity might go down over time. And because of that unknown and Moderna wants to always stay at the forefront of a fight against COVID-19, we decided to take into our clinic out of an abundance of caution a new vaccine called MRNA 1273.351 for the South Africa strain that we’ll be testing in the clinic very quickly. Our goal and we’ve been asked to have good alignment with the FDA soon but our goal will be to run a very quick boost, a single dose, into potentially the Phase 1 study that as you know was something our last mark in the US, so it’ll be kind of at the one year anniversary. We run that boost and get that data to look at the neutralizing antibody and we are gonna to do that both for mRNA1273, the current authorized product, but also for mRNA 1273.351 for the new strain and then we’re going to expand that to the Phase 3 to boost the Phase 3 participant again single dose to get that data like this eve in the fall there is a need because of waning immunity into the elderly to put on the market that spring, we will be ready. We cannot be behind, we cannot fall behind this virus. We just wanted to be cautious, not for now, but for the future.
TIRRELL: What is your expectation of what the regulatory pathway for that new vaccine would look like, do you anticipate that we should have the correlates of protection, essentially, knowing what level of antibody response or T cell response you have to get with your vaccine to be protective, or do you think you need to run efficacy studies out there in the world against COVID.
BANCEL: So I want to speak cautiously because of course it is not my decision. It is FDA decision. But our understanding is most probably this will follow a path similar to seasonal flu, where indeed running neutralizing antibody is going to be required most probably in the smaller sample set vendor Phase 3 and they will not be need for an efficacy study. Again, this has to be confirmed by the regulators but that will make sense given it’s already done in the flu. And if you think about the mRNA technology because mRNA is a platform that new product 1273.351 uses the same chemistry for vmRNA and the same manufacturing process so the products are very similar with just a few mutation change like the natural virus B1351.
BECKY QUICK: Stephane, just from a consumer’s perspective, I know people who have gotten the shots already who feel like they’re, you know, invulnerable to anything at this point, they feel like they can go out and reclaim their lives the way they had in the past. If these new variants become more, more of the strain that is that is more popular here in the United States if you get more of those things, what would you be telling people to do if, if they’re older if they’ve gotten these vaccines already should they be cautious about getting back into the general public, should they still be wearing masks, should they still be doing social distancing.
BANCEL: So it’s a good question Becky and I think there are several parts to your question. The first part is for quite some time because we don’t know yet how well the vaccines protect infection from person to person, even people vaccinated need to wear a mask to protect themselves but most probably to protect others. Because if you’re vaccinated as you know vaccine has very high efficacy, most probably you get no disease if you get re-infected or infected for the first time. But what is unknown today is your ability to infect somebody else who might not have been protected by the vaccine so we all need to stay cautious still for a few months while vaccinated. And what we will basically I think move to is a world of the flu where over time, you can have, most people immunized either naturally for an infection or for vaccination. And over time as the strain mutates and it’s gonna keep on mutating so we should all understand that these virus will keep mutating, some mutation will be irrelevant but some mutation that goes we have seen recently might be relevant and they’re going to keep mutating. I will not be surprised if down the road with a new generation out of the current 351 first identified in South Africa, and then another mutation from that one is just unknowable so we need to stay all cautious. I still believe that as Dr. Fauci has said that there is a time in late summer for where we can take the mask off because you know people have been vaccinated but we need to not leave our guard down which is why out of caution we want to put this vaccine in the clinic for that new strain just in case it is needed later, in case immunity wanes, especially in the elderly.
TIRRELL: Alright well Stephane, got about a million more questions for you but we have to leave it there for today, thank you for being with us. We appreciate it.
BANCEL: Thank you.