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Moncef Slaoui

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10
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2020-11-12
most recent
2020-11-12
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  1. “So we await more interim and final looks from the phase three studies, and in light of the positive data we've just seen, we would expect the focus to shift and our focus to shift to a few key factors. We're looking at the regulatory approval path and timing to market. As we mentioned earlier, December, January approval seems likely for high-risk groups. We'd be looking for the additional data from the phase three trials, including impact on severe disease, potentially prevention of infection and durability here. Are we looking at a situation where we need to take an annual vaccine on the Ford? We'll also be looking at the outlook for the other phase three COVID-19 vaccine candidates. So apart from Pfizer and Moderna, we're watching AstraZeneca, which guides to providing XUS data for their vaccine by end of 2020. J&J will be watching as well as NovavaVax. And then we're looking at Santa Fe Galaxo Smith Klein, given these are two”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  2. “Is the possibility that the FDA does not approve a vaccine based on emergency use authorization, but the expanded access program is another path in discussion for granting early access to a vaccine. You know, per your optimism, we did really just have some excellent data for Pfizer and Biontex vaccine. Also, we are monitoring for safety events as these phase three trials progress. Productor Moncev Slauy, the chief scientific officer of Operation Warp Speed, about 90% of adverse events related to vaccination take place within the first 42 days. So that is positive in that sense. So we'd be watching for rarer side effects that occur in larger populations over time. A challenge could also be in convincing the broader population to get vaccinated. That's going to be a key focus here on the Ford. And one thing we'd be looking at is on distribution. We note coal storage infrastructure is required to various degrees. This does exist in developed countries.”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  3. “To one billion Pfizer Biontech expects to have greater than 1.3 billion doses available and other phase three vaccines such as Novavax will have a supply of 2 billion AstraZeneca has signed contracts for over 3 billion and J&J expects to have greater than 1 billion and we note J&J is the only vaccine potentially that could be available with a one-dose regimen.”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  4. “EUA filing. So we expect full approval for these two vaccines in early 2021 based on the full efficacy analysis of the trials and then distribution to the broader population in 2Q21 in terms of supply and distribution, we estimate for population wide or 100% vaccination that the US-EU, UK, Canada, and Japan would have a surplus of vaccines contingent on the totality of agreements and these vaccines working. If you look at the US by year end, Moderna guides the availability of 20 million doses now each individual needs two doses and Pfizer Bayantech Guide to 30 to 40 million doses with the potential for 100 million doses by March 2021. If you think of a more global picture for 2021, Moderna does expect to deliver COVID-19 doses of 500 million.”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  5. “Sure, Jake. So, a best case scenario here would involve emergency use authorization. This is a process by which during an emergency, the FDA can determine that the vaccine is worth approving for use even without the full evidence to establish its effectiveness and safety, which would lead to a December, January approval potentially for high-risk groups. Remember, despite the positive interim and efficacy data released by Pfizer and Biontech, a median of two months follow-up on safety is required following the second dose of the vaccine. We believe the safety data will be available by the third week of November for Pfizer BionTech, and by November 24th for Moderna post which they can file for emergency use authorization, Dr. Scott Gottley, the XFDA Commissioner and a member of Pfizer's Board of Directors, recently did project that it could take the FDA about two to four weeks to approve a vaccine after an”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  6. “So, with the success that Pfizer announced and the potential for success on the Moderna front, a lot of the attention is now turned to sort of production, distribution, approval processes. What's the best case scenario timeline look like for vaccine approvals and distribution in the United States?”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  7. “Was published and took two months to manufacture the vaccine for clinical trials. So the speed of development is really possible given Moderna's modular manufacturing capabilities that leverage AI and machine learning.”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  8. “So, my colleague Terence Flynn covers Pfizer with regard to Moderna. We should view this as a positive read-through given the technology is identical and the constructs are pretty similar for these vaccines. Basically how they work here is that they introduce an mRNA molecule into the body through an injection. And this provides the body with directions to make a specific protein. In this case, it is the spike protein that is on the surface of the SARS-CoV-2 virus. This then elicits an immune response in the body to the SARS-CoV-2 virus in order to prevent or defend against future infection. Both Moderna and Pfizer Biontech have developed their vaccines to be administered in two doses, one to prime the immune response and the second to boost it. For COVID-19, though, we'd note, and this is, you know, kind of a nice feature here of the mRNA vaccines, Moderna designed the vaccine in two days after the genome sequence.”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  9. “Something you closely cover Moderna, which also has a late stage vaccine and development, does the Pfizer news imply anything about the likelihood of Moderna to be successful? And is there a way that we can read across that success to think about Moderna's vaccine?”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT

  10. “So on Monday, Pfizer and Biantech released positive data from their Phase 3 COVID-19 vaccine study for their asset known as BNT 162B2. And they showed us vaccine efficacy of greater than 90% in terms of preventing COVID-19 in patients without prior evidence of SARS-CoV-2 infection. This did occur at seven days post the second dose. The results were based on a first interim analysis per an evaluation of ninety-four confirmed cases of COVID-19. There were no serious safety concerns on the ford here. There will be more interim analyses for the final look at 164 cases. Given this was the first demonstration of phase three efficacy for a COVID-19 vaccine, the markets understandably reacted quite positively.”

    2020-11-12 · Goldman Sachs Exchanges · Vaccine Progress and What’s Next · IDENTIFIED FROM THE TRANSCRIPT