Salveen Richter, lead analyst for the US Biotechnology sector in Goldman Sachs Research, talks about Pfizer’s clinical-trial results for its COVID-19 vaccine and the obstacles that still lie ahead for FDA approval and widespread distribution.
This is an unofficial transcript meant for reference. Accuracy is not guaranteed.
Did they exchanged comic, actually discussed velvet curly, shaping markets, industries in the global economy objects. You would over a corporate communication chaired the fur, then a big weaken the news across. board, but particularly in the race for a covert nineteen vaccine to get the latest on that and what still ahead were joined by solving Richter need analysed for the a biotech sector for Goldman Sachs Research saw me in welcoming the programme Jake. Thank you for having me. Do you know, do its huge news earlier this week, when Pfizer released, encouraging vaccine results. One of those results and how have markets reacted Yes, so, on Monday, Pfizer and by an intact released positive data from their face three covet. Nineteen vaccine study for their asset, known as BNP, one six tube, he too, and they showed us
Maxine efficacy of greater than ninety percent in terms of preventing covert nineteen impatience without prior evidence of Sars could be to infection. This did occur at seven days post, the second doze. The results were based on a first interim analysis for an evaluation of ninety four confirmed cases of covert nineteen. There were no serious safety concerns on the Ford here. There will be more interim analyses for the final look at a hundred and sixty four cases given this was the first time, installation of face three efficacy for encoded nineteen vaccine, the markets under and ably reacted quite positively? Being you closely cover Madeira, which also has a late stage. Vaccine development does find your news imply anything about the likelihood of maternity be successful, and is there a way to weaken it the cross that success to think about but dared as vaccine. Yes, sir, my colleague
parents when covers Pfizer. With regard to maternal, we should view this is a positive read through, given the technology is identical and end. The constructs are pretty simpler for these vaccines basically How they work here is that they introduce an emigrant a 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 spite protein that is on the surface of the Sars Kogi to virus this than the list. It's an immune response in the body to the source code be too virus in order to prevent or defend against future infection, both maternity I hereby, Arctic have developed their vaccines to be administered in two doses, one to primed immune response and the second boosted for coded night even though we note in this is: u no kind of a nice feature here: the MRI, Nay vaccines, but Donna Design, in the vaccine in two days after the genome sequence was published and took too
to manufacture the vaccine for clinical trials. So this speed of development is really pie. The ball given Madonna's modular, manufacturing capabilities that leverage a high and machine learning. So, with the successful your Nelson and the potential for success on the Medina front, water the tensions that turned user production distribution, approval prophecy. What's the best cases, Your time. Why look like for backing approval and distribution in United States. Sure Jake's. way 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 three December January, approval potentially for high risk groups, remember despite the past in the interim and efficacy data released by Pfizer and by Contact a meeting
of two months follow up on safety is required. Following the second oh said, the vaccine, we believe the Safety- data will be available by the third week of November for Pfizer Biotech and by November twenty fourth form internal post, which they can for emergency use authorization, Doktor, Scott Godly, the exit. Commissioner, a member Pfizer's board of directors recently did project that it could take the FDA about two to four weeks to approve a vaccine after and U S filing, so we expect full approval for these two vaccines and early twenty twenty one, based on the full efficacy analysis of the trials and then distribution to the broader population in two to twenty one. In terms of fly and distribution. We estimate for population wide or a hundred percent vaccination that they? U S. Eu Uk Canada and Japan would have a surplus of vaccines, tension on the totality of agreements and these seems working. If you look at the U S,
by your end, maternal guides to availability of twenty million doses. Now each individual needs to do says and Pfizer by on TAT guy too thirty two, forty million doses with the potential for hundred million doses by March when you twenty one, if you think of our more global picture, for twenty twenty one. Madonna does expected deliver covered Jeanne doses of five hundred million to one billion Pfizer Biotech expects to have greater than one point three billion to us is available and other face you back means such as Nova backs. What will have a supply of two billion asked. Rosetta has signed contracts for over three billion and Joy J experts have greater than one billion and we'd know changes the only vaccine. Potentially, that could be available with a one dose regiment I am an optimist, I like to focus on best case scenario. Both when are we run through some of the risks The delay that rapid, relatively rapid distribution there,
the possibility that the FDA does not approve a vaccine based on emergency. You solve resolution for the expanded access programme is another path in discussion for granting early access to a back seen. You know her your optimism. We did really just have some excellent data for Pfizer by on tax back seen. Also, we are monitoring for safety events as these face three trials: progress, product or months slowly the chief scientific officer of operation Warp speed about ninety percent of ads. Events related to vaccination take place within the first forty two days, so that is positive in that sense and soon be watching for rarer side effects that occur in larger populations over time. A challenge- it also being convincing the broader population to get vaccinated. That's gonna be a key focus here on the board and one thing we Looking at his on distribution, we know: cold storage infrastructure is required to various degrees. This does exist in developed countries and that, while frameworks procured access priority,
Using hires populations do exist, we all want to see execution on this front you covered a lot of the candle their lines for some risks, those deadline. What are you gonna be? the sun, looking ahead to determine course of action going forward. 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 our focus to shift to a few key factors were looking at the regulatory approval, path and timing tomorrow As we mentioned earlier December January, approval seems likely for high risk groups, we'd be looking for the additional data from the face three trials, including impact on severe disease, potentially prevention of infection and durable be here, are we looking at a situation where we need to take an annual vaccine on the Ford, also be looking at the outlook for the other face We covered nineteen vaccine candidates, so part of fire and maternal watching asteroid.
Monica which guides to providing ex? U S, data for their vaccine by end of twenty twenty Jane J will be watching as well as Nova backs and then we're looking at sanity collapsed Psmith Klein, I'm given these are two tradition back soon. Players where they're gonna have phase when to data likely by December with they face three trawl initiation by your and twenty. In addition to all of this, we do. It anticipate focus on covered nineteen vaccine manufacturing capacity and supply dynamics. District you shouldn, as well as supply chain inputs such as syringes and byles. Her right that's a lot to keep track of. You can have a busy winter. You've had a busy year and it doesn't sound like it's going to let up anytime soon, we'll have to have you back on to checking on the prowl. in a couple months, but something thanks for joining us today. Jake. Thank you my pleasure. That concludes this episode with changes coming back
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Transcript generated on 2021-07-01.