As far as the current state of play, these past three weeks we have seen three crucial positive readouts of data from leading programs. The first came from pfizer, the second came from moderna, and the third one this morning just came from astrazeneca and the team at oxford. These are three leading vaccine front runners, all three in late stage studies appear to be effective, the first to 95 effective in preventing covid19. Thatnity is expected to do late november, early december. That will set up an fda decision, all eyes turning to the agency to see how quickly they can approve it and for what subgroups of the population. Vaccineing on in the phase, but there is a lot going on and muchneeded positive news when you think about the surge that we have seen in cases, hospitalizations, and deaths. The fda approval, how quickly could they approve it, and what could keep them from being approved, and how is the fda ensuring confidence in the public in the safety of these vaccines . Guest i talked to peter marks, who is in charge of this process. He outlined a process and said it would be measured in multiple beats. We are seeing that play out. It is a Crucial Group of independent experts that is going to meet on december 10 to discuss pfizers vaccine. That vaccine is already filed. Pfizer has submitted their emergency use authorization last friday. It will take the agency until december 10 together these experts, whether to recommend these authorizations were not. It will take a week or two more, my own guest, on my own guess. By midtolate december we could see one way or the other authorizations from the fbi. I at least on the effectiveness front, modernity and pfizer show 95 effectiveness. They wanted at least 50 effectiveness. It might make the gap part simpler. Do we see good trends in the data as far as does it reduce the changes you get taken to the hospital, in an ic unit an icu unit, or that you die from the virus. Was very upfront as far as saying what we know and what we dont know, and what we dont know about the vaccine is still the durability of protection, how longlasting immunity would be, and the longterm safety profile host longterm safety profile. Ast i know this is taking lot faster. Well take 17 days from the committee to meet . It seems like a long time from right now. Guest that is what i went back and forth with dr. Marks on. The fda is really intent on ensuring public trust in this process. That is probably the top priority. They dont want it to appear to anyone on the outside that they are rushing to a vaccine without gathering the independent group of experts to look at the data and to vet it themselves. They want to go through it with eight transparent way. The upshot is that it takes time, dr. Marks calculates they are moving as quickly as they can while going through all the steps of the process. They need to prepare briefing documents for the Committee Members that go through all this data. These are massive studies of tens of thousands of people. There have been a lot of data points to sift through, and the agencys primary responsibility is to make sure they are not missing anything in the data set, and that takes time. Host give viewers a number to call in with questions that you might have on this process, develop a phone lines. Democrats, 2027488000. Republicans, 2027488001. Ndependents, 2027488002 it Health Care Reporter from Business Insider, andrew dunn. It is businessinsider. Com where you can see his stores. One question for the last segment on the story that the caller wanted me to ask you when you came on was, how these , concernsre developed that they were made from stem cell lines and therefore there might be religious considerations that some folks might have about whether to inject it. Guest it is not something that has been too pertinent in my covers or something i have seen from a lot of people i have talked to. That came up a lot with the regeneron antibody drug that donald trump took. Authorizationd over the weekend. That digs back that dates back to the 1970s. It is many iterations away from that in the scientific process. I have not seen that concern being raised, but it is something im watching out for. Cash on afternoon at astrazeneca news this morning, effective, 95 in the other vaccines. Take us to the positive of thees or drawbacks various vaccines and what astrazeneca provides. Guest you start with pfizer from two we should go and that was highly effective. One of the biggest downsides, the biggest limitations of that beduct is that it needs to stored at extremely cold temperatures, 70 degrees celsius, which when you think of the infrastructure needed to support that, the u. S. Health care system, the World Health Care systems are not set up to accommodate that. Product also shows a high degree of effectiveness. You can store that in a refrigerator for about 30 days. That gives the Health Care System more leeway in figuring out how to distribute it across the country, get it to retail pharmacies get to people who might not have access to a metropolitan health care center. Astrazenecas news came out today and we are sifting through it. This data is from brazil and the u. K. , so it is not necessarily it is closer to 20,000 people. It is 70 effective on average, which is a little bit below the first two results, the researchers found they were testing different variations, different doses of astrazenecas vaccine, and they found if they gave a low dose first followed by a second dose, there was 90 effective. There are still a lot of questions around it. That is only based on 2741 people who received that type of dosing combination. So we will want to see that number in a bigger group of people. That study is ongoing in the u. S. Inrazeneca, that can be cap a typical refrigerator storage for about six months while keeping stability. That is very encouraging to see. When you think about vaccinating the world and immunizing developing countries that might not have the same infrastructure , the stream the cold storage, it is an Encouraging Development to see for sure. Host plenty of callers already. Claudia is up first out of an osha, wisconsin, on the republican line. Go ahead. Caller good morning. I know on the previous segment people were talking about who should get it first. My concern is increasing the number of dosages. I know that pfizer and moderna, the two leading companies right now and modernity has better capability for storing it at lower temperatures, but i am wondering why they cannot maybe solicit other manufacturers who already create injectables and have cold Storage Capabilities to try to increase those numbers , rather than having it be a social issue of who is first, but to really emphasize maybe doubling the amount of production host that can happen. Thanks of production that can happen. Host claudia, thanks for the question. Andrew dunn . Moderna, ando of pfizer come as far as when you get such a great readout, which is what they see with high effectiveness, the next question becomes how much do you make . I pulled these numbers today as we are looking at astrazeneca 2 million immunizations in december. Moderna can immunize about 10 Million People. It is a little under 40 Million People in december. How can you ramp that up and expanded through 2021 . That remains to be seen to some level. They have a trajectory that shows that growing into it eventually billions of doses. But it will take time to get there. One of the biggest hurdles is the supply chain. These are very complicated vaccines, especially pfizer and modernity. They are based on a new technology called messenger rna. There is a requirement to make the vaccine that is not typical. You need to get the , these fatty containers that you can carry the it is complex stuff and it requires hunting the globe to find these things in many Different Developers are making them. It will be interesting to see. If one appears to be highly effective as we get more data, what another Pharmaceutical Company volunteer its own manufacturing power, or would a government step in and say we are going to try to impel you to do this . That is something im watching very closely. We havent seen that yet. I think it is due to the complex city of the biology. These are not pills coming off the supply chain line, these are really complex, intricate medicines to develop. Host craig and washington, d. C. , line for democrats. Caller good morning. I wanted to i see a lot of people youre dying a lot and going to the hospital. I would like to know is it possible that people would get regeneron, the same medicine that the president got, and the steroids . Are they available . Quantities are very antibodyn regenerons therapeutic. Almost playing to that last that the manufacturing process around an antibody drug is really complex. Regeneron is made of two different antibodies used together to some level, which is a very complicated manufacturing process. So doses are going to be greatly limited on that, especially when you see the surging levels of cases in hospitalizations. The government has taken over that distribution question. Those decisions will be made by hhs and we will be following along to see where those doses actually go. His access equitable . I think that is is access equitable . When we have limited quality seville quantities available, how do you make sure they go to the right places at the right time and in an equitable way . Host in our last segment we talked about the group that is advising the cdc here, the Advisory Committee on. Mmunization practices, a cit who gets to be on that . Who are those folks . Nott the a cip is government scientists. They are not appointees by political figures. The is a group really of fdas Advisory Committee. It is a group of nerds. That are going to come together come about a dozen of them, and decide the best way to figure out a game plan for how to allocate limited doses. That meeting should happen sometime in december. I think the details are still being worked out as far as when they will have enough data to finalize a decision. Should Health Care Workers get it first, should the elderly with comorbidities, or should other groups we prioritized . That is an independent group of experts. The leader that is jose romero from the university of arkansas, who chairs that committee. When you think about allocation and distribution of the vaccine. Bet who decides who gets to on that committee . Is it selfselecting or is there an appointment process . Guest im not 100 sure on that, to be honest. I think the cdc plays a role in choosing those rules, but im not 100 sure. In crawford, is maryland. Independent. Your next. Covid19,u know this scientists are still developing and learning about this and we have these vaccinations. Is going to be a benchmark for things to get back to normal if people take this. It seems like without understanding the stability about this, is this really going to be a cure or is this just going to be similar to a flu shot where it mitigates it a little bit, minimizes the effect, and we know that fact it, other than the has a higher infection rate, it is similar to the flu without a mandatory vaccination, how is it going to get ahead of it . We cannot mandate flu shots. I dont expect that america will be able to mandate these. I would just like your thoughts on that. This is not the cureall, the endall beall. Andrew dunn. Guest thats a good point. I have talked to a lot of developers and experts who agree with that overall sentiment, that the vaccine in and of itself is not a Silver Bullet out of the pandemic. In the interim, mask wearing and social distancing are going to be critically important to the topharmaceutical innovations limit transmission of the virus. You brought up some great points as far as Unanswered Questions about the vaccine. This is something the fda will have to be very upfront about in the early months, that we dont know the durability of protection. Modernity,pfizer and is promising as it is, seeing 95 protection from the covid19 disease. That is just a couple weeks after getting the twothose regimen. We still dont know what happens in among, two months, six months, a year, if people need booster shots. A lot can happen in that time. We see it with the flu where every year there are different mutations, different strains to be vaccinated against. That means it is a real challenging virus to be immunized against. Will we see that with covid . We have not seen troubling mutations so far. That is something that will definitely be top of mind in 20 want to see if a mutation can get around this vaccine and lower the effectiveness. That would be troubling. I would also say another point to bring up, these studies might be run in the future, but these initial trials were not designed to test to see if they can prevent transmission. We were looking more for preventing severe disease or moderate disease, symptomatic covid19. But there is still a chance you could get the vaccine and it could be highly effective. You still dont want to throw away your masking and social distancing because there could be a chance you could be an asymptomatic carrier and transmitted unknowingly to people. If those other people have not gotten the vaccine, it could lead to severe outcomes for them. It would take how complex Public Health messaging to make sure the messaging is straight, clear and levels with the american people. Host on that messaging, as well as the distribution here and the approval, how much is that being impacted by a president ial transition . Guest we will find out, i guess, as far as it is going to be interesting to see how prepared, how seamless a transition that can be from one administration to the next in january. A couple things to watch for on that is what happens with operation warp speed. That is a big question in my mind. This is the Coronavirus Vaccine initiative that has been very ambitious, shepherding in cold billion dollars to administrators, putting the foot on the gas pedal as far as developing these vaccines. Lets do the trial simultaneously instead of in a sequential order, and lets ramp up manufacturing before we know it works so that we have doses if it does prove successful. What does the Biden Administration want to do with operation warp speed . Do they want to change leadership . Those are Unanswered Questions that will be very important to follow in the next few months. And seeing if there are any hit ups any hiccups between the administrations will be something to watch for. Jeff from just plainfield, illinois. Since most of the Companies Making the vaccine are developed countries like the united states, how do other countries that are underdeveloped are they going to be last in line to receive it , like bangladesh were places like that . What is the priority of countries getting the vaccine . Guest that is a great question because it is i think that is one of the more troubling things that i think about longterm. The way i think about it is the u. S. Is probably months away from having a widely available the , and you can see Anthony Fauci, u. S. Government scientist leaders, that this is anywhere from early spring to late summer of next year in the u. S. Global distribution is another ballgame, reaching 7. 5 billion people across the world. Like you said, countries like ethiopia, developing nations that might not have the infrastructure or purchasing power of the u. S. To spend 12 billion on vaccine programs. One initiative to watch closely as the World Health Organization , kovacs alliance. This is a group of most of the countries around the world where the u. S. Is not a part of this, but most of the countries around the world agreeing to share some level of resources and basically try to not leave developing mitigations behind in the rush to get a vaccine, to make sure that some of the units go to developing nations. But i think you are right, as far as when you think about each country fending for itself and trying to do its own population, it is going to be challenging for developing nations to find a way to get their hands on the vaccine and get their hands on the best one because there are about 200 different want different ones and development. We have only seen the ones from pfizer, journey, astrazeneca moderna, and astrazeneca. What happens with the rest . That is a huge challenge that the World Health Organization will start to address but is probably use away from being available on the global level. Bridgeport, connecticut. Howard, a democrat. I was just curious, are there any respected scientists, personnel, organizations that have a contrary opinion as to the efficacy or the safety of the vaccines . Absolutely. One i have talked to over the last few months is an Infectious Disease expert at harvard who harvard inenter at the 1980s, the 1990s, a longtime biotech exec who has been in this industry for a while. He expressed to me hesitancy around himself, how he things about the decision. He wants to see longterm safety, longterm durability. He worries about Something Like a mutation or that waning immunity over time that could leave people susceptible. To reiterate, these are definitely theoretical concerns. We dont have data that shows protectionity of waning, but that is how he is thinking of it. Though he sees it, especially that pfizer and moderna, there orno federally approved mra therapeutic vaccines out there. So what do these do in the long term . At least where he comes down on or twois waiting a year to see that longterm data for political trials to know for sure it is safe before getting it himself. Host thursday the White House Coronavirus task force held their first meeting in months. One of the issues that came up with this issue, and dr. Fauci addressed some of the concerned americans might have about getting the vaccine. This is what he had to say. Dr. Fauci the only way you can get an Effective Program is when people take the vaccine. We are going to be talking to you about that. I hear a lot now when we made these announcements this past monday, and then two mondays ag