辉瑞总裁谈疫苗防控奥米克戎变种,做好准备接种第四针

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,辉瑞制药公司董事长兼总裁Albert Bourla在接受媒体采访时,首次提出“疫苗防御奥米克戎变种,最终可能需要接种四针,也就是针对奥米克戎变种的特殊疫苗。最快在三月份之前完成从研制到临床验证安全有效性。”

日前公布的疫苗加强剂量针对奥米克戎变种中和反应作用是实验室模拟变种病毒,并非是真实世界环境中的验证结果。”

辉瑞总裁形容“接种疫苗就好像建立防护墙,第一、二剂量不够高,防不住奥米克戎变种,它能越墙而过,所以我们需要把防护墙再加高。。。”。

也有人开始担心了,如果再加高‘墙’,‘墙’塌了也会把人砸死的(如此短时间内,连续接种疫苗,是否把人体免疫系统彻底打乱呢?)

观看采访|视频|,文稿记录参见下文:

CNBC Transcript: Pfizer Chairman and CEO Albert Bourla

以下是采访辉瑞董事长兼总裁 Albert Bourla的访谈记录(未经本人审阅)


TIRRELL: thanks so much Pfizer Chairman and CEO Albert Bourla joins us now with more information on this announcement this morning. 
Albert, it's really great to see you and this news I think welcomed by a lot of folks. Does this mean that three doses of your vaccine should potentially be enough to restore at least the antibody levels against Omicron and maybe mean we won't need to update the vaccine here?
ALBERT BOURLA: Yes, what we saw in this study that we did, and this is the first of many that will follow, it is that three doses of our vaccine against Omicron basically is equivalent to two doses of our vaccine with the original strains. 
And as we remember, the original strain this antibody levels were translated to very, very high efficacy of 95%. So these are good news and the two doses, the reduction was significant, but the third dose restored those titles very, very high.
TIRRELL: What information are you expecting to get over the next couple of weeks both from within, you know, Pfizer and BioNTech and also from around the world? 
We saw the South Africa data last night, we know that academic labs everywhere are working on this. How will you make that decision about whether those threedoses are enough or if you do need to switch to that Omicron specific vaccine which we understand you started working on already and could have by March.
BOURLA: The data that we received are data that we got from what we call pseudovirus, so this is not the real virus
It is a virus that we have constructed in our labs and it is identical with the Omicron virus. 
This is a very well-known study and the first data that are coming up from this. We are working to produce, also will produce the same results with the real virus and that will come in may be a week or two and those typically are more accurate because those studies are, those essays are more sensitive. 
The ultimate proof is coming from real world data. 
We need to see where people that they have received the three doses, people who have received the two doses, if we have enough breakthrough cases, the severity of the cases, etc., etc. 
And that will come again I think by the end of the month, so by the end of the month we'll enough data to say if Omicron the solution will be just a third dose and they won't monitor to see when the third dosewains or not or if we need to go to specific against Omicron variant vaccine. 
Again, based on the studies that we did because we didn't test only the currentvaccine against Omicron, we tested some other vaccines that we have in our toolbox that are not commercially available, but they, they have been constructed just in case. 
We are getting enough conclusions to believe that when, if there's a need for an Omicron which we're working, that should be a very good one. I think we will have a good chance to see if we need an Omicron vaccine to have it in months to be very, very effective and that we will not lose any of our 4 billion annual capacity if we have to switch to an Omicron vaccine. So all of that are good news.
BECKY QUICK: Hey Albert, just to clarify things. All, all three of the shots, the two original shots and then the booster shot, it's the same formulation. 
It's the same thing. Is it a combination of those three working together and somehow making it work better against the Omicron variant or is this just a situation where people who got the shot a while ago and then are boosted and updated, that's what provides the effectiveness and I'm trying to figure that out because there are people who have gotten their shots more recently and then there are kids ages 12 to 17 who got their shots a while ago but aren't eligible for the booster yet. Where does that leave all those categories of people?
BOURLA: The best way to see it is the virus is the enemy if we want to protect ourselves, should build that wall. 
The first dose builds a wall but it is not very high. The second dose builds a wall on top of the first that's really high and now and it was very good for other variants. 
Now it looks like the Omicron has the ability to jump over this wall. The third dose takes the wall very high and should stop, expect to stop the Omicron. So people that they have two doses, they should get the third one. 
But if they have two doses it's very likely that you are better protected than if they don't have any or if they have only one because there are different elements of immune responses that the vaccine is creating like the memory cells and those cells recognize a spike in Omicron that it is almost 80% identical so they should give protection, against severe disease protection.
JOE KERNEN: Hey Albert, trying to decide whether the, the monoclonals, the therapeutics that we have that we also worry about whether they're not specific enough for the change, somewhat changed spike protein. 
They don't, they're not suited for, they don't do any T cell work. Do you think any part of the retained immunity we have for your original formula of the vaccine, do you think that means these monoclonals aren't effective at all because some of it is T cell mediated? 
Or do you think that it's just partly effective because there's enough of the spike protein that's similar where there is some efficacy?
BOURLA: I don't have enough data myself to make this conclusion. I've heard that some of the companies said about their own monoclonal, they have concerns and some other said that it looks it works and that's what everybody will their test. 
What I can speak it is about the treatment that we have, the oral treatment and I expect that we will not lose any efficacy against Omicron because the mode of action as we described is not on the spike. It's working on a different element of the virus and this element is very essential for survival of the virus for the production of virus so it's very difficult for the virus to create a variant that will resist the antiviral effect of our oral treatment.
TIRRELL: Albert, justgoing back to the booster question for a moment. We understand that you filed for clearance for 16- and 17-year-olds to be able to get boosters and some ofthe reporting suggested we can hear from the FDA on that really any day now. What are you expecting in terms of that availability?
BOURLA: We will have it available. It's the same formulation for 16 or 17. We did file with FDA and is up to FDA to make their judgement and whenever they feel they are ready to make something like that we will be ready immediately to provide.
TIRRELL: And then how about down to age 12. As Becky mentioned, a lot of those teenagers and 12-year-old have also had their two shots a little while ago. When do you expect to file for adolescents to get boosters?
BOURLA: This is a good question and in light of Omicron that we need to move faster on this. I think third boost, third doses was a very good policy and they need to be accelerated. This is what the Omicron results are telling them. You need the third boost.
TIRRELL: Right and also for kids of course ages five to 11. They're just getting their first two shots now. I heard you talking with Savannah Guthrie earlier and suggesting other countries have moved the space between the two doses and the booster to as short as three months
Is that something that you'll be looking at for kids potentially also to guide when they should get boosters, if they should get boosters, and also for even the younger kids asking as a mom of a three-year-old. We understand you expect those data by the end of the year. How does all of this information about Omicron play into that kind of time line?
BOURLA: I think it's more a question of CDC, FDA or healthcare authorities of this country to assess the situation and make a determination if they need to give boosters earlier than six months based on the totality of data that we are having. This is what the UK did, this is some other European countries did and it's up to again the healthcare authorities to decide what is the best healthcare policy.
QUICK: Albert, Israel's already working on fourth vaccination shots. What, what has it gotten them to that point where they think that that's necessary and what are the results, the real world results, you've seen as, as a result of that?
BOURLA: Look, many countries have given four doses to immunocompromised and to special population, I think including the US, so if you're immunocompromised, you may get it way sooner than would make it more than three. 
And I think that they're, they're having a precaution. I think when we see real world data will determine if the Omicron is well covered by the third dose and for how long. And the second point, I think we will need the fourth dose. I've said that multiple times. 
With the previous, I was projecting that that will be on 12 months after the third dose. With Omicron, we need to wait and see because we have very little information. We may need it faster. 
But for right now, the most important thingit is that we have winter in front of us. From healthcare perspective, it is important to understand that we need to be well protected to go through the winter. 
A third dose will give very good protection I believe with everything we have said so that we will go without concerns through the winter plus the treatment for those that they will have to get that they will be infected that they will not have to go to the hospital. I think we should be in very good safe to control the winter based on what we say right now. And then if there isa need for something different better, we will be able to have in months.
KERNEN: Albert, the risk of additional variants is always front and center for things that we talk about. 
You made a point yesterday that, you know, if, if there's a lot of the COVID still around in billions of people, invariably there will be the risk of another variant. And we had already had, seen a paper that says that immunosuppressed people for example, in South Africa perhaps, that one person that lived 150, 160 days with COVID because of a very weak immune system, there were 50 plus mutations in just that single person in the, in the COVID virus that they had. 
Do you think there's a bigger risk of variants emerging from billions of people one at a time just with a variant or you can get a variant out of a single person that's immunocompromised that maybe has the disease festering for like 160 days? Both?
BOURLA: I think clearly the more people, the more replications of the virus so the higher the risk of getting variants. 
My assessment is that we will be having regular, the appearance of different variants and that's why we are preparing for that format. So, every time that we have a new variant and there will be more I'm sure or I'm very highly, it's very highly likely. We will be monitoring to see if there's something that we need to do.
TIRRELL: I want to ask you about the antiviral drug, PAXLOVID. You mentioned before you don't expect that to be affected by Omicron. You mentioned that at a conference yesterday morning that the FDA has asked to see the final results from the trial where you show that 89% reduction in hospitalizations and deaths with this pill when given early because the Merck data really declined between the interim look and the final look but you expect potentially that this could be available by the end of the year. 
Has the FDA indicated it wants to hold an advisory committee meeting to discuss this drug or do you think with that final data, they'll just make a decision?
BOURLA: I think it's up to FDA. I don't know what will be their decision if they will need an advisory board or not they asked for the data and we will provide those data. 
We will have the full set in few days. It is not that we will have them in a fewmonths, in few days. And we will submit them and I feel comfortable that the data will mimic at large what we saw in the first part of the study for several reasons that have to do with the attack rates or disease rates that we have seen that they are similar in the first and second. 
So, we have the data, I don't expect them to have difference. So, they will do it this month. FDA already is reviewing the file. They will make their decisions to give or not approve or how fast, with or without an advisory board but I think they have a very high sense of urgency and we have already seeped product in the US. So, product will be available this month if it's approved this month.
TIRRELL: And you, you just mentioned you don't expect to see a major change between the final results and what you saw at the interim.
BOURLA: I don't.
TIRRELL: Alright, Albert, it's been great to have you on this morning. This was news I think a lot of people were hoping to hear about. 
Thank you for sharing this with us and we'd love to stay in touch with you as you get more of this information about the vaccine against Omicron. Thanks again.
BOURLA: Of course, we'll have news about the vaccine and the treatment but very important. people need to get their boosters. Very important message.
TIRRELL: Albert, thanks again.

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