UN Geneva - Multimedia Newsroom : WHO Press conference SAGE - Johnson & Johnson COVID-19 vaccine 17 March 2021

Thank you very much for joining for this briefing.

Another one of the W2 Strategic Advisory Group of experts on immunisation, the stage presenting its interim recommendations on the Jensen vaccine, the AD 26 dot COVID 2 dot S vaccine.

And of course, our experts will go into depths on this one.

Before I let the experts talk, let me just walk through the procedures and then make a comment here.

So a, you heard that you saw the line, the document recommendations still on the embargo.

That's, that's fine.

That means the, the documents will be live on the website as of 1300 Central European time.

The briefing now is live cast on some occasions.

So that's completely fine.

So we're not on the embargo now just to stress this right away.

Secondly, after the introductory remarks and the explanations by Professor Caviotto, we'll open the floor for questions.

Before I introduce to this, could the guests, let me also say we do have this briefing as a SAGE expert group meeting on the Jansen vaccine.

This is not the Global Advisory Committee, Committee on Vaccine Safety, on any of the vaccines or on the AstraZeneca vaccine.

Please bear that in mind, a, throughout the briefing and B, before we get into the questions.

So again, this is the SAGE briefing on the Jansen vaccines, not the Global Advisory Committee on Vaccine Safety.

Thank you.

And with this, let me introduce our our guests and our speakers today.

So of course, we have with us the chair of the Strategic Advisory Group of Experts on Immunisation.

That's Professor Alejandro Caviotto joining us online.

Thank you and welcome.

We have Doctor Kate O'Brien, director for the Department of Immunisation, Vaccines and Biologicals from Babajo.

Good morning, Doctor O'Brien.

Oh, by the way, it's actually noon.

And finally, last but not least, Doctor Alice Wilder Smith, Technical Advisor to the Stage Secretariat here at WHO.

Hello and welcome to everyone from wherever you're listening.

And let me hand over straight to Professor Caviotto over to you.

Good morning from my side.

Good afternoon or good evening where wherever you're joining us from.

As Christian said, the strategic Advisory Group of experts on immunisation met on Monday to review the evidence related to the Jansen vaccine for against the SARS COVID 2AD26 COV 2 point S.

And we have the following recommendations to make after reviewing the evidence.

We have a vaccine that shows to be safe and it shows to be have the unnecessary efficacy to be recommended by us for use in people above the age of 18 without an upper age limit.

This is A1 single dose vaccine given intramuscularly, which is a regular advantage in the sense of having the capacity to vaccinate more people, but not different in reality in its capacity to protect against severe disease or death or hospitalisation than all the other ones that we have already reviewed and recommended.

The vaccine is relatively safer than others in the sense of knowledge for use in pregnant women since we have the experience with another Jansen vaccine based on the same Adeno 26 platform that has been extensively used to control Ebola outbreaks in the Democratic Republic of Congo and in other parts of West Africa.

In fact, there is a follow up of close to 1600 women, pregnant women that were vaccinated with this Ebola vaccine in which it was shown that the risk benefit of vaccinating them against the risk of court of having severe Ebola disease was totally justified.

And the same can be said for women who are breastfeeding.

In this case, we do have follow up of another vaccine with the same platform, the one for Ebola, showing that it is safe for women who need to be vaccinated and at the same time are breastfeeding their children.

In the sense of the of the vaccine, whether the vaccine should be given to people who have already been exposed to the virus, we continue to recommend that they do.

And in this case, we could still recommend as an act of solidarity due to the scarcity of vaccines, to wait up to six months if you have been infected to be able to give the others a chance to get their first doses.

However, in countries where you have an issue of circulation of what we call variants of concern, these are the variants that are circulating that have been shown to have either more transmissibility, the capacity to infect others, or in the papers in the last week, more capacity to cause a severe disease and death.

Then we recommend that you don't do not wait to get vaccinated more than a week or two if you have already been infected with the SARS COV 2 virus.

As we have said in in in the with the other vaccines.

We believe that, given the the notes in our WHO prioritisation road map that SAGE presented and and endorsed some months ago, we believe that groups that are disproportionately at risk of being infected with the SARS COV 2 virus should be vaccinated first.

That means of course, our frontline workers, people who are in direct care or services for people who are infected, and of course those that live in environments where the virus circulates in a much wider capacity.

In that sense, we feel that this gives the vaccine the chance to really help stop the pandemic.

We do not vaccinate, we do not recommend the vaccine for people travelling.

There's still no information related to the safety of that and we still do not recommend any type of certificate for travelling because that's the prerogative of the International Health Regulations Group that has already said that this is not the time to establish those type of controls.

In the countries where there is a **** spread of the variants.

And in countries where we now have information about the use of these vaccine to control SARS COVID 2 caused by these variants, we recommend that you use it.

And that would be, for example, data coming out of the USA, Europe, Africa, South Africa, Brazil, etcetera.

I think that regarding the vaccine, that would be my last message, except that we are continued to insist that there needs to be a coordinated approach regarding the vigilance of the circulation of the variance.

And that requires countries to share information to increase the search for this variance through systems that allow them to sequence the viruses and see where they are and especially how **** risk groups are affected by by these issues.

In the case of children below 18 years of age, we still do not have a vaccine that is useful for them.

The Pfizer one has been recommended up to 16 years, but that's all.

But we know that there are a number of vaccines being already tested in children up to 12 years or even younger.

And we hope to have that information soon to be able to protect that group of Christian.

I would leave it there and, and start opening the the questions.

Thank you.

Thank you very much.

Professor Caviotto.

With this, we're heading right over to the questions.

I see a longer list already.

And we're we're taking it right from the top.

Again, just to remind everyone, this is the briefing to say briefing on the Jensen vaccine.

Jamie Keaton, please.

Hi, Kristen, Thank you very much for for taking my question.

I wanted to just ask just generally there's been a lot of questions about the vaccines and in general.

And I'm just wondering if you could give us sort of a blanket statement about the importance of vaccination campaigns and and if you have any concerns about suspensions of vaccines.

And I'm sorry to do this, but if, if Doctor O'Brien is there, maybe she could address just the AstraZeneca situation.

I know that it's not the briefing today, but it's the thing that is on everybody's mind.

Doctor O'Brien, is there any possibility that EMA or WHO or AstraZeneca could, could tweak the recommendations that they have if there are certain dangers that may be found without actually recommending a full suspension of use of of a vaccine like AZ?

Thank you so much.

So without with before I hand over to the two experts, we are expecting to maybe come for a statement by the Global Advisory Committee on vaccine safety to have a statement out today.

Again, we're expecting it to, it may come, it may not come.

It's up to the committee that should cover most of it.

But maybe Doctor Brian can then give a quick remark in overall.

But maybe I can ask Professor Klaviota for an overall statement on on the importance of vaccination campaigns in general before we get a bit deeper into with Doctor O'Brien.

Is that OK?

Professor Traviotto, does the question refer just to the COVID-19 vaccines or or is the question about all vaccinations covering?

Because that's our worry, our worry that the COVID vaccines are taking the place of our vaccination programmes worldwide and we're not immunising enough children with the basic vaccines because we're dedicated to the other parts.

We have programmes for the elderly which are not, have not been part of many vaccination programmes in our countries.

And therefore we insist that the children should receive their normal vaccines within the safety measures that we can have for these processes.

But we cannot continue to delay the process of vaccinating as we normally do with all the other vaccines that we have available, because then we're going to have a massive problem related to outbreaks of things that we haven't seen in years in many parts of the world.

If it relates to the COVID vaccines, we feel that the issue of availability is very important.

But as soon as a country can have access to these vaccines, they must have a vaccination programme in place to be able to use them effectively and efficiently.

In the sense of trying to protect first the people that we have prioritised as essential workers because they are the ones who are keeping the rest of the population safe.

And then of course, the age stratification according to how we have defined the groups so that you have protection against the people who are more liable to get sick and more liable to die from the pandemic.

I think what I would like, if you don't mind, is to ask Annalise if she could also tell us with this vaccine 2 factors that have been important in the sense of our recommendations that go a bit further to what I said at the beginning.

Thank you.

Yeah, Let me ask Doctor Will the Smith to comment on that, as you just said, and then go to Doctor O'Brien for more general remarks on the other vaccines over Doctor Smith.

Will the Smith please.

Thank you.

So we want to highlight again that this vaccine is a non replicating vaccine.

So it's inactivated.

It has no infective materials, It does not contain preservatives, adjuvants, materials of animal origin which is important.

So it is halal.

It is also it does not contain any foetal tissues.

So, so this is overall a vaccine where we have a good safety profile and based also on the extensive experience from the AD 26 platform, we have also good data on pregnancy.

I think this is what Alejandro wanted me to talk about.

Happy to add anything.

Thank you very much.

And let me hand over to Doctor O'Brien.

Doctor Kate O'Brien, please.

Yeah, we will.

We will as as we've said, try and constrain this, this press conference to the Johnson Johnson product.

But I will just make some general comments about the AZ situation with respect to how we deal with any potential adverse event for any vaccine.

And the specific question you asked, Jamie, was, you know, can a product insert be tweaked or can the recommendations be tweaked?

I think that was the word you used to adjust them as more information comes comes through.

And the answer to that is that that is always the case.

Vaccine recommendations are dynamic.

We continue to look at the evidence on all vaccines as it continues to come through over weeks, months, years, but particularly for new vaccines in those early phases of use.

And of course, we're in an unprecedented situation with the the rapid scale out of vaccine.

So we're getting a lot of information with the, you know, millions of doses that are being used around the world.

I also want to just draw your attention to examples of vaccines without, without pointing to anyone specific vaccine, but just to give you an example.

It's not that it's not a unique example, but we do have situations where a vaccine does have rare events that are associated with a vaccine.

The rotavirus vaccine we know has an association with interception events, and those are rare events.

The benefit of rotavirus vaccine far outweighs the risk of those rare events, but recognising that they can occur allows management of those events in in the, you know, the rare events that do occur.

So certainly recommendations are adapted to new information and an assessment of that benefit risk profile as that benefit profile changes.

And often the benefit profile increases over time as we get more and more measurements of what vaccine impact really is and the risk profile matures in terms of what we understand about risks of vaccines, notwithstanding that, that for some vaccines, there are rare significant events that that do need to be managed.

Thank you very much all.

And with this we go to the next question, Vanilla von Hall, Svenskader blooded, please.

Yes, can you hear me?

All good.

Thanks for taking my question.

It's on, on Jansen or Johnson and Johnson, the vaccine.

There have been cases in the study of similar bleedings and clothes, even though rare as in the case of AstraZeneca.

How worrying is this?

Do you think countries should keep a closer look on this?

And even if there is an association, as you mentioned in the case of Johnson, is it also that you know the benefit will be bigger than than the risk?

Thank you.

Thank you very much, Kunal.

We'll start with Doctor Welder Smith, please.

Sorry.

So I'm now on which.

Thank you.

Sorry indeed.

The trial had about 44,000 subjects.

So half of them, about 22,000 did not receive the vaccine and therefore I called the placebo arm and indeed in that group, and that's good to know as a comparison or as a background, there were 1010 cases of thromboembolic events.

So clots, be it either deep enterobosis or pulmonary embolism or another blood clot.

So this is your background.

So there were 10 in 22,000 in the placebo arm, in the vaccinated arm, in the arm that in the in the group that received the, the, the Johnson vaccine, there were 14 events also out of 22,000.

So this is about the same.

There's a slight imbalance, but it's still not statistically significant.

I have to add that obviously thromboembolic events are indeed and that a phenomenon of the disease itself of COVID-19 itself.

And therefore we do need to look out for, for thromboembolic events in in general and, and we are thank you very much for this important clarification.

Let's move on to Peter Kenny, please.

Actually, I was going to ask a similar question.

So could you just elaborate a bit more on the thromboembolic elements in COVID-19?

Is it more likely to be due to the COVID or to the vaccine?

If you could just elaborate a bit more on that.

Thank you.

Thank you very much.

Yeah, that gives us an opportunity to to clarify that in the the comparison with the placebo arm and the the vaccine arm was also very important.

Doctor Will Smith, can I ask you to elaborate a bit and then we see if somebody else wants to come in.

Sure.

We need to be reminded that the vaccine intentionally recruited persons that are at higher risk of COVID.

So older persons, persons with comorbidities, obesity who may have naturally already a higher risk of of, of of thrombotic thromboembolic events.

So I think we could use this the 10 out of the 22,000 as kind of a of a background.

And to your question whether COVID as a disease is associated with from embolic event.

In fact, COVID really predisposes patients through it causes a hypercoagulable state where indeed many of the deaths that we see are in the severe cases are due to thromboembolic events.

As for the vaccine itself, we have not seen it in a trial that, you know, there's no reason to think and no biological plausibility as far as we understand now that the vaccine could cause thromboembolic events itself.

However, we have to be open.

For new events, and we have to take it seriously and we have to look at all the data.

And I think those data will come out tomorrow.

When when, when?

The EMA also takes a very, very serious look at all the details over.

And to know that thrombolic events are having a fairly **** percentage in a normal population anyway.

All right, let me head over to Kate O'Brien for further comments.

O'Brien, please.

Yeah, I just think we we want to emphasise this is being very carefully looked at by both EMA and WHO there.

I think as everybody knows, they were expecting EMA to have a statement out decision out about an asset their assessment tomorrow and The Who Global Advisory Committee on Vaccine Safety is, is undertaking a similar review.

So you can fully expect that there will be an assessment done looking at the benefit risk ratio related to this vaccine and related to this, this safety signal.

I think what's also important is there are clear statements out both from WHO and EMA that at this point the benefit risk assessment is to continue with vaccination.

There are many countries that are continuing with vaccination vaccines.

We did speak about the importance of vaccine campaigns and assuring that the pace of these vaccine campaigns is is providing protection as early as possible to people.

So I just want to emphasise that events occur when hundreds of millions of people are being vaccinated.

All of the usual things that are happening to people with respect to their health will continue to happen to them unrelated to whether or not they were vaccinated or not.

And of course, the main point here is to try and separate out events that are related or potentially related to a vaccine from events that are happening coincident with but not related to the vaccine itself and teasing those things out with respect to time and clustering of events.

Sometimes there are clustering events that is coincidental and sometimes they happen related to an exposure, in this case a vaccine.

So that's the work of these committees is to is to deliberate on all of that evidence that is coming in from all, from all corners of of the world.

Thank you.

Let me move to the next question and that's Bodhi Hugger from Phoenix TV.

Bodhi, over to you, please.

Thank you for taking my questions.

I tried to put the two questions together.

According according to the COVAX vaccine list, some vaccines from China ranked ahead of Johnson.

Johnson, why we haven't seen the research results from Chinese vaccines, is that the random seconds or because of Chinese vaccines lack the support of international standard research documents?

And what is the process for WHO or SAGE to review the candidate vaccines?

Thank you.

I'll take that if I may.

So Sage, first of all, we the interest of WHO is to have as many vaccines from wherever they come in the world to be deployed to be reaching EUL and to be used around the world.

Our interest is to provide to assure that the world has the vaccines that that are needed everywhere and anywhere in the world for everyone and anyone who needs these vaccines to to have that that access.

The the the assurance that WHO provides is that any product that is goes through the EUL process successfully is essentially affirming that there is those products are meeting the international standards for safety, efficacy and quality of manufacturing.

And as a result of a WHOEUL listing, then country regulatory authorities can rely on that assessment that has been done and move with speed for their own regulatory processes and rely on the dossier that has been reviewed.

If the manufacturers allow for the sharing of that dossier, there is that process is going on for a number of candidate vaccines, including several Chinese candidate vaccines that are in a very mature phase of that assessment.

In EUL there is a document, perhaps somebody can put the link up in the in the chat that provides you with a weekly update of the progress of each of the products that has come to WHO to seek a UL listing.

The important thing I want to emphasise there is WHO can go only as fast as the data that are submitted by the manufacturer to WHO.

We are totally reliant on the manufacturers providing the information that is needed and requested and the responsiveness of manufacturers to provide the data in the the format that is needed and in the detail that it's needed.

And, and we work iteratively with manufacturers to give them feedback about what more is needed and, and whether or not what they've already provided is sufficient.

So, but that is the, that is the pace at which we can go.

We can't make it go any faster than the pace at which manufacturers respond.

There is a separate process which is the SAGE process and this is the policy process.

So EUL is about the safety efficacy and quality of manufacturing.

So that's sort of answering the question if a vaccine should be could be used and the policy process answers the question of how a vaccine should be used.

We have it is an independent process.

So it's a it's a separate set of experts and independent experts that review for safety, efficacy, programmatic use.

And we the SAGE is not the entity that looks at quality of manufacturing in WHO we have these two processes very carefully lined up because clearly we would not have a policy process if we don't already have assurance that the regulate regulatory processes is near the completion.

So we are in the process of a number of different manufacturers have presented their information to the Sage work group that is focusing on COVID vaccines that includes several Chinese manufacturers and other manufacturers.

Sage has set the standard that we will review any product that has either emergency use listing from WHO or has authorization through a stringent regulatory authority.

So Sage will focus its time on those products where the regulatory process has been assured through either of those two processes and that's the timing that we follow.

So in a sense the policy process is also subject to the ability of the manufacturers to provide information through the regulatory process.

And similarly, we have a set of standards for the type of information that that the expert group requires and the way in which the information is provided and have been working carefully with manufacturers including in China for for going back and forth about what information is needed.

We do expect to have next week on the SAGE schedule a first session on two of the Chinese manufactured products, Synofarm and Synovac.

And that session will be to begin the information for Sage.

But because the emergency use listing has not been completed, we will not be asking for a recommendation from Sage because we're not at that phase yet.

Thank you very much for this really important clarification.

And maybe time for me to add, there's the regular SAGE meeting that Doctor O'Brien just managed mentioned starting next week 20, Monday 22 and going until 25 March, to my knowledge.

Well, this we'll head over to the next question.

That's Chamil Shad.

Chamil, please unmute yourself.

Hi, can you hear me?

All good.

OK.

Mr Craviotto, a question on the six month delay of vaccines.

I'm a journalist from Brazil.

You mentioned that in the case of Brazil the six months should not be waited.

Basically my I have two questions, clarifications on that.

That is a recommendation to all vaccines, correct, not only Johnson.

Secondly, why is that?

Why are you asking Brazilians basically to go and vaccinate themselves, even if they have had?

If you could just elaborate so we can explain to the public in a better way.

Also, thank you.

Thank you for the question.

I think it's very important.

First of all, I think the problem in Brazil, as you well know, it's a circulation of the variant that has really affected places like Manaus where you have had a research of infection even after people have been already infected the first time.

So in that sense, the problem of waiting was initially an issue of solidarity, since we don't have enough vaccines for everybody and we need to raise the minimum amount of protection in the as many people in the population as possible.

What we said is looking at the way that the follow up studies have shown that a person who has been infected, even with an asymptomatic infection, can have protection for at least 6 to 8 months.

Then we said before the variant really started circulating that if you could wait by your own choice for six months so that all the other people who had not been vaccinate or had not been infected could be vaccinated with at least one dose of the vaccine.

Then you would be helping for your country to be able to achieve this level of what we call herd immunity in a faster way.

And that especially the vaccines could be actually used to protect the **** risk groups such as the health workers or the frontline workers.

To be able to be a benefit for the whole population with the circulation of the variants and especially in places where there is a **** circulation.

South Africa, Brazil, now the United States, be there we 117.

We have decided that in those situations, we don't recommend people waiting to get vaccinated even if they have been exposed to the virus.

Because as we have seen in those people, the booster from the vaccination in the first dose allows them to be more confident that we have a much fuller protection in them to be able to avoid an infection even by the variants if they have already been infected by the 1st virus.

So in that sense, that's where the recommendation comes from.

If your country doesn't have the circulation of a variant, the situation of the axis of vaccine is small because they are vaccines are not arriving in sufficient quantity for a higher number in your population and you have been infected and decide to wait, that's perfect.

But if you're in a place where you have a circulation of variance and that exposes you to have a second infection by this new virus, then we don't recommend that you wait if you have access to a vaccine in those places.

I hope that answers your question.

Thank you very much.

Professor Caballotto and Dr Will Smith will add on.

Yes, thank you.

I would like to add that WHO recommends that everyone who is eligible for vaccination according to the prioritisation road map should be vaccinated regardless whether they have had the disease or not.

So, therefore, we also do not recommend that we should screen for anyone whether they had a past infection or not.

It is just as Professor Carbiota said, in the time where we still have limited vaccine supply and where we do know that natural infection does provide a very good protection against reinfection for at least six months, if not 8.

And we would say that those persons can consider delaying their vaccination until we have more vaccines available.

It's just that we also now have seen that from some data from South Africa that that with a variance, you're less protected against natural reinfection.

And therefore, we said in those countries, you know, just go for your vaccine when it's offered to you.

Thank you very much for this.

We'll move to the next question.

That's Jeremy *****, LFV.

Jeremy, please unmute.

Yes, thank you, Christian.

The question about pregnant women, it seems that on this particular vaccine you have more infos because what I understand is that the vaccine is kind of similar in a way to a previous one for Ebola and that you know that it's particularly safe for pregnant women.

So the question is, at this stage, is the chance vaccine the safest for pregnant women and breastfeding women?

And, and would you advise probably that it should be prioritised for, for this category of population?

I guess that's good for Professor Caviotto, please.

In reality, no, we, we don't have more information about this vaccine specifically, excuse me, than we have about the others.

In this case, we have another vaccine with the same platform that has been shown to be in the risk benefit analysis, a safe vaccine to use, and that's the Ebola one.

But we do need to have specific information about this vaccine also in pregnant women before we make any recommendations specifically about it or to show that this vaccine is more effective or more safe in this in this group.

For now, what we have said is that all the vaccines that we have reviewed so far do not seem to have a safety profile of danger if used in pregnant women.

And that the risk analysis has to be made in the sense of whether the vaccination will protect them against the possibility of having a disease and that being a severe problem for them and the child that they're expecting.

But for now, I don't think we have any vaccine that is has been shown to be more effective or better for recommendation in pregnancy.

I don't know if analysts would like to add something like that coming out of the working group.

Please do Thank you.

Indeed, all vaccines for which the SAGE or WHO has now issued that policy recommendations are all basically inactivated vaccines.

So they're not live vaccines.

So they they should have a good safety profile.

It is just that pregnant women were excluded from the trials so that we don't have a real data to show this.

But theoretically, they should all have a good safety profile.

And just to show you the, the, the Pfizer and the, and the Modena vaccines were rolled out are, are being used in pregnant women in the US with, with a good safety profile.

I think we can be reassured about the safety issues.

But of course, we want to accrue more data.

And all companies have assured us that they will obtain more data also in pregnant women.

Thank you very much.

And the next question comes from Isabel Sacco.

Long time no here.

Isabel, please unmute yourself.

Isabel, do you hear us, Sir?

Yes.

What's me?

My my fault.

So good morning, Isabel Sacco with FS punishing insurgency.

I would like maybe Mr Doctor Graviotto to comment on the efficacity of this Johnson vaccine compared with other vaccines.

If you can give us some details.

And also what can you say to the for the general public understanding on what makes this vaccine as good as the others with just one dose?

Because some people can think that is they are rather protected by two doses and by 1.

So if you can explain for general understanding.

Thank you.

Thank you, Professor Grabiotto, please.

Thank you for the question.

We given the way that the vaccines have been tested separately and have used different endpoints to be able to see what is the efficacy of the vaccine regarding what we call severe disease, hospitalisation, deaths etcetera.

We are not in a position to make comparisons of 1 vaccine against another and this idea that the percentages of efficacy that have been reported as a way of comparing them is wrong.

What we have said clearly is that in this phase of the problem, what we want are vaccines that have a safety profile that has been proven and on the other hand, that they have a defined efficacy, about 50%, that would allow them to prevent serious disease, hospitalisation and deaths.

And in that case, all the vaccine have been shown to be able to do that regardless of the differences that they have shown during the clinical trials.

In fact, in the follow-ups that we have seen, for example, in the UK comparing 1 vaccine against another after the first dose, the differences are much smaller than what was shown apparently in the clinical trials.

So in that sense, I think that the vaccines should be compared in the sense of what is their impact for the general population in the way that we have shown that at this stage, which is to prevent severe disease and that's during the pandemic.

We will know more about them in the sense of whether they are able to stop the virus from going from one person to another.

And the other thing that we do not know because of the length of the of the surveillance is how long will the protection afforded by each one of these vaccines last, whether they receive one dose or two doses.

For now, the recommendation for the Johnson and Johnson is to achieve a level of protection that will allow a person not to go to a hospital or get severely sick is of 6070%, which is what they have shown and that is good enough for the recommendations we're making.

How long that will last, we do not know, as we do not know for the other vaccines or whether this vaccine will eventually require a second dose or a different dose if we want to prevent this same vaccine from not causing, not having disease by another type of virus, we're talking about the variance.

So in that sense, I think for now we cannot make comparisons of that change because they would not be valid.

What we want to really show is that all the vaccines that are becoming available are good for this stage of control of the pandemic.

I think Kate or or analyst could add something to that and that would be that would be good.

Great.

Yeah, I really want to reemphasize what Doctor Carvey Otto just said, WHO set some some benchmarks for the target of what we were aiming that the vaccines would be able to do as demonstrated in clinical trials.

The products that have been reviewed both for EUL and for SAGE recommendations have all met those standards.

The world is in a place where there is insufficient supply to meet the requirements of people who need to be vaccinated.

And clearly any of these vaccines are life saving products.

They need to be used as quickly as we can get them deployed.

People can have confidence in their safety and and efficacy and in the quality of the manufacturing of the products.

And so it is, it's a really not the, the comparisons that some people may be making between results of 1 clinical trial and another clinical trial.

I also want to emphasise that you will see for some products where there were a variety of clinical trials that were done, the estimate and we always refer to these as estimates on the efficacy.

The estimate on the efficacy is really related to who was actually in the trial.

The characteristics of people, you know that that when somebody becomes vaccinated, they either will or they won't get disease.

And what a trial does is it gives you that measure of the collective experience of a large number of people.

But there are many attributes of those people that influence whether or not they will or won't get disease.

The degree to which they avoided, they avoided exposure, the other underlying conditions that they have there, there's so many things, the amount of transmission that was going on in their community at the time when the trial was being conducted.

So the trials are large and and they are randomised, which means that we hope that the trial has balanced out those other things that affect whether or not somebody gets disease or not.

But an estimate from a trial is, is really that.

And that's why we also have a confidence interval around those estimates because the the ongoing true experience of that vaccine is going to vary in community by community in time period by time period in the people who are actually vaccinated.

So we shouldn't make, we should not over interpret these, these specific numbers that come out of trials.

They're all highly effective vaccines, they're all life saving vaccines, they're all safe vaccines and we should get on with deploying them.

So anybody who's offered vaccines should take whatever is being offered by the programme and, and, and assure that the vaccines that are being produced are, are used to their maximum benefit.

Thank you very much for these important clarifications.

I see that the status of COVID-19 vaccines link with the EUL listing was the link was shared with everyone in the in the chat.

So please refer to that at any time.

The next question comes from Gabriella Sotomayor Progresso.

So please go ahead, Gabriella.

Good morning, Kristen.

Thank you very much.

Couple of questions, short questions, 11 clarification.

For any vaccine, what is the risk benefit?

For example, for a million vaccines, how many accidents are normally expected?

Or if there's a ratio or something like that, then how many, if you know, how many Jansen vaccines will go to Kovacs?

Because this could be very useful for countries like Latin America or in another parts of the world.

And 3rd, very quick.

There are many people who want to be vaccinated right now, but they are afraid of the AstraZeneca.

So if SAGE has a message for them, especially for those who receive the vaccines of the mechanism COVAX.

Thank you very much, Gabriel.

And I think the believe the accidents you were mentioning were first, you're referring to adverse events in in general.

And just to mention that adverse events can be any light swelling on your arm where you get the vaccine, which disappears in a few hours.

That's also an adverse event.

But I'll ask Doctor O'Brien to get into this, please.

Yes, thank you.

So to address the first question, the risk benefit is, it's not like there's a formula that is applied to a risk benefit assessment.

What is really assessed in in a benefit risk analysis is an understanding of the the disease, the frequency of the disease, the severity of the disease, the groups in whom that disease occurs, and then an assessment of the product in question.

What benefit is that product actually bringing to the prevention of the disease, the impact that that product could have, and assessing that against the both the nature of and the frequency of any potential risks that that product confers.

And those risks actually are not just biological risks, but they're also risks that people would stop doing other things that they should be doing there.

The the risk of, of a, a, a product or a programme is considered in a very sort of broad context.

So there's no specific formula that we would say when an an adverse event meets this frequency, then we consider the risk benefit to have tipped over.

It really depends on the severity.

As we know from these products, it's very common to have local reactions.

It's very common to have for some of the products a period of not feeling well, a day or two of not feeling well.

And so we look at both the frequency and the severity of the risks over time in relation to the benefit and the benefit is both an individual benefit and a community benefit.

So, so that's the nature of a benefit risk assessment.

And in the SAGE documents, you will see how the committee weighs those, you know, the the assessment of the evidence and, and how that evidence to the recommendations was actually drawn through what was being looked at the issue around the Jansen vaccine.

So there is an agreement in the Kovacs facility for hundreds of millions of doses of the Jensen product to be deployed through the Kovacs facility.

There are some options on that, on the numbers.

So we have some flexibility around whether or not it will be a greater number of hundreds of millions of doses or a fewer number of hundreds of millions of doses.

The the the Jensen product like the AstraZeneca product has a number of sites that are doing the manufacturing and the product site of manufacture for the Jensen product would come out of bio E in India.

So we will be also looking to that process to happen for the production to the tech transfer and the production to happen for the Kovacs facility.

On the, I'm sorry, there was a question on the AstraZeneca product and I wrote down that it was an AstraZeneca product question.

Now I've forgotten what the question is.

Could you just repeat the last question, general men question about the confidence in in AstraZeneca or in a vaccine in general?

Yes, again, I think we should point to a couple of things for the AstraZeneca product.

We'll we'll continue to reinforce them.

Again, there are millions and millions of doses of the AstraZeneca product that have been deployed already both in Europe and starting around the world.

The in the clinical trials, there was no signal of a safety issue in the for the AstraZeneca product as millions of doses are rolled out.

It is not unheard of.

It is not unusual, highly unusual, to identify rare events that happen.

We are in the assessment phase of determining whether or not the reports of these events recently are related or likely to be related to the vaccine, and we will really need to wait the next day or two for those assessments to be completed and for those expert committees on safety to to deliberate and to come forward with a recommendation.

What we know at this point, we will continue to emphasise is those committees have said that at this point the evidence does not signal that there is a change in the benefit risk assessment and that there is no there is no change in the recommendation at this point around the vaccine.

So I think the reassurance to the public is that regardless of whether or not the committee ultimately assesses that there may be an association between these events and the vaccine, that in in any event, these are very rare events and we really do need to wait for the committee to complete its work and provide their best recommendation on on how to proceed.

But I do want to emphasise that for not just vaccines, but also other products that we decide have benefit for us.

And there are known rare events that occur.

And I think one example of this is I think a very well known event that for some contraception, some birth control pills, there are rare events also related to clotting issues and, and, and blood clot issues.

And that is a recognised rare risk for women who are taking some forms of birth control pills.

And of course, in our daily lives, we also accept that there are risks and things that we do.

Every time we get in a car, there is a risk that we will be in a car accident and it could be a fatal car accident.

And so we as, as in our daily lives, we do also accept this trade off of benefit and risk.

Thank you.

And Professor Caviota wanted to weigh in.

Thank you.

Kate.

The, the question was also whether someone who has been vaccinated could have one of these events now after the vaccination.

And I think if you would like to address that also, it would be very good.

Umm, sorry, I, I, I'm not sure I understood, but you were referring to, so whether some, I, I got the AstraZeneca vaccine 2 weeks ago, would I be liable to have one of these clotting effects?

So, so I, I think what is also important to say here is that the kinds of events that we're talking about are known medical events.

They do happen to people who have not been vaccinated.

And what we're really trying to figure out is whether or not having vaccination is itself related to increasing the risk of one of these events.

So certainly people who are unvaccinated and people who are vaccinated all have some underlying risk of any of these clotting events happening unrelated to vaccine.

So certainly there are people who are vaccinated who might have one of these rare events.

What we don't know is whether or not that experience is, would be related to having been vaccinated.

So I think the important point is that if anybody is having symptoms, any serious medical symptoms, regardless of whether you've been vaccinated or not vaccinated, it's important to seek medical care for the presence of those symptoms.

But it's, it really want to emphasise there is an underlying risk of these events happening.

And that was why when Doctor Wilder Smith was speaking about the the control arm, the placebo arm of these clinical trials, we do see clotting, clotting thrombotic events happen regardless of whether having not received vaccine.

One thing that I would like to emphasise is that we are actually vaccinating a much older group than we're accustomed to see, which is also liable to have a lot more different complications than normally we see in the children or the pregnant women which have been the focus of our vaccination here.

We're really doing a a massive vaccination of older people that except for the influenza vaccine in many countries, really has not been the group that we have selectively chosen for vaccination.

So we have to consider all the other things that happen with people who are over 60 years of age or even older, which has been a problem also in the sense of qualifying this adverse effects, whether they're related to the vaccine or they are something that happens just because of this is the age group in which you have a higher, a higher frequency of this type of events, although or at specific risk, of course.

Exactly.

Thank you very much for that important clarification.

And I hope that clarifies a lot of these worries out there.

The next question I have from Christophe AFE.

Christophe, please go ahead.

Hello, thank you for taking my question.

I was just wondering like with the Jensen being a one job vaccine, it's easier to store than most of the others.

How much of A game changer is it do you think, Doctor Brian, maybe?

Yes, thank you.

And I realised, sorry in the last question, I didn't answer the the specific number at just the Jensen product has a, a deal with the Kovacs facility for 500 million doses.

So I just wanted to be specific on the the number there.

The this product as A1 dose product is, is an A refrigerated product as opposed to a frozen product does provide some what we would call programmatic or operational flexibility.

Clearly it's more simple to give a full vaccine regimen where all you have to have is 1 encounter with people who are coming to be vaccinated and not figure out that they have to come back.

You know, 4 weeks, 12 weeks, 8 weeks, 3 weeks, whatever the interval is a second time.

So having a one dose product is really an advantage from a programmatic perspective and having it out of a frozen cold chain is also more simple than it is having to keep a product frozen.

It's just those other requirements are more more stringent, makes it a little bit more challenging to provide a programme that way.

That being said, all of our infant and and child programmes largely are related to have products in them that require multiple doses.

I also want to emphasise though that though the immunisation programmes are very used to giving products that have multiple doses related to completing the protection series, we really do see that any product that could be a single time exposure to the vaccine.

So a single dose vaccine, any vaccine that would be a non injectable vaccine would be a great vaccine and simplify the way that we have to deliver.

And any vaccine that could be taken completely out of the cold chain would also be ideal.

So we're still not where we would ideally like to be.

And that's what the target product profile was specifying is those ideal characteristics that we would love a vaccine to be and that we put those out there so that developers, manufacturers can continue to improve the products towards what what operationally, programmatically would be would be the easiest to actually deploy and make it more and more accessible.

But we do see for sure and in some circumstances, especially for migrant populations, for populations that are undocumented populations where maybe getting people back for a second doses would be quite challenging.

I'll also just point that for the products that are two dose products, ones that we've reviewed already, there is growing evidence around the magnitude of protection that is achieved even after the first dose, although most people are going on to get their second dose.

So I don't, I want us to also be clear that for two dose regimens, the first dose is not, is not absent protective effect.

There is now evidence that we get substantial protection from the first dose.

And so optimising how vaccines are used and what the regimens are will be an ongoing effort.

Thank you very much.

And Doctor Wilder Smith to add on, I don't see on the screen.

No, there you are.

I just wanted to add so, so I would not call it a game changer.

I would call it an additional weapon.

And we need as many weapons in this in our fight against and against COVID-19.

And so this is an additional weapon and we are a welcome additional weapon.

Thank you very much for this.

So what I see the last question now coming from Jamil Shad.

Jamil, please, back to you, Christian.

That's very kind of you.

My question is again to Doctor Graviotto.

Graviotto.

And maybe as a Latin American question, how worried are you with the situation in Brazil and slipping out of control even to the region and elsewhere?

Thank you.

I would not be able to really have an opinion about Brazil because I wouldn't know enough about it.

But I can tell you that in the working group, we have one of your compatriots who has been one of the most active members, helping us to understand the situation there and making it known to the group on how you have been handling with that, including the testing and the fabrication of vaccines, which is quite unique in Latin America.

So in that sense, Brazil is way ahead of other Latin American countries in its capacity to actually produce vaccines locally that will be of health to the population.

I think it's countries having it's own situation challenge by the numbers and and by the difficulty in many of our countries to be able to reach those that are most in need.

It is not the same thing to have a small country in which things are accessible, to have a problem in our massively big countries in which just reaching some of the population is something that is very hard.

What I do think is that in Latin America, we have had in general, some countries that have been able to organise themselves even before in their vaccination services in a much more efficient way than others.

And there I think the Pan American Health Organisation has been a wonderful tool and helpful partner in the sense of of setting up a lot of these issues that are really challenging both for the COVID situation and for the restart of our vaccination services, which are really stalled.

And with a huge number of children that have not gone through the process of immunisation correctly.

And could be the source of future outbreaks in the sense of measles, of the sense of diphtheria or in a sense of other diseases that we haven't seen in in in a long time or, or in the Verity that we have seen recently, such as measles, which is very worrying.

I would say that in in that sense, the availability of vaccines now either because country have made the effort to buy them independently or because they have a part of either the Patho revolving fund or the Kovacs facility is a way to be able to cope with the way that we have to handle the security of our populations at this time of of need.

And in that since I think if you look at the way vaccines have been moving on, especially now that the COVAX ones are being deployed, I think most of the countries in Latin America will soon have the capacity to either start or maintain or continue the vaccination effort that has really just began and we hope will continue and improve in the next months.

I would leave it at that in that sense.

Thank you very much, Professor Caviotto.

And with this we come to the end of our briefing.

We exceeded the time anyway.

I want to thank specifically all the participants, Special Professor the Vanderbilt Caviotto, the Chair of the SAGE, who was up very early in the morning for us today.

Thank you, Doctor Kate O'Brien, Director, Department of Immunisation, Vaccines and Biologicals, and Dr Annalise Wilder Smith, technical advisor to the SAGE Secretariat.

Thank you all very much.

Thank you all for the questions.

We will send the link to this webcast and the documents which are now live on the websites as soon as we can afterwards.

On a separate note, Please note I was just informed we will you should be expecting a statement on the AZ vaccine very soon today.

That's what I hear.

Thank you all very much.

Have a good day.