WHO Press conference 26 January 2021

All right, let's get started.

Hello and welcome from WHO Geneva, hosted by the UN office in Geneva, the Palais.

And this is a virtual press briefing in this case for the Palais journalists.

The documents we will mention a moment.

I will mention a moment you have received already and they will go live soon after this briefing.

So I'm very glad to announce my first briefing since a while, and it's the briefing today on the WTO Strategic Advisory Group of Experts on Immunisation, presenting its interim recommendations on the use of Moderna COVID-19 vaccine.

And as you see by now, we are spread out physically very much.

Doctor Alecano Caviotto, the chair of the SAGE, is joining us from Mexico City.

And I'm very happy and very thankful that you could join us at such an early hour.

Thank you very much.

And I'm also joined here by Doctor Kate O'Brien, who's the Director at the Department of Immunisation, Vaccines and Biologicals here at W Joe, and Doctor Joachim Hombach, who's the executive secretary to the strategic advisory.

What we will do, the run of soul.

Oh yes.

So we shared with you the interim guidelines, the draught guidelines, because we this time had the big advantage that I thought it's a very technical meeting.

The meeting happened already on 21 January, hence there was a bit of time to bring these guidelines together and we could share them with you already.

We also shared with you the speaking notes or some introductory remarks which explain the role of SAGE.

Hoping this will help you a bit in the process of what we all know is sometimes a very technical subject.

Without further ado, we will let then we'll ask Doctor Kavyoto to start and run us through the main findings of the key findings, the recommendations of SAGE on the use of the Moderna COVID-19 vaccine.

And then we will start with questions and answers as usuals.

And I understand that we'll try to monitor the the order of hand raises in order to go through the questions, but just thank you very much.

And Doctor Caviotto, over to you, please.

Thank you very much, Christian, and good morning, good afternoon or good evening wherever you are in the world.

The Strategic Advisory Group of Experts on Immunisation was established in 1999 by the Director General of The Who as the principal advisory group to provide independent advice on vaccines and immunisation.

We are a group of 15 people from around the world that meet regularly and we look into the process of how vaccines and immunisation work and advise the Director General on their use for the purpose of looking at the COVID-19 vaccines.

SAGE established a working group as we usually do for any vaccine in June of last year and this group consists of 26 experts who have been considering all aspects that would inform policy recommendations including issues regarding ethics, clinical trials and of course programmatic considerations.

Over these months, we have had a three-step process for the overall vaccination of against COVID-19, and these include, first of all the elaboration and approval of a values framework for the allocation of the vaccines and a prioritisation of the process.

This was approved and published in September of last year.

The second document is a prioritisation road map in which what we try is to make clear which are the groups that should be vaccinated sequentially given the constraint in the supply of the vaccine.

And this was also published last year in October, in January of this year, early on, I mean early on, in January of this year, on the 5th, we looked into the Pfizer vaccine, the Pfizer Biontech vaccine and made recommendations about it for its use.

And today or on the 21st, we made recommendations about the second mRNA vaccine available, which is the one produced by Moderna.

The main approval or the main recommendation for the use of this vaccine is that based on the current evidence, we recommend that it should be given in two doses of 100 micrograms or .5 ML each with an interval of 28 days between the doses.

In exceptional cases, this interval might be moved to 42 days, but the evidence we have doesn't go beyond that time.

So that is the extent that we can recommend for now.

We do recommend that the vaccines are given in a place where you can follow if there there any anaphylaxis or allergic types of responses as we did with the with the other mRNA vaccine in so that we are sure that this vaccine is given safely to anybody who receives it.

In the case of specific groups, we have two recommendations.

1 is that pregnant women can be vaccinated if the risk for them because of their job or because of their situation is much higher than the possibility of the vaccine causing them any harm, which today hasn't been shown to be a a factor.

But we still don't have any trials done specifically in pregnant women to make us be secure about making a recommendation about the widespread use of this vaccine in this group.

And the same can be said about women who are breastfeeding their children, for which we do not have enough information to be able to make a recommendation.

But we still say the same thing.

If these women belong to a **** risk group, then they should be offered the vaccine under the advice of the clinical practitioner.

In the case of a history of having had COVID, we do recommend that anybody is vaccinated.

Regardless of that, we don't feel that the the antecedent or the history of having had COVAX or having had COVID is enough to make a person not be accessible to have the vaccine.

But we do feel that the groups that are disproportionately affected by COVID, especially those who fell who face health inequities, be prioritising this process so that they are the ones who receive the vaccine first due to in order to reduce the health inequities for these groups.

In the case of international travellers, given the situation of the supply of vaccines, we don't re recommend at this time that people should be vaccinated in against COVID.

We feel that unless the travelling is essential, people should try to stay home and keep the social distancing measures that have been put in place that have been proven to be much better to prevent infection than any other measures so far.

I would leave the things there and if there are any questions, I'll be happy to to help with the answers.

Christian, thank you.

Thank you very much, Doctor Caviotto, and welcome to everybody.

So I see in the order of questions now starting with AFPI.

Hope that's the right order to take it.

And we would start with Angus from AFP, please.

Yes, hello everybody.

Thank you for taking my question.

I wanted to know why you are publishing these recommendations concerning the Moderna vaccine before.

WHO has approved an emergency approval for this vaccine?

So why do you do that before, which wasn't the case for the Pfizer?

And when do you expect the, the, the decision on the approval will be will be made?

[Other language spoken]

It would be good if you could also tell us about the effectiveness faced with the variance after a Moderna announcement of yesterday.

[Other language spoken]

First of all, I think this would be perfect for Doctor Cavioto to answer what's basically what's the difference between the the emergency use listing and the recommendations.

For further questions, I would ask you please to stick to one question.

We will always come back for more questions if we find the time, but don't please stick to one question at a time.

[Other language spoken]

This being a question about The Who policy, I would rather prefer that Doctor O'Brien takes it.

Very happy.

I just saw her on the list.

There she is.

Can we please unmute Doctor Brian?

Yes, yes, I've been unmuted.

[Other language spoken]

Thank you for that question.

[Other language spoken]

First of all, the policy process and the regulatory process, the emergency use listing process by WHO are are distinct processes and they are undertaken by distinct committees and review similar evidence, but not exactly the same evidence.

You're you're correct.

The Moderna vaccine has yet to be granted an EUL by WHO.

Moderna is in contact with WHO and is working with WHO on the data submission package and the review of the evidence for the purpose of emergency use listing and we're working with Moderna to go as quickly as possible.

We do have a a table that is publicly available on the website.

We'll send you the link which is updated on a weekly basis, which shows the timing and expectations around the steps for each of the manufacturers for each product that is engaged with WHO on the review for an EUL process.

However, the Moderna vaccine did have a review by EMA, which is considered a regulatory authority of the, you know, stringent regulatory authority.

And so it does meet WH OS criteria for SAGE consideration in this in this exceptional environment that we all find ourselves with the pandemic, WHO always is serving all countries and not just countries that are either of, you know, low income status, low middle income status, we're serving all countries and, and those countries, some countries have arrangements with Moderna for the procurement of vaccine.

So because these two processes consist of separate assessments, we are examining data with some different concerns in mind, the policy perspective which includes the delivery components of that, that may be less of a focus for some regulators.

So these are not fully interdependent nor do they need to occur in a given sequence, though the preference is indeed that both occur together in as tight a timeline as as possible.

So we can't really comment on when an EUL might be issued or whether or when it might be issued by WHO.

It really has to be formally assessed through that, through that process.

But we are urging all manufacturers to share the data with WHO for both purposes, for EUL consideration and for policy consideration in a way that enables a very prompt review and an allowance for us to move at greatest speed and greatest haste so that every country in the world can benefit from reliance on the recommendations that come out of SAGE and can benefit from the assessment conducted by WHO on the EUL process.

[Other language spoken]

Agnes, could you remind us of the second part of the question please, the one you added at the end?

Can we bring Agnes back on microphone please?

[Other language spoken]

I will repeat my question.

We wanted to to have your reaction or expertise on what Moderna said yesterday about the effectiveness of the vaccine faced with the new variants.

[Other language spoken]

We are concerned about new variants and this is a very dynamic space right now.

The information, the scientific evidence, especially the lab studies that are ongoing to look at the sera, so the the blood from people who have been vaccinated and to test that blood, the antibodies that are in that blood against the viral variance is ongoing work.

The we're aware of the report from from Madonna yesterday and what is what is needed is to also have clinical evidence.

So there there is, this is, this is an area that we're concerned about.

And I think the readiness of vaccine manufacturers and the preparedness that they have to potentially make modifications to the vaccines that they are continuing to develop is is very welcome that they are watching.

And we are watching as the the epidemic evolves and as the pathogen also changes.

To date, the the preponderance of evidence, albeit a small amount of evidence is that the vaccines in hand now are are extremely valuable as part of the toolbox for fighting the pandemic and really crushing this virus.

But we will continue to respond to as new scientific evidence comes out.

Thank you very much.

With this, I move to the next in line that's Jeremy launch.

Jeremy, please.

[Other language spoken]

Thank you Christian.

Nice to see you.

[Other language spoken]

You, you're saying that you're saying that vaccination is important for, for for pregnant woman, but at the same time you recommend that they do not get the shots as of now.

So the question is when will WHO be able to say if pregnant woman are at risk or not?

Are those risks any different than than from any other vaccines that you received during pregnancy?

And and do you have already studies that show that there's differences between being three months pregnant and six months pregnant and and receiving receiving the the vaccine shot?

[Other language spoken]

I would think this is something for Doctor Caviotto now, am I right?

[Other language spoken]

The only way we can recommend vaccines for pregnant women is when there is a clinical trial that involves this group so that we can answer exactly what Jerome was saying.

At what period of the pregnancy can we give a vaccine safely as we have done with a number of them that are currently used?

In the case of these two vaccines, so far that we have looked into the Pfizer and the Moderna, both companies have told us that they will be doing studies in pregnant women to be able to answer those questions and that these studies will be done soon, but they haven't been done yet.

Now we have some data from the studies that were done in the first phases of the development of these vaccines that show that at least in animals, there's no reason to indicate that the vaccines might cause harm either to the animal when it's pregnant or to the product that the coming out of of of the pregnant women or the pregnant animals.

I'm sorry.

So in that sense, we can say that the safety data is good enough for us to think that the vaccine would cause no harm if given to a pregnant woman.

But in a sense of a recommendation that we cannot say now that this is something that we can do for any woman who's pregnant and requires A vaccine.

However, given the amount of women in **** risk groups, especially the health workers, the teachers, people who will be vaccinated in this priority groups that we have decided are the first one that should be offered the vaccine.

In those cases, if the risk to the woman is higher than the possibility of the vaccine causing any harm to her or her product, then under the advice of her treating physician or her clinical practitioner, then there is no reason to think that the woman should not be vaccinated.

And the same can be said about women who are currently breastfeeding.

I don't know if Kate or Johan would like to add anything to that.

Doctor Brian, can we unmute you, please?

Let me ask Joaquim to to actually add to that.

And I think he has a point he'd like to make.

Yes, thanks very much.

[Other language spoken]

Just quickly to add that we know from the ongoing vaccination campaigns in countries that pregnant women are being vaccinated.

This is not specifically about the Moderna vaccine, but vaccines that are being used.

So also obviously the Pfizer vaccine.

So the United States for instance, where many health workers are being vaccinated, we have already more than 7000 pregnant women that have been vaccinated in the context obviously of a benefit risk assessment as Professor Kavyoto just has pointed out.

And there will of course be follow up of these pregnant women.

Companies are obliged to set up so-called pregnancy registries for this follow up.

So apart from dedicated studies, every effort is made from the use of the vaccine under the specific circumstances to gather data on the safety and the performance of the vaccine.

So this is work also that is happening in parallel and we will be reviewing this the emerging data as as they become available.

Doctor Ryan, did you want to add something?

Do we go to the next question?

[Other language spoken]

Yes, I think it's also important to emphasise that based on the nature of these vaccines, they're not live.

They're not live vaccines.

And especially for Moderna and Pfizer, the mRNA vaccines, the mRNA is degraded quickly.

There's no chance of it.

It's like impossible for it to change anything in your DNAI think people have had a lot of misunderstanding around that.

So there's no there's no reason why we think that there would be a problem in pregnancy.

And I think what has been pointed out is policy makers, regulators are really data-driven people.

And to secure, you know, the confidence and the, the, the kinds of recommendations that we made, we really do lean on, on the data as, as far as we possibly can.

So we don't believe that there's any reason to be concerned about this, but we are acknowledging that the data are not there at this point, hence the really strong importance of the the pregnancy registries so that we can continue to strengthen and mature our policy, our policies as we move forward, as we do for all vaccines.

Thank you very much, all three of you.

And now let's move on to next in line, Catherine Fiong Kong.

[Other language spoken]

Very nice to see you back and to have you back.

My question is regarding the recommendation of SAGE that the vaccine should only be administered in settings where any anaphylaxis can be treated.

So does it mean that it excludes a part of developing countries where we know that the health system is not very robust?

And also for even Western countries, does it mean that certain regions or certain people that are not living close of such equipped hospitals have not to be vaccinated?

Could you please elaborate a little bit on that point?

[Other language spoken]

Doctor Crabioto, If I'm right, I think Doctor Hombach will take this one.

[Other language spoken]

Very sorry.

[Other language spoken]

With pleasure.

Thanks for the question.

Yes, we have to say that the ability to treat anaphylaxis is actually something that we routinely request that immunisation programmes are equipped to do.

So it's nothing really very specific for this vaccine.

It is actually a capacity that we we recommend immunisation programmes have now in relation to the mRNA vaccines, there have been observed cases of anaphylaxis.

We don't know yet exactly what is the rate of it.

We also have obviously less experience in large scale vaccination of older adults.

So therefore there is this really this stronger request to have the capacity to manage and treat anaphylaxis.

We make this very clear in our recommendation in terms of also allowing for an observation period of individuals who have received the vaccine.

This is, we have to acknowledge, a complicating factor for for countries that set up their immunisation programmes to have that infrastructure in place.

It should be best practise in any case, but we are here emphasising it.

It is a precautionary measure for the Moderna vaccine.

There was actually just a publication coming out from the United States that suggests that the rate of anaphylaxis is actually pretty rare and pretty low, but this is preliminary findings and that needs to be monitored.

Thank you very much.

Let's move to the next question and I have Gabriella Sotomayor here for me.

[Other language spoken]

You're very close to Alejandro.

[Other language spoken]

Very nice to see you, Christian here and welcome.

[Other language spoken]

Yesterday in Mexico, Lopez Gatel, the the person in charge of the pandemia in Mexico, said that he doesn't find it necessary to buy Moderna because they have enough vaccines.

And but I saw what happened with Pfizer.

There's a lot of health personnel that didn't have the vaccine.

So I would I would like to know your recommendation for Mexico and also if one big quick petition if later I can connect with you will be assume or some or somehow and have a little a little statement in Spanish for proceso.

Thank you if possible.

[Other language spoken]

I'm really not aware of the declarations of the Under Secretary about that.

But let me make a general point about the access of different countries to to vaccines.

I think that the idea initially was to be able to have a wealth system of a location that would help with a system of with a situation of equity.

And I'm sure Kate can speak more about that than I can.

But in that sense, I think that these bilateral agreements that countries are making due to the pressure in each one of them to have vaccine available for their for the populations is something that is making a large amount of deals that will have to be taken into account in relation to the vaccine supply.

In the case of of Mexico, I think we have been able to secure vaccine from a number of companies and that will mean the availability that the country has to be able to secure the product so that we can increase the number of people vaccinated per day.

I do not know what the availability for acquiring the Moderna vaccine would be, given the production that they have and the agreements they have with other countries.

So in that sense, it would depend very much on the relationship that the country could make with each one of these companies.

On the other hand, I do think that having a system of unified purchase of the vaccine to be able to supply especially low income countries should be the goal of everybody in that sense.

And SAGE has discussed this and has made a clear recommendation in the sense that a purpose of the vaccination should be to have every country with access to these products and not just the ones that can afford it by themselves.

And in that sense, I I think that a recent report that came out from the International Chamber of Commerce clearly indicates that not vaccinating the whole world is going to create a massive economic impact for everybody.

So it should be interest of all countries, regardless of their income status, to be able to help everyone in the world to have access to these vaccines.

[Other language spoken]

Given the supply, given both supply constraints and given the number of products that are coming through clinical development and demonstrating efficacy and safety and the ability to manufacture at **** quality, I think we envision that all countries, if not the vast majority of countries will have a mix of products in their programme.

There are probably very few programmes that are going to have a single product and countries are having to make decisions about what that mix will look like.

That is based on a number of factors that includes of course supply, availability, cost of the product.

They do have different cost points, some of the characteristics of the product, for instance the cold chain requirements.

So I think it's just an in general, I think this is what we would expect to see from from many if not all countries is that programmes will have a mix of products and this will continue to mature in terms of a market as additional products are coming through clinical trials and coming through very quickly.

So we'll we will see more, more mixtures of of products and programmes.

[Other language spoken]

Thank you very much.

Could I add something Christian in that sense, given the question before about pregnant women?

What we have been discussing with several groups is that in the allocation of vaccine to any country, one of those products at least should be safe to use in pregnant women and in lactating women.

And that is something that we would like to stress as part of the package of, of vaccines that any country will receive.

[Other language spoken]

Thank you very much.

I'll be happy to make a statement in Spanish for a professor at the end if if Gabriella wants, there's no problem with that.

[Other language spoken]

And at the same time, we Gabriel also knows we cannot go into details in in non national issues, but we'll have to keep it very general.

Thank you, all of you.

And now we move on to Shamil.

[Other language spoken]

Hello there.

Can you hear me very well, Christian, the best news of the year so far?

Very quick question to Doctor O'Brien.

And if Mr Caraviotto also wants to to join in.

My question is about basically how to distribute these vaccines once they're in countries.

There are many Latin American countries, including mine, but others as well.

Mr Caraviotto knows the situation very well.

We're private clinics, rich companies and rich groups are trying to buy vaccines on their own and not waiting the government.

What is your position regarding this?

Not I'm not talking about the specific country.

I'm talking about the morality of most of this, of, of having the rich being able to buy these vaccines, cutting governments.

What is your position on this?

Doctor Brian and Mr.

Carter, thank you so much.

Yeah, WHO's position is quite clear on this.

Our position is that there is no solution to this pandemic if we are not committed to a fair and equitable allocation.

And that is both.

It has two concepts in it.

1 is about assuring that all countries have access to vaccines in the volumes that are needed at the same time so that there's not a set of countries that are left behind in a set of countries that are racing ahead within a country.

The policies about where the priorities should be placed is, are exactly what SAGE has already provided in September and October in two documents.

And that analysis is based on evidence and data about what will be most effective at ending this pandemic.

The the reason that we've prioritised healthcare workers at **** risk of transmission and and infection and the older adults who are at highest risk of severe disease and death is that the reason that we're in the situation we're in around, you know, economic and social implosions in all of our countries is because of the severity of the illness.

If this was, I've used this analogy before, if this was a pandemic of an, an infection that caused a, a time limited non severe skin rash, we wouldn't be doing all of the things that we're doing, even if the amount of disease was the same amount of disease as we're experiencing with COVID.

In other words, in every country and you know, moving its way through through populations, it's because of the severity of the disease that is compromising our health systems, causing untold numbers of deaths, severe cases, long term complications.

That's the problem here.

And so in order to take the the limited supply that we have and deploy that where it's going to make the most difference for a country, we really have to be committed to prioritisation based on epidemiology, based on what the science says about how we're going to get out of this.

And so that's the reason for the SAGE recommendations and it's the reason why countries should be looking carefully at what will be most impactful in this first early distribution of vaccine.

And more is coming, right.

There is going to be enough vaccine for everybody who needs it.

And and I think this is the global solidarity, the national solidarity that we're all in this together.

And for those people who are not in the highest risk group, they need to wait their turn in order to achieve the best impact of this vaccine for the limited number of doses that are starting to to come through.

So I think that's what the SAGE recommendations that have been taken on as WHO recommendations say very clearly.

And and we are urging countries to to use those recommendations as the basis for the use of vaccine and the national policies that are being stood up in all countries.

Thank you very much, Doctor O'Brien.

But this let's move on to Nina Larson from AP Nina, please.

AFP, sorry.

Hi, Kirsten, you've you've been gone for too long.

[Other language spoken]

Sorry.

Thank you for taking my question.

[Other language spoken]

I was just wondering, looking at these recommendations that look very similar to the ones on the Pfizer Biontech vaccine, if there were any differences in your estimations of of how the the two vaccines should be used?

[Other language spoken]

I think we give that to Doctor Caviotto.

In reality, no, I think the vaccines are very similar.

The difference is in the the range of time between the two doses.

It's a bit different between the two vaccines.

This one is 28 days.

The one in Pfizer is 21.

But the recommendations seem to us fairly similar.

One thing to watch, of course, are the allergic reactions.

And as Doctor Hombach said, the report from the CDC published yesterday shows that this vaccine might be a bit less allergenic than the other one.

But I I don't find anything in difference between the two of them.

I don't know if you're he would like to add something to that Doctor Alma.

[Other language spoken]

I mean, it's actually remarkable how similar these vaccines are from the clinical data that have have been presented using obviously also very similar technology.

They are slightly different in the way they formulate the the messenger in our RNA.

There is slight difference in relation to the age indication because the Moderna vaccine has only been studied down to the age of 18 years, Pfizer down to the age of 60 years.

Both companies are now engaged in paediatric studies.

So the differences are really suffer.

And then obviously we are awaiting data from the use of these vaccines in relation to their larger scale safety and effectiveness profile.

So we may maybe we'll see differences in in the future.

But from the data that had been presented, there look need to be very similar.

Apart obviously.

Just the last point again to mention, apart obviously from the quite important issue on storage conditions, which are much easier for them.

[Other language spoken]

Maybe we could elaborate a bit on the storage of the cold chain.

Doctor O'Brien, do you want to add something?

Yeah, I think again, just to emphasise that the Pfizer vaccine does require transportation at an ultra cold chain.

So between -60 and -90°C, there is the opportunity to take that vaccine out of that ultra cold chain for a limited period of time.

It can be in refrigerated conditions for a limited period of time and that, but that's different than the Moderna vaccine, which has storage conditions at -20 a regular freezer temperature and a longer period of time where it can be maintained at, at refrigerated temperatures.

So these delivery characteristics are really important and it's how countries are also deciding how to use these vaccines in countries.

I'll, I'll give one example in a country, **** income country like Canada, using the Moderna vaccine in rural northern communities, because curiously, although those are cold communities, having the ultra cold chain up in those communities is, is really difficult.

And so using the Moderna product in in that setting.

So programmes are deciding how to mix these products that are available according not only to, you know, dosing regimens and things like that, but really very, very much about the delivery characteristics.

I think the other two things to say is one question that comes up a lot is whether or not you can mix and match these vaccines.

These are two mRNA vaccines.

Joaquim just mentioned how similar they are in terms of the clinical data that's come out from them.

And I just maybe I'll just sort of, you know, short circuit that one.

Both recommendations say that we have no evidence on which to make a recommendation about mix and match.

So we do recommend that you use the same vaccine that you received for your second dose that you received for your first dose.

But if it is necessary, if there's no other option, getting a dose from a second product does not mean that you should go ahead and get a third dose after that.

To to, you know, to have a matched product.

And then the final thing is that there are differences between the vaccines in terms of whether the Pfizer vaccine needs a diluent added to it.

It needs to be mixed with a non vaccine related liquid, whereas the Moderna product does not need to be diluted.

I think those are the only other sort of delivery characteristics of different, different things.

Thank you very much, all.

Let's move ahead with Jamie Keaton, this time from AP.

[Other language spoken]

Right.

[Other language spoken]

You got that AFP twice there, Kristen, by the way, great to see you back.

The question is for Doctor Ryan and Doctor Pravia.

So they, I, I just wanted to know, Doctor Ryan, you mentioned in sort of generic terms that that you need more data from the manufacturer is what is that specifically?

What is the problem with the Moderna EULI mean is that is, is that why are you just not getting the data from the manufacturer or is there some other reason?

And then I just wanted to also talk about, you mentioned the similarities between the two MNRMRNA vaccines.

What's the status on the Oxford AstraZeneca approval process that both the EUL and the SAGE recommendation, where, where, where do we stand on that?

[Other language spoken]

I'll address the timing on the EUL process for Moderna.

So WHO issued expression of a request for expressions of interest late last year, Can't remember the exact date, but we can get it for you.

I think it was in November.

In other words, a call out to manufacturers to say if you believe you are going to have or you already have data, that would be the kind of data, the sufficient data and the nature of the data that is is required for an EUL.

Please let us know that you intend to make a submission to WHO?

So Moderna has responded to that EOI.

We're in discussions with Moderna about the package of information that is needed and about the timing of submitting the data and, and doing everything we can with Moderna to accelerate that that process.

So the, the EUL, the review of data, the submission of data, the review of data and the steps that are needed to, to undertake that assessment are in motion.

And, and we're encouraging all manufacturers to do this at haste and to prioritise this given the range of work that they have to do with individual countries.

But to to prioritise WHO?

So that is also a discussion with Moderna.

And I do you, I'm just sorry, let me, we're not all in the same room, obviously between Joe Akim and Alejandro.

Do you want me to take the AZ one or do one of you want to take that?

I think we'll let Doctor Hombach take that.

[Other language spoken]

So the AstraZeneca product, you probably know that it is currently under review also by the European Medicines Agency and we expect actually a deliberation from EMR by the end of this week.

And at parallel, the file has been submitted to WHO for emergency use listings.

So this is also in process.

The radio is ongoing.

The tentative timelines as referred to the spreadsheet that I think was already mentioned before is around mid February.

So we are actually also in the SAGE working group actively reviewing the data from AstraZeneca.

And we have tentatively I really have to underline tentatively scheduled a meeting off SAGE to discuss a policy recommendation in February 8.

And which would then be pretty much probably time to with the emergency use listing process of WHO and would, would, would follow the opinion from the European Medicines agencies and then it positively authorization by the European Commission probably early next week.

So that's the timelines that we have there are still tentative, but we are hopeful that we progress accordingly.

Thank you very much.

[Other language spoken]

I have now next in line Catherine, but that's the second round of question.

So I'll keep you a bit further down Catherine and continue with first questions.

Isabel Sacco is the next one.

[Other language spoken]

Really nice to see you Christian, really nice.

I'm very happy.

Listen, say my question is say shall we commence the administration of two doses within an interval of 880, sorry 28 days between the doses and if necessary it could be extended to 42 days.

But experts and yesterday include it was Doctor Fauci saying this that extended delay between the 1st and 2nd dose could provoke the emergence of new virus because of immunity factors.

It changes in the way the immunity is provoked.

So I could have, I would like to have a comment on this, please.

[Other language spoken]

Yep, in this case, I was unmounted.

Let me look around the room.

So to say, who's would be taking this one, Doctor Honbach?

So, yeah, thanks for this question.

And obviously, we know that this is a a very controversial issue.

So we have looked quite closely into the issue of the delayed administration of the second dose.

We have chosen 42 days or essentially 6 weeks because this is the range up to where we have actually data from the clinical trials available.

To be very specific, Moderna, we have 43 days.

This is the largest deviation from the four weeks that was included into the analysis that was submitted also to the regulatory authority.

So that was rationale and obviously there is data that show that the vaccine is efficacious after administration of 1 dose.

We obviously do not know for how long, but there is a demonstration of efficacy.

And obviously there's also immunogenicity data available after the administration of 1 dose, which show that indeed the antibody titers are somewhat lower than after the second dose.

This is probably also the observation to which Doctor Fauci has been referring to.

We do not know how these antibody titers would decay if you would not administer the second dose.

That's why we are also having this rather cautious recommendation not to to go beyond 42 days for the time being as we have minimal data.

The whether you actually trigger the OR select for variance with a lower level of immunity is an hypothesis at that point in time, but requires clearly very careful monitoring.

And that's by the way, one of the research questions that Sage has really highlighted is to very closely look into cases where individuals get the disease despite A vaccination, something that can always happen with vaccine failure, and to understand what is the makeup of the virus that actually has triggered this breakthrough.

So I think this is something that needs to be monitored very closely and very carefully.

But we can't do not have a an indication of a selection of variants through this through this means.

[Other language spoken]

Before I want to give Kate O'Brien a chance to add on this, let me just mention we have four more questions on the line in the queue and the roughly 10 minutes to go.

So I just want to ask everybody to keep it a bit short.

Thank you, Doctor O'Brien.

Yeah, I just want to, sorry, I just want to go back to Jamie Keaton's question about the AZEUL.

There is a little bit of a complicated situation with the AZ product because I think as you know, the product is being manufactured in a number of different sites around the world.

And the Serum Institute of India is one of the major manufacturers of this product.

And it is the source of the doses for the COVAX facility that will be used for the AMC countries.

And so that's a separate EUL process that is also underway.

And so I just do want to distinguish these two AZEUL processes.

They're not the same.

They're running in parallel.

And the for the, let's call it the AZI don't know how to refer to it, but the AZ, you know, proper, I guess not, not Sai, but AstraZeneca itself, it has multiple manufacturing nodes around the world.

And it is the South Korea facility that will be providing doses to the COVAX facility for the self financing participants.

So that's a really critical facility for us in the process of EUL to, to be to be looking at.

So I just want to acknowledge that there are these two parallel processes over.

Thank you very much.

With this, I come to Tomohiro de Gucci.

Tomohiro, please.

[Other language spoken]

Yes, very well.

[Other language spoken]

Yeah, great to see you back and congratulations.

And my question goes to is on the recommendation which I mentioned about the the person who tested positive within six months that they don't need to rush to get vaccinated, Does this apply to all the age groups and those person who have existing conditions as well?

[Other language spoken]

Let me see who's best prepared for that.

Doctor Humbaugh, maybe?

[Other language spoken]

So the first thing with this recommendation that needs to be highlighted is that we are not formulating this as a recommendation for programmes, but we are formulating this as a recommendation for individuals.

So individuals may essentially opt not to take the vaccine for around up to six months if they have a previous SARS COV 2 infection because the data that we have are really suggestive that you are protected after an infection for probably at least six months.

We are not, however, recommending that programmes essentially exclude individuals on that basis.

The question you're asked in relation to whether this applies to all age groups is I think an important an important one.

We have the majority of the data that show protection after infection are for middle-aged people.

We have indication this is also the case for older people.

That's why we actually, but we we may have weaker level of evidence.

This is why we formulate this cautiously.

This is also why we are not going beyond the six months even though there is indication that protection from natural infection may go beyond six months.

But you're absolutely right that one needs to be somewhat cautious in relation to specific population groups.

That's why we have a careful phrasing around this recommendation that eventually also needs to be refined as our knowledge improves.

It is clearly a recommendation that is based along the concern that there is shortage of vaccine.

And so this is something that could in the short or medium term help in relation to really administering the vaccine.

To those who are gratefully thank you.

[Other language spoken]

And Doctor Caviotto to add, I guess, no, I think you're him touched on the last point.

This is just because we have a constraint of vaccine supply for the time being.

[Other language spoken]

Let's move to the next.

And I have Bodhi Haga, who's remotely connected.

Let's see if we can get him online.

[Other language spoken]

Could you hear me?

[Other language spoken]

Have two type of questions to doctors.

MSF has pointed several times that the data disclosed by Moderna is not enough to support the effectiveness of the **** percentage.

And what do you think about that second part is, is there any further verification of the other candidate vaccines?

And what about the future plans for a vaccine passport provide could provide it globally?

[Other language spoken]

There we have a couple of questions.

I'll ask Doctor Cavioto to start and then maybe Doctor O'Brien to come in the to the to the vaccine passport part.

[Other language spoken]

Doctor Cavioto, please, I'm, I'm sorry, but I, I really didn't understand the first part, but I can take the part about the passport for the time being.

And given the recent recommendations from the International Health Regulations Group, we do not feel that at present there's any way of or need to actually certify that someone has been vaccinated to be able to travel.

We don't recommend people travelling in general during these conditions and this situation.

But in that sense, we do not feel that at present, given the supply of vaccine, the amount of people that have been vaccinated and the actual needs of of moving from 1 country to the next under special circumstances, that this would be required.

I hope that you're him could understand or, or let me let me jump in because I have it here.

I can I can repeat the question.

[Other language spoken]

OK, so MSF has pointed out several times that the data disclosed by Moderna is not enough to support the effectiveness of a **** percentage of the **** percentage.

What do you think about this second part?

[Other language spoken]

And the second part, is there any further verification of other vaccines, such as vaccines made in Russia or China?

Any any process in the line there, Doctor Homba?

[Other language spoken]

So this vaccine, the Boudreira vaccine was tested in a pretty large study was 30,000 participants.

The efficacy estimate that came out of this study is pretty robust and also statistically pretty robust.

It's also a study that includes different ethnic groups and and people with comorbidities relevant to to COVID.

It is correct that the study has only been conducted in the United States.

So maybe this is something that some see as a concern.

But again, the study has been done within the US trying to be fairly representative in terms of different minorities and ethnic groups.

So we are very confident in relation to the data that have come that have come out of this study.

And obviously, As for any other vaccine, if you roll it out in different statutes, you want to monitor the safety and the effectiveness of the vaccine.

And this is something that is is going to be done.

But as such, the data that has been submitted are, are pretty robust.

So I'm, I'm not really AI cannot really follow this point of criticism.

[Other language spoken]

Yes, it seems we don't have the the MSF mentioned any with us anywhere.

But Doctor O'Brien, you wanted to add something.

Would you like me to repeat the question about Russia and the other vaccines?

Let me do this.

So are there any further verification of other vaccines or any other vaccines in the pipeline for SH to look at such as the vaccines made in Russia or China?

I think Doctor O'Brien wanted to come in on that.

[Other language spoken]

So I'll just reemphasize that submission of the data is the critical component.

We can't of course, undertake any policy recommendation without having full access to to the data.

We are in contact with the folks related to the Gamalay Institute, the the Sputnik vaccine as well as Sinopharm, Sinovac, Cansino.

So we are in contact with each for the Sinovac and Sino farm.

Again, the EUL process is proceeding.

They've submitted the package of data and that data is being reviewed.

There are the manufacturing facilities, There are folks on the ground in China still in quarantine, but are there now to do the necessary assessments of the manufacturing facilities.

So those are again in the spreadsheet tracker of the products that are going through the EUL process for assessment.

And again, SAGE will be undertaking policy recommendations for any vaccine that comes forward with with the with the data that's necessary for us to formulate a policy.

I do also want to just address the vaccine passport.

We are strongly supporting the idea that for the delivery of this vaccine that countries proceed with, wherever possible, electronic individually held records of vaccination status.

These are a really important tool not only for COVID vaccines but for all vaccines, and so this is a great opportunity for countries to move ahead with implementing those into programmes.

And that's really different than whether or not there should be any requirement of demonstrating vaccination status for international travel.

The emergency committee of WHO met 10 days ago and deliberated on this and has a very clear statement that this is not recommended at this time and for a variety of reasons.

So I would point you to that, to that statement.

It's really the emergency committee and the IHR regulations that that govern that.

[Other language spoken]

Thank you all.

With this, I have now one more question for Lisa Schlein on the list here.

Katherine, if you I see your hand was lowered, if that is so, that's fine with me of course.

And but in case you wanted to come back, then please put up your hand again.

Otherwise we have now Lisa Schlein with the last question.

[Other language spoken]

Hey, I just had to come in to say hi and welcome you back.

My question isn't important, all questions are.

There you go.

Anyway, I may be a little fuzzy with my details, but I'm sure you'll all set me straight on that.

I believe that the Moderna vaccine was modified somewhat in order to be what they say is effective against the COVID variant.

Now, given the similarities between Moderna and Pfizer, do you believe that Pfizer also could easily modify, or I don't know how easily, but could modify the the vaccine itself in order to be efficacious against some of the COVID variants?

And is this advisable, do you believe?

[Other language spoken]

Let's see who would be best placed to deal with this.

[Other language spoken]

The again, I think we want to be clear, what Moderna was talking about yesterday is the the ability that they have to modify the mRNA to address a new variant.

It's not that they have modified the vaccine at this point, nor at least in my reading of the public statements that they've made, are they planning to implement that at this point.

It was a readiness to to do so is how I how I read the, the press statements.

And in principle, any mRNA vaccine can actually do this.

And frankly, that part of the beauty of mRNA is the speed with which if if they can connect up what the changes are that are driving the variant, that's the mRNA is basically the recipe, the instructions for producing the spike protein.

And so that's why mRNA vaccines are such a powerful tool, which we just didn't even have until now.

So I think this is again, a very evolving space.

So in principle of any mRNA vaccine can make these changes.

The question is, are they needed?

Would they go into production?

How would regulators view them?

Would this be a new product?

How would that regulation of a new product?

Would it be like the influenza vaccines where it's kind of a strain change on an annual basis?

Would you just have to show immunogenicity?

So all of these issues about how to how to authorise and regulate shifts in vaccines are, are still in discussion.

And I and the I want to emphasise the early days we're in on understanding whether any of these variants are really going to have an impact on the performance of the existing vaccines.

So I I hope that addresses some of your questions.

[Other language spoken]

Thank you very much.

[Other language spoken]

Let's not forget that this is again, a process which took months rather something that has taken years and years in other cases, other diseases.

Anybody to add Doctor Amber to add?

No, in this case, I'll then just yes, move back to the last question now.

Catherine, it's your honour to have the last question.

Thank you so much, Christian.

In fact, I'm like Lisa, I want some details, some very precise details to my on my previous question, Doctor Ombach said that the rate of anaphylaxis is pretty low.

Could you please give a figure if possible?

And also Doctor O'Brien say that in the future we will certainly see countries having a mix of products.

So would a Moderna vaccine be likely to be avoided in certain regions because of the the Moderna and Pfizer vaccines would be more advice to be used in developing countries because of the anaphylaxis possibilities?

In my last question is regarding what the question that was asked by my colleague also about the the fact that for the moment you don't advise people that have had COVID-19 to get vaccinated.

So is it related by the fact that they've been already infected?

Is there a danger or you don't know yet what the reactions could be if you've developed COVID-19 and that you vaccinated after and last is how long does the immunity?

Do you do you have an, an, an idea about the immunity about Moderna?

And does it mean that maybe after one year people will need to have a new shot, like for the flu, for instance?

[Other language spoken]

Thank you very much for very many details.

And it's a good opportunity to maybe to, to get a few facts straight.

Joachim Hombach, Dr Hombach, do you want to go 1st?

And then I think we all want to add on here.

[Other language spoken]

So let me start and I'm sorry I probably haven't noted down all questions.

All right, let me take the the your question on the NFL axis.

So I was referring to a report that has come out from the CDC just a few days ago that has been reporting through a so-called passive reporting system, the cases of anaphylaxis that have been reported after the administration of the Moderna vaccine.

And so they have, with more than 4 million doses of vaccine administered, they have recorded 10 cases of anaphylaxis.

So this makes a bit more than 2 1/2 cases per million.

This is the rate that has been reported from Moderna.

I think we need to be cautious.

This is this is the first set of data, but nevertheless, it's already a pretty large sample of more than 4 million vaccinated people.

Obviously it's the passive reporting system, so there are some caveats with this, but I think this gives us a robust indication in terms of the rate of anaphylaxis and, and it is indeed different from what so far has been reported for fire.

So all this needs to be continued to be monitored.

I think there was a question in relation to the safety of the vaccine if it is administered to people who were previously infected.

Is this correct?

I believe so.

So we have there have been people that had previous infection that have been that have received the vaccine in the Madonna study, also in the study from the Pfizer vaccine.

And what we see from this is that it is absolutely fine to administer the vaccine to people whose previous immunity.

So that is that's absolutely clear in duration.

In relation to the question on the duration of immunity, I think we would, we can for the time being only speculate.

We see that the antibody titers that are being visited are very **** also compared to what we see after a natural infection.

We see a strong response after the administration of the second dose.

You see with these vaccine very **** level of efficacy.

So all these makes us quite positive and hopeful that this will elicit durable immunity.

But I think it would be really far fetched now to give you a specific time how long this immunity lasts.

And of course it will also eventually be related to the importance of variance as you have already discussed here in this in this conference.

So I think I have not answered all about some of the questions.

Thank you, Doctor Humbach.

And yes, I'd like to invite Doctor O'Brien to chip in here.

[Other language spoken]

I want to be really, really sure that we're, I'm not sure I heard it correctly, but if there's any misunderstanding that we corrected for the for people who have had COVID disease, we are recommending that they go ahead and get vaccinated.

I just want to be really clear.

We are not recommending that people delay their vaccination.

That's not a, that's not a proactive recommendation.

What we are saying is that in a setting with limited supply because there is evidence that if you've had disease you do have some immunity and and the data seem to indicate that a, a six month period is probably a period where you are much less likely to actually get disease.

Again, we're, we're essentially offering to individuals, if you're in a setting where you, you know, you're maybe you're a healthcare worker or maybe you're a, you know, somebody else who's prioritised and you say, you know, I know I already had disease and the vaccine is in short supply.

So I'm willing to step back from my place in line and let someone else go first, knowing that I probably have at least a period of time where I'll be protected.

So we're simply giving that individual flexibility for people to to know what, for how long could I potentially defer before I actually get get vaccinated?

There's no problem to get vaccinated if you've already had disease.

We we want people to get go ahead and get vaccinated.

So I just want to make that really clear.

And then the second question that was asked, I don't think we've addressed is just about using modern or Pfizer products in low income countries.

We, we believe these vaccines can be used in all countries.

We've provided no restriction on or concern about where these vaccines are used.

As Doctor Hambach mentioned before, it is a routine part of the immunisation programme that every immunisation programme at all sites where vaccines are given should have the ability to deal with an allergic reaction.

So this is not something new, but given the experience of anaphylaxis reactions and the ongoing monitoring of exactly how frequently they occur, we're simply re emphasising that importance as these programmes get stood up in adult settings where the dosing of Epipens for instance, may not be a paediatric dosing, but needs to be an adult dosing.

So just this awareness of the programme, you do need to be able to handle an allergic reaction as we recommend for all vaccine programmes.

So there's nothing specific to these particular vaccines around what the programme should be able to do.

And so no, we don't.

We don't think that there's a limitation of where these vaccine could be used with respect to income strata, Certainly some limitations about how they're used with respect to cold chain, but that's true of the considerations of all countries.

[Other language spoken]

Thank you very much, Doctor O'Brien.

With this, we come to the end of it because I also see you all have another briefing by UNDP in just 15 minutes.

So we need to wrap this up.

I want to thank everybody that I want to ask, first of all, Doctor Cavionto, maybe for some last comments.

We will also have him for one more minute afterwards to answer or give a quick statement in Spanish for Gabriela, possibly Isabel.

And then let me thank you all and actually web TV for hosting this tweet today on the UN.

[Other language spoken]

And Doctor Caviotto, please, I'd like just to take a minute to thank everybody that has been involved in the work that SAGE has been doing.

We have had the collaboration of people around the world for many, many hours to be able to come up with these recommendations.

And of course, the support of the SAGE Secretariat with Doctor Homba and has been essential for the work.

We will continue to do it.

I think everybody's very much geared towards looking at the next vaccines and, and I think SAGE has been very glad to be involved in this process in the sense of, of helping in, in that way.

Thank you very much.

Thank you very much, Doctor Javioto, and thank you, Doctor O'Brien, Doctor Hombach for joining us at this time, and thank you all for listening.