SAGE Virtual Press conference transcript — 21 January 2022
Overview
00:00:03
CH The meeting or the press briefing we’re holding today discusses the outcomes of the extraordinary meeting of the WHO Strategic Advisory Group of Experts on Immunization, the SAGE, which was held on 19th January 2022. You were sent a list of highlights and the key conclusions. There was an embargo until just about now, so there is no more embargo on this, just to clarify. With this, let me welcome our guests today who will be discussing the outcomes with you.
First and foremost, there is Professor Alejandro Cravioto, the Chair of the Strategic Advisory Group of Experts in Immunization. Dr Kate O’Brien, Director at the Department of Immunization Vaccines and Biologicals at WHO. Dr Joachim Hombach, who’s Executive Secretary to the Strategic Advisory Group of Experts here, at WHO. And Dr Annelies Wilder-Smith, Technical Advisor to the SAGE COVID-19 Working Group at WHO. With this, I’ll hand over to the Chair and to Kate O’Brien for the initial remarks, and then we will go off for question. Professor Cravioto, please go ahead.
00:01:40
AC Thank you very much and good morning, good afternoon, or good evening, wherever you are joining us from. On Wednesday January 19th, the Strategic Advisory Group of Experts on Immunization met for its first extraordinary meeting of 2022. This meeting was focused on a major revision of the WHO SAGE roadmap for prioritising use of COVID-19 vaccines, as well as the interim recommendations for use of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine.
In both cases, there was a significant amount of new evidence that we reviewed, leading to the vaccine policy update. Equally important, the COVID-19 pandemic continues to evolve in both the epidemiology and the virus itself, and the vaccine recommendations are responding to these changes. The overall primary objective of the vaccine approach remain unchanged, that is the protection of those who are at highest risk of serious disease and death, and protecting those who serve the health system are prioritised. This is the first and crucial step towards protecting the wellbeing of everyone.
00:02:45
SAGE issued a roadmap for use of vaccines in October of 2020. This roadmap has guided countries in the prioritisation of vaccine use under the situation of constraint supply. SAGE has now provided a substantial revision on this document, which is what we presented and discussed. While the previous versions of the roadmap were developed in the context of vaccine supply constraints, this updated version pivots to optimisation of vaccine use as the supply for countries is easing.
The revised roadmap for prioritised use of COVID-19 vaccines aims to guide countries in the decision-making to address their specific context, taking into account increasing vaccine availability, current vaccine coverage and ever changing epidemiology, which includes, of course, the circulation of variants of concern. The recommendations in the roadmap are grounded in supporting equitable vaccine access and coverage, and since this remains critical to the ending of the acute phase of the pandemic.
Development of the roadmap draws from comprehensive evidence reviews and involved an intense consultation process, through which, all six WHO regions were solicited for comments. The roadmap now includes the prioritisation of vaccine doses beyond 50% of the population coverage, and includes consideration of vaccine use in children and adolescents, as well as prioritising of additional and booster doses.
00:04:35
Given increasing vaccine availability, the document also expands further in lower priority use groups. Four categories of priority use groups have been specified. Highest, high, medium, and lower, with simple specifications of the populations that are in each one of these groups to help ease implementation. There are two key findings noted in the roadmap.
The first one is that within a priority use group, increasing the primary vaccination series coverage rate will have a greater impact on reducing hospitalisations and deaths per dose than use of equivalent vaccine supply to increase the booster coverage in that group. And the second one is that across priority groups, increasing the booster dose coverage for higher risk priority use groups will usually yield greater reductions in severe disease and death than use of equivalent vaccine supply to increase the private vaccination series coverage rates of lower risk priority use groups.
Therefore, our main recommendations are that countries with low rates of primary serious coverage should first achieve high primary serious coverage rates among the higher risk priority use groups before offering the vaccine doses to lower risk groups. And that countries with moderate to high primary serious coverage in higher risk priority use groups should, preferentially, prioritise available vaccine supply to first achieve high booster dose coverage in higher risk priority use groups before offering vaccine doses to lower priority use groups.
00:06:49
As I mentioned, SAGE is also examining evidence on all products, for which, we have already provided product specific interim recommendations. And at this meeting, we updated our recommendation for the Pfizer-BioNTech COVID-19 vaccine. We will be updating, in the same way, the recommendations for all other products on topic areas relevant to each one of them, as evidence becomes available and is made available to SAGE.
For the Pfizer-BioNTech COVID-19 vaccine, SAGE reviewed new evidence regarding age of administration. We have updated the interim recommendations of this product to extend the age indication down to five years with a reduced dosage for those five to 11 years. However, I wish to remind you that in keeping with the revised roadmap, this age group is in the lowest priority use group for vaccination, except for children who have comorbidities who are in the high priority group.
Also aligned with the revised roadmap, SAGE has updated the interim recommendation for the use of booster doses of the Pfizer-BioNTech vaccine, emphasising the need to start with the highest priority use groups, such as older adults and health workers, four to six months after the completion of the primary series. That means the booster doses four to six months after the two primary vaccinations. The objective of the booster dose is to restore the vaccine effectiveness of the two dose primary vaccination series, which has been shown to the client over time.
00:08:45
SAGE has also made more minor updates on evidence regarding the effectiveness of the Pfizer-BioNTech vaccine against variants of concern, on safety and interchangeability, which are included in the updated interim recommendations. They are now available on the SAGE web page. Updates to the product specific interim recommendations of the other WHO EUL approved vaccines are under review and will be made as soon as they are completed.
Thank you for the opportunity to share the outcomes of the SAGE meeting and I’ll turn it over to Christopher, thank you.
CH Thank you so much, Professor Cravioto, for this excellent introduction and I will go for Kate O’Brien for further information.
KO Thank you so much, Dr Cravioto, for providing the summary of what SAGE has reviewed, which has been offered as a recommendation to WHO and we will be moving forward with these recommendations. I do want to emphasise that in the updated revised roadmap, we continue to have, as the highest priority, the full vaccination of the highest priority risk groups. And this, although the roadmap does provide a fuller view of how to proceed down the priority straight out, the priority categories, the emphasis continues to be through both response to the acute pandemic and through a vaccine equity lens, assuring that there is full vaccination of the highest priority groups, notwithstanding the specifications now provided for lower priority groups.
00:10:42
So, I think with those last comments, we can probably move to questions from all of you. Thank you.
CH Perfectly said, thank you very much. And with this, we are open and please always use the raise your hand icon, in order to get into the queue. The first question goes to Jamil Chade [?] from O Estado de S. Paulo. Jamil, please unmute yourself.
JC Can you hear me?
CH Very well.
JC Thank you. Mr Cravioto, a question on going down to five year old children. When you make this recommendation, are you based, obviously, in terms of security, safety for these children. What is the information you have on the risks that these vaccines put to children. Is there any risk at all? And if so, what is the dimension? I’m asking this because in my country, in Brazil, there’s a vast campaign of disinformation, claiming these vaccines are dangerous for children, with even politicians of very high calibre taking this note. What is your conclusion on the safety of these vaccines? Thank you.
CH Thank you very much, Jamil, for this opportunity to clarify and we’ll start with Professor Cravioto.
AC I would like to stress that SAGE would never recommend a vaccine that has not a proven safety record after reviewing all the evidence that we have. This goes first through our regulatory process approval. In this case, it has been done by the Food and Drug Administration of the United States. And then we review it carefully and thoroughly, before we make a recommendation.
00:12:38
I can assure you that if there was any doubt about the safety of any of the vaccines that have EUL approval for use in any of the age groups that we have recommended, there would be no recommendation. But I will turn it over to Dr O’Brien, if she would like to extend this answer, please.
KO Thank you for this. It’s such an important question and safety is always paramount. It is overriding issue for, frankly, any vaccine policy making committee. So, I’d like to just add two things to the comments from Dr Cravioto. The first is that the roadmap provides the prioritisation groups. It is the product specific recommendations that we have that give details, specific details, on a product by product basis around the use of vaccines in different age groups and different risk groups.
So, at this SAGE meeting, we have updated only one of the product revies, and that’s the Pfizer-BioNTech product, for the inclusion of our review of evidence on children below 12 years of age. And for this specific product, WHO also has a Global Advisory Committee on Vaccine Safety, referred to as GACVS. And we rely, in SAGE, on reviews from GACVS to provide input on the policy process, specifically on the safety issues.
00:14:07
With respect to children who are 11 to five years of age, for which, the update now is inclusive for the Pfizer recommendation, there have been clinical trials that have evaluated the safety in this age group for this product and there have been post-deployment studies that have started to accrue evidence. But I’ll remind you that in this age group, the five to 11 year old age group, this is a recent recommendation from regulators, and the post-deployment evidence will continue to accrue.
Nevertheless, in the clinical trials, the safety profile was very good in these children, and no concerns were raised about safety concerns for application of the vaccine in this age group. I’ll also note that the dose that is used for children five to 11 years old is a different dose than is used for those 12 and above. Thank you.
CH Thank you very much, both, for these clarifications. Next question goes to Corinne Gretler from Bloomberg. And before we go to you, let me, again, remind everyone, please raise your hand if you want to get into the queue to ask your questions. Corinne, please unmute yourself.
CG Hi. Thank you. I just wanted to see if WHO is onboard with this recommendation. Does it plan to change its stance on boosters, considering it’s been emphasising the need for doses to go to under vaccinated countries?
CH Dr Kate O’Brien, please.
00:15:56
KO I really appreciate you asking this question because we want to be very clear around WHO’s position on boosters. The first point is that the Director General has been very clear about WHO’s position, that the focus of vaccines in the setting of vaccine supply constraint must be to get those who are at highest risk of significant severe disease and of death, that must continue to be the highest priority.
That’s what will address the acute pandemic and the issues that are also causing severe stress on the health systems in countries around the world. Now, what has evolved over time, and he has always said that we will follow the evidence, and what has changed over time is the accrual of evidence on the performance of vaccines over time, since individuals have received their doses.
And it was on December 7th that SAGE did a deep evidence review, not only around the performance of the vaccines following the primary series, but also, the evidence on when you give a booster dose, what is the accrued benefit of having received that dose? As well as a review of the supply situation from a global perspective for 2022.
And fourthly, an extensive set of modelling evidence that would provide a way to understand, for any tranche of doses that you get as a country, what is the best impact that you can get from those doses either to use them to continue to vaccinate ever lower priority groups with primary doses, or should you use those doses, to go back to the highest priority groups and administer booster doses to those groups?
00:18:02
It’s on the basis of that evidence that we issued an update to our interim recommendations from WHO around boosters on the 22nd December. And what you see in the roadmap now, which has been accepted by WHO, and this is now WHO’s roadmap, accepting the recommendations from SAGE, as a result of the meeting on Wednesday, what you see in this roadmap is the inclusion of boosters as part of the schedule to achieve the best impact of vaccines.
And what I want to emphasise again that Dr Cravioto mentioned, and then I reinforced, and I’ll do it just one more time, this does not mean giving boosters as a priority to everybody in all ages and all priority groups. We continue to have the highest focus on the full vaccination of the highest priority groups, and those priority groups are what are laid out in this roadmap.
So, boosters are part of the vaccination programme, but it doesn’t mean unfettered use to all ages. In fact, specifically, I’ll just point out that in the five to 11 year old age group, there is no evidence yet on the use of boosters in that age group. The update to the recommendation for the Pfizer product is only for the primary series.
So, we will continue to emphasise the principles that are laid out in the roadmap, and then it is the product recommendations about the doses that are used to achieve that best impact in the highest priority groups. Thank you.
CH Thank you very much. Next question goes to Donato Mancini from the FT. Donato, please unmute yourself.
00:19:58
DM Hi, folks. Good afternoon. Does the SAGE update mean that the WHO is now relatively upbeat about supply projections for 2022? I know the guidance does not include different types of vaccines, but if there is a switch, to a different type of vaccine to contrast Omicron or other variants, how do you think things will change? And just to get this absolutely right, the WHO has adopted these recommendations, is that correct? It now forms part of what it is saying we should do, correct? Thank you.
KO Thank you. I’ll answer the last part of your question first, because it’s the most simple one to answer. Yes. These are WHO recommendations. They’re up on the web. They are WHO’s position. The second question, which is are we upbeat about the supply situation? And I’d like to address this in a couple of ways. Again, we’ll refer you to the, and we do provide all the materials that are reviewed at SAGE on the website, so you do have access to the materials that were presented on the supply side of the considerations at the December 7th meeting.
Our analysis of the global supply situation for 2022 is a positive analysis. What the analysis shows for our projections on the total global availability of supply is that the number of doses that are being produced on a monthly basis, and that accumulation does provide sufficient supply for most of the scenarios of how countries would choose to deploy vaccines.
00:21:54
And that is inclusive of scenarios of very high use of vaccines, if countries were to set, as their objectives, and achieve the objectives, of high population coverage of 70% or more, and if all countries chose to be giving booster doses quite broadly. In that rather implausible scenario of achieving all of that by the second quarter, across all countries by the second quarter of 2022, our projection is that there would, nevertheless, be sufficient global supply to meet that kind of scenario.
Now, what that doesn’t say is that will not be achievable if the distribution of those vaccines is highly inequitable. It simply means that there is likely to be sufficient supply, should that supply be distributed in an equitable way. And that is the bigger task, assuring that supply is getting to the places where it’s needed. And I’ll just remind you that we are still in a position where there are 34 countries that are below 10% coverage at this point. I’ll just repeat that, below 10% coverage at this point.
And a larger number of countries, approximately 86 countries, that are below 40% coverage. Now, that is as a result of the accumulation of the severe supply constraint in 2021 and the relief of that supply constraint really only in the past two, two and a half months. So, we do see a very positive outlook for supply, but only if the continuation of sharing of doses continues and if manufacturers continue to supply COVAX with the commitments that they have and to AVAC with the commitments that they have.
00:23:55
CH Thank you so much, both, for the question and a very comprehensive answer. Let me just, again, flag please raise your hands. We still have room for more here. The next question goes to Sara Jerving from Devex. Sara, please unmute yourself.
SJ Thank you so much. Can you please clarify the percent figures around moderate to high primary series coverage? Is that above 50%? And what are the figures that are for the low rates of primary series coverage? Is that below 50%? And then what is the age threshold in the high risk in moderate, or for high risk individuals in moderate to high countries? Thank you.
CH Do we want to start with Professor Cravioto?
AC I would defer the answer to Dr Hombach, if you don’t mind.
JH We have not specifically defined the coverage rates because they may differ from country to country in terms of what is achievable. But the figures we have given are absolutely reasonable figures. But we have refrained from specifying this because what we expect is every reasonable attempt to achieve high coverage or highest coverage. And what we don’t want is a situation in which countries essentially do not progress and don’t go to the next lower priority population, because they cannot achieve a certain level of coverage.
00:25:44
That is the reason why we have not specified this, but the figures that you have given are reasonable. In relation to the older age definition, again, we are not exactly specifying this because again, this is somewhat country dependent. But 60 years or 65 years are reasonable thresholds that countries should consider when they implement this roadmap.
CH Thank you very much, Dr Hombach. Anybody want to add? Dr Wilder-Smith? Dr O’Brien? Dr Wilder-Smith maybe.
AW Every country has a different population age structure. In some countries, the proportion of people about the age of 60 is only 5%. In others, it’s far more than 20%. And that is one of the reasons why we left the decision for a threshold to the countries. But typically, it’s 60, but some countries my choose for 55 or 50, others, for 65.
CH Dr O’Brien.
KO I really like this question because you’re getting quite concrete about what the guidance is. And I think what’s important is that we give countries the direction to head in, based on the evidence. The question about what the age strata are, I think Dr Wilder-Smith and Dr Cravioto have answered that. Clearly, each country has a slightly different age demographic and is experiencing the pandemic. We don’t want to create hard and fast rules about what the specific age is, and I think they’ve answered that.
On the issue of these four categories of vaccine coverage in a specific risk strata, for which, you then might move to the next risk strata. And as we’ve described, we have low, moderate, high, and very high. Again, we haven’t provided a specific number there, but I think we can give some general categories, some general directionality about what the committee has in mind, what we would consider moderate coverage, what we would consider high coverage.
00:28:14
And certainly, that’s based, in part, on the experience of countries. And what we’ve seen is that there are a limited number of countries that have been able to get above 70% coverage. And so, we would consider something above 70% coverage as going into the very high category. We’ve also seen that within any risk strata, that the first effort, the first push on vaccinating people, tends to get somewhere around 40% coverage.
And so, these are some benchmarks. They’re not in the document, but I don’t want to leave it completely ambiguous about what we mean by low, medium, high, and very high coverage. So, I’m just giving you some benchmarks, around which, what those numbers look like. And obviously, when you think about the routine immunisation programme, again, of a different age group, but young children, we would consider very high coverage, upwards of 90% coverage.
CH Thank you very much. Professor Cravioto wants to come in. Are you unmuted? There you go.
AC One thing that has come up, which is clear, and also, in answer to the question, is how do we approach groups that we have not really vaccinated in many low and middle income countries as part of our vaccination programmes? And that includes, for example, older people who are now a high priority group.
00:30:04
And this is why we go back to what Dr Hombach said that we cannot put constraints in percentages to something that is really an evolving process to convince older people to come out and get vaccinated against something that they have never been really accustomed to do is something that takes some time. And therefore, as the process continues, we don’t want to wait until we get a certain percentage of that population group vaccinated before we start thinking about the others.
Therefore, putting this type of tight constraints, percentages, is not something that we’re looking forward to, because that is also not a help of the implementation of these vaccination programmes, which, in many countries, are a new process that has to be developed, tested, and especially, constructed as it moves on. Thank you.
AW And, indeed, if I may add, many countries are struggling to reach the older age groups, especially low to middle income countries that do not have a programmatic approach on how best to reach older age groups. And this roadmap also provides links to training resources, tools, and guidance, to help those countries really reach the older age groups, and the older age groups remain the highest priority group.
CH Thank you very much, all, for these clarifications. Sarah Jerving, you had a follow-up. I assume this has been covered now in the discussion, otherwise, please raise your hand.
00:31:39
SJ Yes.
CH Yes, thank you.
SJ Thank you so much. When Dr O’Brien gave the 40% to 70%, I just want to clarify that that would be within the strata of a high group. It’s not overall population, it’s within that strata, correct?
KO That’s exactly correct. And for those of you who have been covering this for a long time, we want to be clear, and it is very clear in the document, but you have to read it carefully, that it is vaccine coverage rates, it’s the coverage rate within the strata and that’s how you read across the columns. It’s not the total population coverage that we’re referring to, which was referred to in the previous roadmap. And that’s why we’re calling this a major revision to the roadmap. They’re different concepts.
CH Do you maybe want to elaborate on that a little bit?
KO Yes. The previous roadmap was the roadmap for prioritisation in the context of constrained supply. And it specified which groups were the highest priority groups, when you had only enough supply for 10% coverage of your total population, 20% coverage of your total population, and down to 50% coverage of your total population for that supply. We have sunsetted that roadmap. This revised roadmap is specifying the optimisation of use of vaccines across risk strata.
00:33:11
And what it explains is who are the groups that you start with in terms of vaccination? And all countries have now started vaccinations, so they’re using the highest priority risk group as the primary target to whom vaccine would be offered. And as both supply increases and the programme achieves coverage within that strata, how far do you go with your effort in that strata before you start to deploy vaccine to the next risk group?
And that’s what these low, medium, high, and very high coverage levels refer to. In other words, if you only have 10% coverage of your highest priority group, a country should continue to focus on getting coverage in that priority group, rather than distracting supply and the programme effort into lower priority groups. The most important thing is to get everybody in that highest priority group, to the best of the ability of the programme, covered with primary doses and then booster doses.
And of course, any programme is going to start to work in multiple risk strata, but only doing that, once achievement of relatively good coverage has been achieved in the highest risk strata.
CH Thank you very much. A very important clarification. I see that Corinne Gretler has a follow-up as well. Corinne, please go ahead.
CG Thank you so much for taking my question again. I was just wondering, did SAGE discuss the roadmap on how to develop vaccines as new strains emerge? And if so, what were some of the conclusions reached so far?
00:35:10
AW The emergence of Omicron has really highlighted the need to even emphasise, much more than before, that we had prioritised the older age groups. So, really provide direct protection to the vulnerable age groups, now knowing that the vaccine impact for Omicron is reduced for milder disease and for transmission. And it’s because of this, so although we really have a big emphasis on protecting the schools and children, it is less urgent to vaccinate children, we still have to prioritise those who are at highest risk of severe disease.
CH Thank you very much, Dr Wilder-Smith, for that clarification. That brings me to a question we have online here, which may be a good follow-up. Will this booster be the last one or will there be new ones for new areas of concern? The question, which has been debated publicly a lot. Dr O’Brien maybe.
KO We certainly are focusing the attention in this roadmap and in the product specific recommendations on the updates that are inclusive of giving a booster dose. We will continue to be evidence-driven. We’re fully aware that there are some countries that are making decisions to deploy let me call it additional boosters, and I think we’re not even quite clear how to use the terminology here. But there are some exceptions that I would like to point out.
00:37:01
We’ve already provided a recommendation for individuals who are moderately or severely immunocompromised that the usual recommendation for a primary series, a two dose recommendation, does not provide the same kind of immune response as in people who are not significantly immunocompromised. And as a result, a recommendation for immunocompromised persons is that they receive three doses of vaccine as part of their equivalent of primary series.
And we reference that third dose as an additional dose. It’s not being used as boosting, which is the returning of your primary series response after waning over time. So, for those individuals, they also require a booster dose, just as for people who are not immunocompromised. And so, for those individuals, it would be a fourth dose. But generally speaking, we have no evidence that is of settled science about giving a subsequent booster dose to a broader group of people.
We’re fully aware of the data that is emerging from a limited number of countries, Israel, in particular, around a decision to give a fourth dose, and evidence that is starting to emerge from Israel that we’re following very carefully. But at this time, SAGE is clear and WHO has adopted the recommendation that we are referencing a single booster dose and we will continue to follow the evidence.
What Dr Wilder-Smith was also referring to in the previous question is that SAGE did discuss and did review the situation with Omicron, the situation of the emerging evidence on the performance of the vaccines against Omicron, the performance of both primary series over time and the performance of booster doses, specifically for Omicron in relation to their performance with Delta.
00:39:06
And it’s a timely update to this roadmap to provide the provision for the use of booster doses, again, specifically highlighting that it is the highest priority group that must remain the focus and getting coverage in all countries for that group, so that we can really address the severe end of the disease spectrum.
CH Very good. Thank you very much. That leads to another question, which also came in online. We discussed it in the beginning, I think, but it seems to be worth mentioning again. Are the general recommendations on boosters for every EUL vaccine or just Pfizer? Maybe we want to go back to Professor Cravioto, because he mentioned it in the beginning.
AC The one we have now reviewed and updated is the Pfizer-BioNTech vaccine, because that is the evidence that we have so far. And we are in the process of reviewing the other vaccines that have been approved for the same purpose, as the evidence becomes available. I don’t know if Dr Wilder-Smith would like to expand on that.
AW Indeed, we are in the process of updating all the EUL vaccines with regards to boosters. Also, when data becomes available for an age indication or extension to younger age groups, we will also update accordingly.
CH Thank you very much. I see that Donato Mancini has his hand up still or again. Donato.
00:40:45
DM Yes, I do have a follow-up. My apologies if you have answered this. This change to the guidelines do not take into account the potential need to switch to targeted vaccines, is that right? This is just on ancestral wild type vaccines. This is the first question. The second question that I have for you is on heterologous boosting. You’re basically saying the heterologous boosting can be done, mix and match can be done for every type of vaccine that you have on the EUL, is that correct or not? Thank you.
KO I’ll address the first one and have Alejandro address the second.
CH Exactly, let’s do that. thank you very much. We’ll start with Kate O’Brien for part one and then Professor Cravioto will come to you for part two.
KO I’d like to just perhaps correct a little bit about the question that you asked on the first one, are these recommendations specific to the ancestral strain? The answer is no, it’s not specific to the ancestral strain of the virus. These are contemporary recommendations in the context of Omicron and Delta, which is, in some places, still circulating. So, this is not about looking back at ancestral strain evidence.
We’re looking at evidence across all of the evidence that has come through across time, which considers all of the variants, but specific reference to the Omicron variant as well, which, as I mentioned, SAGE has looked at. But I think perhaps this ties into a little bit of a previous question, which is about variant adapted vaccines. And of course, we don’t have variant adapted vaccines at this point.
00:42:36
We are following that very carefully in WHO through a number of committees, specifically the technical advisory group on the composition of vaccines, which is a very tightly linked committee to the SAGE committee. And the TAG-CO-VAC, along with SAGE, will be reviewing whatever the earliest evidence is from the manufacturers about variant adapted vaccines. And it will be the SAGE remit to provide policies on how those vaccines should be used.
Should they become authorised for use? It’s the remit of the TAG-CO-VAC to provide recommendations on the need for and the composition of those vaccines. So, this roadmap update with the inclusion of booster doses and the inclusion of adolescent vaccination and childhood vaccination, and about where do those kinds of vaccine doses fit in the priority scheme? This is in the context of the current epidemiology of what’s going on around the world.
So, maybe just turning over to Dr Cravioto and then Dr Wilder-Smith about the heterologous mix and match on both primary and on boosting.
CH I think Dr Hombach wanted to come in for the heterologous question.
JH Let me start and then I’m sure my colleagues can add. The topic is, indeed, very important, and we know that it’s programmatically extremely important for counties to have flexibility in terms of providing vaccines in a certain combination, particularly if there are interruptions in supply. We have actually very systematically reviewed the data that are available, both in relation to primary immunisation and combining different vaccines or different platforms here, as well as in relation to booster.
00:44:35
And we have released a policy statement, end of last year, just prior to the holidays, that summarises the information and provides guidance in relation to this. I think what is important to say is that we do not have data in relation to all possible combinations, because obviously, there are many permutations, but there is a couple of clear principles that emerge and they are summarised in this statement on heterologous schedules.
So, for instance, for the Pfizer vaccine, for the, say, mRNA vaccines, as we are discussing this year, there is relatively little benefit in coming up with heterologous or coming up with a second dose of the vaccine of a different platform, even though for vectored, for instance, it is pretty neutral, for inactivated, it is not neutral, it would be a slight decrease. To start with inactivated and come with an mRNA vaccine, then you have a significant advantage.
And we have done the same analysis in relation to starting, so to speak, as a reference for vectored vaccines, and then looking at the trade-off in relation to inactivated vaccines or in relation to mRNA vaccines and the same also in relation to inactivated vaccines. So, we clearly make statements in terms of preferential considerations that counties should look into, if they want to provide heterologous scales for whatever reasons.
So, it’s not necessarily an anything goes, but there is significant flexibility. The other things, which we have pointed out is that for some of the combinations, we don’t have many data, so it’s very often relatively small scale immunogenicity studies. There may also be a modest increase in reactogenicity with some heterologous combinations. And we actually refer, in the roadmap, to this document.
00:46:44
So, we have integrated it into the roadmap. There is much more detail in this document I refer to that was published on December 22nd, but the essence is in the roadmap as well.
CH Thank you very much, Dr Hombach. Looking around the room, so to speak, if anybody wants to add on this one. If not, we have time for one last question, and this one goes to Rhoda Odhiambo from the BBC. Rhoda, please unmute yourself. Rhoda, can you unmute yourself? We seem to not have sound from your end. Now we’re good, please go ahead.
RO Hello. Can you hear me?
CH Please go ahead, yes.
RO Hello, can you hear me?
CH We do, but it seems like you cannot hear us.
RO I can hear you now. I can ask my question.
CH Yes, please.
RO Thank you so much. My question can be answered by either Dr O’Brien or Alejandro. In terms of children, your recommendation that children between the ages of five and 11 are to get the Pfizer vaccine, would you also be recommending that they get a booster shot, especially those who are living with underlying conditions? Thank you.
00:48:20
CH Dr O’Brien, please.
KO Let me be really clear on this. The roadmap specifies where children, five to 11, come in in the prioritisation scheme. We’re not making a specific recommendation that children should get the Pfizer vaccine. There are additional vaccines that have stringent regulatory authority authorisation for younger age strata.
We will be updating our recommendations according to the evidence on the subsequent products, and we will be coming forward with those recommendations and updating, product by product, the recommendations. So, there’s no product specific recommendation for five to 11 year olds at this point. It’s just a timing issue of which ones we’re able to do in which order, and we want them to come out as quickly as possible, so that we don’t hold them back as we get them done.
But I do want to also be specific that with respect to children five to 11 years of age, there is no product for which, there is evidence on booster doses for those children. And you will see in the roadmap that we’re specific in the table of the groupings of priority that for those who are under 12 years of age, we simply don’t have evidence yet on the need for or the evidence on the performance of boosters.
00:49:51
So, let’s just be clear that we’re talking in that age group at this point, only about the primary series. And I’ll just reinforce again that we will be updating recommendations on other products where there is evidence for younger age groups below 12 years of age. We will be incorporating that evidence in our review and we will be aligning with the regulatory process as well. I don’t know if others would like to add anything to that.
CH A quick look into the room, I don’t think so. Then I thank you all very much. The panel, of course, as well as the many journalists online. With this, we conclude the virtual press conference and the outcomes of the SAGE extraordinary meeting.
The meeting was held on 19th January and we thank Professor Alejandro Cravioto, Chair of SAGE, Dr Kate O’Brien, Director of the Department of Immunization, Vaccines, and Biologicals, Dr Annelies Wilder-Smith, Technical Advisor to SAGE COVID-19 Working Group, and Dr Joachim Hombach, the Executive Secretary for SAGE. Thank you all very much and have a good day.