this is bbc news with the latest headlines. the prime minister will fly to brussels later in what could be the final attempt to salvage talks on a post—brexit trade deal. cabinet minister michael gove says the government wants a deal but the eu would need to "temper" its demands. we want to avoid tariffs on our trade with the european union, but it can't be ideal at any price. but it can't be a deal at any price. thousands receive the first coronavirus vaccine, but there's a warning of a long road ahead. and if you want to get in touch about any of today's stories, please do. you can tweet me @annita—mcveigh or use the hashtag #bbcyourquestions. loneliness, anxiety and depression. a survey finds more than half of students have struggled

with their mental health since the start of the pandemic. the route map to net zero, the committee on climate change publishes a major report on how the uk can meet its carbon cutting targets. and the world's smallest species of possum, thought to have been wiped out by australia's devastating bushfires, has been found on kangaroo island. borisjohnson will head to brussels later for face—to—face talks with the head of the european commission, ursula von der leyen, in what's being seen as a last—ditch attempt to make a breakthrough in the trade negotiations before the end of the brexit transition period. major disagreements remain on fishing rights, business

competition rules and how a deal will be policed. any progress the two leaders make will not mean a deal is done but set out the limits to which their officials can negotiate. there may be signs of optimism. the uk and eu reached an agreement on northern ireland border checks and trading rules yesterday. the two sides have until the end of the month to agree a deal. this report is from our political correspodentjessica parker. borisjohnson is going to brussels, that as negotiations have stalled, and phone calls with the european commission president, ursula von der leyen, have failed to find a way through. so, tonight, dinner, face—to—face. with just over three weeks until the brexit transition period ends, an 11th hour effort to give these trade talks a high level political push. there is a deal to be done. if it's not done, then that will be a failure on the part of the european union,

a failure on behalf on the part of the united kingdom and a failure and the part of the personalities that have been negotiating. nobody wants that failure, and it's in nobody‘s interests to have that failure. so you have to hope and believe that, as i said, albeit late in the day, a deal will be done. progress tonight, said a uk government source, may allow the negotiations to resume in the coming days. but they added it was important to be realistic, an agreement might not be possible. the sticking points remain — fishing rights, competition rules and how a deal would be enforced. i truly hope, of course, that we will not go for the worst case scenario. but we cannot speculate. but it is very important that we get clarification on whatever deal it's going to be, because customers and citizens are waiting for answers. meanwhile, separate discussions on specific trade arrangements for northern ireland did reach agreement yesterday. further details are expected to be set out in the commons later.

jessica parker, bbc news. in a moment we will talk to our political first to nick eardley at westminster. good morning to both of you. nick eardley, first of all, is this the last opportunity do you think to really get rid of the glow thatis think to really get rid of the glow that is holding these sticking points together for the two sides? yes, look, it is an important day because dave's talks have been stuck for the best part of a week now, according to the uk side, very little progress has been made since friday. so this is a chance for the politicians do come in and try to find some way through the arguments that have been there for some time. i suppose it is a bit like coming up with the jump leads to restart a car, to see if that process can somehow get back on the road in the next few days. there is no guarantee that will happen. it is quite clear,

speaking to downing street this morning, that there is still that pessimism there, they're not com pletely pessimism there, they're not completely convinced that there is a way through, but they are going to try. it was interesting hearing from the cabinet office minister michael gove this morning, he thinks that both sides are going to need to compromise if this trade deal is to be done. have a listen to him on bbc brea kfast. some of the demands that have been made in recent weeks by the european union shot '5 negotiating team do need to be tempered. one of the things that has been put forward is the idea that when the european union changes its rules, that the uk has to follow suit or face consequences. and the prime minister has been clear that we are going to maintain high standards in this country but we are also going to be a sovereign country, and that we need to be in control of our own rules and regulations, our laws and ways of doing things. europe, of course, sees things slightly differently and thinks this is about protecting the single

market. and i suppose the reason that the big issues are still there, fishing, how trade would work, and whether there would be any penalties for breaking the rules, and how that is enforced, the reason those big issues are still there is because they are the hardest ones to solve. what i don't think you will get tonight is a eureka moment where somebody comes back with a bit of paper and says, we've side on the. >> line, here is a trade deal. but the hope in downing street is that there is some room there tell the two sides to get back around the negotiating table in the coming days. we have missed many deadlines already, and it is not totally clear what the final one is, annita, but remember, the further 31st of december, the rules change, whatever happens to. let's go to nick beake in brussels now. analogies and metaphors abound, but when it gets to the nitty—gritty of these two litres meeting —— leaders meeting later on today, is it about setting

out the parameters for any possible compromise or might even get that far? good morning, annita, yes, what we are being told here i think mirrors what nick was hearing from london. eu officials in brussels think that if this dinner goes really, really well, it will allow the talks between the chief negotiators to have a new sense of life, really, because we know they have been going round and round in circles and they have not been able to make any progress on the really key issues. yesterday, of course, there was some cause for hope because this deal was reached, an eu- uk because this deal was reached, an eu— uk accord was reached, agreement was found, specifically relating to northern ireland and trading and customs arrangements, it was all to do with the divorce deal that was agreed last year. it's not necessarily the case that that success necessarily the case that that success translates to this trade deal, which as we know has been very difficult. but if we are looking for some sort of positives, angela merkel has been speaking in the last few minutes, she is widely seen as the most influential politician in

europe and she has told the german parliament that she still sees a chance for a trade deal, but using language with which we are familiar now, she said the eu would reject u na cce pta ble now, she said the eu would reject unacceptable terms. she said, a deal could still be done, but it can't be done if it endangers the integrity of the common market. so, once again, those warnings from the eu side, but also saying, it can still be done if the will is there. nick beakein be done if the will is there. nick bea ke in brussels, be done if the will is there. nick beake in brussels, thanks for bringing us up—to—date. joining me now to discuss this further as the conservative mp and former international trade secretary liam fox. good to have you with us this morning. good morning. what do you think can be achieved in this face—to—face meeting, that these incredibly intensive talks have not been able to do, so far?|j incredibly intensive talks have not been able to do, so far? i think it is dealing with the politics. i think you have to remember that this isa think you have to remember that this is a unique trade negotiation, it is the only one in the history of trade

as far as the only one in the history of trade as farasi the only one in the history of trade as far as i know where we began with identical regulations, identical tariffs, identical trade law. the problems here have not been in the traditional trade areas, the problems have been around constitutional issues, particularly dealing with the uk sovereignty. and i think that the key issue is that the uk has been willing, on a whole range of areas, to make compromises, we got the agreement yesterday over the northern ireland protocol. the thing is that the european union must accept that we have left the european union, we are a sovereign nation and need to be treated in the same way as the eu has treated other sovereign nations. but you mention the northern ireland protocol but do you think the eu is somehow going to give the uk a quid pro quo credit, if you like, for saying it is not going to do what the eu and indeed many conservative politicians have said it should not have been threatening to do in the first

place, which was to break international law, albeit, the famous quote, in a specific and limited way? well, what the uk was seeking to do was no different from the situation in germany. the german federal court has said that of course in germany, domestic law could be used to supersede treaty law if required. so, the legal principle wasn't different. again, the question here is, will the european union treat the uk as a sovereign nation? in other words, will it allow the areas around dispute resolution to follow a familiar international pattern, rather than involving the european court? and will there be this concept that britain would have to change its rules whenever the european union did so? this goes back to the accession to the treaty of rome, which has this concept of the application of european law directly to the uk. that might have been acceptable while we were in the european union, although many of us voted to leave because of it, but it

is certainly not acceptable when you're outside the european union, to a cce pt you're outside the european union, to accept laws that are made by the eu and then applied to the uk. that in fact eu and then applied to the uk. that infact in eu and then applied to the uk. that in fact in many ways would be worse than being in the eu because we would have to accept rules that we had no role in actually formulating. the two sides, if i may interrupts, have been stuck on the sticking points for a long time now, if there is to be compromised, where does that come from, in your opinion, on both the uk and eu sides, do you accept that there needs to be compromise on both sides at this stage? well, there are areas where you can have compromise, on the fisheries issue, for example. the important point here is that the uk has control of its waters. now, what the uk chooses to do with that over the uk chooses to do with that over the coming years is potentially a matter where you could have some agreement. so, there is still some room for manoeuvre and trade—off, as

there always is, in trade agreements, but the fundamental point about britain determining its own laws i think is the red line that can't be crossed, because that is what the referendum was ultimately about, and many of us voted not on issues of immigration oi’ voted not on issues of immigration or money, it was about our sovereign control over our or money, it was about our sovereign control over oui’ own or money, it was about our sovereign control over our own laws and the prime ministerfully control over our own laws and the prime minister fully understands that, and he takes that principle to the eu. and we are only asking the eu to treat britain in this trade agreement the way it has treated canada, when the uk was a part of the eu, the agreement we had with canada did not involve what is called dynamic alignment, but as michael gove described it, it means applying rules to the uk if the eu changes there is, and that is not how you treat another sovereign country. i take your point, but obviously canada wasn't part of the eu to begin with, was it, so we do seem eu to begin with, was it, so we do seem to have this clash between the desire for sovereignty on the one

side and on the other side, protecting the integrity of the single market. if we focus on trade now, with your hat as a former secretary of state for international trade, do you realistically expect that businesses in the uk will be able to get ready for whatever emerges on the other side of 31st december? well, the campaign by the government has been going for quite some time now to help companies get ready for that, but it is not a question... but we don't know what thatis, question... but we don't know what that is, with respect, we don't know what that exactly is? well, if we getan what that exactly is? well, if we get an agreement, we've got a very clear idea that it is not part of the single market but it is as close access to that single market as we can. and we know what no deal would look like, and those preparations have been made. but the point is that we are not seeking, as perhaps you intimated there, to be part of the single market. we understand

that leaving the european union means we are outside the single market. what we want to get is as close access as we can get to that, without undermining the principal of written‘s independence and our ability to make our own laws. that i think is that very narrow territory on which the conversation tonight over dinner is likely to be based. you must be disappointed, though, that this hasn't been sorted sooner. we have heard from honda today about their plant in swindon, some of that disruption is pandemic related but they are also talking about other companies stockpiling parts and that is causing problems for them, less than 20% of businesses in northern ireland ina than 20% of businesses in northern ireland in a survey say that they are ready for the end of the transition period. so, you know, it would be a big ask at any time for businesses to make this transition, but with christmas and new year and the pandemic and still the uncertainty of exactly whether or not a deal will be done, how concerned are you that there be

significant disruption after 31st decemberfor significant disruption after 31st december for uk firms are? well, there is potential there and of course it is notjust for uk firms, it is also for european firms, particularly french, dutch and belgian firms who would face the same sort of disruption. and i think we have to understand that beyond europe, given the pandemic and given the reduction in global trade that was there before the pandemic even started, made worse by the pandemic, people are looking to see whether we can get confidence restored to those international markets, and i think that there is a responsibility beyond just a britain and the eu's bilateral relationship, that we can actually send a signal at a difficult time to the rest of the global economy, by reaching an agreement, which i think is all the more pressure on both sides to make the necessary compromise is to achieve it. liam fox mp, former international trade secretary, thank you very much. the carmaker honda is stopping production at its plant in swindon today because of a shortage of parts.

the carmaker honda is stopping production at its plant in swindon today because of a shortage of parts. the carmaker honda is stopping production at its plant in swindon today because of a shortage of parts. it has told its employees that it is experiencing vessel delays and congestion at uk ports, caused by the pandemic. the companies responsible for transporting shipping containers are warning there could be further disruption when the brexit transition period ends injanuary, as emma simpson reports. the honda car plant in swindon. like all the other car manufacturers, the parts arrive when they are needed, a just—in—time supply chain. but it's been hit by delays caused by congestion at the ports. its production line won't be running today as a result. gary runs an online toy company and he's had weeks of delays at his busiest time of the year. we're particularly affected by things that we are importing coming in from china on containers. there's lots of congestion at the ports. the ports can't cope. and some boats are being turned around and sent back to holland. others are being diverted to other british ports. every company is the same.

every company is in complete and total chaos. but christmas will go ahead. we will get there and we will not let anyone down. so what's gone wrong? container ships are the arteries of global trade. covid—i9 has disrupted the flow, especially from china. ports around the world are now having problems. felixstowe, britain's biggest container port, has been hardest hit here. it's grappling with a surge in containers ahead of christmas, as well as brexit stockpiling, and it had a backlog of ppe containers, too. a perfect storm. and the congestion has spread to other big ports, too. the ports say things are improving, but volumes could remain high for months. the whole supply chain now wants the government to look at ways to improve capacity to keep these containers on the move. emma simpson, bbc news.

and just a reminder that we would love to hear your comments if you wa nt to love to hear your comments if you want to get in touch with us about any of the stories covering today. do get in touch with me on twitter. the headlines on bbc news... the prime minister will fly to brussels later in what could be the final attempt to salvage talks on a post—brexit trade deal. cabinet minister michael gove says the government wants a deal but the eu would need to temper its demands. thousands receive the first coronavirus vaccine but there's a warning of a long road ahead. and it is hoped the oxford job could also be available for use after a study found it was safe and effective. the coronavirus vaccination will continue to be given out across the uk today, after thousands of people received the first jabs yesterday. the health secretary, matt hancock, has said the nhs now faces a herculean task as it embarks

on the largest programme of mass vaccination in its history. people aged over 80, care home workers and some health staff are currently the highest priority for the vaccination. our health correspondent anna collinson is at saint george's hospital in london for us this morning. anna, how are they preparing for the day? yes, good morning from st george as hospital, as you say, in south london. and it is day two of the vaccine roll—out. yesterday this hospital saw around 100 vaccinations ta ke hospital saw around 100 vaccinations take place, and they are hoping for similar numbers today. and we actually saw the first vaccination ta ke actually saw the first vaccination take place this morning, her name was angelo, she works in a local ca re was angelo, she works in a local care home and she described it as a bit of a pinprick and she felt absolutely fine and you really wa nted absolutely fine and you really wanted to speak out, to show what was happening and to encourage others to follow in her steps. as i say they are hoping to do a lot more

work today, we are expecting it to be very busy, so let's talk to two members of staff. first of all, catherine, you have been working on the frontline with your colleagues in what must have been a really difficult year, how significant have the last 2a hours been for you and your colleagues? i think it is wonderful because it is like a little ray of sunshine in what has been the most difficult year that i have ever had in my career over 27 yea rs. have ever had in my career over 27 years. and i think throughout this timei years. and i think throughout this time i have been so buoyed up with the whole team, the whole team have worked phenomenally hard to make this day come to pass, and particularly also all the people across the world who have signed up for clinical trials and i really wa nt to for clinical trials and i really want to thank them for coming forward selflessly to make this vaccine come to light. because that is what you have been working on, you've been working on that clinical trials? yes, so, we've done you're clinical vaccine trials here, myself and paul keith and eva gleason, and i have been amazed at how many people have really wanted to join in. they get nothing themselves for

it, they are just doing it for the benefit of society. there are the stories they tell of the difficult times that they have had in their lives and what has prompted them to come forward to take part for the benefit of society has been amazing, it has been really, really buoyed us up it has been really, really buoyed us up over this difficult time. and thatis up over this difficult time. and that is really important for people to remember, all those volunteers who have made this possible and made this day possible. robert, what has demand been like for the vaccine, are you getting calls from people, what is going on a? yes, we have seena what is going on a? yes, we have seen a great response from day one. we had 100 patients through here yesterday but lots of calls asking if they could access the hub here, whether they could have their vaccine. we absolutely have more than 100 people booked in today, as ofa than 100 people booked in today, as of a couple of minutes ago, 150 people booked in, and our team are continuing to book individuals into the clinic. i appreciate you might have friends and relatives who want their vaccine, we will contact you, we are currently offering the vaccine to over—805, care home staff

and some nhs frontline staff, we are working through our lists internally and we are contacting staff and patients to come in and have their vaccine, well into the hundreds of ca re vaccine, well into the hundreds of care home staff that are signed up to come to st george's hospital and have their vaccine. as you say, around 100 yesterday, hopefully more today, are you hoping to keep boasting those numbers as the weeks go on? yes, the capacity of the clinic, we can do up to 400 a day at this clinic, we have seven booths working 12 hours a day. so as i said, we have those lists of patients that are known to us, we've got a team phoning those patients and we are also writing to them so you will hear from us and have an invite to come in. we appreciate that some of those patients want to speak to their relatives, we encourage them to do that, and there is also information about the vaccine on the nhs website so by all means read about it before that calling off it is important to remind people this morning that even though this is brilliant news, we

are not going to see the positive effects of these vaccines for at least a month, and then going out into wider society for even longer? yes, it is a two stage vaccine so you have two doses 21 days or 28 days apart. we are booking patient backin days apart. we are booking patient back in for their follow up appointment, but it takes time and there is time to build an immune response but also the number of patients we will have to get through. don't underestimate the need to continue social distancing, avoid touching your face, regular hand washing and wearing facemasks when out in public. are you concerned that people aren't going to turn up for their second dose? we've asked patient when they've been coming in yesterday and today and it is a very positive response, they absolutely want that second dose and it has really helped them already having that date and time for the second dose so they don't have to remember to book it, we give it to them at the point of coming today. and what i would just end with, annita, is, catherine, we were talking about the dosages earlier,

and with previous vaccines that has been some failure in pickup, particularly with the mmr or some child vaccines but the hope is that because this has been so well—publicised, people will com plete well—publicised, people will complete the full process. so that is it from us for now but i think it is it from us for now but i think it is only going to get busier as the day goes on. i bet it is, anna collison, thank you very much an good luck to all the staff there. people in wales who need to self—isolate or quarantine will only need to do so for ten days from thursday, the welsh government has announced. the new advice, endorsed by wales' chief medical officer, applies to anyone returning from a country which is not exempt from quarantine rules, those who recieve a positive test for covid—19 and their close contacts. meanwhile, the welsh government has been accused of losing control of the virus by opposition parties, following a significant rise in infections. the first minister, mark drakeford, has defended his government's strategy. the virus is in a very difficult position in wales. i wouldn't describe it as out of control, and we took further action on friday of last week

to continue to bring it under control, in the teeth, i must say, of opposition from other parties here in wales. so, we have taken the actions that we think are necessary. it is in the hands of every welsh citizen to bring the virus under control. and let mejust and let me just tell you that around half past nine, we will be crossing live to westminster for coverage of a special inquiry being held jointly by two committees of mps examining the lessons to be learned from the response to the coronavirus pandemic so far. that is at half past nine. us president—electjoe biden has set a goal of 100 million coronavirus vaccinations during his first 100 days in office. the country has recorded more than 15 million cases of the infection with 285,000 deaths. our north america correspondent peter bowes reports.

the news that couldn't come soon enough. the us regulator, the food and drug administration, found no safety concerns to stop approval of the pfizer/biontech vaccine. with millions of americans enduring some of the most severe stay at home orders since the pandemic started, the vaccine could be available within days. at a white house covid—19 summit, donald trump and members of his administration's coronavirus task force celebrated the speedy development of the vaccine, but the vice—president said there was still work to do. with cases rising and hospitalisations rising in virtually everyjurisdiction around america, it is time once again to redouble our efforts, to put the health of our families, our neighbours and our communities first. as he prepares to take over the government's response, the president—elect, joe biden, said that his goal was 100 million inoculations in his first 100 days in office,

prioritising the most at risk. that includes healthcare professionals, people in long—term care, and as soon as possible, we will include educators. this will be the most efficient mass vaccination plan in us history. mr biden also intends to ask americans to wear masks for 100 days after he is inaugurated, a move that is supported by the country's top infectious disease expert. we would prefer to use our power of persuasion to get people to realise the importance of doing something and to do it on their own will. if they don't do it, then you might have to resort to something that is a mandate. better times are on the horizon, but america is still bracing for a long, dark winter. peter bowes, bbc news, los angeles. some good news from australia,

where the bushfires earlier this year that devastated so much wildlife were thought to have all but wiped out one of the smallest species of possum. but this pygmy possum has been found on kangaroo island, off the south australian coast, for the first time since fire destroyed 88 per cent of their habitat. the possums weigh less than 10 grams, and are also found in tasmania and sometimes mainland australia. now it's time for a look at the weather with carol. adorable pictures, nice to have a bit of good news, and what news is there in the weather, a bit milder this morning, but wet? that is right, you got the whole lot right there, well done! no, no, no it is really over to you, carol! quite a bit of cloud to start with, we have also got some rain, and then brightening up before more rain later on. showery rain in the east

clearing off as we go into the afternoon. the cloud behind starting to break up allowing sunny skies to develop. towards the west we will see thicker cloud and eventually the rain will arrive, and quite blustery winds around dumfries and galloway. as annita said, not as cold as it was yesterday. we start with some clear skies in eastern areas tonight. but the cloud welcome in from the west, with all the rain. and that will be sinking southwards. and that will be sinking southwards. and a cold night in the east, not as cold under the cloud in the west. tomorrow, we start off with a fair bit of cloud, some spots of rain across the north and west of scotla nd across the north and west of scotland where it will also be quite breezy. later in the day a new band of rain arrives, with a fair bit of cloud, some spots of rain across the north and west of scotland, where it will also be quite breezy.

all hello, this is bbc news with annita mcveigh. the headlines: the prime minister will fly to brussels later in what could be the final attempt to salvage talks

on a post—brexit trade deal. cabinet minister michael gove says the government wants a deal — but the eu would need to "temper" its demands. as thousands receive the first coronavirus vaccine — it's hoped the oxford jab could also be approved for use after a study found it safe and effective. loneliness, anxiety and depression. a survey finds more than half of students have struggled with their mental health since the start of the pandemic. the route map to net zero — the committee on climate change publishes a major report on how the uk can meet its carbon—cutting targets. and the world's smallest species of possum — thought to have been wiped out by australia's devastating bushfires — has been found on kangaroo island. we re were going to take you to the house of commons for that important committee meeting we were talking about, the health and social care committee and the inquiry into lessons to be learned from the coronavirus pandemic so far,

professor patrick vallance, chris whitty and jenny harry is amongst those appearing before the committee. we undertook to complete our scientific evaluation and approval in the shortest possible time whilst complying with established and robust safety, quality and effectiveness standards. we have extensive knowledge within the medications health care products regulatory agency on vaccine development for existing vaccines and that is applied by our very experienced scientists clinicians including those at the institute of epidemiological standards and control. we adopted an novel, innovative regulatory process known asa innovative regulatory process known as a rolling review, and all required documentation must be submitted together to start an evaluation to improve a medicine or

vaccine —— approve. in this case with a rolling review, we reviewed data in packages or tranches, as soon as data in packages or tranches, as soon as they became available from the studies on a staggered basis. by reviewing data as soon as it became available, we could reach an opinion sooner on available, we could reach an opinion sooner on whether the medicine or other vaccine would be approved, so, in this case, teams of clinicians and scientists worked on various aspects of the data acquired, to com plete aspects of the data acquired, to complete in as short a time as possible, and that in no way compromise the level of scientific rigour and i compromise the level of scientific rigourand i can compromise the level of scientific rigour and i can say from knowledge that many thousands of pages of ta bles that many thousands of pages of tables and graphs were deliberated over and poured over. pretty much around the clock from early october onwards, because an extra layer to build confidence in scientific rigour as well as to strengthen our

own analyses, all our data and a nalyses own analyses, all our data and analyses have been thoroughly reviewed by the government was independent advisory body, the commission on human medicines. they have all had human —— full access to the data, all the members and chair, and they do have physically reviewed every aspect of safety and effectiveness and quality in order to give advice to the government so in summary, the highest standards of safety, effectiveness and monitoring have been met with no quarter being cut, no compromises on standards whatsoever. thank you doctor. we are very grateful for that. and also for what you to which was the extraordinary hard work over many weeks and indeed now of your team. that is very much appreciated by everyone. let me just consider. that is very much appreciated by everyone. let mejust consider. this rolling review has been the key to

doing it quickly. why don't other countries do that? why has it not occurred to them that this might be a good way to do it? it has certainly occurred to other countries. as the committees will understand, the company data has been provided to other regulators, in particular the european medicines agency and the food and drug administration in the usa, and they too have been able to look in a rolling way, but i would say that the flexibility and agility of the clinicians and scientists at the nhra, coupled with their familiarity with vaccine development and approval and the access to independent expert advice was key to our ability to progress in the shortest time. i, too, would like to pay tribute to and thank our

government's independent advisory body, the commission on human medicines, because they met at night and at weekends, particularly in recent weeks, to be able to be delving into the detail in the absolute way that the authorities would expect. flexibility and agility on all sides, given the importance of the situation the country is in at the moment with the pandemic. thank you. in your discussions with other countries, are any of them looking to move to the kind of model that you have followed in this country? certainly. they have been welcoming the ability to look at data in advance rather than the former model of the one—stop shop. i have stressed that the agility that has been employed not just by the agility that has been employed notjust by our own staff but by our external experts has enabled us to progress in the shortest time

possible. it is my understanding that the food and drug administration will be looking this week to conclude their review and the european medicines agency very shortly thereafter. thank you. we have been talking about the pfizer vaccine. would you expect to com plete vaccine. would you expect to complete your review of the oxford astrazeneca vaccine? the data packages for the astrazeneca oxford vaccine have been arriving. we expect a further package in the coming days. the committees will be aware of the publication in the la ncet aware of the publication in the lancet just yesterday, a peer—reviewed journal, testifying to excellent and intensive work that has been done by the oxford group and astrazeneca. i would not be able to give the committee is a firm date, because the review is clearly a very active review. there will be

questions and deliberations that we will be pursuing in exactly the same way as we have done for the pfizer—biontech vaccine. not to be able to give a firm date but we can assure the committees that work is proceeding intensively and with great scientific rigour. one of the features of the oxford astrazeneca data and trials is that there were two different doses that were part of the investigation. are you evaluating the use of both types, the full dose and the half dose, or just one of those? our regulatory review is all—encompassing. we will look at all available data that give us look at all available data that give us the insight to benefits and risks that are necessary to reach a position, and clearly, we have great interest into the possible reasons for the different doses, having a

different efficacy and effectiveness readout, but the position is we will look at every piece of evidence. the interim data, as i have mentioned, has just been published. interim data, as i have mentioned, hasjust been published. it interim data, as i have mentioned, has just been published. it is interim, and we will be reaching a position on the basis of all completed studies and analyses, but of course, part of that will be to examine with great rigour the basis for the appropriate dosage regimen for the appropriate dosage regimen for uk people. do you expect coming out of that do have approval, license approval assuming the conditions are met for a particular dosage regime, or will there be a choice left to clinicians? it would not be appropriate for me to predict at this moment. we will look with meticulous care act not only the different efficacy readouts for

those two different regimens, but for the possible reasons with the immune response being different, if there is a scientific basis, and therefore i wouldn't be able to predict where the final approval, if it is reached, will either have two or one regimen. going back to the pfizer vaccine that you have approved, the food and drug administration in the us has said the pfizer vaccine has offered significant protection after one dose. does that conform to your findings, your evaluations? certainly there is a mean protection after one dose, but we are looking to optimal protection and that is why the authorisation in the uk for use of this vaccine looks at the two doses, 21 days apart, because we know that there is a very good level

of protection seven days after the second dose. we know that there is protection from one dose, but how much higher is it after two? talking about two of the vaccines, can you give us an update on where you are with the moderna vaccine? we are engaged with the developers in the rolling review, and in the same way, are expecting to have a mature data package in the coming week or two, and therefore, we will be immobilising the same parallel teams to deliver a rolling review outcome, as soon as to deliver a rolling review outcome, as soon as is possibly able to achieve. thank you forjoining us. this is a lessons to learn inquiry, asi this is a lessons to learn inquiry, as i described it at the beginning, you have been good enough to come and give us your experience on something that is very live, but the

developments and approval of vaccines has clearly been a crucial pa rt vaccines has clearly been a crucial part of this response to the pandemic. reflecting back, if you have the ability to do that, given the immediacy of your work, are there any lessons that can be learned, do you think, already, given your long experience as a medical regulator, for how we might approach the development of vaccines and other drugs in future? we have learnt very important lessons about the absolute imperative of engagement with developers in a proactive way from the earliest stages. of the importance of independence and expert advisory committee is being able to bring in expertise and to strengthen the assessments that we deliver, and i

would say that, when we think about the future, and the important role of vaccines in our switch to a preventive health care system, that this is vital therapeutic tools, and they should be a part of our national infrastructure, and therefore at the agency we look forward greatly to the vaccines centre coming on stream that our own inspectors and experts in the field have been working to help establish, so have been working to help establish, so very important lessons for the future, which we will learn from to enable the uk to have access to the best therapeutic options and vaccines that are so important in health to minimise or even eliminate certain infectious diseases. jeremy

hunt. in the global race to approve a vaccine, we have got the gold medalfor britain, like in the olympics. ijust medalfor britain, like in the olympics. i just wonder what you think it says about british science. it tells us very important things about british science. this country has brilliant scientists, and their ability to move to areas of public health importance has been totally impressive, and i think that the agency, impressive, and i think that the as impressive, and i think that the agency, as we impressive, and i think that the say impressive, and i think that the agency, as we say is an independent regulator, formally seen as perhaps a watchdog should now become an enabler by active engagement in the earliest stages with these brilliant scientists. where would you say we stand as a country and global rankings when it comes to our science? i would say that we are in the top rankings. i say that with

evidence from our covid response. for example, the ability to show that dexamethasone is the drug which reduces mortality in the seriously ill and hospitalised patients. that was a gift if you like from the uk to the road, and this has saved probably in excess of a million lives. the technical expertise, i would allude to the consent native positive airway device which university college hospital together with mercedes formula 1 and our team of medical device specialists again associated with a reduction in mortality, and the reduction in use of ventilators, so i would say with confidence that uk science is in the top ranking, and we can provide the evidence for that. congratulations to you and your team. just a final question. as you know, in russia and

china they have been distributing vaccines for some time. can you just explain the differences between what we have done and what they have been doing? i would perhaps begin my response by saying that the uk mhra isa very response by saying that the uk mhra is a very active member of the international coalition of medicines regulatory authorities, and helped this coalition become established in re ce nt this coalition become established in recent years. this brings together countries including china and russia and therefore provides a forum to try to answer the very important question you have asked. clearly, around the world, regulatory rules and standards are different. and approaches to early access are different. and although we have established a coalition it is early days to fully understand how china and russia have managed to start

their particular programmes of immunisation. i would say that the standards that we use here in the uk have been established through very robust processes, which the international conference on harmonisation and close working with the world hope health organisation and therefore the british public can have confidence in the standards that we adhere to. —— the world health organization. thank you. thank you, chairman. morning, doctor. i wonder if you would mind just explaining to us, for completeness of the evidence that we are gathering, the importance of the role of mhra in allowing medical products and devices to come into use. our role is in a nutshell to

enable access, but the evidence that we require is that the benefits outweigh any risks and, therefore, we take every care scientifically and in terms of our robust procedures, to ensure that these standards are met. we also, at the point of approving, create a proactive plan to monitor those benefits and risks in typical use, so our benefits and risks in typical use, so ourjob doesn't stop this week. it started in this new phase yesterday, as soon as people began to receive their covid—19 vaccines, and if it would help the committee i can provide more information on the very careful plans we have made for real—time vigilance, so the role is before, during and after, and there isa before, during and after, and there is a true end—to—end looking from the scientific laboratory bench through to the patient who yesterday

first received the vaccine and, as an illustration to this, i may share with committees that, even last evening, we were looking at case reports allergic reactions. we know from the very extensive clinical trials that this wasn't a feature, but if we need to strengthen our advice, now that we have had this experience in the vulnerable populations, the groups that have been selected as a priority, we get that advice to the field immediately. thank you so much. looking at that from a slightly different angle, what would your comments be about the use of a treatment or a device for a purpose that it was not licensed by mhra for, how would you view the

promotion of such a treatment or device that hasn't been approved by mhra? the law permits health care professionals to use a treatment or medicine, if they consider it in the best interests of their patients, with full information to the patient. promotion means something rather specific to us, and there is no ability to advertise a medicine which hasn't been approved. the committees may know that we took careful steps, before the particular approval this week, to make sure that the availability of the covid—19 vaccine through our temporary authorisation supply in the pandemic, could be particularly the pandemic, could be particularly the subject of appropriate promotion. in my experience

certainly, unlicensed products have been used but in that circumstance what kind of information would you expect to be passed through the person who was subject to the use of that product, before an unlicensed product was used for the purposes that are unlicensed ? product was used for the purposes that are unlicensed? may i first stressed that the covid—19 vaccine, which has been subject to temporary authorisation, has met all standards. i'm sorry, i should be clear. i'm not talking about the vaccine but about general principles. in general terms the expectation would be that the health ca re expectation would be that the health care professional would share full information with the person who they judged met the need to be met by an unlicensed product, and that they would take full responsibility to monitor safety, they would record

that conversation, and the necessary point that the person would be aware that it hadn't been licensed for that it hadn't been licensed for that particular use. there is good advice, and we have provided that advised to health care professionals, around this issue, particularly so that there isn't a barrier but the obligations are very clear for better practice. i would expect health care professionals to be clear about what they were advising, that it was something that any memberof their advising, that it was something that any member of their profession would be able to say is evidenced in terms of their experience. very quickly. in terms of gathering evidence on that product would you expect that evidence to be gathered using a specific protocol, research protocol? that would be a most useful thing to do. it is not a

requirement. but we do expect any company who is marketing a product, aware of unlicensed use, to gather data and submit it to us based on safety and effectiveness in the normal way. thank you very much indeed. cani normal way. thank you very much indeed. can i thank doctor raine for coming today, you have a lot on your plate, you have two other vaccines to direct and to work on, and thank you for helping the committee with your reflections this morning. i hope that you will come back in the new year and reflect at some greater leisure on the achievements and what we re leisure on the achievements and what were the components of that, that we can advise our successful —— su ccesses can advise our successful —— successes on this. thank you for joining us today. we are now going to move on to direct questions to sir patrick vallance, to professor chris whitty and to doctor harries,

starting with this question of vaccines, and patrick, you're government chief scientific adviser. i know that you have been personally intensely involved in the move to develop vaccines from the outset. so, perhaps your reflections on what are the components that have allowed us to make this great start, ahead of much of the world, in terms of the assessment of the vaccines? of much of the world, in terms of the assessment of the vaccine57m was my assessment and others as well, very early on, that trying to get a vaccine was going to be a really important part of approaching this disease. and, in order to do so, recognising that many vaccines fail, and there had not been a successful vaccine against any human coronavirus before, it was going to be necessary to look broadly across the world at what was happening and to look at a diversity of

approaches, because there are many new vaccine technologies, the pfizer—biontech one is one example, these sousse called messenger rna vaccine which means that the landscape for making vaccines quickly has changed radically in the past 5—10 years. so, early on, building oni past 5—10 years. so, early on, building on i should say some very important things that were done prior to all of this, which include things like setting up a vaccines trial network that chris may want to speak to, long—term investment in the science of vax and ology and related disciplines in the uk meant we had a good baseline of expertise, and what we did want to do was to bring together people from industry as well to make sure that we had expertise in manufacturing in particular because very often with a vaccine the problem is even when you have got it it is difficult to make it and make sure you can get it out at the right quality at the right

time, so manufacturing, people from industry, academics and others to set upa industry, academics and others to set up a vaccines task force to say that we need to log what is going on across the world, which ones we think might be the most promising, and to work out how we would then support those, where it is appropriate to do so, such as the uk ones and other ones which we thought needed support, and to work out and get a ccess needed support, and to work out and get access will be thought that might be necessary so that was the vision is behind the title vaccines task force which came in to lead this so successfully. and it was important, because we hadn't got a domestic vaccines manufacturing base in this country or a domestic company that is making and discovering vaccines in this country. we have got companies that do do that but they are often done elsewhere in the world rather than the uk, so we knew that we had

domestic resilience to build up. the remit already referred to as part of that, but it was broader as well in terms of so—called fill and finish, which is the final part of the vaccine value for the vial itself, it sounds trivial but it is not, it is complicated and has to be done in certain circumstances and we knew that some of the new technologies would need ultimately specialist facilities in orderfor would need ultimately specialist facilities in order for them to would need ultimately specialist facilities in orderfor them to be made, so it was a rather comprehensive look at this, early on, systematic, linking to those companies across the world that we thought we doing this right, and making sure that, where appropriate, we got options on vaccines. the other thing i would say is that, very early on, we recognise that vaccine nationalism was not the answer, here. we had to get ourselves sorted out but the vaccines need to be available all the world because ultimately this is a pandemic, it is in every country, so as

a pandemic, it is in every country, so as part of this, we were also very keen on initiatives through the who and others such as covac, to see how we become part of a global solution to make sure that doses, money, expertise was available for others as well, and that has been an important part of this. it was a very compressive approach. june raine has spoken about the flexibility and scientific expertise, which were brought in in the vaccines task force to do this in collaboration as quickly as we could, knowing that it would be necessary to get access praise for the uk and across the world. and the final point, i would say, in all of this, it has been important to have links in other countries, and so we had links with the warp speed programme in the us, and in others as well to know what is going on and how we can share information and share approaches where appropriate to do so. thank you very much

indeed. lots there that might have wider applications, as we look to learn lessons here. internationalism, anticipating future needs, having a spread of possibilities that we are associated with, of knowing which is going to come right, to pay attention to the kind of physical and sometimes logistical aspects as well as the intellectual property. these are all themes that have application. let me turn to professor whitty stop clearly the clinical trials science has been an indispensable component of the success. what are your reflections from the vantage point of the day? i would make two points. patrick has spoken clearly about the period from this year leading up as pa rt of period from this year leading up as part of the vaccines task force. going back and forward a bit in

time, back in time as to how we get to where we are, you could go all the way back to january. i would like to go back to the ebola crisis. in the ebola west african crisis which i was heavily involved in as pa rt of which i was heavily involved in as part of the department of international, one of the things that was clear was that there were vaccines that had not been properly progressed, and therefore we had to manage the ebola crisis in west africa in support of the government of sierra leone, very much entirely around case finding and isolation... we are watching senior scientists and doctors in the uk answering questions from members of two government committees on lessons learned from the response to the coronavirus pandemic so far. who you see right now is professor chris whitty, the chief medical officer for england. and this was