Kamis, 28 Januari 2021

COVID-19: Fourth vaccine could be approved in weeks as trial shows it is effective against UK variant - Sky News

A fourth COVID-19 vaccine could be approved for use in the UK within weeks after late-stage trials suggested it was 89% effective in preventing coronavirus.

The prime minister has said the Novavax jab is now going to be assessed by the Medicines and Healthcare products Regulatory Agency (MHRA).

If approved, the vaccine would start to be rolled out in the second half of 2021. The UK has already ordered 60 million doses, which are going to be manufactured in Stockton-on-Tees.

FILE PHOTO: A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Novavax logo in this illustration
Image: The UK has ordered 60 million vials of the Novavax jab

More than 15,000 people aged 18 to 84 took part in the Phase 3 clinical trial in the UK - about a quarter of whom were over the age of 65.

The extensive study also showed that the Novavax jab offered 86% protection against the new British strain of COVID-19, which is up to 70% more transmissible.

A smaller, separate trial also showed that it was about 60% effective against the South African variant, despite concerns that this strain may not respond to vaccines.

Health Secretary Matt Hancock has said the NHS is prepared to start rolling out the vaccine quickly if authorised by the MHRA, adding: "This is positive news and, if approved by the medicines regulator, the Novavax vaccine will be a significant boost to our vaccination programme and another weapon in our arsenal to beat this awful virus."

More from Covid-19

Vaccines minister Nadhim Zahawi was among those who took part in the Novavax trial, and said he was "particularly thrilled" to see such positive results - thanking fellow volunteers for taking part.

The breakthrough comes as a row deepens between the EU and AstraZeneca over vaccine shortages in the trading bloc.

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EU pressures Astra Zeneca over shortfall

Despite Brussels calling for doses to be sent over from British plants to compensate for the shortfall, Cabinet Office minister Michael Gove has warned that the government won't allow vaccines intended for Britons to be sent to the EU.

Reports have suggested that the EU could block millions of coronavirus vaccines from being exported to the UK within days.

The latest figures show a further 1,239 people died within 28 days of testing positive for COVID-19, with another 28,680 lab-confirmed cases of coronavirus in the UK.

Novavax is currently stockpiling vaccines at six manufacturing locations - and is aiming for eight plants in seven countries to produce two billion doses a year.

The effectiveness of the Novavax jab is not far off the 95% success rate seen with the Pfizer/BioNTech and Moderna vaccines, which have already been approved for use, while the Oxford/AstraZeneca vaccine is up to 90% effective.

Dr Amesh Adalja, an infectious disease expert at the Johns Hopkins Centre for Health Security, said the 60% effectiveness against the South African variant of COVID-19 is still promising - not least because US regulators previously said they were prepared to approve a jab that was just 50% effective.

"We've gotten spoiled because we've seen the Moderna and Pfizer numbers," he said. "I know people are going to be alarmed, but 60% efficacy against the new variant is acceptable."

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Like the Oxford/AstraZeneca vaccine, the Novavax jab only needs to be kept at fridge temperature, meaning distribution and supply chain management is easier.

After an initial dose, a second shot is given three weeks later.

At a cost of $16 (£11.66) per vaccination, the Novavax jab is more expensive than AstraZeneca's, but cheaper than Pfizer and Moderna's offerings.

At the moment, we don't have enough vaccines for everybody who really needs it. Pic: AP
Image: At the moment, we don't have enough vaccines for everybody who really needs it. Pic: AP

This sorely needed vaccine appears to be extremely robust
Analysis by Thomas Moore, science correspondent

The first of a second wave of vaccines is almost here.

This is a new kind of vaccine - instead of injecting the genetic material for the spike protein, this is the protein itself. Not the whole virus - it is just the protein which is injected, and it's got very, very good results.

It is 89% effective in the data that's came forward on Thursday night. And what's more, it worked really well in the people that it needs to work in - 27% of the people on the trial were over 65 and significantly, it worked against the new variants circulating here in the UK - there it was 86% effective.

In South Africa where there was another trial, again, a very worrying variant there - perhaps more worrying than the one here - but it was 60% effective there.

So it does seem to be an extremely robust vaccine.

Now it's a matter of getting it through the gates.

So you'd expect it to take about a month to get through the medical regulation, and then we can see 60 million doses coming our way.

And they will be needed, because at the moment we don't have enough vaccines for everybody who really needs it.

Over three nights, Sky News will host a series of special programmes examining the UK's response to the pandemic.

Watch COVID Crisis: Learning the Lessons at 8pm on 9, 10 and 11 February.

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2021-01-29 02:00:55Z
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New Novavax vaccine is “highly effective” against UK Covid variant - BBC News - BBC News

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  1. New Novavax vaccine is “highly effective” against UK Covid variant - BBC News  BBC News
  2. Covid: UK experts back AstraZeneca jab amid Germany ruling  BBC News
  3. Boris hits back at EU bid to snatch 75million Covid vaccines from UK  The Sun
  4. Britain's vaccine success shows the benefits of independence. The last thing we need is a trade war  Telegraph.co.uk
  5. COVID-19: Germany says Oxford/ AstraZeneca jab should not be given to over 65s  Sky News
  6. View Full coverage on Google News

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2021-01-28 22:36:04Z
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Shortfall in jabs pushes EU vaccine drive to crisis point - Financial Times

The EU’s Covid-19 vaccination plan is nearing crisis point after several regions suspended inoculations over the shortage of jabs and Brussels moved to restrict exports of vaccines to conserve stocks.

The independent commission advising the German government on vaccination policy has recommended that the Oxford/AstraZeneca jab not be used for people aged over 65, a move that heaps pressure on the bloc’s vaccine effort.

Meanwhile, authorities in Paris have stopped administering first injections of Covid-19 jabs, while Lisbon said its vaccination rollout would be slower because of shortages.

The Paris region and two other regions accounting for about a third of the French population have postponed new vaccinations for up to four weeks to conserve doses for those entitled to second and final injections of the BioNTech/Pfizer vaccine.

The French health ministry said on Thursday night that deliveries of the Moderna vaccine to the country would also be below expectations in February, with 25 per cent fewer than planned for the month.

Faced with similar shortages, Portugal said its vaccination campaign would be delayed by up to two months. The country follows the Madrid region, which warned on Wednesday that it would pause its campaign for 10 days.

Brussels is attempting to reassert control of the push in the midst of an escalating row with AstraZeneca over supply problems.

Charles Michel, European Council president, wrote to the leaders of four member states calling on the bloc to explore the use of new legal powers and “enforcement measures” to ramp up vaccine production in the EU. The bloc’s faltering vaccination drive comes as inoculations proceed at pace in other countries including the US and UK.

The EU will on Friday propose empowering governments to block exports of vaccines, forcing pharmaceutical companies to seek authorisation before shipping the life-saving jabs out of the bloc.

The ire of EU member states is focused particularly on AstraZeneca, which is awaiting authorisation for its vaccine in the EU but last Friday reported big production shortfalls.

An EU official said this week that the drug company was now planning to deliver only a quarter of the previously planned 100m or more doses in the first three months. The commission and EU capitals are asking questions over shipments to the UK of vaccines produced by AstraZeneca inside the EU.

The EU’s new rules on jab exports would potentially hit supplies of the first three western-made vaccines to come to market, as all have manufacturing operations in the EU. BioNTech/Pfizer supplies the whole world apart from the US from its Belgian plant, while Moderna produces its non-US vaccine supply in Switzerland but fills and finishes the vials in Spain.

AstraZeneca produces jabs in Belgium and the Netherlands, as well as the UK. It has run into trouble in Germany, where the Standing Vaccine Commission at the Robert Koch Institute, Germany’s main public health agency, said there were “insufficient data currently available to ascertain how effective the vaccination is above 65 years”.

The agency recommended the jab be used only on people aged 18-64. AstraZeneca rejected the recommendation.

The EMA is expected to reach a decision on Friday on approval of the Oxford/AstraZeneca vaccine for use in the EU.

Reporting by Jim Brunsden, Sam Fleming and Michael Peel in Brussels, Leila Abboud and Victor Mallet in Paris, Guy Chazan in Berlin and Donato Paolo Mancini in Rome

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2021-01-28 21:26:00Z
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Covid-19: Novavax vaccine shows 89% efficacy in UK trials - BBC News

Novavax
Reuters

A new coronavirus vaccine has been shown to be 89.3% effective against Covid-19 in large-scale UK trials.

The Novavax jab is the first to show it is effective against the new variant of the virus discovered in the UK, the BBC's medical editor Fergus Walsh said.

The PM welcomed the "good news" and said the UK's medicines regulator would now assess the vaccine.

The UK has secured 60m doses of the jab, which will be made in Stockton-on-Tees.

The doses are expected to be delivered in the second half of this year, if approved for use by the Medicines and Healthcare Products Regulatory Agency (MHRA), the government said.

The Novavax jab is only the second to enter large scale trials in the UK; the other has been developed by the University of Oxford.

The jab was shown to be 89.3% effective at preventing Covid-19 in participants in its Phase 3 clinical trial in the UK, which enrolled more than 15,000 people between 18-84, of which 27% were older than 65, Novavax said.

The trial was conducted in conjunction with the UK government's Vaccine Taskforce with its chairman, Clive Dix hailing the "spectacular results".

Health Secretary Matt Hancock said the NHS "stands ready" to roll the jab out if it is approved.

He said: "This is positive news and, if approved by the medicines regulator, the Novavax vaccine will be a significant boost to our vaccination programme and another weapon in our arsenal to beat this awful virus.

"I'm proud the UK is at the forefront of another medical breakthrough and I want to thank the brilliant scientists and researchers, as well as the tens of thousands of selfless volunteers who took park in clinical trials."

Nadhim Zahawi, the minister responsible for the vaccine rollout, added: "Having taken part in Novavax's vaccine trial myself, I am particularly thrilled to see such positive results. I want to thank the thousands of trial volunteers, without whom these results would not have been possible."

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2021-01-28 22:25:00Z
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Covid: UK experts back AstraZeneca jab amid Germany ruling - BBC News

Chief Pharmacist Richard Harrison with the Oxford/AstraZeneca coronavirus vaccine at Askham Bar park-and-ride in York
PA Media

The prime minister and Public Health England have both defended the use of the Oxford-AstraZeneca jab, after Germany recommended that it should only be given to people aged under 65.

Dr Mary Ramsay of PHE said the jab offers "high levels of protection" against Covid-19, particularly against severe illness.

Boris Johnson said he was not concerned by Germany's recommendation.

AstraZeneca said the jab's trial data supported efficacy in the over-65s.

Germany's vaccine committee said the AstraZeneca vaccine should only be given to people aged under 65, citing a lack of sufficient data to recommend use among older age groups.

The European Medicines Agency (EMA) is to decide on Friday whether to approve the vaccine for use across the EU.

But Dr Ramsay, head of immunisations at Public Health England, said: "Both the AstraZeneca and Pfizer-BioNTech vaccines are safe and provide high levels of protection against Covid-19, particularly against severe disease.

"There were too few cases in older people in the AstraZeneca trials to observe precise levels of protection in this group, but data on immune responses were very reassuring."

Mr Johnson said he was not concerned by Germany's recommendation, adding that the UK's watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), had "made it very clear" that the AstraZeneca vaccine is "very good and efficacious" and gives a "high degree of protection after just one dose, and even more after two doses".

Speaking during a visit to Scotland, the prime minister added: "The evidence that they've supplied is that they think it is effective across all age groups [and] provides a good immune response across all age groups, so I don't agree with that [Germany's recommendation]."

An AstraZeneca spokesperson said the latest analyses of clinical trial data for its vaccine "support efficacy in the over 65 years age group", adding that the firm was awaiting "a regulatory decision on the vaccine by the EMA in the coming days".

2px presentational grey line
Analysis box by Michelle Roberts, health editor

All of the regulators and experts in different countries have been looking at the same data on the Oxford-AstraZeneca vaccine.

That data comes from clinical trials, and those did recruit fewer elderly people overall.

That's because they started off first with younger volunteers to get results as quickly as possible, given the urgency to find out if a vaccine would work well enough to help get us out of the pandemic.

The scientists who ran the trials have always been upfront about this.

But they say there is other evidence to suggest the vaccine will work well in older adults.

Studies show the over-65s have a strong immune responses to the vaccine. After receiving the shots their blood has plenty of the required antibodies that can fight coronavirus.

The UK has been using the AstraZeneca vaccine in its mass immunisation programme for weeks now and should soon have more proof from the real world setting about how much protection the shots give.

2px presentational grey line

Prof Paul Hunter, of the University of East Anglia, told BBC News that the elderly should not worry about receiving the jab.

He said: "I'm almost 65 myself and I would happily take any of the vaccines, including the Oxford-AstraZeneca vaccine. We do know that it is safe in people over 65.

"They have much fewer side effects than younger people and it almost certainly provides substantial benefits in terms of preventing severe disease and reducing the chances of going into hospital."

'No concerns' over safety

Prof Adam Finn, a member of the Joint Committee on Vaccination and Immunisation (JCVI), told BBC's Radio 4's PM programme that Germany's recommendation "just reflects different levels of caution", adding: "What they are basically doing is saying 'We'd like to wait a big longer and know a bit more before we move."

Prof Finn, professor of paediatrics at the University of Bristol, said: "We have no concerns about the safety of the vaccine in any age group".

Dr Doug Brown, chief executive of the British Society for Immunology, said the MHRA would have "carefully scrutinised the evidence" on the AstraZeneca jab before making their recommendation, and referred to its original report which stated that there is "there is limited information available on efficacy in participants aged 65 or over, although there is nothing to suggest lack of protection".

He said this reflected a "need for more data" on the effectiveness of the jab in this age group, but noted the jab had shown a "good safety profile" in all published reports.

Prof Jim Naismith, director of the Rosalind Franklin Institute at the University of Oxford, said German scientists had "not said the vaccine is ineffective for over-65s".

He added: "Scientists often disagree about how much evidence is needed for any new advance and there is always more data to be secured.

"Normally this all happens out of sight of the glare of the media and not in a pandemic, but such debates are an important part of the scientific process that is familiar to anyone who has ever been through peer review."

Chart showing UK coronavirus data

Meanwhile, the EU and AstraZeneca are involved in a row over vaccine supply shortages.

AstraZeneca has previously said it could deliver only a fraction of the doses between January and March that it had promised to the bloc, blaming production issues at EU plants for a reported 50 million-dose shortfall.

The EU has demanded that UK-made jabs are diverted to mainland Europe to fulfil contractual obligations.

But Cabinet Office minister Michael Gove has said there would "be no interruption" to UK vaccine supplies.

It comes as the UK recorded a further 1,239 deaths within 28 days of a positive coronavirus test on Thursday, according to government figures. There have also been another 28,680 new infections.

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2021-01-28 21:14:00Z
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EU orders RAIDS on AstraZeneca factory amid threat of UK Covid vaccine export ban - Daily Express

The probe was ordered by Brussels chiefs unconvinced by the Anglo-Swedish firm's explanations for a predicted shortfall in deliveries to EU member states. Investigators have been asked to verify claims of production problems and also to establish if doses produced on EU territory are being diverted to the UK. Samples and records were removed from the factory at Seneffe, 25 miles south of Brussels, and further inspections of the facility are expected in the next few days.

Officials were furious to learn that while supplies to the EU are in doubt, AstraZeneca has reassured Downing Street it will be able to produce 2 million doses a week for the UK in order to fulfil an order of 100 million jabs.

A spokesman for the Belgian health ministry said the inspection was carried out to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”.

The extraordinary development comes amid warnings that millions of doses of vaccines could be blocked from entering Britain from the EU within days, as part of Brussels’ response to a shortage of doses among its member states.

The European Commission said new rules would be established to give national regulators the power to refuse to exports vaccines made in their own country.

One official said: “There is a possibility on certain circumstances not to allow the export to come forward.”

Such a move could hit supplies of the Pfizer/BioNTech vaccine of which the UK has ordered 40 million doses.

READ MORE: BBC bias row erupts as Katya Adler accused of taking EU's side

The vaccines row erupted when Anglo-Swedish firm AstraZeneca told the EU it would have to cut deliveries to the bloc by 60 percent because of production problems.

The announcement left most countries' roll-out plans in tatters but AstraZeneca has refused to divert doses made in Oxford and Staffordshire to the EU.

Officials said they wanted to avoid export bans but warned a block on the export of vaccines such as those produced by Pfizer/BioNTech in Belgium for the UK was possible.

One EU official accused Britain of blocking the export of certain coronavirus medicines and warned Brussels would protect itself from "acts of protectionism".

The official said: “In an ideal world, we would not be here in an ideal world, the whole story of vaccination would run smoothly without any problems.

"But unfortunately we are not in an ideal world, and we have seen over the last weeks that not all works well.

“And we have seen that when it comes to the shortage of vaccines, when it comes to the export of vaccines that there are obviously deficiencies, we have to look at, we have to monitor, and we have to tackle.

“That’s why, and given the circumstances around with certain states around the world, even in our neighbourhood, acting in terms of restrictions of exports, even banning exports for certain products, I think we need to be upfront, and we need to react.”

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He said the criteria for blocking exports will be published tomorrow with the adoption of the new authorisation mechanism expected within the coming days.

Earlier, EU health commissioner, Stella Kyriakides, insisted millions of AstraZeneca doses made in the UK should be transported to the EU and rejected suggestions the British Government had first claim because it signed a contract three months before Brussels.

She said: “We reject the logic of first come, first served.

“That may work in a butcher’s shop but not in contracts and not in our advanced purchase agreements.”

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2021-01-28 19:07:00Z
CBMieGh0dHBzOi8vd3d3LmV4cHJlc3MuY28udWsvbmV3cy9wb2xpdGljcy8xMzkwNDU0L0VVLWNvdmlkLXZhY2NpbmUtcm93LXVrLWFzdHJhemVuZWNhLWZhY3RvcnktcmFpZGVkLWJlbGdpdW0tdWstZXhwb3J0LWJhbtIBfGh0dHBzOi8vd3d3LmV4cHJlc3MuY28udWsvbmV3cy9wb2xpdGljcy8xMzkwNDU0L0VVLWNvdmlkLXZhY2NpbmUtcm93LXVrLWFzdHJhemVuZWNhLWZhY3RvcnktcmFpZGVkLWJlbGdpdW0tdWstZXhwb3J0LWJhbi9hbXA

Covid: UK experts back AstraZeneca jab amid Germany ruling - BBC News

Chief Pharmacist Richard Harrison with the Oxford/AstraZeneca coronavirus vaccine at Askham Bar park-and-ride in York
PA Media

The prime minister and Public Health England have both defended the use of the Oxford-AstraZeneca jab, after Germany recommended that it should only be given to people aged under 65.

Dr Mary Ramsay of PHE said the jab offers "high levels of protection" against Covid-19, particularly against severe illness.

Boris Johnson said he was not concerned by Germany's recommendation.

AstraZeneca said the jab's trial data supported efficacy in the over-65s.

Germany's vaccine committee said the AstraZeneca vaccine should only be given to people aged under 65, citing a lack of sufficient data to recommend use among older age groups.

The European Medicines Agency (EMA) is to decide on Friday whether to approve the vaccine for use across the EU.

But Dr Ramsay, head of immunisations at Public Health England, said: "Both the AstraZeneca and Pfizer-BioNTech vaccines are safe and provide high levels of protection against Covid-19, particularly against severe disease.

"There were too few cases in older people in the AstraZeneca trials to observe precise levels of protection in this group, but data on immune responses were very reassuring."

Mr Johnson said he was not concerned by Germany's recommendation, adding that the UK's watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), had "made it very clear" that the AstraZeneca vaccine is "very good and efficacious" and gives a "high degree of protection after just one dose, and even more after two doses".

Speaking during a visit to Scotland, the prime minister added: "The evidence that they've supplied is that they think it is effective across all age groups [and] provides a good immune response across all age groups, so I don't agree with that [Germany's recommendation]."

An AstraZeneca spokesperson said the latest analyses of clinical trial data for its vaccine "support efficacy in the over 65 years age group", adding that the firm was awaiting "a regulatory decision on the vaccine by the EMA in the coming days".

2px presentational grey line
Analysis box by Michelle Roberts, health editor

All of the regulators and experts in different countries have been looking at the same data on the Oxford-AstraZeneca vaccine.

That data comes from clinical trials, and those did recruit fewer elderly people overall.

That's because they started off first with younger volunteers to get results as quickly as possible, given the urgency to find out if a vaccine would work well enough to help get us out of the pandemic.

The scientists who ran the trials have always been upfront about this.

But they say there is other evidence to suggest the vaccine will work well in older adults.

Studies show the over-65s have a strong immune responses to the vaccine. After receiving the shots their blood has plenty of the required antibodies that can fight coronavirus.

The UK has been using the AstraZeneca vaccine in its mass immunisation programme for weeks now and should soon have more proof from the real world setting about how much protection the shots give.

2px presentational grey line

Prof Paul Hunter, of the University of East Anglia, told BBC News that the elderly should not worry about receiving the jab.

He said: "I'm almost 65 myself and I would happily take any of the vaccines, including the Oxford-AstraZeneca vaccine. We do know that it is safe in people over 65.

"They have much fewer side effects than younger people and it almost certainly provides substantial benefits in terms of preventing severe disease and reducing the chances of going into hospital."

'No concerns' over safety

Prof Adam Finn, a member of the Joint Committee on Vaccination and Immunisation (JCVI), told BBC's Radio 4's PM programme that Germany's recommendation "just reflects different levels of caution", adding: "What they are basically doing is saying 'We'd like to wait a big longer and know a bit more before we move."

Prof Finn, professor of paediatrics at the University of Bristol, said: "We have no concerns about the safety of the vaccine in any age group".

Dr Doug Brown, chief executive of the British Society for Immunology, said governments both in the UK and elsewhere had to "make important policy decisions in the face of fast-moving situations where our knowledge of the underlying science is still evolving" and that it should not be surprising when it sometimes results in governments "making different decisions from each other".

He added that the MHRA would have "carefully scrutinised the evidence" on the AstraZeneca jab before making their recommendation, and referred to its original report which stated that there is "there is limited information available on efficacy in participants aged 65 or over, although there is nothing to suggest lack of protection".

He said this reflected a "need for more data to be gathered and published on the effectiveness of the vaccine in this age group", but that the jab had shown a "good safety profile" in all published reports.

Chart showing UK coronavirus data

Meanwhile, the EU and AstraZeneca are involved in a row over vaccine supply shortages.

AstraZeneca has previously said it could deliver only a fraction of the doses between January and March that it had promised to the bloc, blaming production issues at EU plants for a reported 50 million-dose shortfall.

The EU has demanded that UK-made jabs are diverted to mainland Europe to fulfil contractual obligations.

But Cabinet Office minister Michael Gove has said there would "be no interruption" to UK vaccine supplies.

It comes as the UK recorded a further 1,239 deaths within 28 days of a positive coronavirus test on Thursday, according to government figures. There have also been another 28,680 new infections.

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In other developments:

Around the BBC - Sounds
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Have you been affected by vaccine supply issues? Share your experiences by emailing haveyoursay@bbc.co.uk.

Please include a contact number if you are willing to speak to a BBC journalist. You can also get in touch in the following ways:

If you are reading this page and can't see the form you will need to visit the mobile version of the BBC website to submit your question or comment or you can email us at HaveYourSay@bbc.co.uk. Please include your name, age and location with any submission.

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2021-01-28 19:01:00Z
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