Babak Belurs

Kamis, 28 Januari 2021

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

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".

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.

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.

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.

However, both sides pledged to work together to resolve the crisis.

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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LOCKDOWN: The rules in your area
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TRAVEL: What are the UK's rules?

In other developments:

Scotland is "on track" to meet its Covid-19 vaccine targets, First Minister Nicola Sturgeon has said
One in three police officers has been threatened by someone who they believed had coronavirus, a survey suggests
Scientists behind a study tracking coronavirus in England say there are signs of a "shallow decline" in infection levels
Welsh Secretary Simon Hart says a UK-wide policy for reopening schools would make sense
Black MPs from across the parties have joined together in a video encouraging people to get a Covid vaccine

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2021-01-28 18:51:00Z
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COVID-19: EU told to consider legal action and blocking exports over AstraZeneca coronavirus vaccine row - Sky News

The EU should consider legal means and even block exports if it does not receive the vaccine doses promised by drug companies including AstraZeneca, the president of the European Council has said.

Charles Michel made the comments in a letter to four EU leaders as Brussels and AstraZeneca are embroiled in an escalating row over the bloc's slow start to its inoculation programme.

The European Commission has asked Belgian authorities to inspect production at a plant in Belgium that makes the AstraZeneca vaccine, where problems have led to a large shortfall in supply.

Belgium's Federal Agency for Medicines and Health Products (FAGG) said on Thursday that the EU executive, which has coordinated vaccine orders for the European Union, had requested an inspection of production flows.

Live COVID updates from the UK and around the world

The row has come about after AstraZeneca announced it would have to cut the amount of jabs delivered to the bloc's 27 nations before the end of March from 80 million to 31 million, citing production issues at European factories.

Brussels believes it will get even less than that - just one quarter of the doses that member states were supposed to get during the first three months of 2021 - and has accused AstraZeneca of a breach of contract.

Mr Michel, who represents the EU's 27 member states, said in a letter to four EU leaders: "I support all efforts to resolve the matter with companies through dialogue and negotiation.

"However, if no satisfactory solution can be found, I believe we should explore all options and make use of all legal means and enforcement measures at our disposal under the Treaties."

EU rules on monitoring and authorising exports of COVID-19 vaccines in the 27-nation bloc could lead to exports being stopped if they violated existing contracts between the vaccine maker and the bloc, an EU official said.

It comes as Germany has said the AstraZeneca vaccine should not be offered to people over the age of 65, a source close the country's government has told Sky News.

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Germany's vaccine committee made the recommendation, citing insufficient data about how effective the jab is for older people, not because of any safety concerns, Reuters reported.

UK prime minister Boris Johnson said he was not worried because Britain's medicines regulator had judged it is "effective across all age groups and provides a good immune response across all age groups".

He added "I don't agree" with the apparent assessment in Germany.

A senior EU official suggested on Thursday that coronavirus vaccines produced in the UK should be shared with the bloc as its supply comes under pressure.

Brussels health commissioner Stella Kyriakides said given AstraZeneca is blaming production problems at factories in Europe on the shortfall in jabs delivered, the pharmaceutical giant's plants in Britain should be used instead.

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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2021-01-28 18:04:44Z
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Scottish independence: Boris Johnson urges voters to ignore 'pointless' referendum talk - Sky News

Boris Johnson has dismissed the prospect of a second Scottish independence referendum and questioned "what it's all meant to be about".

The prime minister called for a "focus on the issues that really matter" and urged Scottish voters to ignore "pointless constitutional wrangling".

"I think endless talk about a referendum without any clear description of what the constitutional situation will be after that referendum is completely irrelevant now to the concerns of most people, who I think want us to beat this pandemic and come through it strongly together," he said.

Mr Johnson on Thursday visited a COVID vaccine laboratory in Livingston, where French company Valneva has begun large-scale manufacturing of its vaccine candidate.

But his trip attracted criticism, with Scottish First Minister Nicola Sturgeon among those to question whether his travel would be deemed "essential" under coronavirus restrictions.

Asked why he had made the 400-mile trip during a lockdown, Mr Johnson said he had come "as prime minister of the whole country to thank our hardworking officials and public servants across the whole of Britain who are doing fantastic work".

His visit came after a recent poll of Scots found that 49% supported Scottish independence compared to 44% who favoured remaining in the UK.

Meanwhile, the SNP recently published an 11-point plan on how they intend to bring about another independence referendum.

If Ms Sturgeon's party wins a majority at this year's Scottish Parliament elections, the first minister has said the SNP will hold an independence vote, regardless of whether Westminster consents to the move.

Mr Johnson declined to answer on whether he would boycott a referendum in Scotland, if the UK government had not approved it.

"My focus is on defeating the pandemic, I believe that should be the focus of everybody in this country," he said.

"I believe in the power of doing things together.

"Going on and on about another referendum - we don't actually know what that referendum would set out to achieve.

"We don't know what the point of it would be - what happens to the army? What happens to the Crown? What happens to the pound? What happens to the Foreign Office? What happens to the security services?

"Nobody will tell us what it's all meant to be about."

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The prime minister said he was "inclined to stick with what they said last time", as he referred to the No vote by Scottish voters at the 2014 independence referendum.

Mr Johnson refused to comment on the description of Ms Sturgeon as a "moanalot" by Jacob Rees-Mogg, the Leader of the House of Commons.

"I don't want to be distracted by any kind of petty, personal, political issues," the prime minister said.

"This is a time for the country to come together, beat the virus, protect the NHS, save lives."

The UK has secured 60 million doses of the Valneva vaccine, should it be approved by the regulator.

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2021-01-28 16:54:59Z
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COVID-19: Germany says Oxford/ AstraZeneca jab should not be given to over 65s - Sky News

Germany has said the Oxford/AstraZeneca vaccine should not be offered to people over the age of 65, a source close to the country's government has told Sky News.

It comes after Reuters reported Germany's vaccine committee made the recommendation, citing insufficient data about how effective the jab is for older people, not because of any safety concerns.

But UK prime minister Boris Johnson said he was not worried because Britain's medicines regulator had judged it is "effective across all age groups and provides a good immune response across all age groups".

He added "I don't agree" with the apparent assessment in Germany.

Live COVID updates from the UK and around the world

A spokesperson for AstraZeneca said its research findings "support efficacy in the over 65 years age group".

And Public Health England said the immune response data was also "very reassuring", though it added there were too few cases in older people in trials to say what precise level of protection the over 65s get.

Dr Mary Ramsay, head of immunisations at PHE, said: "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.

"The risk of severe disease and death increase exponentially with age - the priority is to vaccinate as many vulnerable people as possible with either vaccine, to protect more people and save more lives."

The European Medicines Agency is expected to make a decision on whether to approve AstraZeneca's COVID-19 vaccine on Friday.

It comes as Brussels and the pharmaceutical giant are embroiled in an open, escalating row over the EU's slow start to its inoculation programme.

Belgian authorities said on Thursday they had carried out an inspection of a vaccine factory in the town of Seneffe on instruction from the EU Commission.

AstraZeneca announced it would have to cut the amount of jabs delivered to the bloc's 27 nations before the end of March from 80 million to 31 million, citing production issues at European factories.

But the EU's health commissioner Stella Kyriakides said AstraZeneca should make up for the shortfall by shipping over jabs made at its plants in Britain instead.

Sky News understands that AstraZeneca has agreed to publish its supply contract with the EU.

Professor Stephen Evans from the London School of Hygiene and Tropical Medicine said there is "no reason at all for anyone in the UK or elsewhere to think that this Oxford/AstraZeneca vaccine is ineffective at any age".

He added: "Its ability to be delivered to people in GP surgeries and care homes makes it a vital component in the attempts to reduce hospitalisation and deaths, especially in the elderly."

Prof Andrew Pollard, chair of the UK government's Joint Committee on Vaccination and Immunisation, also said: "There is limited information available on efficacy in participants aged 65 or over, although there is nothing to suggest lack of protection."

Analysis: Why has Germany reached its decision?
By Thomas Moore, science correspondent

The German decision threatens to undermine public confidence in the rollout of the AstraZeneca vaccine in the UK.

The widely-respected Robert Koch Institute concludes that there just isn't enough data to prove the vaccine protects the elderly against COVID.

And yet they are precisely the people at the front of the queue in the UK.

This all hinges on data from the late-stage clinical trials done by the pharmaceutical company.

Just 8% of the volunteers were between the age of 56 and 69. And only 4% were over 70.

Critically there weren't enough COVID infections in those age groups to show there was a statistical difference between those who got the vaccine and those who got the placebo.

But AstraZeneca has published evidence from earlier clinical trials in The Lancet medical journal. These were lab-based tests of antibodies produced by people given the vaccine.

They show that the antibodies in the elderly are just as effective at killing the virus as those from younger people.

That was enough for the UK medical regulator, the MHRA, to approve the vaccine.

And to be fair, many independent scientists would agree with that assessment.

There is a good relationship between 'neutralising' antibodies seen in the lab tests and real world protection - and there is no magical cut-off in the age of a patient beyond which a vaccine stops working.

But the German authorities clearly want more evidence. And it may be that the European Medicines Agency agrees when it publishes its assessment on Friday.

AstraZeneca is already doing an additional large-scale clinical trial in the US that includes more older volunteers.

It's almost certain that the US regulator, the FDA, will wait until those results come through before licensing the vaccine at all.

The UK authorities are likely to hold firm, arguing that there is good-enough evidence that the vaccine works - and given the high infection rate rolling out the vaccine will save lives.

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2021-01-28 16:32:34Z
52781336752031

COVID-19: Germany says Oxford/ AstraZeneca jab should not be given to over 65s - Sky News

Germany has said the Oxford/AstraZeneca vaccine should not be offered to people over the age of 65, a source close to the country's government has told Sky News.

It comes after Reuters reported Germany's vaccine committee made the recommendation, citing insufficient data about how effective the jab is for older people, not because of any safety concerns.

But UK Prime Minister Boris Johnson said he was not worried because Britain's medicines regulator had judged it is "effective across all age groups and provides a good immune response across all age groups".

He added "I don't agree" with the apparent assessment in Germany.

Live COVID updates from the UK and around the world

A spokesperson for AstraZeneca said its research findings "support efficacy in the over 65 years age group".

The European Medicines Agency is expected to make a decision on whether to approve AstraZeneca's COVID-19 vaccine on Friday.

It comes as Brussels and the pharmaceutical giant are embroiled in an open, escalating row over the EU's slow start to its inoculation programme.

Belgian authorities said on Thursday they had carried out an inspection of a vaccine factory in the town of Seneffe on instruction from the EU Commission.

AstraZeneca announced it would have to cut the amount of jabs delivered to the bloc's 27 nations before the end of March from 80 million to 31 million, citing production issues at European factories.

But the EU's health commissioner Stella Kyriakides said AstraZeneca should make up for the shortfall by shipping over jabs made at its plants in Britain instead.

Sky News understands that AstraZeneca has agreed to publish its supply contract with the EU.

He added: "Its ability to be delivered to people in GP surgeries and care homes makes it a vital component in the attempts to reduce hospitalisation and deaths, especially in the elderly."

Analysis: Why has Germany reached its decision?
By Thomas Moore, science correspondent

The German decision threatens to undermine public confidence in the rollout of the AstraZeneca vaccine in the UK.

The widely-respected Robert Koch Institute concludes that there just isn't enough data to prove the vaccine protects the elderly against COVID.

And yet they are precisely the people front of the queue in the UK.