Babak Belurs

Jumat, 29 Januari 2021

Novavax vaccine – New 89% effective Covid jab works on UK and South Africa strains – and we’ve ordered 60m - The Sun

A NEW Covid jab for Britain is effective in 89.3 per cent of cases, it was revealed last night.

Sixty million doses of the Novavax vaccine will be produced on Teesside — as the EU is trying to scupper exports of jabs.

😷 Read our coronavirus li v e blog for the latest news & updates

Britain celebrates a vaccine boost with 150million doses on the wayCredit: SWNS:South West News Service

The drug, shown in UK trials to be effective against the Kent variant of Covid, was hailed by PM Boris Johnson.

Britain's incredible vaccine campaign got a triple boost with the news of 150million extra jabs.

The Government has secured 60million doses of the drug — which experts said was also 85.6 per cent effective against the sweeping UK variant of Covid-19.

The Sun can reveal results of trials for the one-shot US Janssen vaccine are expected imminently — with Britain having ordered 30million doses.

A French firm is using a Scottish factory to produce another 60million doses of a promising vaccine.

It means 120million of the extra jabs will be UK-produced.

Approval of the Novavax vaccine is likely to come next monthCredit: SWNS:South West News Service

It came as figures showed 7,447,199 Brits have now received their first does, and 476,298 have had their second.

The Novavax jab’s 89.3 per cent efficacy in UK trials was called “spectacular” by expert Clive Dix.

It is likely to be approved next month and will be manufactured in Stockton-on-Tees for use this summer. The factory, owned by Fujifilm, has capacity to ramp up production to 180million doses.

Novavax boss Stanley Erck said it has been shown to work against “UK and South Africa variants”.

Vaccine Minister Nadhim Zahawi, one of 15,000 UK volunteers to take part in the Novavax trials, said: “I am particularly thrilled to see such positive results.”

Health Secretary Matt Hancock said: “If approved by the regulator, the vaccine will be a significant boost and another weapon in our arsenal to beat this awful virus.

'UK AT THE FOREFRONT OF ANOTHER MEDICAL BREAKTHROUGH'

“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.

“The NHS stands ready to roll this vaccine out as quickly as possible if it is authorised.”

PM Boris Johnson said it was “good news”.

Meanwhile French firm Valneva has started large-scale manufacturing of its vaccine in Livingston, West Lothian.

It can supply up to 250million shots annually. On top of this, US tests on the Janssen vaccine are expected to pave the way for 30million doses to start arriving in the UK as early as July.

Janssen is the Belgium-based vaccine arm of US pharmaceutical giant Johnson & Johnson.

The drug has been hailed by PM Boris JohnsonCredit: AFP or licensors

Vaccine Minister Nadhim Zahawi was one of 15,000 UK volunteers to take part in the Noravax trialsCredit: PA:Press Association

Through its Vaccines Taskforce, the UK has now secured early access to 367million jabs.

There was further good news when Israel announced that less than 0.04 per cent of patients who received two doses of the Pfizer vaccine have developed Covid.

But holidays to European hotspots will be off until they sort their shambolic vaccination rollout. Senior cabinet minister Michael Gove has hinted that stricter border measures could be in place for months, even after the UK comes out of lockdown.

The jab will be manufactured in Stockton-on-Tees for use this summerCredit: Reuters

Yesterday the UAE, a favourite of social media influencers, was added to 30 no-go countries.

An estimated 24,000 Brits across the globe now face dashing back to avoid having to quarantine in hotels on arrival, expected to be imposed on February 8. But for the next week, arrivals will have to isolate for ten days at home.

Mr Gove said: “I think it’s important to stress that people shouldn’t expect any premature lifting of these restrictions.”

Novavax CEO Stanley Erck explains how new Covid vaccine will work

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2021-01-29 08:19:00Z
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Covid: AstraZeneca contract must be published, says European Commission chief - BBC News

European Commission chief Ursula von der Leyen

The head of the European Commission, Ursula von der Leyen, has called for the EU's vaccine contract with drug-maker AstraZeneca to be published, in a growing row over reduced supplies.

The contract signed in August contained "binding orders", she told German radio, and she demanded "plausible explanations" for the hold-ups.

UK-Swedish AstraZeneca is blaming production delays at two plants.

Its vaccine is expected to be approved by the EU medicines regulator later.

The August deal was for 300 million doses for the European Union to be delivered after regulatory approval, with an option for 100 million more.

But EU sources say they now expect to get only about a quarter of the 100 million vaccines they were expecting to receive by March, a shortfall of about 75 million jabs.

AstraZeneca says the production problems are at its plants in the Netherlands and Belgium.

Its chief executive, Pascal Soriot, has said that the contract stipulated that the company would make its "best effort" to meet the EU demand and did not compel the company to stick to a specific timetable.

The EU is under pressure after criticism that the pace of vaccine distribution in several member countries is too slow.

"There are binding orders and the contract is crystal clear," Mrs von der Leyen said in Friday morning's radio interview.

"AstraZeneca has also explicitly assured us in this contract that no other obligations would prevent the contract from being fulfilled," she said.

The company is producing the jab at its UK plants too and there have been no problems with its contract with the UK authorities.

Mrs von der Leyen said two UK plants were mentioned in the contract as production sites for vaccine destined for the EU.

On her call for the contract to be published, she demanded transparency: "We are speaking with the company about which parts need to be redacted. But we want to achieve transparency."

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2021-01-29 08:05:00Z
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Kamis, 28 Januari 2021

COVID-19: How the Novavax vaccine works - and the benefits it has over the three already approved - Sky News

A jab made by the US firm Novavax could become the fourth vaccine to be approved in the UK after promising data from a late-stage trial emerged.

Nearly 7.5 million people across the UK have received their first dose of a coronavirus vaccine - with the nationwide rollout seen as the country's best hope of bringing the pandemic to an end.

The Pfizer/BioNTech and Oxford/AstraZeneca jabs are already being distributed, while the Moderna vaccine has been given the green light for use.

But what is so different about the Novavax vaccine - and how many doses has the UK ordered?

How effective is the Novavax vaccine?

Phase 3 trials of the experimental vaccine suggest it is 89.3% effective against COVID-19.

The vaccine candidate was shown to be 95.6% effective against the original strain of coronavirus, and 85.6% effective against the variant first detected in the UK.

The study involved more than 15,000 participants aged 18 to 84, with 27% aged over 65.

Does it work against the South Africa variant?

An early stage study was carried out on 4,400 people in South Africa, including some volunteers with HIV.

Among the HIV-negative volunteers, the vaccine appears to be 60% effective. When immune-compromised volunteers are included, the jab offered 49% protection overall.

Novavax plans to immediately start development on a vaccine specifically targeted to the South African variant.

How does the vaccine work?

The Novavax vaccine differs from those already being used in the UK.

It combines an engineered protein from the virus that causes COVID-19 with a plant-based ingredient to help generate a stronger immune response.

If the body encounters coronavirus in the future, the body is primed to fend it off.

How many doses will be available?

The UK has ordered 60 million vials of the vaccine.

They will be manufactured at the Fujifilm plant in Stockton-on-Tees.

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How many doses of the vaccine will each person need?

People will be given two doses of the vaccine, three weeks apart.

How is it stored?

The Novavax vaccine, called NVX-CoV2373, only needs to be stored at fridge temperatures - much like the AstraZeneca and Moderna vaccines.

This means distribution and supply chain management is easier than it is for the Pfizer vaccine, which has to be stored at the much lower temperature of -70C.

How much will it cost the UK government?

The treatment comes at a cost of $16 (£11.66) per vaccination.

The jab is therefore more expensive than the AstraZeneca vaccine, but cheaper than both Pfizer and Moderna treatments.

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2021-01-29 02:48:45Z
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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.

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."

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.

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.

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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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

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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Jumat, 29 Januari 2021

'UK AT THE FOREFRONT OF ANOTHER MEDICAL BREAKTHROUGH'

Kamis, 28 Januari 2021

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