Category Archives: Pharmaceuticals industry

Germany set to give AstraZeneca jab to older people

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Regulator concedes process had ‘somehow gone wrong’ and could soon approve vaccine

Germany could soon authorise the use of the AstraZeneca vaccine for seniors after the head of the country’s vaccination committee said his body’s advice to give the Oxford-developed vaccine only to those under 65 had “somehow gone wrong”.

Unlike the European Medicines Agency or Britain’s MHRA, Germany’s Standing Committee on Vaccination (Stiko) last month recommended against the use of the AstraZeneca vaccine on seniors, citing a lack of conclusive trial data to prove its efficacy in that age group.

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Johnson & Johnson one-shot Covid vaccine gets nod from FDA advisory panel

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Vaccine, along with those from Pfizer and Moderna, should provide US with more than enough supply to vaccinate every person

The battle against Covid-19 took a major step forward on Friday as the US moved closer to distributing its first one-shot Covid-19 vaccine, after an independent expert advisory panel recommended drug regulators authorize the Johnson & Johnson vaccine for emergency use.

The authorization would be a significant boost to the Biden administration’s vaccination plans, making Johnson & Johnson’s vaccine the third available to the public. Janssen, Johnson & Johnson’s vaccine subsidiary, told a congressional hearing this week that it expects to deliver 20m doses by March and a total of 100m doses before the end of June.

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AstraZeneca expected to miss EU Covid vaccine supply target by half in second-quarter – report

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Expected shortfall of 90m doses could hit the EU’s ability to meet its target of vaccinating 70% of adults by summer

AstraZeneca has told the European Union it expects to deliver less than half the Covid-19 vaccines it was contracted to supply in the second quarter, an EU official told Reuters on Tuesday.

Contacted by Reuters, AstraZeneca did not deny what the official said, but a statement late in the day said the company was striving to increase productivity to deliver the promised 180m doses.

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South Africa leads backlash against big pharma over Covid vaccine access

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Pressure mounts for patent waivers to allow poorer countries to develop their own manufacturing capacity to boost availability

The domination of global medicine by major pharmaceutical companies needs to be confronted to provide fairer access to vaccines, a leading South African official has said.

The scramble over Covid vaccines should alert rich countries to the power of profit-driven companies that control production of crucial medicines, said Mustaqeem De Gama, South Africa’s delegate at the World Trade Organization (WTO) on intellectual property rights.

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Life savers: the amazing story of the Oxford/AstraZeneca Covid vaccine

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A year ago, two scientists began work on the response to a new virus. Now, as their vaccine is being given to millions, they tell of their incredible 12 months

Exactly a year ago, Oxford University scientists launched a joint enterprise that is set to have a profound impact on the health of our planet. On 11 February, research teams led by Professor Andy Pollard and Professor Sarah Gilbert – both based at the Oxford Vaccine Centre – decided to combine their talents to develop and manufacture a vaccine that could protect people from the deadly new coronavirus that was beginning to spread across the world.

A year later that vaccine is being administered to millions across Britain and other nations and was last week given resounding backing by the World Health Organization. The head of the WHO’s department of immunisation, vaccines and biologicals, Professor Kate O’Brien, described the jab as “efficacious” and “an important vaccine for the world”.

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AstraZeneca set to weather Covid in better health than rivals

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The Anglo-Swedish firm already had a strong lineup of cancer drugs when vaccine success gave it a further boost

Before the pandemic, AstraZeneca was highly regarded in the business and pharmaceutical world – seen as one of the UK’s best companies. Now, thanks to Britain’s successful vaccine programme, it is a household name.

The Anglo-Swedish firm, which publishes annual results on Thursday, has sprung to prominence as maker of one of the world’s first Covid-19 vaccines, approved for use in the UK, EU and India. Inevitably, headlines have followed. AstraZeneca has been the focal point of the vaccine supply wars between the UK and the EU and has, as part of that row, faced questions over the effectiveness of the jab in the over-65s.

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Oxford Covid vaccine almost as effective against Kent variant, trials suggest

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Scientists say it offers only slightly lower protection compared with original Covid

The Covid vaccine developed by the University of Oxford and AstraZeneca is nearly as effective against the Kent variant as it is against older forms of the virus, according to preliminary research results.

Researchers analysed swabs from trial volunteers who developed asymptomatic or symptomatic infections to determine which variant of the virus they had caught after receiving the vaccine or a control jab.

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Single dose of AstraZeneca vaccine could cut transmission by 67%

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One jab could also offer protection of up to 76% for up to 12 weeks, a new study shows

One dose of the Oxford/AstraZeneca vaccine provides sustained protection against Covid for at least three months and cuts transmission of the virus by two-thirds, according to research that appears to support the UK’s decision to delay booster shots.

Analysis of fresh data from three trials found that the first shot conferred on average 76% protection against symptomatic infections from three weeks until 90 days, and reduced transmission of the disease by 67%.

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Even with vaccines, we still need treatments for Covid. So what works?

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Analysis: death rates in intensive care are falling as doctors identify more ways to help those with the disease

Vaccines may have been described as the great escape route from the Covid pandemic – but treatments, which are bringing down death rates, will be needed as much as ever in the era of jabs because the virus is not expected to go away in the foreseeable future, experts say.

“It’s going to take a long time to vaccinate the world,” said Peter Horby of Oxford University, chief investigator of the Recovery trial into Covid treatments and chair of the New and Emerging Respiratory Virus Threats Advisory Group (Nervtag). “I don’t know what the estimates are, but we’ve already seen issues with manufacturing scale-up and difficulties in delivering at scale.

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How EU’s floundering vaccine effort hit a fresh crisis with exports row

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A new rule on exports from Europe suddenly blew up into a threat to the withdrawal agreement – and a hasty backtrack

It started with a tweet by a blogger at 4.36pm on Friday. It ended with the prime ministers of the UK and Ireland warning the European commission president, Ursula von der Leyen, during late night calls, that she had put peace at risk by effectively seeking to erect a vaccine border between Northern Ireland and the Republic.

“OK, I’m not usually on here any more, but I’m making an exception because this is very interesting: the EU’s regulation on export controls for vaccines *does* include vaccines going to Northern Ireland, and the EU is invoking Article 16 of the Ireland/Northern Ireland Protocol,” @dijdowell had tweeted. “I really didn’t have Article 16 being used *by the EU* in the first month of the Protocol’s operation on my list of predictions for 2021. I would be fascinated – *fascinated* – to know what the Irish Government makes of setting this precedent.”

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How effective is the Novavax Covid vaccine and will it work against variants?

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Everything you need to know about the trial results for a new coronavirus vaccine

In an interim analysis of a phase 3 clinical trial conducted in the UK, the vaccine has shown 89% efficacy, with 27% of participants in the trial – almost 4,000 people – older than 65. That trial suggested 95.6% efficacy against the original coronavirus and 85.6% efficacy against the more recent UK strain. Those results were based on the first 62 cases of Covid-19 identified among volunteers, with 56 cases among those given a placebo against just six in those given the vaccine.

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EU could block millions of Covid vaccine doses from entering UK

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European commission says new mechanism will give national regulators power to refuse exports

Millions of doses of coronavirus vaccine could be blocked from entering Britain from the EU within days after Brussels said it had to respond to shortages emerging in member states.

Following reports of a lack of doses across the bloc, the European commission announced plans to give national regulators the power to reject export requests. The development raises concerns over the continued flow of the Pfizer/BioNTech vaccine, for which the UK has a 40m-dose order, from its plant in Belgium.

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Britain and EU clash over claims to UK-produced Covid vaccine

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EU health commissioner dismisses AstraZeneca argument it is contractually obliged to supply UK first

Britain is on a collision course with the European Union over vaccine shortages after Brussels refused to accept that people in the UK have first claim on Oxford/AstraZeneca doses produced in local plants.

The EU’s health commissioner outright dismissed on Wednesday an argument made by Pascal Soriot, the Anglo-Swedish company’s chief executive, that he was contractually obliged to supply the UK first.

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Why the EU and AstraZeneca are stuck in a Covid vaccines row

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Explainer: AstraZeneca’s Pascal Soriot gives insight into ‘glitches’ that constrained production

The chief executive of AstraZeneca has dismissed suggestions that the UK is being unfairly prioritised for Covid-19 vaccine doses, in a wide-ranging interview revealing “glitches” that have constrained production.

Pascal Soriot offered the deepest insight yet into a scientific process that has been dragged into the political sphere, as leaders in Brussels and several EU capitals voiced anger that Europe will not get the vaccine as quickly as hoped.

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Head of AstraZeneca confirms UK has prior claim on vaccine

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Chief executive of pharmaceutical giant says the firm will honour UK’s earlier contract despite EU anger over shortfall

AstraZeneca’s chief executive has insisted the UK will come first for vaccines as he rejected calls to divert doses to the European Union following a breakdown in supply.

Amid a growing row, Pascal Soriot, the French head of the pharmaceutical giant, said the UK was benefiting from being early to sign a contract for 100m doses.

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EU means business over Covid vaccine exports, says Von der Leyen

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Commission president says firms must deliver on orders after AstraZeneca warns of shortfall

The EU “means business”, Ursula von der Leyen has said, as the bloc doubled down on plans for tighter monitoring of vaccine exports to countries outside of the union, such as the UK.

Speaking at the World Economic Forum, the president of the European commission said the EU had invested billions and “companies must now deliver” to the 27 member states.

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Pharmaceutical giants not ready for next pandemic, report warns

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Ten of the world’s most infectious diseases identified by the WHO not being catered for by drug firms

The world’s biggest pharmaceutical firms are little prepared for the next pandemic despite a mounting response to the Covid-19 outbreak, an independent report has warned.

Jayasree K Iyer, executive director of the Netherlands-based Access to Medicine Foundation, a not-for-profit organisation funded by the UK and Dutch governments and others, highlighted an outbreak of the Nipah virus in China, with a fatality rate of up to 75%, as potentially the next big pandemic risk.

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I’ve had my first vaccine jab. It gives me hope of liberation… but not yet

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Exactly a year after his first story about coronavirus, our science editor received the Pfizer injection last week. Here he reflects on a remarkable scientific achievement

I marked a grim anniversary in an unexpected manner last week. On 18 January last year, I wrote my first story about a mysterious disease that had struck Wuhan, in China, and which was now spreading around the world. More than two million individuals have since died of Covid-19, almost 100,000 of them in the UK.

Remarkably, 12 months to the day that the Observer published my story, I was given my first dose of Covid-19 vaccine, allowing me to follow nearly six million other newly immunised UK residents who are set to gain protection against a disease that has brought the planet to a standstill. It was a rare, comforting experience after a year of unremitting sadness and gloom.

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World’s poor need action, not Covid ‘vaccine nationalism’, say experts

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Nations outbidding each other creates an ‘immoral race towards the abyss’

Pharmaceutical companies should do more to transfer vaccine technology to prevent the poorest countries falling behind in the distribution of Covid-19 vaccines, according to an expert.

The warning came from Dag-Inge Ulstein, the co-chair of the global council trying to speed up access to Covid vaccines for the world’s poor, known as the Act (Access to Covid-19 Tools) Accelerator. Ulstein, Norway’s international development minister, oversees the drive to ensure vaccines reach the poor – the Covax programme.

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Single Covid vaccine dose in Israel ‘less effective than we thought’

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Surge in infections dampens optimism over country’s advanced immunisation programme

Israel’s coronavirus tsar has warned that a single dose of the Pfizer/BioNTech vaccine may be providing less protection than originally hoped, as the country reported a record 10,000 new Covid infections on Monday.

In remarks reported by Army Radio, Nachman Ash said a single dose appeared “less effective than we had thought”, and also lower than Pfizer had suggested.

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