Category Archives: Pharmaceuticals industry

Ireland suspends AstraZeneca Covid vaccine over blood clot concerns

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Deployment of Oxford vaccine temporarily deferred after latest reports from Norway

Ireland is suspending use of the Oxford/AstraZeneca coronavirus vaccine as a precautionary measure following further reports of blood clots in people who have received it, this time from Norway.

The deputy chief medical officer, Dr Ronan Glynn, said Ireland’s advisory body on vaccines had recommended that deployment of the AstraZeneca jab should be “temporarily deferred” with immediate effect. He stressed, though, that there was no proof that the vaccine had caused blood clots.

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EMA says AstraZeneca vaccine can continue to be used during investigation

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Several countries suspend inoculations but regulator says vaccine benefits outweigh its risks

The European Medicines Agency has said the Oxford/AstraZeneca Covid vaccine can continue to be used during an investigation into cases of blood clots that have prompted several European countries to pause their use of the shot.

The EMA said 30 cases of “thromboembolic events” or blood clots had been reported among 5 million people who had received the jab in Europe so far. “The vaccine’s benefits continue to outweigh its risks,” the regulator said in a statement.

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Israeli real-world data on Pfizer vaccine shows high Covid protection

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Jab has 97% efficacy against disease and death and 94% against infection without symptoms

The Pfizer/BioNTech vaccine appears to give high protection against asymptomatic Covid-19, according to data from Israel – a finding that will boost hopes that mass vaccination can stop the spread of the virus.

The top line of the real-world results, issued by the Israeli ministry of health and the companies but not yet peer-reviewed by scientists, is efficacy of 97% against disease and death and 94% against infection without symptoms.

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From Pfizer to Moderna: who’s making billions from Covid-19 vaccines?

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The companies in line for the biggest gains – and the shareholders who have already made fortunes

The arrival of Covid-19 vaccines promises a return to more normal life – and has created a global market worth tens of billions of dollars in annual sales for some pharmaceutical companies.

Among the biggest winners will be Moderna and Pfizer – two very different US pharma firms which are both charging more than $30 per person for the protection of their two-dose vaccines. While Moderna was founded just 11 years ago, has never made a profit and employed just 830 staff pre-pandemic, Pfizer traces its roots back to 1849, made a net profit of $9.6bn last year and employs nearly 80,000 staff.

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WHO chief: waive Covid vaccine patents to put world on ‘war footing’

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Dr Tedros Adhanom Ghebreyesus says he supports patent waiver to help countries make and sell cheap vaccine copies

Opinion: A ‘me first’ approach to vaccination won’t defeat Covid

The normal rules of business that protect the profits of vaccine manufacturers will have to be set aside if that is what it takes to ensure everybody is immunised against the coronavirus, according to the director general of the World Health Organization.

Writing in the Guardian, Dr Tedros Adhanom Ghebreyesus says the world needs to be “on a war footing”. Before a key meeting of the World Trade Organization next week on the anniversary of the declaration of the pandemic, he supports a patent waiver that would allow countries to make and sell cheap copies of vaccines that were invented elsewhere.

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Covid: Germany and France under pressure to shift Oxford vaccine

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Both countries urged to take action to avoid pile-up of unused AstraZeneca vaccine doses

Authorities in Germany and France are under pressure to come up with creative solutions to shift the AstraZeneca vaccine at higher speed in order to avoid a pile-up of unused doses over the coming weeks.

On Monday, France’s medical regulator reversed its advice not to use the AstraZeneca jab on over-65s, and Germany’s vaccination committee is coming under increasing pressure to follow suit or even scrap prioritisation altogether.

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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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