Category Archives: Pharmaceuticals industry

Revealed: big shortfall in Covax Covid vaccine-sharing scheme

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Only a fifth of Oxford/AstraZeneca doses expected by May delivered as export bans, hoarding and supply shortages bite

The global vaccine-sharing initiative Covax has so far delivered about one in five of the Oxford/AstraZeneca doses it estimated would arrive in countries by May, according to a Guardian analysis, starkly illustrating the cost of export bans, hoarding and supply shortages for a scheme that represents a key lifeline for many in the developing world.

The organisations that run Covax had predicted countries would receive fewer vaccines than expected after the Indian government restricted exports from its largest manufacturer in response to a catastrophic second wave there, but the figures reveal the shortfall to be severe, leaving many governments scrambling to secure doses elsewhere.

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African health workers left without Covid jabs as paltry supplies dwindle

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Fear of third wave and new variants as sub-Saharan vaccine distribution is dogged by supply disruption

Millions of healthcare workers in sub-Saharan Africa continue to risk their lives to fight Covid-19 as authorities across the continent struggle to obtain and distribute vaccines to frontline medical staff.

Though hundreds of millions of people in western nations are now protected from the virus, doctors, nurses and others on the frontline of the fight against Covid in Africa will have to wait months, or even years, for a vaccine.

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EU agency examines reports of blood clots with J&J Covid vaccine

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EMA says four serious cases reported, one fatal, and also expands inquiry into AstraZeneca vaccine

The EU’s drug regulator is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s Covid-19 vaccine and has expanded its inquiry into AstraZeneca’s shot to include reports of a bleeding condition.

Of the four serious cases of clotting and low platelets, three occurred in the US during the rollout of J&J’s vaccine from its Janssen pharmaceuticals unit, the European Medicines Agency (EMA) said on Friday, adding that one person had died and one case was reported in a clinical trial. It was the first news of EMA’s inquiry into the J&J vaccine.

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UK ministers silent on AstraZeneca vaccine shipment to Australia

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Downing Street will not confirm or deny report that more than 700,000 Covid jabs were sent after EU blocked export

British ministers and officials did not deny that more than 700,000 shots of the AstraZeneca vaccine were secretly dispatched from the UK to Australia a few weeks ago as the EU blocked the drug’s export.

The Sydney Morning Herald reported that 717,000 AstraZeneca doses were dispatched in late February and March from the company’s British operations – also during a period when the EU was demanding the vaccine from the UK.

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AstraZeneca Covid vaccine: weighing up the risks and rewards

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Despite scientific advice to continue getting the jab, answers about fatal blood clots are urgently needed

Vaccines have side-effects, as do all medicines. Most often, jabs cause sore arms, a headache or a bit of nausea – none of which would be very significant when weighed against the toll of a serious virus such as Covid-19.

But sometimes the risk-benefit calculation may look less simple, as in the case of Oxford/AstraZeneca’s Covid jab and cerebral venous sinus thrombosis (CVST), the blood clots in the brain that have led to fatalities in the UK and Europe.

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Pfizer vaccine has 91% efficacy for up to six months, trial shows

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Findings based on two doses three weeks apart are first to show shot remains effective for many months

The coronavirus vaccine developed by Pfizer and its German partner BioNTech protects against symptomatic Covid for up to six months, an updated analysis of clinical trial data has found.

In a statement released on Thursday, the companies reported efficacy of 91.3% against any symptoms of the disease in participants assessed up to six months after their second shot. The level of protection is only marginally lower than the 95% achieved soon after vaccination.

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Canada suspends use of AstraZeneca Covid vaccine for those under 55

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Immunisation panel says there is ‘substantial uncertainty about the benefit’ of the vaccine given risk of rare type of blood clot

Canada on Monday suspended the use of the Oxford/AstraZeneca coronavirus vaccine for people under 55 following concerns it might be linked to rare blood clots.

The pause was recommended by the National Advisory Committee on Immunization for safety reasons. The Canadian provinces, which administer health in the country, announced the suspension on Monday.

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‘Vaccine prince’: the Indian billionaire set to make Covid jabs for the UK

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Serum Institute boss Adar Poonawalla has rented a Mayfair mansion for £50,000 a week

The AstraZeneca vaccine has made Prof Sarah Gilbert – who led the Oxford team that created it – one of the UK’s most famous modern scientists and turned the Anglo-Swedish pharmaceutical company into a household name.

But almost half of all the AstraZeneca shots, destined for the arms of hundreds of millions of people around the world, are being produced by a 40-year-old Indian billionaire with a penchant for private jets and Picassos.

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How the AstraZeneca vaccine became a political football – and a PR disaster

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Newly accused of data manipulation by the US, AstraZeneca has faced unprecedented scrutiny over the past six months

It was billed as the vaccine to deliver the world from Covid. But over the last six months, AstraZeneca – whose jab was designed to save thousands of lives for no profit – has found itself stumbling along an extraordinarily rocky road, facing accusations over the efficacy, supply and side-effects of its vaccine from all quarters, and being kicked about like a political football.

This week, AstraZeneca faced unprecedented public criticism in the US from a high-level scientific body claiming the British-Swedish company massaged the data from its long-awaited trial there. And in Italy, military police entered a factory on behalf of the European commission investigating allegations of 29m hidden doses, said to be intended for shipment to the UK. The commission, which is demanding AstraZeneca supplies more jabs to Europe, meanwhile drew up regulations which could block vaccine exports to the UK.

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AstraZeneca plant investigated by Italian police at EU’s request

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Investigation is fresh sign of breakdown in relations between Brussels and Anglo-Swedish vaccine supplier

An AstraZeneca plant has come under investigation by the Italian police at the request of Brussels in a sign of the breakdown in relations between the Anglo-Swedish vaccine supplier and the EU.

Officers were sent into the facility in the town Anagni, east of Rome, on Saturday evening after the European commission contacted the Italian government with concerns.

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EU to widen criteria for possible Covid vaccine export bans

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Bloc expected to assess countries’ Covid vaccination coverage and record in facilitating exports to EU

The EU is expected to take into account the level of vaccination coverage in a country and its record in facilitating exports to the bloc when deciding on whether to prohibit individual vaccine shipments to the UK and elsewhere.

The revision of the export authorisation scheme, widening the criteria that will guide Brussels’ decisions on export requests, is due to be announced on Wednesday. EU leaders will then on Thursday discuss going further in controlling vaccine distribution when they meet by videoconference.

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European countries to resume AstraZeneca jabs after safety backing

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EMA says benefits outweigh risks but it is continuing to study possible link with very rare blood clotting disorder

Italy, France and several other countries will resume administering AstraZeneca jabs from Friday after Europe’s medicines regulator said the vaccine was “safe and effective” and its benefits outweighed its risks.

Germany and Portugal will resume on Monday, Spain and the Netherlands next week, while Sweden’s public health agency said it would take “a few days” to decide.

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AstraZeneca vaccine ‘safe and effective’, says European Medicines Agency – video

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The Oxford/AstraZeneca coronavirus vaccine is 'safe and effective' and its benefits outweigh the risks, Europe’s medicines regulator has said. The director of the European Medicines Agency, Emer Cooke, said the agency’s safety committee had reached 'a clear scientific conclusion' and had not found that the vaccine was associated with an increase in the overall risk of blood clots

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What price a child’s life? India’s quest to make rare disease drugs affordable

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Parents whose only hope was finding foreign sponsorship or a clinical trial are now looking for homegrown breakthroughs

For three years, Vidya tried to find the cause of her son’s recurrent fevers and low cognitive development. When she found out, she was devastated.

Vineeth, 10, has an incurable illness – mucopolysaccharidosis type 2 – that affects his organs. Afflicting just one in a million, the enzyme-replacement medication that can help stop the illness getting any worse costs £100,000 a year, far beyond the reach of even a wealthier Indian parent.

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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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