EU mulls AstraZeneca legal action as WHO calls for blood clot data

OSTN Staff

The EU executive informed member state envoys of its plans on Wednesday (local time), the diplomats told AFP, confirming information first published by the Politico website.They said any lawsuit against AstraZeneca would begin in a Belgian court — the jurisdiction agreed under the commission’s contract with the British-Swedish pharmaceutical company.A Commission spokesman, Eric Mamer, told journalists that “no decision has yet been taken”.Another spokesman, Stefan De Keersmaecker, added: “As you know, AstraZeneca is not delivering the number of doses which have been agreed upon in the contract… This is one of the reasons why we keep our options open together with member states to take any further steps.” One EU diplomat said the commission wants EU member states — which also had a role in negotiating the vaccine contracts for the bloc — to back the lawsuit and to say so by the end of this week.“The problem is that the member states do not know the complaint” being formulated, the diplomat said. “It is a sensitive procedure and you do not want to further damage trust in the vaccine.” Another diplomat said that “not all member states are in agreement” on taking the company to court, stressing that their aim was simply to have AstraZeneca deliver the doses it had promised in its contract.AstraZeneca has so far delivered just 31 million of the 120 million doses it had promised. It has warned it will likewise provide just 70 million of the 180 million more meant to be delivered over the rest of this year.Public confidence in the AstraZeneca jab has taken a blow after the European Medicines Agency, the bloc’s regulator, said it was likely linked to a very rare, but often fatal, form of blood clot affecting the brain.The EMA and the commission have not changed their stance on a general use of AstraZeneca, saying its benefits outweigh the risks, but several EU countries have restricted its use to older citizens, aged over 50, 55 or 60.The EU, however, is now increasingly relying on the BioNTech/Pfizer vaccine for its rollout, which has been accelerating since the end of March.NED-3588 Covid Strains ExplainedDe Keersmaecker said that the commission opted to let lapse a deadline to activate an option for 100 million extra AstraZeneca doses. “This option will not be exercised,” he said.AstraZeneca’s French-Australian boss, Pascal Soriot, has argued that his company’s contract with the EU binds it only to a “best reasonable efforts” clause.But the commission says the rest of the contract shows greater legal responsibility than that, and EU diplomats and lawmakers have pointed out that the company has largely delivered promised doses to Britain, where it is headquartered.A Brussels lawyer who has studied the AstraZeneca contract, Arnaud Jansen of the firm De Bandt, told AFP that, if any legal action were to go ahead, “it’s a process that could take months” before a court rules on it.WHO WANTS MORE ASTRAZENECA CLOT DATA FROM OUTSIDE EUROPEThe World Health Organization’s vaccine advisors have called for more data on the incidence of blood clots in people who received the AstraZeneca COVID-19 vaccine outside Europe.The WHO’s Strategic Advisory Group of Experts (SAGE) on Immunisation updated their guidance on the use of AstraZeneca’s coronavirus jab, rewriting the section on precautions in light of data from Europe on clotting.“WHO continues to support the conclusion that the benefits of these vaccines outweigh the risks,” the UN agency stressed in a statement.On April 7, SAGE said a link between AstraZeneca’s COVID-19 jabs and blood clots was plausible but unconfirmed, underlining that reported occurrences were “very rare”.In light of evidence emerging from ongoing vaccination programmes, they have updated their recommendations on the AstraZeneca jab, which is being deployed in 157 territories according to an AFP count.SAGE said most clotting cases were reported in Britain and the European Union, with very few cases noted in other countries.They said it was unknown whether there was a risk of clotting from the second dose of the vaccine, while recommending that those who suffered blood clots after their first injection should not be given the second dose of the two-shot vaccine.COVID-19 World Numbers“A very rare syndrome of blood clotting combined with low platelet counts, described as thrombosis with thrombocytopenia syndrome (TTS), has been reported around four to 20 days following vaccination,” the new guidance says.“A causal relationship between the vaccine and TTS is considered plausible although the biological mechanism for this syndrome is still being investigated.“Most of these cases were reported from the UK and the EU. There is considerable geographic variation with regards to the reported incidence, with very few cases reported from non-European countries, despite extensive use of the vaccine.“An estimation of the risk outside Europe needs further data collection and analysis.” The vaccine currently forms the backbone of the Covax scheme, which ensures that poorer countries can access doses, with donors covering the cost.Covax has so far shipped more than 40.5 million COVID-19 vaccine doses to 118 participating territories.The SAGE guidance said that data from Britain, dated March 31, suggested the risk of TTS was approximately one case per 250,000 vaccinated adults, while the rate in the EU was estimated at one in 100,000.It said current data from Europe suggested that the risk might be higher in younger adults compared with older adults.“No specific risk factors have yet been identified,” it said.Whilst stressing that the benefit of vaccination against COVID-19 “far outweighs” the risks, the assessment may differ between countries.“Countries should consider their epidemiological situation, individual and population-level risks, availability of other vaccines, and alternate options for risk mitigation,” the guidance said.“The benefit-risk ratio is greatest in older age groups.“It is currently unknown whether there is a risk of TTS following the second dose.” The safety surveillance and monitoring section was also rewritten, recommending research into serious adverse events including cerebral venous sinus thrombosis and thrombotic events with thrombocytopenia.It also called for research into the incidence of TTS by region, age and sexUS PASSES ‘STUNNING’ 200M COVID JAB GOALUS President Joe Biden has hailed his government’s “stunning” achievement in administering 200 million COVID-19 vaccine shots across the United States ahead of schedule.Mr Biden said the landmark had been reached a week before he hits his administration’s 100-day mark — the deadline he’d announced for meeting the 200 million doses challenge.“Today we did it, today we hit 200 million shots,” he said in a televised speech from the White House. “This is an incredible achievement for the nation.” Mr Biden called the 200 million shots in 100 days a “goal unmatched in the world or in prior mass vaccination efforts in American history”. “The progress we’ve made has been stunning,” he said.Announcing a tax break to encourage businesses to give all employees a day off for vaccinations, Mr Biden said the country was still “on track” to being able to celebrate the July 4th Independence Day holiday in relative normality.But he warned that rising infection rates in parts of the country showed that it was too early to declare victory.“If we let up now and stop being vigilant, this virus will erase the progress,” he said.While the United States leads the world in reported COVID-19 deaths, it has also raced ahead in the vaccination stakes, outperforming some major European countries and neighbouring Canada.Mr Biden came into office on January 20 initially vowing to get 100 million shots administered in his first 100 days. On March 25, with vaccination deliveries far ahead of their targets, he doubled the goal.Starting in May, all states will be required to lift restrictions on eligibility for access to the free shots. Many have already done that.Dampening the celebratory mood in the White House is a surge of infection rates in parts of the country, including the state of Michigan.Death rates, however, remain down nationwide as a result of the high vaccination rate among the elderly and improved care.INDIA IN COVID CRISISIndia’s brutal new COVID-19 outbreak set records on Wednesday with more than 2,000 deaths in 24 hours, as hospitals in New Delhi ran perilously low on oxygen.Highlighting the strain on health authorities, 22 patients died in a hospital after an oxygen leak cut off the supply to 60 ventilators for half an hour, officials said.India has been in the grips of a second wave of infections blamed on lax government rules and a new “double mutant” virus variant, adding almost 3.5 million new cases this month alone.Health ministry data on Wednesday showed a record 2,023 fatalities and 295,000 new cases in 24 hours, among the world’s biggest daily case totals and on a par with numbers seen in the United States during a deadly surge in January.In an address to the nation on Tuesday night, Prime Minister Narendra Modi said that the country of 1.3 billion people was “once again fighting a big fight”.“The situation was under control till a few weeks back, and then this second corona wave came like a storm,” he said.There had been hopes that despite its packed cities and poor health care, India had managed to dodge largely unscathed a pandemic that has killed more than three million people around the world.Recent weeks have seen mass gatherings, including millions attending the Kumbh Mela religious festival, as well as political rallies, lavish weddings and cricket matches against England.Production of key coronavirus drugs slowed or even halted at some factories and there were delays inviting bids for oxygen generation plants, according to press reports.Distraught relatives are now being forced to pay exorbitant rates on the black market for medicines and oxygen and WhatsApp groups are white-hot with desperate pleas for help.“I am scared for my parents and relatives more than I am scared for myself because they are not young anymore and getting admitted into a hospital right now is next to impossible,” one Delhi resident told reporters.NZ AIRPORT STAFFER COULD HAVE PASSED ON INFECTIONA coronavirus-infected airport staffer who cleaned planes from high-risk countries also worked on aircraft bound for Australia.There are now fears the staffer may have passed the infection on just two days after the trans-Tasman bubble opened.New Zealand’s director of public health Caroline McElnay said authorities believed the case was linked to a returning passenger from Ethiopia.“The person who has become infected works at cleaning planes from international flights,” she told reporters on Wednesday.“This includes countries that are deemed red zone where COVID-19 is widespread, but also includes having cleaned green zone planes flying back to Australia on Monday.”Dr McElnay noted it was the same protocol used in Australia.“The person wore full PPE while cleaning and we have been in touch with Australian authorities to notify them about this case,” she said.“Our assessment is that there is no additional risk to any passengers who travelled on those flights cleaned by the infected person.”The worker has received both doses of the COVID-19 jab, which means the risk to the community is low.

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