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LONDON (March 14): AstraZeneca plc’s European vaccine nightmare is worsening, with several countries suspending injections out of safety concerns as delivery delays lead governments around the world to rack up doses that have already received.
Ireland on Sunday joined a growing list of about a dozen countries mobilizing to suspend the injection over concerns about the possible side effects of two batches of vaccines. While the European drug regulator said there were no signs of any problems, reports of severe blood clotting after inoculation triggered a series of suspensions that spread to Thailand.
The health fear arose in a context of new supply problems. The drugmaker’s efforts to make up the European Union’s shortfall by obtaining injections elsewhere have hit a wall as governments around the world protect their own supplies. The United States has rejected pressure to share doses and is holding on to its stock of AstraZeneca, even though the injection is not yet licensed for use there.
The drama keeps AstraZeneca at the center of a political storm in Europe, weeks after manufacturing problems first brought the two sides into conflict. Meanwhile, the EU is lagging further behind the UK and the US in vaccines, creating a political crisis for the bloc’s leaders.
In addition to low yields that produce less vaccine than planned, a plant in the Netherlands is still awaiting regulatory approval to implement the doses. The site, owned by manufacturer Halix, is manufacturing the vaccine drug substance for AstraZeneca and is part of the EU and UK supply chains.
An AstraZeneca spokesperson said the approval time is in line with original plans and has had no impact on EU deliveries. Halix did not respond to a request for comment outside of normal business hours.
But the various problems meant that AstraZeneca could only deliver around 100 million doses to the EU in the first half of the year, it said on Friday, about a third of the originally planned amount. Thirty million doses are expected to be delivered by the end of this quarter and the remainder in the next three months.
Italy has already responded with direct action, using a new EU measure to prevent AstraZeneca from sending some doses to Australia. Prime Minister Mario Draghi hinted on Friday that he would do so again if necessary.
“The European Union has made clear commitments to pharmaceutical companies and we hope they will be respected,” Draghi said. “We have made some strong decisions against companies that have delayed deliveries and we will continue to do so.”
The latest developments will do little to encourage adoption of the AstraZeneca vaccine in the EU, which had already encountered problems in recent weeks in light of variable efficacy rates, potential loss of protection against new variants of the virus, and concerns. on its efficacy in older adults. Until recently, several countries had restricted the use of the injection to those under 65 years of age.
In a YouGov survey on March 7, the perception in EU countries about the safety of the injection of AstraZeneca and the University of Oxford was lower compared to the vaccines of Pfizer Inc and its partner BioNTech SE, and Moderna Inc On the contrary, the British saw AstraZeneca as the safest. of three.
Suspensions may incorporate even more negative opinions, despite guidance from the European Medicines Agency (EMA). The EMA guidance was not enough to convince Ireland to continue with the vaccine and its health minister recommended on Sunday to temporarily halt the injection.
Support for the vaccine in the developing world, where the relatively low price and the ability to store the injection without special refrigeration boosted its initial appeal, could also be affected by suspensions. AstraZeneca has pledged significant supplies to the Covax program, a facility that aims to distribute vaccines equitably around the world.
The number of reported incidents, about 30 out of a group of about five million, is no greater than what would have occurred naturally in that population size, according to regulators and scientists.
“Genuine problems with a batch are very rare and are almost always related to contamination by bacteria or physical particles” such as glass detected by the manufacturer, said Stephen Evans, professor at the London School of Hygiene and Tropical Medicine. “Pausing usage in this case is not based on evidence.”
The UK has administered more than 25 million doses of vaccines, many of which are AstraZeneca injections, without raising any alarms about clotting. Safety data covering more than 17 million AstraZeneca doses administered “has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia,” the company said in a statement Saturday after the Norwegian decision.
The AstraZeneca vaccine has become an emblem of growing pandemic nationalism as countries rush to inoculate populations as quickly as possible. The United States has already ordered nearly enough vaccines from the three manufacturers with clearance from the Food and Drug Administration to immunize its adult population twice.
“We’re going to start by making sure Americans are taken care of first, but then we’ll try to help the rest of the world,” US President Joe Biden said Wednesday.
In Europe, meanwhile, the EU spent much of last week in another war of words with the UK after it accused the UK of blocking vaccine exports. The EU itself has exported millions of doses, although it also has controls that it can use to ensure that pharmaceutical companies honor contracts.
“I think it’s an incredible irony that the European Union is complaining that other countries are protectionist,” said Mark Eccleston-Turner, an infectious disease and law specialist at Keele University in England. “At the beginning of this pandemic, they referred to this vaccine as a public good, and then they sought to buy as many doses as they could and put export controls in place.”
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