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London (CNN Business) – After joining Oxford University, AstraZeneca produced a safe and effective vaccine against Covid-19 in just nine months. It is a great achievement that will help end the pandemic. But a series of mistakes along the way exposed the lab to devastating criticism from lawmakers and health officials, tarnishing its heroic image in the fight against coronavirus.
The Anglo-Swedish pharmaceutical industry mistakenly gave some volunteers half a dose of the vaccine during clinical trials and has been criticized for omitting crucial information from their public statements. US regulators questioned the accuracy of their vaccine data. Severe production delays in Europe have caused a political storm and a breakdown in relations with the leaders of the European Union.
“The fact is that AstraZeneca is not being clear, which justifies the suspicions”, sentenced Philippe Lamberts, Belgian member of the European Parliament, in a radio interview with the BBC on Wednesday (24).
AstraZeneca’s delay in delivering tens of millions of promised doses to the European Union, which is struggling to implement vaccination programs, led the bloc to impose export restrictions that made at least one shipment of vaccines to Australia unfeasible. Leaders can make import restrictions even tighter on Thursday (25).
Meanwhile, the US National Institute of Allergy and Infectious Diseases raised concerns earlier this week after AstraZeneca submitted “outdated” data from the vaccine’s efficacy trial. Agency director Dr. Anthony Fauci called the case “an unforced error” that can undermine confidence in a “very good vaccine.”
AstraZeneca updated its data Thursday and reported that tests showed its vaccine to be 76% effective in preventing Covid-19 symptoms, correcting the 79% efficacy information released earlier in the week. The rare disapproval from US regulators was a major blow to the company’s credibility.
“They made one mistake after another,” said Jeffrey Lazarus, head of the health systems research group at the Barcelona Institute for Global Health.
Jump of faith
AstraZeneca entered the Covid-19 crisis with little vaccine experience. In recent years, it has generated a large part of its income from the production of popular cancer drugs, such as Tagrisso, which is used to treat lung cancer.
But when the pandemic hit, the company decided to be in the race to develop a revolutionary immunizer.
“I don’t think they intended to be a vaccine company,” said Andrew Berens, a pharmaceutical industry analyst at SVB Leerink. “I think they embarked on this, and they have been very transparent about it, because they wanted to help humanity and fight the scourge of Covid-19.”
The efforts paid off. AstraZeneca received emergency use authorization in the UK at the end of December and in the European Union a month later. As the vaccine was cheaper and could be stored at higher temperatures than those developed by Pfizer and Moderna, it was heralded as a breakthrough, especially for less wealthy countries that may lack sophisticated logistics networks.
AstraZeneca has generated even more goodwill by committing to supply its non-profit vaccine during the pandemic and by partnering with the Serum Institute of India, which has agreed to produce more than 1 billion doses for low- and middle-income countries.
“They went into an area they are not known for and they did very well,” Lazarus praised.
Mistake after mistake
However, almost immediately problems began to arise. Before the AstraZeneca dose received approval for emergency use, the company had doubts about the large-scale test data released in November.
The volunteers received different doses due to a manufacturing error, which led to confusion about their actual effectiveness. AstraZeneca did not mention that an error caused the dosing discrepancy in its initial announcement, raising concerns about a lack of transparency.
“I hate to criticize academic colleagues or anyone on the subject, but spreading information like this is like asking us to try to read the luck in tea leaves,” said Dr. Saad Omer, a vaccine specialist at the School of Medicine of Yale on the hour.
In January, the German vaccine commission said AstraZeneca vaccines should not be given to people over 65, citing insufficient data for the age group. France also initially limited vaccines against AstraZeneca to children under 65. Both countries changed positions earlier this month.
Lázaro called these problems “easily avoidable” as they were related to the design of the trial.
AstraZeneca said its clinical data confirms effectiveness in the age group over 65. In an interview in January, CEO Pascal Soriot said the Oxford scientists who carried out the tests did not want to recruit older people until they had “accumulated a lot of safety data” for people aged 18 to 55.
Had the vaccine launch been smooth, these hurdles could have been overlooked. But the continuing shortage of vaccines in Europe, which is now facing a third wave of coronavirus infections, has triggered a political crisis in the bloc. The leaders of the European Union would meet on Thursday (25) to decide whether to adopt the European Commission’s proposals for even stricter controls on the export of vaccines manufactured in the bloc, including those from AstraZeneca.
“We have the option of banning a planned export,” European Commission President Ursula von der Leyen said in a recent interview. “This is the message for AstraZeneca: You must fulfill your contract with Europe before you begin to deliver to other countries.” .
European countries expressed frustration that it appears that the UK has been prioritized for delivery and that tens of millions of doses are being shipped overseas.
The frustrations came this week after 29 million doses of the AstraZeneca vaccine were discovered in an “accident” at a factory in Italy.
An AstraZeneca spokesperson rejected reports that the doses were part of a “stock”, saying that the vaccine was manufactured outside the European Union and had been brought to the factory to be put into vials prior to distribution in Europe and its export to low and middle income countries.
EU Commission Vice President Valdis Dombrovskis said he could not comment on the origin or potential use of the doses allegedly discovered in Italy, but noted that the pharmaceutical company is “very far from its contractual commitments”.
Some politicians and the media may be looking for a scapegoat while vaccination programs stumble.
Still, Simona Guagliardo, an analyst at the Center for European Policy, said delays in the delivery of AstraZeneca “certainly played a role in slowing down vaccination in Europe.”
“What seems clear is that AstraZeneca may have promised too much in terms of distribution compared to actual production capacity,” the analyst said.
Difficult road ahead
According to Prashant Yadav, a medical supply chain specialist and principal investigator at the Center for Global Development, AstraZeneca appears to have spread widely, with a long-range supply chain that is more likely to stumble than the Pfizer and Modern vaccines. AstraZeneca claims to have built more than a dozen regional supply chains to produce its vaccine, with more than 20 partners in more than 15 countries.
According to Yadav, it is also more difficult to predict how much vaccine can be produced from batches of AstraZeneca’s product due to the type of components the immunizer contains, although this variability could have been anticipated when drafting the contracts. AstraZeneca declined to comment, but cited the “expected below-production flow” as a major complication in Europe.
“As our teams learn from each other and improve their knowledge, performance increases,” Soriot said in February. “The manufacture of a vaccine is a very complex biological process.”
Not all AstraZeneca headaches are the result of corporate mistakes, Lazarus noted. He doesn’t blame the company for fears about side effects like blood clots, which caused more than a dozen European countries to stop vaccines earlier this month. The European Union regulator conducted an urgent review last week and again concluded that the vaccine is safe.
But other concerns, such as the alleged misrepresentation of data in its recent US trials, have undoubtedly damaged the company’s reputation, especially compared to other drug manufacturers that have produced safe and effective vaccines but have generated less. negative headlines.
Ronn Torossian, CEO of 5W Public Relations, noted that AstraZeneca’s mistakes come at a time when mistrust of authorities and benefits from vaccination remain high, raising the stakes. “The public is already skeptical. I think it is something very, very difficult to solve for AstraZeneca at this point, ”he said.
Berens of SVB Leerink believes that the company will be able to overcome these problems, especially since vaccine production is not a business that it depends on to make money.
The company’s shares fell more than 2% in 2021, lagging gains on the FTSE 100, but Pfizer shares have also lost ground since the beginning of the year.
But Berens wonders: If AstraZeneca could go back in time, would it choose to get involved again in resource-intensive vaccine production? At that point, you are no longer so sure.
– Chris Liakos contributed reporting.
(Translated text. Click here to read the original in English).
