“What we have with AstraZeneca is a company that is not simple, that cannot be trusted,” Philippe Lamberts, a Belgian member of the European Parliament, said in a radio interview with the BBC on Wednesday.
“They have 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 generated a large part of its income by producing popular cancer drugs, such as Tagrisso, which is used to treat lung cancer.
But when the pandemic hit, the company decided to take part in the race to develop a game-changing shot.
“I don’t think they ever intended to be a vaccine company,” said Andrew Berens, a pharmacist. SVB Leerink analyst. “I think the reason that they embarked on this, and they have been quite evident about it, is that they wanted to help humanity and fight the scourge of Covid.”
“They came to an area that they are not known for and they did very well,” Lazarus said.
Step after misstep
Almost immediately, however, problems began to arise. Before AstraZeneca injection received emergency use approval, the company faced questions about data from large-scale trials presented 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 my fellow academics, or anyone else, but spreading information like this is like asking us to try to read tea leaves,” said Dr. Saad Omer, a vaccine specialist at Yale School of Medicine, at the hour.
Lazaro called these problems “easily avoidable” as they were tied to the test design.
AstraZeneca has said that its clinical data supports efficacy in the age group over 65. In an interview in January, CEO Pascal Soriot said the Oxford scientists conducting the trials did not want to recruit older people until they had “accumulated a large amount of safety data” for people between the ages of 18 and 55.
If the launch of the vaccine had been smooth, it is possible that those mistakes would have been forgotten. 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. EU leaders will meet on Thursday to decide whether to adopt the European Commission’s proposals for even tighter controls on the export of vaccines manufactured in the bloc, including that of AstraZeneca.
“We have the option of banning a planned export,” said European Commission President Ursula von der Leyen in a recent interview with the German publishing group Funke Mediengruppe. “That’s the message for AstraZeneca: first fulfill its contract with Europe before starting to deliver to other countries.”
European countries have expressed frustration that it appears the UK has been prioritized for delivery while facing deficits and that, unlike others, they have been shipping tens of millions of doses overseas.
An AstraZeneca spokesperson rejected reports that the doses were part of a “stockpile”, saying the vaccine was manufactured outside the European Union and had been brought to the factory to be filled into vials before being distributed in Europe and exported 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 drug maker is “very far from its contractual commitments.”
Some politicians and the media may be looking for a scapegoat as vaccination programs stumble.
However, Simona Guagliardo, an analyst at the Center for European Policy, said delays in AstraZeneca deliveries “have certainly played a role in slowing deployment in Europe.”
“What seems clear is that AstraZeneca may have overpromised in terms of distribution compared to effective production capacity,” Guagliardo said.
Hard way forward
According to Prashant Yadav, a medical supply chain expert and a senior fellow at the Center for Global Development, AstraZeneca appears to have spread too far, with a long-range supply chain that is more likely to have setbacks than those fueled by vaccines from Pfizer and Moderna. AstraZeneca touts having built more than a dozen regional supply chains to produce its vaccine, with more than 20 partners in more than 15 countries.
It is also more difficult to predict how much vaccine can be produced from batches of AstraZeneca’s product because of the type of components it contains, Yadav added, although that variability could perhaps have been anticipated when drafting the contracts. AstraZeneca did not provide comment for this story, but said that deliveries to the European Union were hampered by “lower-than-expected production from the production process” and export restrictions imposed by countries outside the bloc.
“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.”
But other concerns, such as the alleged misrepresentation of data in his recent US trials, have undoubtedly it damaged the company’s reputation, especially compared to other drug manufacturers that have produced safe and effective vaccines but have generated fewer 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,” he said. “I think it’s a very, very difficult thing to figure out for AstraZeneca right now.”
SVB Leerink’s Berens believes the company will be able to overcome these problems, especially since vaccine manufacturing is not a business it relies on for money.
But Berens wonders: If AstraZeneca could go back in time, would it choose to get involved again in the production of resource-intensive vaccines? In that sense, he is not so sure.
– Chris Liakos contributed reporting.