How AstraZeneca went from pandemic hero to villain

“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.

AstraZeneca updated its data on Thursday and reported that trials showed its vaccine to be 76% effective in preventing Covid-19 symptoms. Earlier this week, he had said that his injection was 79% effective. The rare reprimand from US regulators was a major blow to the company’s credibility.

“They have made one mistake after another,” said Jeffrey Lazarus, head of the health systems research group at the Barcelona Institute for Global Health.

The AstraZeneca vaccine is administered to a patient in a London pharmacy.

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.”

The efforts paid off. AstraZeneca received emergency use authorization from the UK in late December and the European Union a month later. Because the vaccine was cheaper and could be stored at higher temperatures than developed by Pfizer (PFE) Y Modern (MRNA), was heralded as a breakthrough, particularly for less wealthy countries that may lack sophisticated logistics networks.
AstraZeneca generated more goodwill by committing to supply its non-profit vaccine during the pandemic and by partnering with the Serum Institute of India, which agreed to produce more than 1 billion doses for low- and middle-income countries. They have provided more than 30 million doses to more than 58 countries through COVAX, an initiative that seeks supplies for the poorest nations.

“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.

In January, Germany’s vaccine commission said AstraZeneca injections should not be given to people over 65, citing insufficient data for the age group. France also initially limited AstraZeneca vaccines to those under 65. Both countries changed course earlier this month.
A nurse prepares a dose of the AstraZeneca vaccine at the Edouard Herriot hospital on February 6 in Lyon, France.

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.”

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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.

Frustrations boiled over this week after 29 million doses of AstraZeneca’s vaccine were discovered in a “raid” on a factory in Italy.

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.”

Not all AstraZeneca headaches have been the result of corporate mistakes, Lazarus observed. 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 concluded again that the vaccine is safe to use.

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.

Stocks are down more than 2% so far in 2021, lagging gains in the FTSE 100 (UKX), 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 the production of resource-intensive vaccines? In that sense, he is not so sure.

– Chris Liakos contributed reporting.


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