How AstraZeneca went from pandemic hero to villain

“What we have with AstraZeneca is a company that is not direct, 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, reporting that tests have shown that its vaccine is 76% effective in preventing Covid-19 symptoms. Earlier this week, he said his shot was 79% effective. The rare disapproval of American 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 of Global Health.

Leap of faith

AstraZeneca entered the Covid-19 crisis with little experience in vaccines. In recent years, it has generated a large part of its revenue from the production of popular cancer drugs, such as Tagrisso, used to treat lung cancer.

But when the pandemic hit, the company decided to enter the race to develop a revolutionary shot.

“I don’t think they ever intended to be a vaccine company,” said Andrew Berens, a pharmaceutical company analyst at SVB Leerink. “I think the reason they embarked on this – and they have been very apparent 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 United Kingdom in late December and from the European Union a month later. Because the vaccine was cheaper and could be stored at higher temperatures than those developed by Pfizer (PFE) and Modern (MRNA), was announced as an advance, especially for less wealthy countries that may lack sophisticated logistics networks.
AstraZeneca has generated more goodwill by committing to provide its vaccine without profit 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 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 they are not known for and they did very well,” said Lazarus.

Wrong step after wrong step

Almost immediately, however, problems began to arise. Before the AstraZeneca injection received approval for emergency use, the company faced doubts about the large-scale test data presented in November.

The volunteers received different doses due to a manufacturing error, creating confusion about its real effectiveness. AstraZeneca did not mention that an error caused the dosing discrepancy in its initial announcement, raising concerns about the lack of transparency.

“I hate to criticize academic colleagues or anyone on the subject, but disseminating information like this is like asking us to try to read the tea leaves,” said Dr. Saad Omer, a vaccine specialist at Yale Medical School in Tempo.

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

Lazarus called these problems “easily avoidable”, since they were linked to the test design.

AstraZeneca said that its clinical data confirm the effectiveness in the age group over 65 years. In an interview in January, CEO Pascal Soriot said the Oxford scientists carrying out the tests did not want to recruit older people until they had “accumulated a lot of safety data” for those aged 18 to 55.

If the vaccine’s launch had been smooth, these stumbling blocks could have been overlooked. But the continuing scarcity of vaccines in Europe, which now faces a third wave of coronavirus infections, has unleashed a political crisis in the bloc. EU leaders will meet on Thursday to decide whether to adopt European Commission proposals for even stricter controls over the export of vaccines made in the bloc, including those from 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. “This is the message for AstraZeneca: you first fulfill your contract with Europe before you start delivering to other countries.”

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European countries have expressed frustration that the United Kingdom appears to have been prioritized for delivery while facing deficits and that, unlike others, they have been sending tens of millions of doses abroad.

The frustrations came this week after 29 million doses of the AstraZeneca vaccine were discovered in an “attack” reported at a factory in Italy.

An AstraZeneca spokesman rejected reports that the doses were part of a “stock”, saying the vaccine was made outside the European Union and that it had been brought to the factory to be put into bottles before distribution in Europe and export. down 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.

Even so, Simona Guagliardo, an analyst at the European Policy Center, said that delays in the delivery of AstraZeneca “certainly played a role in slowing down the launch across Europe”.

“What seems clearly is that AstraZeneca may have promised too much in terms of distribution compared to the actual production capacity,” said Guagliardo.

Difficult way forward

According to Prashant Yadav, a specialist in medical supply chain and a senior member of the Center for Global Development, AstraZeneca appears to have spread widely, with a long-range supply chain that is more likely to go into hiccups than vaccines from Pfizer and Moderna. 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.

It is also more difficult to predict the amount of vaccine that can be produced from batches of AstraZeneca’s product due to the type of components it contains, added Yadav, although that variability might have been predicted during the drafting of contracts. AstraZeneca did not comment on this matter, but said that deliveries to the European Union were hampered by “production below the expected production process” and export restrictions imposed by countries outside the bloc.

“As our teams learn from each other and improve their knowledge, performance is increasing,” said Soriot in February. “The manufacture of a vaccine is a very complex biological process.”

Not all of AstraZeneca’s headaches resulted from corporate mistakes, Lazarus noted. He does not blame the company for fears about side effects such as blood clots, which caused more than a dozen European countries to suspend vaccination 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 data misrepresentation in his recent US trials – undoubtedly it damaged the company’s reputation, especially compared to other drug manufacturers that produced safe and effective vaccines, but generated fewer negative headlines.

Ronn Torossian, CEO of 5W Public Relations, noted that AstraZeneca’s slips come at a time when the authorities’ distrust and the benefits of vaccination remain high, raising the stakes.

“The public is already skeptical,” he said. “I think it is a very, very difficult thing for AstraZeneca to resolve right now.”

Berens of SVB Leerink believes that the company will be able to overcome these problems – especially since producing vaccines is not a business on which it depends to make money.

Shares have fallen more than 2% so far in 2021, lagging behind the FTSE 100 (UKX), but Pfizer’s 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 vaccines with many resources? About this, he is not so sure.

– Chris Liakos contributed reporting.