IIt was listed as the vaccine to rid the world of Covid. But for the past six months, AstraZeneca, whose heist was designed to save thousands of lives on a nonprofit basis, has found itself stumbling down an extraordinarily rocky road, facing accusations about the efficacy, supply and side effects of its vaccine from everyone. sectors. and get kicked like a political football.
This week, AstraZeneca faced unprecedented public criticism in the US from a high-level scientific body that claimed the British-Swedish company tampered with data from its long-awaited trial there. And in Italy, military police broke into a factory on behalf of the European commission investigating allegations of 29 million concealed doses, said to be destined for delivery to the UK. Meanwhile, the commission, which requires AstraZeneca to supply more injections to Europe, drew up regulations that could block exports of vaccines to the UK.
The alleged politicization of the Oxford / AstraZeneca vaccine is particularly evident in Europe, where the distribution of injections has lagged far behind progress in the UK. A UK government source suggested that the raid on the Italian factory, which turned out to contain doses for Belgium and the developing world pending quality controls, was embarrassing for those who “tried to whip an anti-AZ mob because it gives them political coverage “. .
Earlier this year, it looked like post-Brexit animosity could be behind the shooting. On January 25, the German newspaper Handelsblatt caused a firestorm with a cover story claiming that the vaccine was only 8% effective in the elderly. On January 29, French President Emmanuel Macron claimed it was “almost ineffective” in those over 65. Germany and France rejected its use in that age group. Although those restrictions have been lifted, many in those countries are reluctant to get vaccinated.
Now, faced with a third wave in Europe, low acceptance and criticism from French doctors who accused him of encouraging vaccinations, Macron has taken a 180-degree turn, saying he would be happy to be inoculated himself, while Prime Minister Jean Castex had the AstraZeneca jab live on television.
However, the anti-aircraft fire continues to fly. Belgian MEP Philippe Lamberts this week accused the company of dishonesty and arrogance. He said he had “promised too much and delivered insufficiently”, hinting that there were still problems with safety even though the European Medicines Agency has given him good health.
AstraZeneca’s embattled scientists feel they have been unfairly targeted for trying to do something that goes against profit-driven grains in the pharmaceutical industry: produce a low-cost, easy-to-use vaccine that will work well in income countries. low and medium, but it will not make them money in the short term.
Sir John Bell, the Oxford University professor who helped push the vaccine’s development, suggested that morale at AstraZeneca is plummeting and that it had never received due credit for its decision not to make a profit. Others are making fortunes: Moderna expects $ 18 billion in revenue this year from the vaccine and Pfizer / BioNTech $ 15 billion.
Citing the Macron attack and unsubstantiated allegations about safety and efficacy, Bell said the company might reconsider its philanthropic stance. “There is a point where AstraZeneca could just say, ‘You have to be kidding, let’s stop [charging cost price] now because we don’t get any credit for what we’re doing. The stock price has gone down, it hasn’t gone up. We are making more vaccines than everyone else. This is a safe and effective vaccine, but nobody seems to care, ”he said this week.
It’s hard to pinpoint a single reason that AstraZeneca should be constantly on the defensive, but its problems date back to September last year when its trials were halted due to a reported adverse reaction in the UK, which turned out to be transverse myelitis: inflammation. of the spinal cord.
If there is a common thread, critics and some friends alike say, it is a failure to communicate well. The UK regulator gave the green light to restart trials in a few days, but the Food and Drug Administration, which approves the drugs in the US, maintained the suspension for a full six weeks. They weren’t happy that they weren’t informed of the problem promptly enough, it came up, and they were dissatisfied with the company’s explanations.
But the Oxford / AstraZeneca team also failed to keep things simple. Drug regulators dealing with for-profit drug companies are used to seeing data from a large trial that meets all the requirements for age, ethnicity, health status, and other factors that could skew the results. Pfizer / BioNTech and Moderna did just that and came up with an impressive number of efficiencies – around 95%.
Oxford / AstraZeneca did not. The Oxford University scientists who started the first trials were academics, researching the best way to prevent this disease.
“I think some of the difficulties were that Oxford was organizing the trials to answer public health questions, whereas clearly the Pfizer / BioNTech and Moderna trials in the US were set up to get FDA approval.” Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, told The Guardian.
Oxford / AstraZeneca had two numbers, not one: 62% effective overall and 78% in people who had originally received half the dose due to a delivery problem. Industry analyst Dr Adam Barker of Shore Capital said people forgot that hope was a 50% effective vaccine and compared the results to those of Pfizer. It didn’t help that the reason for the higher number was later reinterpreted as a longer gap between the two doses. Nor was it that older people were late to be recruited into the trials because of Oxford’s ethical concerns. Infections declined in the UK over the summer, so fewer died, which meant there wasn’t much data on how well it worked in those over 65.
“There is no question that the setbacks and confusion about interpreting the data and all the noise that we have seen affects confidence in vaccines,” Barker said.
Communication appears to be the key to the dispute with the Data Security and Monitoring Board (DSMB) in the US, the independent scientists overseeing the trials. Generally, Evans said, “The DSMB is a very private group. You don’t let them know who is there, so they can’t be pressured ”. It is very unusual for them to be made public. However, on Monday night, less than 24 hours after AstraZeneca reported the vaccine’s success in US trials, DSMB said the company had presented “outdated and potentially misleading” data to the world.
Once again, it seems to have been a pointless fight. The company says the agreed cut-off point for the data was February 17, by which time 141 deaths had occurred and the efficacy was 79%. Within 48 hours, AstraZeneca had added more recent data. Out of a total of 190 deaths, there were 76% efficacy (and as always 100% against serious illness and death). There is not much difference.
No other Covid vaccine manufacturer has had the bad publicity AstraZeneca has suffered. Its vaccine has been suspended in some European countries due to blood clots, although there have been similar reports with all vaccines and a death, related to the Moderna puncture, is being investigated in the US. vaccines. Pfizer has had production declines and Johnson & Johnson and Novavax have warned that supply may be lower than originally thought.
But AstraZeneca is under extreme scrutiny all the time. It may be due to his declared desire to save the world. It may be because a misstep or two causes everyone to seek out others. It may be because it draws political criticism as a representative of the UK, especially in a post-Brexit world. Whatever it is, the University of Oxford and the company now hope that accumulating evidence of how well the vaccine works in the real world will cause the heat to subside, although they may have to solve supply problems first.