met was announced as the vaccine to deliver to the world from Covid. But in the past six months, AstraZeneca – whose jab was designed to save thousands of nonprofit lives – has found itself stumbling across an extraordinarily rocky road, facing accusations about the effectiveness, supply and side effects of its vaccine from all quarters, and being kicked like a political soccer ball.
This week, AstraZeneca faced unprecedented public criticism in the United States from a high-level scientific body, claiming that the Swedish-British company modified the data from its long-awaited test there. And in Italy, the military police entered a factory on behalf of the European Commission investigating allegations of 29 million hidden doses, allegedly intended for shipment to the United Kingdom. The commission, which is demanding that AstraZeneca supply more jabs to Europe, has drafted regulations that could block vaccine exports to the UK.
The alleged politicization of the Oxford / AstraZeneca vaccine is particularly evident in Europe, where the distribution of jabs is far behind progress in the United Kingdom. A UK government source suggested that the raid on the Italian factory – which ended up holding doses for Belgium and the developing world waiting for quality checks – was embarrassing for those “who tried to prepare an anti-AZ crowd because it gives them political coverage “.
Earlier this year, it looked like post-Brexit animosity could be behind the snipers. On January 25, the German newspaper Handelsblatt caused a storm with a front-page article stating that the vaccine was only 8% effective in the elderly. On January 29, France’s President Emmanuel Macron said he was “almost ineffective” in the 65-year-old age group. Germany and France refused its use in this age group. Although these restrictions have been lifted, many in these countries are reluctant to receive the vaccine.
Now, facing a third wave in Europe, low acceptance and criticism from French doctors who accused him of encouraging the vaccine’s hesitation, Macron made a comeback, saying he would be happy if he himself was vaccinated, while Prime Minister Jean Castex, had the AstraZeneca jab live on TV.
Still, the flak flies. Belgian MEP Philippe Lamberts this week accused the company of dishonesty and arrogance. He had “over-promised and under-delivered,” he said, and hinted that there were still problems with safety, although the European Medicines Agency gave him a clean bill of health.
AstraZeneca’s troubled scientists feel they have been unfairly targeted for trying to do something that goes against the profit-driven grains in the pharmaceutical industry – producing a low-cost, easy-to-use vaccine that will work well for low- and middle-income countries, but it will not bring them money in the short term.
Sir John Bell, the professor at the University of Oxford who helped propel the vaccine’s development, suggested that AstraZeneca’s morale is plummeting and that it has never received due credit for its decision not to make a profit. Others are making fortunes – Moderna expects $ 18 billion in revenue this year with the vaccine and Pfizer / BioNTech $ 15 billion.
Citing Macron’s attack and baseless accusations of safety and effectiveness, Bell said the company could rethink its philanthropic stance. “There is a point where AstraZeneca could simply say, ‘you can only be kidding, let’s stop [charging cost price] now because we’re not getting any credit for what we’re doing. The stock price fell, it did not rise. 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 is difficult to pinpoint a single reason why AstraZeneca should be constantly retreating, but its problems date back to September last year, when its tests were interrupted because of an adverse reaction reported in the UK, which ended up being transverse myelitis – spinal cord inflammation spinal.
If there is a common thread, say critics and some friends, it is a failure in communication. The UK regulator authorized testing to resume in a few days, but the Food and Drug Administration, which approves drugs in the United States, maintained the suspension for six full weeks. They were unhappy that they had not been informed of the problem well in advance, and it arose, and dissatisfied with the company’s explanations.
But the Oxford / AstraZeneca team also failed to keep things simple. Drug regulators who deal with for-profit pharmaceutical companies are used to seeing data from a large trial that fills all boxes of age, ethnicity, health status and other factors that can skew the results. Pfizer / BioNTech and Moderna did just that and showed an impressive number of effectiveness – about 95%.
Oxford / AstraZeneca does not. The scientists at Oxford University who started the first tests were academic, investigating the best way to prevent this disease.
“I think some of the difficulties were that the tests were being set up by Oxford to answer public health questions, while the Pfizer / BioNTech and Moderna tests in the US were set up to get FDA approval,” Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the Guardian.
Oxford / AstraZeneca presented two numbers, not one: 62% overall effectiveness and 78% for people who originally received half a dose due to a supply problem. Industry analyst Dr. Adam Barker of Shore Capital said people had forgotten the hope of a 50% effective vaccine and compared the results with those of Pfizer. It did not help that the reason for the higher number was later reinterpreted as a longer interval between the two doses. Not that older people were slow to be recruited for trials because of Oxford’s ethical concerns. Infections fell in the UK during the summer, so fewer people died, which means that there was not much data on how well it worked among people over 65.
“There is no doubt that setbacks and confusion about the interpretation of the data and all the noise we have seen affect confidence in vaccines,” said Barker.
Communication seems to be the key to the fight with the Data Security and Monitoring Council (DSMB) in the United States – the independent scientists who take care of the tests. Typically, said Evans, “the DSMB is a very private group. You don’t let anyone know who you are, so they can’t be pressured ”. It is very unusual for them to go public. Still, on Monday night, less than 24 hours after AstraZeneca reported the vaccine’s success in testing in the U.S., the DSMB said the company had presented “outdated and potentially misleading” data to the world.
Again, it seems to have been a pointless fight. The company says the cut-off point agreed for the data was February 17, when 141 deaths had already occurred and the effectiveness was 79%. In 48 hours, AstraZeneca added more recent data. Out of a total of 190 deaths, there was 76% effectiveness (and, as always, 100% against serious illness and death). It doesn’t make much difference.
No other Covid vaccine manufacturer has had the negative publicity AstraZeneca has endured. His vaccine has been suspended in some European countries because of blood clots, although there are similar reports with all vaccines and a death is being investigated, linked to the injection of Moderna in the United States. The supply of other vaccines was also not straightforward. Pfizer’s production has declined and Johnson & Johnson and Novavax have warned that the offer may be less than they initially thought.
But AstraZeneca is under extreme surveillance at all times. It may be because of your stated desire to save the world. It may be because one or two mistakes cause everyone to look for the others. It may be because it attracts political criticism as a UK prosecutor, especially in a post-Brexit world. In any case, the University of Oxford and the company now hope that the accumulated evidence of how well the vaccine works in the real world will lessen the heat – although they may have to solve supply problems first.