Europe’s former chief drugs regulator has called for calm in the growing controversy over claims made by AstraZeneca and Oxford university for their Covid-19 vaccine in late-stage trials.
The Anglo-Swedish drugs company and Oxford’s Jenner Institute revealed earlier this week that, depending on the dosage, their vaccine was either 62 or 90 per cent effective. However, what they did not initially point out was that the higher efficacy rate applied only to a small sample of patients aged 55 or less, or that it had come about seemingly by mistake.
These omissions have sparked a storm of criticism over transparency and risk, fuelling anti-vaccine campaigners in the midst of what is still a raging pandemic.
Yet, speaking to the Financial Times, Guido Rasi, who ran the European Medicines Agency until two weeks ago, said both efficacy rates met regulators’ targets for approval. “We’d set a 50 per cent threshold,” he said. “In the end, what matters most is what regulators say when they have the data.”
Regulators and the rest of the world will soon have the full data. The Oxford academics who developed the vaccine have submitted a paper setting out their full Phase 3 results to The Lancet medical journal. They will be working over the weekend to answer questions from the journal and its referees and the article could be published as early as Thursday.
“Vaccine makers have committed to publish all the clinical trails in peer-reviewed publications . . . to an extent like never before; whether they are good or bad,” said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers and Associations. “That is the only way to address concerns of people who are vaccine-hesitant.”
In the meantime, however, questions will continue to circulate about how AstraZeneca, one of the world’s most successful drugs companies, and Oxford university found their credibility under fire.
After all, the Oxford vaccine, even if confirmed as less effective, will still be crucial to fighting the virus in developing countries, say experts. Not only has AstraZeneca promised to make no profit from it during the pandemic, but the vaccine is easier to store and transport than the two other most advanced candidates from the Pfizer/BioNTech partnership and from Moderna. These may have higher efficacy rates of 90 per cent or more, but they have to be stored at temperatures well below zero.
People with knowledge of the process say that, after learning the results of the interim analysis of the trial results last weekend, the AstraZeneca and Oxford teams focused on how to present the different rates clearly in news releases and a press briefing on Monday, rather than explaining how they occurred. There was little or no discussion of how some of the trial participants ended up receiving only a half dose in the first shot of the two-shot vaccine course, they say.
Yet, within hours of announcing the results, doubts began to emerge about the data. Moncef Slaoui, head of the US vaccine task force Operation Warpspeed, suggested the difference in success rates could be “random”.
Some statistical experts have also suggested that chance could explain why the subgroup who received a half dose of vaccine followed by a full dose a month later were apparently better protected than the larger number of participants who were given two full doses.
Mr Slaoui’s intervention surprised some in the industry, who suspect there may be an element of nationalism creeping into the race to develop vaccines.
But it was still surprising that neither AstraZeneca nor Oxford realised they would have to do more to explain their findings, say industry executives.
“We can definitely say that the transparency from Oxford and AstraZeneca has not been on a par with what we have seen from the others,” said Rasmus Bech Hansen, chief executive of Airfinity, a London-based life sciences analytics company.
“But they are working under tremendous pressure because a third of the world’s Covid-19 vaccine is due to come from AstraZeneca.”
Till Bruckner, the founder of clinical trial transparency advocacy group TranspariMED, said “releasing partial results to the media and investors sows confusion and makes the challenge of ending the pandemic even harder”.
However, the scientists on the trial seem reluctant to admit any mistake or error. Some suggest different processes were used to measure how much active ingredient was in the vaccine.
But whatever the reason, some participants in the early clinical trials received a first dose that was half of what was intended. When the researchers realised what had happened they decided to carry on with this regime for part of the trial, in consultation with regulators.
“It wasn't a mix-up in dosing,” Prof Sarah Gilbert, a leader of the Oxford vaccine project, told the FT. “It's quite usual to look at different dose levels when we do vaccine trials.”
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The controversy has shown up in AstraZeneca shares, which have tumbled nearly 7 per cent over the past week. Several of the company’s longtime investors told the Financial Times they were not particularly worried about the fall. For long-term shareholders, AstraZeneca’s investment case relies on the success of its oncology portfolio rather than a vaccine it had promised to make on a not-for-profit basis. However, all were critical of the group’s handling of events this week.
“They should have put out more information,” said one. “If you are going to put two numbers out that are so different, you need more information. It is also completely shortsighted.”
Nevertheless, it is not the press release published last Monday that really matters, they say, but whether or not the vaccine is effective.
In the end, observed Dr Rasi, “Between a vaccine with an efficacy of 85 per cent and 80 per cent, the best one is the one closest to my house.”
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