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 percent 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 publishing all the clinical trials 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 the concerns of people who are vaccine-hesitant.”