The Oxford / AstraZeneca vaccine may well be effective, as the developers claimed earlier this week, but enough questions have been asked about the trials and reports for drug regulators around the world to think hard and perhaps wait for more data. of tests. – after all, trials are also underway in the US and India – before approving the two-shot vaccine that offers protection against Covid-19.
In September, amid growing concern that vaccine developers rush into trials, ignoring safety concerns, as well as detailed and nuanced analysis of efficacy, companies like AstraZeneca (is developing its vaccine in collaboration with the Oxford University and Vaccitech Ltd, the company that has licensed the adenovirus vector platform used in the vaccine from the university’s Jenner Institute), Moderna, and the Pfizer / BioNTech combination, released elaborate protocols for their Phase 3 trials, unprecedented in the annals of vaccine development.
The coronavirus disease has generated great public interest in a process that is generally restricted to the research departments of pharmaceutical companies, research laboratories and institutions, and peer-reviewed academic journals with thousands (or tens of thousands of readers). In fact, the results of clinical trials are generally advertised in such journals, not in press releases and briefings with investment bank analysts. But with cases topping 60 million, deaths close to 1.5 million (and actual deaths are much higher), and lives and livelihoods disrupted by an airborne virus, it’s not surprising that everyone is more interested in the results of vaccine trials that are in, say, a royal wedding. Both Moderna and Pfizer / BioNTech followed this approach by disclosing the results of their vaccine trials, both based on a previously untested mRNA (or messenger RNA platform). The results were good, 90% in one case, then updated to 95% based on more readings, and 95% in another. That is very high for a vaccine. Even better, a detailed reading of the results by analysts, scientists and experts, including many hobbyists with the ability to convert complex scientific articles and research into language ordinary people can understand, and generated a large following in the social media in the process, it did not. show any gaps or unpleasant surprises. Both vaccines work.
However, there was more at stake with the AstraZeneca / Oxford vaccine. It only required refrigeration, compared to Moderna and Pfizer / BioNTech which required subzero temperatures, and it was going to be inexpensive (meaning it would end up being the vaccine of choice for poor and low-income countries). It was also to be the first vaccine available in India, thanks to an agreement between the Serum Institute of India, the world’s largest vaccine manufacturer, and AstraZeneca / Oxford. There may also have been some pressure on company executives to announce trial results following the success of the Moderna and Pfizer / BioNTech vaccines.
Whatever the reason, AstraZeneca / Oxford seems to have rushed the announcement of the results, and it shows. Following the initial announcement of the results on Monday, it emerged that what was reported as a trial involving an alternative approach to dosing was actually a mistake turned into an experiment; that the announced results combine those of two separate trials with two different protocols and demographic groups; and that the data used were from subgroups within these groups. These are worrying lapses, and scientists, epidemiologists, and biostatisticians have rightly pointed out them. They are unreliable from the perspective of science, data, and clinical trial protocols.
This is a shame, especially since the findings were also encouraging in terms of the candidate vaccine’s ability to prevent transmission (protecting infected people from developing Covid-19 and preventing transmission are two very different things), something that is especially critical in the case. of a disease that has been found to be transmitted significantly by infected people who are asymptomatic.
More trial data may corroborate the efficacy of the vaccine (some experts believe there is a high probability of this happening), but the episode highlights once again that, unlike in the case of food and fashion, there is no science fast.
P.S: Late on Thursday, Bloomberg reported that AstraZeneca CEO Pascal Soriot said he may conduct an additional global trial to assess the vaccine’s effectiveness after some studies raised questions about its level of protection.
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