RIO DE JANEIRO, BRAZIL – The abrupt suspension of the coronavirus vaccine clinical trials developed by Oxford University and AstraZeneca pharmaceutical company sounded the alarm worldwide. However, Pascal Soriot, executive director of the Anglo-Swedish company, minimized the event on Thursday during a videoconference.
“It is very common, as many experts can confirm. The difference with other vaccine trials is that in general the whole world is not closely observing their development. It is normal to stop, investigate what happened and start again,” explained Soriot.
The company director was moderately optimistic, to the point of stating that it is still possible to achieve an effective vaccine against the virus “by the end of this year or the beginning of next year” if the regulatory authority gives its approval soon for the trials to be restarted. “I believe we still have time to collect a sufficient amount of data that we can submit for approval before the end of this year”.
If this should occur, it will be up to the regulatory authority (the European Medicines Agency, in the EU, or its American equivalent, the FDA) to approve and give the go-ahead for the distribution of doses that have already begun to be manufactured.
There are approximately 200 trials in progress worldwide in search of the long-awaited coronavirus vaccine, although only eight of them have shown encouraging evidence of success. Among these, the joint work of Oxford University and AstraZeneca is the one raising the highest expectations. On August 27th, the European Union signed a first contract with the pharmaceutical company to secure 300 million doses, expandable to a further 100 million.
Several politicians from different countries conveyed the idea that the vaccine could start to be supplied before the end of 2020, which is why AstraZeneca’s suspension of its trials and its executive director’s most realistic calculations were a bucket of cold water.
Phase three of the vaccine trial was halted earlier this week after one of the volunteers was found to have suffered a serious adverse side effect. Several reports suggest that it was a woman from the United Kingdom who developed transverse myelitis, an inflammation of the spinal cord. Soriot said that the diagnosis is not yet final and that more tests should be performed.
The preliminary diagnosis should be later presented to an independent safety committee, with no link to the pharmaceutical company or to the trial sponsors, which will decide whether or not trials may proceed safely. Soriot declined to specify the time needed for this process. The typical scenario in this situation is days rather than weeks, depending on whether or not the committee considers the data provided sufficient or requests more details.
“In such circumstances, speed, compliance with procedures, and efficiency can be combined. But in no case can safety be compromised,” he said. AstraZeneca’s executive director said that at the end of the process a total of 50,000 to 60,000 volunteers will have been tested, the number required in this type of procedure.
With funding from several governments, the pharmaceutical company was in a position to take the risk of starting to manufacture doses of the vaccine before the trials could determine its efficacy. Soriot pointed out that the capacity of his laboratories (and those associated with the entire process) would allow them to manufacture some three billion doses.
Source: El País