Pharmaceutical company AstraZeneca announced on Tuesday (8 September) it has suspended global trials of its coronavirus vaccine, in a fresh setback for the global race to find a vaccine.
The decision to pause the trials, including large late-stage trials, was taken after a study participant developed an unexplained illness.
As of yet, the company has not disclosed any more information about the complication, and it is unclear whether it is directly related to the vaccine.
Trials of the vaccine were already underway at different stages in Britain, the US, Brazil, South Africa and India, with others planned in Japan and Russia.
AstraZeneca said in a statement that an independent committee will now review the safety data and work to minimise any consequences for the development of the vaccine candidate.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials,” the company said.
It was widely hoped that the vaccine, which was developed in conjunction with the University of Oxford, might be in line for a potential rollout at the end of the year, as its lead developer had previously suggested.
EU officials also recently suggested that they were hoping to have market authorisation of the vaccine as early as November, depending on the success of AstraZeneca’s vaccine phase III clinical trial.
Nathalie Moll, director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), recently cautioned about raising hopes too soon.
“I think we need to make sure that we stick to actual announcements rather than rumours and then make sure that we have done all the safety and efficacy testing that we need to have absolute confidence to the vaccine,” she told EURACTIV.
Moll added that the EU pharma industry wants to ensure that a rapid vaccine will in no way be at the expense of people’s safety.
Moreover, the World Health Organisation (WHO) said last week that it does not expect widespread vaccination against COVID-19 until mid-2021.
140 candidate vaccines are under development across the world, 30 of which have entered the clinical trial phase.
The European Commission has made a €336 million downpayment to AstraZeneca to secure at least 300 million doses of its potential COVID-19 vaccine, the first such contract signed by the EU with a maker of potential COVID-19 vaccines.
The executive has made similar deals with four other pharma companies while today it signed an agreement with BioNTech-Pfizer to reserve a further 200 million doses of a potential coronavirus vaccine.
“We are optimistic that among these candidates there will be a safe and effective vaccine against Covid-19 to help us defeat this pandemic,” EU health commissioner Stella Kyriakides said without elaborating on a possible date contrary to her recent statements that the EU expected a vaccine by the end of the year.
Commenting on the suspension of AstraZeneca’s clinical trials, infectious disease specialist and member of Greece’s coronavirus committee, Dr Nikolaos Sypsas, said:
“I would call it a good development in my opinion, in the sense that it seems that all the safety rules of the clinical study work. Because you know, there are some governments that are pushing to “jump” some parts (of the study) and especially security. This is not possible. For me it is good news, it reassures me that everything is done properly”.
[Edited by Sarantis Michalopoulos/Zoran Radosavljevic]