AstraZeneca’s chief executive Pascal Soriot has admitted that they need to carry out “additional study” to validate the efficacy data they have released from the Covid-19 vaccine being developed with the University of Oxford.
Questions are being asked about the vaccine trials since it was revealed that a smaller set of participants received less than a full dose initially, followed by a full dose later. This group appeared to show a 90 per cent efficacy rate, against a 62 per cent rate when two full doses were administered.
There are high hopes that a vaccine like the Oxford/AstraZeneca candidate could bring back a return to normalcy for large swathes of the planet, because it is currently cheaper and easier to distribute than others developed by Pfizer and Moderna.
Mr Soriot said now that they have found “what looks like a better efficacy” they have to “validate” that and thus they “need to do an additional study,” reported Bloomberg.
He said it will probably be another international study but it could be “faster” because they know “the efficacy is high” and thus need a “smaller number of patients.”
The AstraZeneca CEO, however, clarified that he doesn’t expect the additional trial to delay the regulatory approvals in the UK and European Union.
Mr Soriot’s comments come as the UK government has asked its drugs regulatory agency to assess whether the vaccine being jointly developed by AstraZeneca and the University of Oxford can be authorised for use or not, amid confusion over its results.
British housing minister Robert Jenrick said he doesn’t’ think “there is any reason to be unduly concerned” and that they have “now written to the body that will independently assess the veracity and the safety of the vaccine.”
“We have to let the independent evaluation happen now,” Mr Jenrick told Sky News.
AstraZeneca’s CEO also said that clearance from the US regulatory authorities may take longer, as they may not approve it on the basis of studies conducted outside the US.
There are several vaccines across the world that are in different stages of trials and awaiting regulatory approval. AstraZeneca’s vaccine is among those that are being closely tracked. The vaccines developed by Pfizer-BioNTech and Moderna have shown the most promise so far purely in terms of effectiveness.
But compared to the others, more people are pinning hopes on AstraZeneca’s vaccine as it can be stored using normal, widely available refrigerators.
On Monday, AstraZeneca had said that they will seek an “emergency use listing from the World Health Organisation for an accelerated pathway to vaccine availability in low-income countries” and that interim results of their analysis are being submitted “for publication in a peer-reviewed journal.”
It claimed that clinical trials are being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries and that it globally expects to enrol up to 60,000 participants.