AstraZeneca plans to re-test its vaccine globally
AstraZeneca is likely to conduct additional global trials to evaluate the effectiveness of its COVID-19 vaccine using a lower dosage, the company’s chief executive said Thursday amid questions from its latest phase of research..
Pascal Sorio told Bloomberg News that instead of continuing its current research in the US, AstraZeneca may start a new study to evaluate a lower dosage of its vaccine that works better than the full.
«Now that we have found what appears to be the best performance, we need to confirm this, so we need to do more research.», – he said, adding that it is likely that the new global study could go faster because it would require fewer subjects as the vaccine is already known to be highly effective..
The news comes as AstraZeneca is facing questions about its success rate, which some experts believe could reduce its chances of getting swift approval from US and EU regulators..
Several scientists questioned the reliability of the results published Monday showing that the experimental vaccine was 90% effective in a subset of trial participants who initially mistakenly received half the dose and then the full dose..
Sorio said he did not expect an additional trial to delay approval of the vaccine by UK and European regulators..
When asked by Bloomberg about the report, an AstraZeneca spokesperson said continued research on the half / full dose regimen is important. According to him, any further conclusions based on the obtained data will be added to the results of existing tests, which are being prepared for submission to the regulatory authorities..
Additional trials may not be too difficult for a UK drug maker in the race to develop a vaccine to help contain a pandemic that has killed over a million people and shook the global economy..
Helen Fletcher, a professor of immunology at the London School of Hygiene and Tropical Medicine, said another trial would not necessarily lead to approval, as the higher dose regimen was still effective in meeting the World Health Organization‘s goal. It is not unusual to conduct new research on approved vaccines, she says..
This vaccine is one of three that can be approved for use by the end of the year. Pfizer and Moderna reported this month that their vaccines were approximately 95% effective in preventing disease, a record high..
Even so, Oxford University’s AstraZeneca vaccine is cheaper to manufacture, easier to distribute, and faster to scale up than its competitors..
On Friday, the UK asked its drug regulator to assess whether a candidate vaccine meets strict safety standards for a temporary supply, a step towards starting a vaccine rollout before the end of the year..
AstraZeneca expects 4 million doses to be available in the UK by the end of next month.
Peer-reviewed analysis of new study data to be published in a medical journal in the coming weeks.
European Medicines Agency did not provide prompt comment to Reuters.
Earlier Thursday, AstraZeneca said the half-dose administration had been reviewed and approved by independent data safety monitors and the UK regulatory body, adding that the regulator had publicly confirmed that «no fear».
However, it may take longer to get FDA approval because a federal agency is unlikely to approve a vaccine based on research done in another country, especially given the questions posed by testing, Sorio said..
Head of Research AstraZeneca Mene Pangalos told Reuters on Monday that the firm will begin negotiations with the FDA to change the course of its research and add a more effective dosing regimen.
First American dosed with Oxford-AstraZeneca phase three COVID-19 vaccine speaks out
Vaccine authorization in some countries expected by the end of the year.
AstraZeneca has signed deals to supply vaccine to several countries, including 120 million doses to Japan and 85 million doses to Australia.
Prime Minister of Australia Scott Morrison in a conversation with the media, expressed confidence in the vaccine produced by the biomedical giant CSL Ltd.
Serum Institute of India is also testing its vaccine.
«Even the lowest efficacy scores reach 60-70%, making it a viable vaccine against the virus», – the institute said in a statement, clarifying that the tests are going smoothly.