US Questions Efficacy And Data Of Oxford-AstraZeneca Vaccine Trials
US¡¯s Data Safety Monitoring Board has stated that the clinical trials that show high levels of efficacy could be based on outdated information in the trials that could potentially change the outcome altogether.
Oxford-AstraZeneca vaccine is one of the few vaccines that have been approved for use in a few nations around the world, including India. But surprisingly it has not yet received approvals from the US¡¯ Food and Drugs Administration (FDA).
Reuters
However, AstraZeneca was working on changing that, as it released new, promising data based on recent US trials that showed high levels of efficacy for its vaccine to safeguard people against the novel coronavirus, with an intention to seek FDA approval for emergency use authorization.
However, it looks like this endeavour for AstraZeneca and Oxford vaccine will be a bit more challenging than expected. Reported first by AFP, the US¡¯s Data Safety Monitoring Board has stated that the clinical trials that show high levels of efficacy could be based on outdated information in the trials that could potentially change the outcome altogether.
The National Institute of Allergies and Infectious Diseases said in a statement, ¡°The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.¡±
Reuters
AstraZeneca is standing by its data and assessment of the results of the trials conducted in the US, saying it would publish new data "within 48 hours" responding to concerns raised by the US National Institute for Allergies and Infectious Diseases.
In case you didn¡¯t know, Oxford-AstraZeneca¡¯s vaccine had comparatively lower efficacy than vaccines by Pfizer and Moderna (both of whom had up to 95 percent efficacy).
The AstraZeneca vaccine¡¯s efficacy shifted depending on the dosage -- when the volunteers were given two high doses, the protection dropped to 62 percent. However, when the volunteers were given a low dose first followed by a high dose, the effectiveness shot up 90 percent.
