Pfizer, Moderna and AstraZeneca Release COVID-19 Vaccine Trial Blueprints

(New York, NY, USA), AstraZeneca Cambridgeshire, England) and Moderna, Inc. (Cambridge, MA, USA), have released comprehensive road maps of their methods of evaluating their COVID-19 vaccines which are currently in trials.

The move aims to earn the trust of the public and scientists who have been demanding details of their studies, according to a report by The New York Times.

AstraZeneca is conducting trials of its adenovirus vector-based COVID-19 vaccine candidate, AZD1222, developed by the University of Oxford (Oxford, UK). Recently, AstraZeneca had confirmed that a participant in the Phase 3 trial of the company’s experimental COVID-19 vaccine candidate had developed a serious spinal inflammatory disorder, forcing it to halt the study which has now resumed. Pfizer and Biopharmaceutical New Technologies (BioNTech Mainz, Germany) are jointly developing a COVID-19 vaccine based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. Moderna is also conducting clinical trials of mRNA-1273, its mRNA vaccine candidate against COVID-19.

According to The New York Times report, the three companies have now revealed details of the methods for selection and monitoring of the trial participants, the conditions under which the trials could be halted early in case any problems arise, and the evidence to be used by researchers to gauge whether the participants who received the vaccines enjoy protection from COVID-19. Moderna also released a potential timetable which may extend to 2021 for determining whether its COVID-19 vaccine works, although Pfizer’s plan did not appear to include any estimated timeline for the availability of its trial results. Moderna’s study will involve 30,000 participants, while Pfizer’s trials will involve 44,000 participants.

According to AstraZeneca’s 111-page trial blueprint, known as a protocol, the company is aiming for a COVID-19 vaccine with 50% effectiveness. In order to determine if AstraZeneca’s vaccine trials have met that target, 150 volunteers who have been vaccinated or given placebo shots must be diagnosed with COVID-19, although the company has a safety board in place for carrying out an early analysis after only 75 cases are confirmed to have COVID-19. In case the vaccine demonstrates 50% effectiveness at that point, then AstraZeneca could end the trials early and apply for emergency use authorization to release the COVID-19 vaccine.

Such plans are not usually shared with the public, although vaccine makers are under increasing pressure to become more transparent about their methods of testing products, forcing them to abandon their traditional secrecy and release the comprehensive road maps of how their COVID-19 vaccines are being evaluated.

Related Links:
Pfizer Inc.
Biopharmaceutical New Technologies
AstraZeneca
University of Oxford
Moderna, Inc.