In light of AstraZeneca’s denial that is it speaking to the FDA to push an emergency use authorisation for its COVID-19 vaccine, AZD1222;

Reynald Castañeda, Pharma Writer for the Investigative News team at GlobalData, offers his view:

“There is intense skepticism surrounding upcoming data releases from the early stage AstraZeneca trial of its vaccine, as well the strategy to pool results from large-scale registrational studies.

“The ongoing early study only requires 30 COVID-19 cases to detect vaccine efficacy, which is much too small to be sure of protection and would only be suitable to support other larger trials. AZD1222 is already in three ongoing large trials in the UK, Brazil and South Africa, while a US-based trial is yet to recruit patients.

“It is tough to extrapolate from the early results how larger trials could perform. At best, earlier-stage trials offer data on immunogenicity, said experts interviewed by GlobalData.

“AstraZeneca has also indicated that pooling its data from the larger trials could lead to a quicker readout of protection data. But combining results from these trials evokes skepticism considering the different designs. Due to protocol nuances such as dosing schedules, merging the data casts doubt on the value of the outcomes.”