Moderna, Pfizer reveal trial secrets in pushback against vaccine rush
NEW DELHI: Moderna and Pfizer, who are developing and testing two of the leading Sars-Cov-2 vaccines, disclosed detailed information about their late-stage clinical trials and how they plan to gauge their shots’ safety and effectiveness, throwing open information that is usually kept a secret.
The moves by first Moderna Inc late on Thursday and then later from Pfizer Inc and its partner BioNTech SE, follow increasing worry that the effort to develop a Covid-19 vaccine is becoming politicised, and that an inoculation could be rushed to market before it is proven safe and effective, news agency Bloomberg reported.
AstraZeneca, which is developing a candidate in partnership with Oxford university, said it too would share its plans. The Oxford-AstraZeneca candidate is largely seen as the experimental vaccine being tested in the largest number of people.
Moderna released its plan ahead of an early Thursday morning investor meeting. The Cambridge, Massachusettsbased biotechnology company decided to share its full trial design to create public confidence that it’s doing everything it can to ensure a vaccine works and won’t cause harm, said chief executive officer Stephane Bancel, according to Bloomberg.
Pfizer soon followed Moderna, publishing its trial design in the form of a 137-page document that details under what circumstances the trial could generate early efficacy results.
Under the Moderna plan, a data monitoring board will take a preliminary look at the efficacy results after 53 participants have contracted the coronavirus, and again after 106 cases are reached. The final analysis will occur after 151 cases, according to slides from investor meeting.
According to a slide being presented at the meeting, Moderna’s trial is only likely to generate clear positive results at the first analysis if it turns out to be very highly effective, reducing Covid-19 cases by 74% or more.
If the vaccine turns out to be a more modest 60% effective, the trial might have to proceed to the final efficacy readout in order to generate clear results, according to Moderna’s 135-page trial protocol. Moderna’s plan is more conservative than the 32-case benchmark being used by Pfizer Inc for its first preliminary analysis of the Covid-19 vaccine it’s developing with Germany’s BioNTech.