New bar set by BioNTech, Pfizer COVID-19 vaccine could see swift influx of challengers
The strong start for COVID-19 vaccines could be quickly followed by more data as infection rates soar
The strong start for COVID-19 vaccines could be quickly followed by more data as infection rates soar.
With interim COVID-19 vaccine efficacy data from BioNTech and Pfizer outstripping the field’s expectations, the results have set a high bar for what could be a rapid wave of readouts accelerated by surges in case counts.
The data shared by BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) Monday represent both a rising tide that lifts all boats, and a sea level change that could potentially sink other candidates.
Recent climbs in infections across the U.S., Europe and South America — which saw the trial jump from under 32 COVID-19 cases on Oct. 27 to 94 cases in less than two weeks — could mean competing data might soon be available from other companies with late-stage trials. Moderna Inc. (NASDAQ:MRNA) is expected to provide data soon on its vaccine, which uses a similar mRNA technology; the company said it would release interim efficacy data once 53 COVID-19 cases were observed.
An interim analysis conducted by an independent data monitoring committee showed Pfizer and BioNTech’s BNT162b2 had an efficacy rate above 90% in the 94 COVID-19 cases identified among 38,955 trial participants who received two doses of the vaccine as of Nov. 8.
While the companies did not release information about the demographics of the cases, the severity of their symptoms or the cohorts they belonged to, the reported efficacy rate indicates that fewer than nine of the cases came from the group that received the vaccine.
The results are the clearest signal to date that SARS-CoV-2 infection can be effectively countered by vaccines. The lack of approved vaccines for any human coronaviruses, and the decades of failure in HIV vaccination despite large-scale worldwide initiatives, served as acute reminders this outcome was not a foregone conclusion.
Pfizer and BioNTech’s data also provide the first proof of concept for BNT162b2’s molecular target, the SARS-CoV-2 spike protein, and its therapeutic modality, mRNA.
If BNT162b2’s high rate of protection is maintained through the trial’s final analyses, other companies may find it difficult to compete if their candidates only meet the field’s original expectations. BioNTech and Pfizer, Moderna, AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and Johnson & Johnson (NYSE:JNJ) all set the bar for their final analyses at around 50% protection in over 150 patients.