Pfizer Inc. and BioNTech SE announced November 9 that an early look at data from its COVID-19 vaccine trials indicated the drug is 90% effective at preventing COVID-19 transmission.
The Phase 3 study which produced the data has not yet formally published its results. New York-based Pfizer and its Germany ally in the vaccine’s development, BioNTech, say they are still on track to seek Emergency Use Authorization from the Food and Drug Administration once 164 participants have been infected with the COVID virus. Pfizer says that 94 cases have been confirmed and estimates that the required safety milestone of 164 cases will be achieved by the third week of November.
The drug used in the study uses messenger RNA technology, or mRNA, to trigger an immune response in patients without containing any actual samples of the virus. According to the interim results, data from the placebo-controlled study indicates patients achieve protection from the virus 28 days after an initial dose of the vaccine is administered, which is then followed up by a second dose.
The study has enrolled 43,538 participants since it began July 27. According to Pfizer, no serious safety concerns have been observed, but data on safety and efficacy are still being collected.
In an open letter to participants in the trial, Pfizer CEO Albert Bourla called the interim results “a great victory for humanity” and thanked the participants in Argentina, Brazil, Germany, South Africa, Turkey and the United States for their help.
“While we do not have the full study results, as this is only an interim analysis, the data demonstrated that the study vaccine can prevent COVID-19 disease in adults who have not previously been diagnosed with COVID-19,” he wrote.
In a separate statement, Dr. Bourla noted the results came as many countries around the world are seeing new record-setting infection rates and economies struggling to reopen.
BioNTech CEO and co-founder Ugur Sahin, in a statement, said “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
