Daily Management Review

Pfizer Is Not Ready Yet To Disclose COVID-19 Vaccine Trial Data


Pfizer is expecting to get its “manufacturing data ready” for submitting to the regulators by late November.

Pfizer Inc has informed that as yet the company not ready to disclose any data related to “late-stage trial of the COVID-19 vaccine” which is being developed in collaboration with BioNTech.
The drug maker further informed the “independent monitor” for determining the success of the trial is yet to carry out “interim efficacy analyses”. Although, the C.E.O of Pfizer, Albert Bourla had earlier stated that the company could come out on the vaccine data earliest by this month. Moreover, Pfizer saw a one percent drop in its share.
President Trump had earlier stated that there was a chance of vaccine availability prior to the election scheduled for November 3, 2020. However, in a more recent statement his administration gave an emphasis on the availability of one vaccine before the year ends. Pfizer is hoping to secure the first spot among its peers to come out with “successful data from a late-stage COVID-19 vaccine trial”. Collaborating with BioNTech, Pfizer launched its three-phase vaccine study which involved “44,000” volunteers in the later part of July.
The “data monitoring board” will be carrying out the first vaccine performance assessment following thirty participants from the trial group are tested positive for COVID-19 virus. However, Brad Loncar, an investor of healthcare sector finds it difficult draw any conclusion be it negative or positive since the trial has not yet conducted its “first interim analysis”. In his Loncar’s words:
“I think this means that the overall infection rate is a lot lower than Pfizer initially estimated”.
While, Dr. David Boulware, a Professor of Medicine in the University of Minnesota, stated that the participants of the trial could follow “social distancing guidelines” more seriously than the “general population”. As Boulware added:
“Who the vaccine trials really need are the people who don’t wear masks, who are going out to bars, who go to crowded events, who are singing in church choirs - those are the high risk people”.
Although, Boulware added that the data could still undergo relatively quick monitoring, maybe in less than a day’s time, once the trial reaches its “first interim point”.
With the outbreak of the pandemic, many of the “Pfizer therapies” have lost their demand while global economies are still dealing with the after-blow effect, therefore the investors have turned their keen focus on the “late-stage study data of the vaccine candidate being developed with BioNTech”.
Furthermore, the company informed that following the success of the trial, it is expecting to “file for emergency authorization of the vaccine candidate from U.S. regulators” as soon as it gathers sufficient “safety data in late November”. While, the company is also expecting to get its “manufacturing data ready” for submitting to the regulators before that.