18 Nov 2020
Pfizer's COVID-19 vaccine '95% effective'; to seek emergency US authorization
Pharmaceutical giant Pfizer and German drugmaker BioNTech on Wednesday said their COVID-19 vaccine has been found 95% effective in final trials.
The final results were made public over a week after the drugmakers had announced interim results, becoming the first to show successful data from a large-scale clinical trial for the vaccine.
Since then, Moderna has also announced that its vaccine is 94.5% effective.
170 trial participants contracted COVID-19, only 8 had received vaccine
The final results of the Phase III trials of the vaccine found that it was 95% effective in preventing infections, Pfizer and BioNTech said.
Out of the 170 trial participants who tested positive for COVID-19, 162 infections were in the placebo group, while eight were among those who received the vaccine shot.
Efficacy was consistent across age, race, and ethnicity demographics, the companies said.
'10 severe cases in trial; only 1 in vaccinated group'
The companies said, "There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group." BNT162b2 is the experimental name for the vaccine.
Emergency US authorization to be sought 'within days'
The companies also said that they will apply for emergency US authorization "within days," adding that they had the required two months of safety data.
"To date, no serious safety concerns related to the vaccine candidate have been reported," the statement added.
Further, the data will be submitted to other regulatory agencies globally and will also be published in a peer-reviewed scientific journal.
50 million doses expected by 2020-end; 1.3 billion by 2021-end
If authorized for emergency-use, the number of doses will initially be limited.
The companies had started manufacturing doses ahead of regulatory approval and are expected to produce 50 million doses by 2020-end—enough to vaccinate 25 million people.
By the end of 2021, the companies hope to produce 1.3 billion doses.
They notably have agreements with the US to provide up to 500 million doses.
India unlikely to procure Pfizer's shots
Meanwhile, India has indicated that it may not procure Pfizer's shots at all.
It has been pointed out that the vaccine shots need to be stored at -70°C, which could be a huge challenge for many nations.
However, NITI Aayog member (Health) Dr. VK Paul, who heads the National Task Force on COVID-19, did not completely rule out the possibility of procuring Pfizer's vaccine.
Pfizer, BioNTech assure solution for cold storage requirement
The companies said they've "developed specially-designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C."
They said, "[Doses] can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer's broad distribution network."