The company expects to produce up to 50 million doses of vaccines globally in 2020 and up to 1.3 billion doses in 2021
Pfizer and Biontech announced on Monday that their vaccine against Covid-19 is more than 90 percent effective, after the “success” of the first interim analysis of their phase 3 trial.
Thus, its candidate mRNA-based vaccine BNT162b2 against SARS-COV-2 has demonstrated its efficacy against the coronavirus in participants without prior evidence of infection, according to the first provisional efficacy analysis carried out on November 8.
The tests have been performed on a total of 43,538 participants and the analysis has evaluated 94 confirmed cases of Covid-19 in trial participants.
After these results, the president and CEO of Pfizer, Albert Bourla, stressed that today is “a great day for science and humanity.” “The first results from our Phase 3 Covid-19 vaccine trial provide initial evidence of the ability to prevent Covid-19,” he said.
At this point, it has celebrated that they have reached this “milestone” in their vaccine development program at a time when the world “needs it most,” with infection rates “setting new records, hospitals approaching their overcapacity and economies struggling to reopen. “
“With today’s news, we are a significant step closer to giving people around the world a much-needed breakthrough to help end this global health crisis. We look forward to sharing additional efficacy and safety data generated by the thousands. of participants in the next weeks “, has pointed out the president of the Pfizer.
Bourla also thanked the thousands of people who have volunteered to participate in the clinical trial, his academic collaborators and researchers at study sites, as well as his collaborators around the world “who are dedicating their time to this crucial effort. ” “We could not have come this far without the tremendous commitment of everyone involved,” he said.
The president of Pfizer has stressed that the first interim analysis of its global phase 3 study “provides evidence that a vaccine can effectively prevent Covid-19.” “This is a victory for innovation, science and a global collaborative effort,” he commented.
“When we embarked on this journey 10 months ago, this is what we aspire to achieve. Especially today, as we are all in the middle of a second wave and many of us locked in, we appreciate even more how important this milestone is on our way to put an end to this pandemic and so that we can all regain a sense of normalcy, “Bourla stressed.
The president of Pfizer has explained that they will continue to collect more data as the trial continues, registering for a planned final analysis when a total of 164 confirmed cases of Covid-19 have accumulated. “I would like to thank everyone who has contributed to making this important achievement possible,” he said.
The phase 3 clinical trial began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the candidate vaccine on November 8, 2020. Approximately 42 percent of global participants and 30 percent of the participants from the United States “have a racial and ethnic background.”
The trial continues to be enrolled and is expected to continue until final analysis when a total of 164 confirmed cases of Covid-19 have accumulated. The study will also evaluate the potential of the candidate vaccine to provide protection against coronavirus in those who have had prior exposure, as well as vaccine prevention against the disease.
In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accumulated seven days after the second dose, the final analysis will now include, with FDA approval, new secondary endpoints evaluating efficacy based on cases that accumulate fourteen days after the second dose as well.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary manufacturing and safety data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
Based on current projections, the company expects to produce up to 50 million doses of vaccines globally in 2020 and up to 1.3 billion doses in 2021.