Pfizer & BioNTech's Experimental COVID-19 Vaccine Candidate More Than 90 Percent Effective
Pfizer's, the US-based Pharma Company and BioNTech, the German biotech organization has announced that their experimental COVID-19 vaccine appears to be working with great efficacy. The vaccine was found to be more than 90 percent effective, according to clinical results released by the company.
“Vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis,” Pfizer said in a statement. That news comes from an interim analysis of a study involving 43,538 volunteers, 42 percent of whom had ‘diverse backgrounds’. Each participant got two injections spaced 21 days apart. The analysis compared the number of cases of COVID-19 among the volunteers getting the vaccine with an approximately equal sized group of volunteers who got an injection of a liquid that didn't contain the vaccine.
Pfizer and BioNTech SE are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine, and this is the first COVID-19 vaccine in development to have data showing that it exceeded that mark. The companies said they have found no serious safety concerns so far, and expect to seek US emergency use authorization later this month.
Along with the efficacy data generated from the clinical trial, Pfizer said both the companies are working to prepare the necessary safety and manufacturing data to submit to the US drug regulator to demonstrate the safety and quality of the vaccine product produced. “Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” it added.
“I tend to be an optimist. I've been in vaccine development for over 35 years,” said Dr. William Gruber, Senior Vice President of Vaccine Clinical Research and Development, Pfizer. “But this is extraordinary, and I think it speaks well not only for the potential of this vaccine but potentially other vaccines that are out there in development for COVID-19.”
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” stated Dr. Albert Bourla, Chairman & CEO, Pfizer.
While promising, this analysis alone does not provide enough information about the vaccine for Pfizer to ask the FDA for permission to distribute it. The agency has informed manufacturers that it wants a minimum of two months of follow-up data from at least half of the volunteers. The FDA says the reason for that requirement is that most dangerous side effects from a vaccine occur within two months of getting the final injection. Pfizer says that data won't be available until the third week in November.
The company didn't say how serious the COVID-19 cases were that occurred in the study, or whether any of them required hospitalization. The Pfizer vaccine trial is what's known as an event-driven study. It does not last for a specified period of time. Instead, the study will continue and won't be considered complete until it has recorded a total of 164 cases of COVID-19 among all the volunteers.
As described in its publicly released protocol, the company had planned to conduct four interim analyses, when a proscribed number of COVID-19 cases had occurred. The results released Monday are from the second one, the company having agreed with the FDA to forgo the first analysis.
“Vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis,” Pfizer said in a statement. That news comes from an interim analysis of a study involving 43,538 volunteers, 42 percent of whom had ‘diverse backgrounds’. Each participant got two injections spaced 21 days apart. The analysis compared the number of cases of COVID-19 among the volunteers getting the vaccine with an approximately equal sized group of volunteers who got an injection of a liquid that didn't contain the vaccine.
Pfizer and BioNTech SE are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine, and this is the first COVID-19 vaccine in development to have data showing that it exceeded that mark. The companies said they have found no serious safety concerns so far, and expect to seek US emergency use authorization later this month.
Along with the efficacy data generated from the clinical trial, Pfizer said both the companies are working to prepare the necessary safety and manufacturing data to submit to the US drug regulator to demonstrate the safety and quality of the vaccine product produced. “Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” it added.
Vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
“I tend to be an optimist. I've been in vaccine development for over 35 years,” said Dr. William Gruber, Senior Vice President of Vaccine Clinical Research and Development, Pfizer. “But this is extraordinary, and I think it speaks well not only for the potential of this vaccine but potentially other vaccines that are out there in development for COVID-19.”
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” stated Dr. Albert Bourla, Chairman & CEO, Pfizer.
While promising, this analysis alone does not provide enough information about the vaccine for Pfizer to ask the FDA for permission to distribute it. The agency has informed manufacturers that it wants a minimum of two months of follow-up data from at least half of the volunteers. The FDA says the reason for that requirement is that most dangerous side effects from a vaccine occur within two months of getting the final injection. Pfizer says that data won't be available until the third week in November.
The company didn't say how serious the COVID-19 cases were that occurred in the study, or whether any of them required hospitalization. The Pfizer vaccine trial is what's known as an event-driven study. It does not last for a specified period of time. Instead, the study will continue and won't be considered complete until it has recorded a total of 164 cases of COVID-19 among all the volunteers.
As described in its publicly released protocol, the company had planned to conduct four interim analyses, when a proscribed number of COVID-19 cases had occurred. The results released Monday are from the second one, the company having agreed with the FDA to forgo the first analysis.
