It could be as early as next month that drug makers Pfizer Inc and BioNTech could be given emergency US and European authorization to usage of the their Covid-19 vaccine after the companies declared completion of their final phase of trials which had shown a 95 per cent efficacy rate with no serious side effects from the shots, the tow companies said on Wednesday.
The companies claimed that data form the completed trials of the vaccine candidate showed effectiveness to fight the disease among participants of different ages and ethnicities which is an important observation since the pandemic has been found to be more impactful for the older age group and people of some particular ethnicity such as Black people.
BioNTech Chief Executive Ugur Sahintold the media that permission for emergency-use of the vaccine could be granted to the company by the United States Food and Drug Administration by the middle of December. He added that by the second half of December, the companies could also obtain conditional approval in the European Union for the vaccine.
“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.
The rate of efficacy of the vaccine developed Pfizer in partnership with German pharma company BioNTech as claimed by the companies was much higher than what the regulators had previously said would be acceptable to them for approval of wide spread usage.
The vaccine development was an important and significant achievement in the efforts to end the pandemic, say experts.
In its trial of more than 43,000 volunteers, there were 170 cases of Covid-19, Pfizer said, and added that the shot rather than a placebo was given to only eight people with the disease. That translated into the vaccine showing an efficacy rate of 95 per cent. One of the Of the ten people who developed severe COVID-19 had received the vaccine.
“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day.”
US emergency use authorization (EUA) would be applied for on Friday, said BioNTech’s Sahin.
The final results announced by Pfizer comes about a week after the company had announced successful interim results for the last phase trial of its Covid-19 vaccine candidate in which the company had claimed its vaccine showed 94.5 per cent efficacy.
This Monday, another United States based pharma giant Moderna announced that preliminary data form the last phase of trials for its vaccine had shown a success rate of 94.5 per cent;
“We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks,” US Health and Human Services Secretary Alex Azar said.
(Source:www.hindustantimes.com)
The companies claimed that data form the completed trials of the vaccine candidate showed effectiveness to fight the disease among participants of different ages and ethnicities which is an important observation since the pandemic has been found to be more impactful for the older age group and people of some particular ethnicity such as Black people.
BioNTech Chief Executive Ugur Sahintold the media that permission for emergency-use of the vaccine could be granted to the company by the United States Food and Drug Administration by the middle of December. He added that by the second half of December, the companies could also obtain conditional approval in the European Union for the vaccine.
“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.
The rate of efficacy of the vaccine developed Pfizer in partnership with German pharma company BioNTech as claimed by the companies was much higher than what the regulators had previously said would be acceptable to them for approval of wide spread usage.
The vaccine development was an important and significant achievement in the efforts to end the pandemic, say experts.
In its trial of more than 43,000 volunteers, there were 170 cases of Covid-19, Pfizer said, and added that the shot rather than a placebo was given to only eight people with the disease. That translated into the vaccine showing an efficacy rate of 95 per cent. One of the Of the ten people who developed severe COVID-19 had received the vaccine.
“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day.”
US emergency use authorization (EUA) would be applied for on Friday, said BioNTech’s Sahin.
The final results announced by Pfizer comes about a week after the company had announced successful interim results for the last phase trial of its Covid-19 vaccine candidate in which the company had claimed its vaccine showed 94.5 per cent efficacy.
This Monday, another United States based pharma giant Moderna announced that preliminary data form the last phase of trials for its vaccine had shown a success rate of 94.5 per cent;
“We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks,” US Health and Human Services Secretary Alex Azar said.
(Source:www.hindustantimes.com)
