Johnson & Johnson has sought permission from regulators in the United States for authorization for emergency use of its single-dose COVID-19 vaccine and the company will apply for a similar permission with the European regulators within the next few weeks, the company said on Thursday.
The application of emergency use for its Covid-19 vaccine was filed by the drug maker with the US Food and Drug Administration (FDA) after the report of a global trial of its vaccine showed and efficacy rate of 66 per cent on January 29.
The request for emergency usage of J&J’s Covid-19 vaccine will be discussed at a meeting on February 26 by the Vaccines and Related Biological Products Advisory Committee of the FDA, the regulator said on Thursday.
In contrast the US regulator had taken just a day after such a meeting to authorize the emergency use of their Covid-19 vaccines from Pfizer Inc/BioNTech SE and Moderna Inc.
Granting permission for use of the single-shot vaccine from J&J will help the US to further increase the supply of Covid-19 vaccines in the country and consequently simplify the immunization campaign in the US even as there are concerns of rise of fresh cases and outbreaks from the more contagious UK variant of the Covid-19 causing coronavirus as well as the possible lower effectiveness of the current vaccines against another variant of the virus that was first detected in South Africa.
The Covid-19 vaccine from J&J is different from those of Pfizer/BioNTech SE and Moderns because the former requires only a single dose while the rest require two shots and does not need to be transported and stored at ultra-low temperatures.
Analysis of the data offered by J&J will have to be analysed and a meeting of the regulator’s advisory committee meeting has to be held before the vaccine developed by the pharma giant can be approved. J&J was on track to roll out the vaccine in Marchthe company's chief scientific officer, Paul Stoffels, had said last month.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping," Stoffels said in a statement announcing the application.
The company would also file a Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks and already has Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks, J&J said.
The potential vaccine from J&J adds on the hope provided by a number of other vaccines which are seen as the best bet to tackle the pandemic that has already killed more than 451,145 people in the US and more than 2,271,152 people globally.
An agreement for 100 million doses of the J&J vaccine for $1 billion has been struck with the company by the United States and the drug maker said that it would be able to supply that entire lot by the first half of the current year. The option of purchasing an additional 200 million doses form the company also rests with the United States.
(Source:www.news18.com)
The application of emergency use for its Covid-19 vaccine was filed by the drug maker with the US Food and Drug Administration (FDA) after the report of a global trial of its vaccine showed and efficacy rate of 66 per cent on January 29.
The request for emergency usage of J&J’s Covid-19 vaccine will be discussed at a meeting on February 26 by the Vaccines and Related Biological Products Advisory Committee of the FDA, the regulator said on Thursday.
In contrast the US regulator had taken just a day after such a meeting to authorize the emergency use of their Covid-19 vaccines from Pfizer Inc/BioNTech SE and Moderna Inc.
Granting permission for use of the single-shot vaccine from J&J will help the US to further increase the supply of Covid-19 vaccines in the country and consequently simplify the immunization campaign in the US even as there are concerns of rise of fresh cases and outbreaks from the more contagious UK variant of the Covid-19 causing coronavirus as well as the possible lower effectiveness of the current vaccines against another variant of the virus that was first detected in South Africa.
The Covid-19 vaccine from J&J is different from those of Pfizer/BioNTech SE and Moderns because the former requires only a single dose while the rest require two shots and does not need to be transported and stored at ultra-low temperatures.
Analysis of the data offered by J&J will have to be analysed and a meeting of the regulator’s advisory committee meeting has to be held before the vaccine developed by the pharma giant can be approved. J&J was on track to roll out the vaccine in Marchthe company's chief scientific officer, Paul Stoffels, had said last month.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping," Stoffels said in a statement announcing the application.
The company would also file a Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks and already has Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks, J&J said.
The potential vaccine from J&J adds on the hope provided by a number of other vaccines which are seen as the best bet to tackle the pandemic that has already killed more than 451,145 people in the US and more than 2,271,152 people globally.
An agreement for 100 million doses of the J&J vaccine for $1 billion has been struck with the company by the United States and the drug maker said that it would be able to supply that entire lot by the first half of the current year. The option of purchasing an additional 200 million doses form the company also rests with the United States.
(Source:www.news18.com)
