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Johnson & Johnson said it has asked US health regulators to authorize its single-dose COVID-19 vaccine for emergency use, and it’ll apply to European authorities in coming weeks.
The drugmaker’s application to the U.S. Food and Drug Administration (FDA) follows its Jan. 29 report where it said the vaccine had a 66% rate of preventing diseases from its large international trial.
The FDA said on Thursday evening that it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26, to discuss the company’s petition for emergency use authorization.
Vaccines from Pfizer Inc/BioNTech SE and Moderna Inc were approved a day after such a meeting.
J&J’s single-shot vaccine could help boost supply and simplify the U.S. immunization campaign, amid concerns of fresh surges because of the more contagious UK coronavirus variant and the potential of lower vaccine efficacy against a version that emerged in South Africa.
Unlike both presently authorized vaccines from Pfizer/BioNTech SE and Moderna, J&J’s does not want another shot or have to be sent frozen.
After the company’s application, regulators will need time to analyze the data along with an advisory committee needs to meet. The corporation’s chief scientific officer, Paul Stoffels, said last month J&J was on track to roll out the vaccine in March.
“Upon consent of our investigational COVID-19 vaccine for emergency use, we are prepared to begin shipping,” Stoffels said in a statement announcing the application.
J&J said it had rolling submissions with several global health agencies and would submit a Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks.
J&J’s application raised hopes for combating a pandemic that has claimed more than 451,145 American lives and more than 2,271,152 worldwide.
The United States has agreed to pay $1 billion for 100 million doses, which J&J said it expected to provide in the first half of this year. The USA also has the choice of purchasing an additional 200 million doses.
The company said it has doses ready for delivery upon emergency approval. It aims to deliver 1 billion doses in 2021 with production in the USA, Europe, South Africa and India.
In J&J’s trial of nearly 44,000 volunteers ran in eight states, the degree of protection from COVID-19 was 72% in the United States, 66% in Latin America and 57% in South Africa where variations are circulating.
Those results compare with the 95% effectiveness of the two-dose vaccines made by Pfizer/BioNTech SE and Moderna.
However, both trials were conducted mainly in the United States and before the spread of new versions.
J&J’s most important study goal was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in preventing acute disease and preventing hospitalization across all geographies and against multiple variants 28 days after immunization.
J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.
The Pfizer/BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA) that requires it to be stored in a freezer.
