Johnson & Johnson Applies for US Approval
With Johnson & Johnson, another manufacturer in the USA has applied for emergency approval for its corona vaccine. The application for an emergency approval in the EU is apparently imminent: the US corporation Johnson & Johnson (J&J) has applied for an emergency approval for the corona vaccine developed by its pharmaceuticals division with the US drug agency FDA. The corresponding documents had been handed over to the FDA, said the company, which is headquartered in New Brunswick, New Jersey. The application for emergency approval from the EU Medicines Agency (EMA) should follow “in the coming weeks.
US Approval on Feb.27 Once the FDA’s approval process is complete and approval is granted, shipments can begin, J&J chief Paul Stoffels said. The FDA set a meeting of its independent vaccine advisory committee for Feb.26 at. This then makes a recommendation. The vaccines from BioNTech / Pfizer and Moderna that had already been approved were approved one day later.
It would be the first US and EU approved vaccine that requires a single injection. Last week Johnson & Johnson announced an interim result of its Phase III study with around 44,000 subjects, according to which the vaccine offers 66 percent protection against moderate or severe Covid 19 disease courses four weeks after administration. The percentages mean that there were correspondingly fewer cases in the vaccinated test group than in the placebo group. Easier storage possibleIn contrast to the vaccines from BioNTech / Pfizer and Moderna, it is a vector vaccine based on a normal cold virus Can be transported and stored at refrigerator temperature. In the case of competing products, which are already used in the EU and which are injected twice at intervals of several weeks, the effectiveness of the study results is, however, significantly higher.
Scientists hope for more flexibility in the fight against the corona virus and its mutations.
Up to 400 million vaccine doses for the EU Johnson & Johnson plans to provide a billion doses this year. The vaccine is to be produced in the United States, Europe, South Africa and India. The United States has secured 100 million doses for one billion dollars. J&J is expecting delivery in the first half of the year. The US also has an option for an additional 200 million cans. The EU has secured up to 400 million doses of the drug.
Johnson & Johnson Applies for US Approval - /10