Johnson & Johnson file for FDA vaccine approval
February 4th 2020, Johnson & Johnson have announced that they have filed approval for US Food and Drug Administration (FDA) approval to use Janssen’s experimental single-dose COVID-19 vaccine.
The Janssen vaccine is built on the company’s AdVac platform which has previously been used to develop experimental vaccines for Ebola, Zika and HIV. The viral vector technology used by the platform makes use of a genetically modified adenovirus.
The FDA filing is based on the Phase 3 ENSEMBLE study which involved 43,000 people in eight countries, including the United States. The first signs of active protection against the virus was observable at day 14, and at day 28 after vaccination the effectiveness at preventing moderate to severe COVID-19 was shown to be from 66-72% - depending on country.
The vaccine also showed 85% efficacy in preventing severe disease in all regions after 28 days, this effect seemed to improve over time and at day 49 no cases were reported in the vaccinated participants.
The cost of the vaccine on the international market is due to be $8.50 per unit.