New Jersey: Johnson & Johnson said Friday that it has submitted data to the World Health Organization (WHO) to list the Covid-19 vaccine in emergencies, which will allow wider access for a single dose.
J&J said the emergency use list is a prerequisite to supplying vaccines to the Covax vaccine program, co-led by the World Health Organization, which aims to deliver doses to poor and middle-income countries.
The J&J vaccine is given in a single dose and can be stored at normal refrigerator temperatures, which is a big selling point in countries with relatively weaker healthcare infrastructure.
The vaccine is under review by the health regulator in the United States, and it is expected that a committee of US Food and Drug Administration experts will discuss authorizing the emergency use of the vaccine next week.
The vaccine is being rolled out in South Africa for the first time outside of a major clinical trial.
J&J said last month that the vaccine was 66% effective in preventing Covid-19 in a large global late-stage trial against multiple types of coronavirus. The level of vaccine protection varied from 72% in the United States to 66% in Latin America and 57% in South Africa.
The company said that the data handed over to the World Health Organization include results from the last phase of the trial.
J&J entered into an agreement in December to support the Covax program.
J&J said the company and Gavi, which also co-leads Covax, expect to enter into a pre-purchase agreement that will deliver up to 500 million doses of the single-dose vaccine to Covax through 2022.