Johnson & Johnson's vaccine is about to be licensed in the US

The United States is close to having a third COVID-19 vaccine produced by Johnson & Johnson, which has shown its vaccine to be safe and effective. However, on Friday, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration, a US government agency (FDA), will hold a meeting to determine the vaccine's performance.

Johnson & Johnson's single-dose vaccine offers protection against COVID-19 with an overall efficacy of 72% in the US and 64% in South Africa, where a highly contagious variant emerged in the autumn, according to the analysis released Wednesday by US regulators.

The vaccine also showed 86% efficacy against severe forms of COVID-19 in US trials and 82% efficacy against severe disease in South Africa. 

This analysis is one step away from FDA evaluation, which on Friday will discuss whether the evidence is strong enough to recommend the vaccine, with a final decision expected in a few days. 

The US pharmaceutical giant has also applied for authorisation for its vaccine in the EU, with a decision due in mid-March. If it gets the green light from the Amsterdam-based European Medicines Agency, it would be the fourth vaccine approved for use in all 27 EU countries. 

J&J's European subsidiary told the watchdog that the "EMA has received a conditional marketing authorisation application for a COVID-19 vaccine developed by Janssen-Cilag International".

They say the regulator "could issue an opinion by mid-March 2021, provided the company's data on the vaccine's efficacy, safety and clarity are sufficiently complete and robust".

The single dose can be stored at normal refrigeration temperatures for at least three months, making distribution much easier than the licensed vaccines manufactured by Moderna and Pfizer-BioNTech, which require two doses and must be stored at cold temperatures.

Moreover, the delay puts the EMA under pressure from European capitals to speed up service. Ursula von der Leyen, president of the European Commission, praised the news and said Brussels "will be ready to grant authorisation as soon as the EMA issues a positive scientific opinion".

The European Commission has requested 200 million doses of J&J's vaccine with the option to order 200 million more. And 100 million doses will be delivered by June if approved.