European Union regulator clears J&J COVID-19 vaccine

A European Union review panel on Thursday recommended that Johnson & Johnson’s (J&J) COVID-19 vaccine be granted “conditional marketing authorization” for use in people 18 years and older.

The European Medicines Agency (EMA) said in its announcement that data regarding J&J’s vaccine was “robust and met the criteria for efficacy, safety and quality.”

“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” EMA Executive Director Emer Cooke said, adding that “this is the first vaccine which can be used as a single dose.”

The EMA cited studies in the U.S., South Africa and Latin America as evidence of the vaccine’s efficacy in preventing COVID-19.

The J&J vaccine is not believed to be as effective as the two-dose options from Pfizer and Moderna, however, it does not require extreme sub-zero temperatures to be safely transported and stored, potentially speeding up vaccine administration.

If approved by the EU, it would be the fourth vaccine approved for use in the European bloc, along with vaccines from Pfizer, Moderna and AstraZeneca.

The EMA stated that a “full risk management plan” on the vaccine would be published within the next few days.

The U.S. approved the J&J vaccine for use last week. According to data from the Centers for Disease Control and Prevention, nearly 500,000 doses of the J&J vaccine have been administered in the U.S. so far.