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EMA Clears J&J Covid Vaccine for Marketing

12.03.2021 - The EU cleared Johnson & Johnson’s Covid-19 vaccine for conditional marketing in all 27member states on Mar. 11 as expected. The single-dose adenovirus shot made by subsidiary Janssen Biotech, under a rolling review since December 2020, is the fourth to be approved by the European Medicines Agency (EMA).

In December and January, the EMA greenlit the mRNA-based -vaccines made by BioNTech/Pfizer and Moderna, with AstraZeneca’s last added to the mix. The US Food and Drug Administration (FDA) granted the J&J candidate an Emergency Use Authorization (EUA) on Feb. 27.

Brussels has ordered 200 million doses of the J&J vaccine with the option for 200 million more. It is not clear, however, when the first doses can be administered, due to confusion over the US healthcare giant’s ability to deliver.

J&J had promised to supply 55 million doses to the EU during the second quarter; however, Reuters earlier this week quoted an anonymous EU source as saying that this might not be possible. The Commission nevertheless has said it has not been informed. In its announcement of the EU approval, the group provided no further details.

Aside from requiring only a single dose, the vaccine can be stored in most standard refrigerators at temperatures of 2 to 8°C  (36 to 46°F), making it easier and cheaper to transport and store. Its efficacy, like that of AstraZeneca’s adenovirus shot, is generally regarded as being somewhat weaker altogether, compared with the mRNA products.

Author: Dede Williams, Freelance Journalist