Europe Approves Single-Dose COVID-19 Vaccine

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Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Johnson & Johnson's (NYSE:JNJ) (New Brunswick, New Jersey) single-dose COVID-19 vaccine has been given a conditional green light by the European Union's (EU's) drugs regulator.

The European Medicines Agency (EMA) said that it has granted conditional marketing authorization for COVID-19 Vaccine Janssen across the EU for those over 18 years of age. It is the fourth vaccine to be cleared for use in Europe and joins those from Pfizer Incorporated (NYSE:PFE) (New York, New York)/BioNTech SE (NASDAQ:BNTX) (Germany), Moderna (NASDAQ:MRNA) (Massachusetts) and AstraZeneca (Cambridge, U.K.). It also has been approved for use in the U.S., Canada and Bahrain. As well as being single dose, the Janssen vaccine can be easily transported and stored at normal refrigerator temperatures.

"This is the first vaccine which can be used as a single dose," said Emer Cooke, EMA's executive director. "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."

The vaccine was found to have an efficacy rating of 67% in preventing COVID-19 in people 18 years old and older. The efficacy study involved more than 44,000 people; half received a single dose of the vaccine and half were given placebo (a dummy injection). Johnson & Johnson said it aims to begin delivery of the single-dose vaccine to the EU in the second half of April, and to supply 200 million doses to the region, including Norway and Iceland, in 2021.

"For more than a year, we have been working around the clock -- leveraging the scientific minds, scale and resources of our global organization to bring forward a COVID-19 vaccine," said Alex Gorsky, chairman and chief executive officer at Johnson & Johnson. "We are thrilled with today's Conditional Marketing Authorization by the European Commission, which enables our single-dose vaccine to reach many more communities in need, as we continue to do everything we can to help bring an end to this pandemic."

EU Internal Market Commissioner Thierry Breton welcomed the permission granted to Johnson & Johnson and said that he is confident that the EU will receive its full vaccine quota of 300 million doses from all four suppliers in the second quarter.

"I learned that when you start to produce, it is a bumpy road," Breton told a news conference, just before Johnson & Johnson received permission. "If I look at Johnson & Johnson, I understand that they had some difficulties in the U.S.; that they had to make an alliance with another company, Merck. We have our target for Q2, and we have already integrated the ups and downs. I am not worried with the internal target that we have, we know that some will do better ... and some may be a little bit late. So do not believe that because one company has a problem that overall it will jeopardize the whole program."

Europe's vaccine rollout has been hampered by some production delays, in particular with AstraZeneca. For additional information, see February 1, 2021, article--Europe Warns AstraZeneca On Low COVID-19 Vaccine Deliveries. In its most recent update, the company stated: "AstraZeneca is disappointed to announce a shortfall in planned COVID-19 vaccine shipments to the European Union (EU) despite working tirelessly to accelerate supply. The company had previously communicated that it is facing shortfalls from its European supply chain due to lower-than-expected output from the production process. It had also stated that it was looking to compensate for part of this shortfall by sourcing vaccines from its international supply network. Half of the EU's supply in the second quarter, and 10 million doses in the first quarter, were due to be sourced from the company's international supply chain. Unfortunately, export restrictions will reduce deliveries in the first quarter, and are likely to affect deliveries in the second quarter." AstraZeneca maintained that it will deliver 100 million doses in the first half of 2021, of which 30 million are due to be delivered in the first quarter.

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