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J&J Vaccine Granted Conditional Approval in Europe as Company Announces Plans to Produce Up to 3BN Shots Next Year

Date: March 12, 2021 | Country: BELGIUMNETHERLANDS | Region: EUROPE | Type: Drug Approval | Keywords: #covid19 #ema #europeancommission #janssen #johnson #vaccine

PRICENTRIC BRIEF:

  • The European Commission has authorized Janssen’s one-shot COVID-19 vaccine for conditional use in the European Union, following a recommendation from the European Medicines Agency’s (EMA) human medicines committee (CHMP) earlier the same day
  • The Commission granted the conditional marketing authorization for use of the shot in people 18 and above, having fast-tracked the decision-making process, allowing vaccination programs to be rolled out across the EU as soon as possible
  • Janssen submitted its application to the EMA in February, following a Phase 3 ENSEMBLE clinical trial in which the Janssen vaccine proved 66% effective overall in preventing moderate to severe COVID-19 28 days following vaccination

 

THE DETAILS

AMSTERDAM, The Netherlands – The European Commission has authorized Janssen’s one-shot COVID-19 vaccine for conditional use in the European Union, following a recommendation from the European Medicines Agency’s (EMA) human medicines committee (CHMP) earlier the same day.

The Commission granted the conditional marketing authorization for use of the shot in people 18 and above, having fast-tracked the decision-making process, allowing vaccination programs to be rolled out across the EU as soon as possible.

The decision means that the Johnson & Johnson-owned vaccine is the fourth vaccine recommended in the EU for preventing COVID-19.

“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,” said Emer Cooke, EMA’s Executive Director, adding, “this is the first vaccine which can be used as a single dose”.

Janssen submitted its application to the EMA in February, following a Phase 3 ENSEMBLE clinical trial in which the Janssen vaccine proved 66% effective overall in preventing moderate to severe COVID-19 28 days following vaccination.

Further, the vaccine candidate was 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older, and it demonstrated complete protection against COVID-related hospitalization and death also 28 days after vaccination.

The European Union has a contract with Janssen for 200 million doses of the vaccine, and the option for an additional 200 million doses, adding to the total amount of 600 million from Pfizer, 460 million from Moderna and 400 million from AstraZeneca.

A single dose vaccine can “make a difference in the speed of rollout,” according to Stella Kyriakides, Commissioner for Health and Food Safety.

She added, “The entry on the market of the Janssen vaccine ensures that we have access to a total of up to 1.8 billion doses of approved vaccines from different technology platforms – this is key to ensuring access to vaccinations for Europe and our international partners. We will continue to work tirelessly to support vaccine producers and ensure they deliver doses, as agreed in our contracts.”

Following the approval, Johnson & Johnson’s chief scientist Dr. Paul Stoffels stated in an interview that Johnson & Johnson has worldwide plans to “deliver the one billion [shots] by the end of the year,” and then “Next year, we can do more than two billion vaccines, and even up to three if we maximize capacity. With Merck on board, we will be north of 2 billion.”

Johnson & Johnson recently struck a surprising deal with Merck to dramatically upscale its vaccine production capabilities.

The former company is currently behind schedule in manufacturing its product but company officials expect the pace to pick up over time.

By the end of the year, Merck plans to help double the manufacturing capacity of Johnson & Johnson’s vaccine, meaning as many as one billion doses will come to fruition.

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