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Wednesday, April 21st, 2021

Johnson & Johnson COVID-19 vaccine gains crucial EU, WHO approvals

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The single-shot Johnson & Johnson COVID-19 vaccine will be available in more places worldwide now, thanks to a conditional marketing authorization granted by the European Commission and emergency use authorization from the World Health Organization (WHO).

The decisions followed similar approval from the U.S. Food and Drug Administration (FDA) in February and the European Medicines Agency (EMA) earlier this month. In all cases, authorization was granted based on available data, which showed that the vaccine protects against COVID-19 related hospitalization, including — although to a lesser effect — against emerging variants.

The vaccine is meant for people 18 years of age and older. It was created by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson. As a result of the approvals, the company hopes to begin delivery to the EU next month and to supply 200 million doses this year. The CMA applies to all 27 member states of the EU, as well as Norway, Iceland, and Liechtenstein.

“For more than a year, we have been working around the clock – leveraging the scientific minds, scale, and resources of our global organisation to bring forward a COVID-19 vaccine,” Johnson & Johnson Chairman and CEO Alex Gorsky said. “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.”

Additionally, with the nod from the WHO, the Janssen vaccine will benefit from vaccination logistics in countries worldwide. In this, it is particularly well-suited since, unlike some other COVID-19 vaccines, it can be stored at mere refrigeration temperatures for up to three months. If kept in freezing temperatures, it can be stored for up to two years.

In its Phase 3 ENSEMBLE study, the Johnson & Johnson COVID-19 vaccine proved well tolerated. It also provided an overall symptomatic COVID-19 reduction of 67 percent, although there was variation region by region. It was 85 percent effective at preventing severe disease and completely effective in blocking hospitalization and death.

The COVAX Facility, which the WHO helps helm, has ordered 500 million doses of the vaccine for equitable distribution worldwide.

“Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic,” said WHO Director-General, Dr. Tedros Adhanom Ghebreyesus. “But the hope offered by these tools will not materialize unless they are made available to all people in all countries. I urge governments and companies to live up to their commitments and to use all solutions at their disposal to ramp up production so that these tools become truly global public goods, available and affordable to all, and a shared solution to the global crisis.”