WHO Emergency Approves J&J One-shot COVID-19 Vaccine

Date: March 12, 2021 | Country: UNITED STATES | Region: NORTH AMERICA | Type: Regulation | Keywords: #acceleratedapproval #bms #cancer #fda #keytruda #msd #oncology #opdivo 
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PRICENTRIC BRIEF:

  • The World Health Organization (WHO) has approved the emergency listing of Johnson & Johnson’s COVID-19 vaccine
  • The approval carves a path for its use in countries that have weaker regulatory agencies and marks the third COVID-19 vaccine backed by WHO
  • WHO also expressed hopes to have doses of the J&J COVID-19 vaccine for use in the COVAX vaccine-sharing scheme by at least July

 

THE DETAILS

GENEVA, Switzerland – The World Health Organization (WHO) has approved the emergency listing of Johnson & Johnson’s COVID-19 vaccine.

The approval carves a path for its use in countries that have weaker regulatory agencies and marks the third COVID-19 vaccine backed by WHO.

WHO also expressed hopes to have doses of the J&J COVID-19 vaccine for use in the COVAX vaccine-sharing scheme by at least July.

In a statement, WHO Director-General Tedros Adhanom Ghebreyesus noted: “Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic. Emergency use listing is the greenlight for a vaccine to be procured and rolled out by COVAX.”

COVAX currently has an agreement for 500 million doses of the J&J vaccine, but WHO is trying to “work with the company to bring that forward,” explained WHO Senior Adviser Bruce Aylward.

He continued, “we’re hoping at least by July that we have access to doses we can be rolling out, if not even earlier.”

The J&J shot is a fantastic addition to COVAX, as the single-dose regimen is more convenient for administration and mass vaccinating, and it doesn’t require an ultra-cold chain environment like some of its counterparts.

Last week the European Commission approved the one-shot 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.

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.

Johnson & Johnson also 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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