FDAnews
www.fdanews.com/articles/200694-who-approves-emergency-use-of-the-pfizerbiontech-vaccine

WHO Approves Emergency Use of the Pfizer/BioNTech Vaccine

January 4, 2021

The World Health Organization (WHO) has granted the Pfizer/BioNTech COVID-19 vaccine an Emergency Use Listing — the first such listing by the standard-setting body since the pandemic began.

The endorsement paves the way for global regulatory agencies to accelerate their own reviews, the WHO said. In addition, the listing enables UNICEF and the Pan-American Health Organization to distribute the vaccine worldwide.

Originally named BNT162b2 but now known as Camirnaty, the vaccine requires ultra-cold shipping and storage, which will pose significant challenges for poorer countries. And with wealthy nations competing for supplies of the highly effective vaccine, securing an adequate supply for poorer countries will be another huge challenge.

Mariângela Simão, the WHO’s assistant-director general for access to medicines, called for “an even greater global effort” to achieve enough vaccine supply to meet the needs of priority populations. “We encourage even more developers to come forward for review and assessment,” she said.

The WHO’s expert advisory group on immunizations is set to meet on Tuesday to discuss recommendations for administering the vaccine.

Cominarty has so far received conditional marketing authorizations in the EU, Canada, Saudi Arabia and Switzerland, and emergency use authorizations in the U.S., Argentina, Costi Rica, Ecuador, Kuwait, Mexico, Panama and Singapore, where inoculations are under way. ― Jason Scott