WHO grants 'emergency validation' to Pfizer-BioNTech vaccine

Geneva—The World Health Organization on Thursday granted emergency validation to the Pfizer-BioNTech vaccine, paving the way for countries worldwide to quickly approve its import and distribution.

Britain launched its inoculation drive with the US-German vaccine on December 8, with the United States, Canada and EU countries following suit.

WHO said the Pfizer/BioNTech vaccine was the first to receive its "emergency validation" since the novel coronavirus first broke out in China a year ago.

"This is a very positive step towards ensuring global access to COVID-19 vaccines," said Mariangela Simao, a top WHO official tasked with ensuring access to medicines.

"But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere," she said in a statement.

WHO said its emergency use listing opens the way for regulators in different countries to approve the import and distribution of the vaccine.

It said it also enables UNICEF, which plays a key logistical role in distributing anti-Covid vaccines, and the Pan-American Health Organization to procure the vaccine for countries that need it.

WHO convened its own experts and those from around the world to review the data on the Pfizer/BioNTech vaccine’s "safety, efficacy and quality," weighing the benefits against the risks.

"The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks," it said.

In late December, Health Secretary Francisco Duque III drew flak over claims he cost the Philippines quick access to Pfizer's COVID-19 vaccine.

Speaking to ANC's "Headstart," he said a confidential disclosure agreement (CDA) he signed with Pfizer had to go through reiterations to ensure the provisions were not "onerous and disadvantageous."

"There's no such thing that I did not act quick enough," he said. "As a physician, my overriding principle in practice of medicine is to err on the side of caution."

He also clarified that Pfizer never promised it would provide the Philippines 10 million doses of its vaccine upon signing the CDA, contrary to reports.

Several officials had said Duque "dropped the ball" in the country's immediate procurement of the Pfizer vaccine, now already in use in the United Kingdom and the United States.

The UN health agency, with the GAVI Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI), are spearheading a global effort called COVAX to secure and distribute vaccines to poorer countries, to ensure shots do not go only to wealthy nations.

The WHO-backed COVAX alliance has agreements for nearly 2 billion doses, with first deliveries due in early 2021. The alliance has been in talks with Pfizer and BioNTech to secure a vaccine.

Even so, the Pfizer/BioNTech vaccine's challenging storage and delivery requirements, including keeping it at minus 70 degrees Celsius, have made deliveries challenging in western countries, and may pose bigger hurdles for developing nations without adequate infrastructure.

The vaccine has gotten regulatory backing from the United Kingdom, the European Medicines Agency, U.S. Food and Drug Administration, Health Canada, Bahrain, Israel, Kuwait, Mexico, Oman, Qatar, Saudi Arabia and Singapore.

Pfizer and BioNTech's messenger RNA vaccine was found to be 95% effective after two doses 21 days apart.

Topics: World Health Organization , emergency validation , Pfizer-BioNTech vaccine
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