Pfizer-BioNTech COVID-19 vaccine gets WHO approval for emergency use

MANILA, Philippines – The Pfizer-BioNTech COVID-19 vaccine became the first vaccine to receive World Health Organization (WHO) approval for emergency use since the outbreak began, the agency announced on New Year's Eve.

Pfizer-BioNTech COVID-19 vaccine gets WHO approval for emergency use

The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.

“This is a very positive step towards ensuring global access to COVID-19 vaccines. 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,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

Regulatory experts convened by WHO from around the world and WHO’s own teams reviewed the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis.

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.

With an efficacy rate of 95%, their vaccine was soon approved for emergency use by the United States and the United Kingdom.

The Comirnaty vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible. For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible.

Pfizer and the Philippines

In December, several officials said Health Secretary Francisco Duque III "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.

Duque said a confidential disclosure agreement (CDA) he signed with Pfizer had to go through due process.

On Friday, the Heath Secretary said the WHO listing Pfizer’s COVID-19 vaccine for emergency use will help fast-track the Philippines’ approval process.

“The one from WHO is a welcome addition to the regulatory approvals and therefore that would be a lot easier for the local FDA (Food and Drug Administration), to already review all the documents and assess the risk benefit ratio of the said candidate vaccine,” he said during a televised press conference at the East Avenue Medical Center.

— The Summit Express

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