The World Health Organization on Thursday gave “emergency validation” to pharmaceutical company Pfizer and its German partner BioNTech’s vaccine against the coronavirus. The emergency listing paves the way for countries to expedite their regulatory approval process to “import and administer the vaccine”.
“The World Health Organization (WHO) today listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago,” the world body’s statement read.
WHO Assistant-Director General for Access to Medicines and Health Products called this a “positive step” towards global access to the vaccines against Covid-19. “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,” he added.
The world health body had convened regulatory experts from across the world along with its own teams, which reviewed the information on the Pfizer/BioNTech’s vaccine 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,” the statement read.
WHO’s announcement on the vaccine also enables the United Nations Children’s Fund and the Pan-American Health Organization to procure the vaccine for distribution to the countries in need.
On December 11, the United States Food and Drug Administration granted emergency use approval to the coronavirus vaccine Pfizer and BioNTech. It was the first vaccine candidate to have been authorised by the country to combat the spread of Covid-19, which has taken more than 2.90 lakh American lives.
The vaccine had shown to be 95% effective in preventing the disease in a late-stage trial.
The Pfizer-BioNTech vaccine was first approved in Britain on December 2, and the residents in UK began receiving the shots on December 8. It was the first clinically authorised, fully tested immunisation effort in the world. Canada also authorised the vaccine and expects to start inoculations next week. In addition, Saudi Arabia, Mexico and Bahrain have also approved the vaccine.
The vaccine uses messenger mRNA technology to introduce the body to the spike protein found on the outside of the coronavirus to provoke an immune response. It requires two doses, administered three weeks apart.
The Pfizer-BioNTech vaccine comes with complex distribution challenges as it must be shipped and stored at -70 Celsius, requiring specialised ultra-cold freezers. Moderna’s vaccine, which showed 94.5% efficacy in final trials, employs the same technology but does not need to be stored at sub-Arctic temperatures.