WHO approves Pfizer/BioNTech vaccine in breakthrough for developing nations

The World Health Organization has approved the Pfizer/BioNTech vaccine for emergency use, paving the way for lower and middle-income countries to begin immunizing their populations against Covid-19.

The vaccine was first approved in the UK on December 8 for emergency use within the country, with the US, Canada and European Union following soon after. All have begun their own vaccination drives.

But the green light from the World Health Organization (WHO) means countries without their own regulatory bodies, or the means to rigorously assess the efficacy and safety of vaccines, can expedite their own approval processes and begin rolling out vaccination programs.

There have been concerns about unequal distribution of vaccines as wealthier countries have bought or signed contracts to purchase large amounts of the doses available or those waiting for approval.

In a statement Thursday, the WHO said organizations like UNICEF and the Pan-American Health Organization could now 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.

“WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.”

The WHO’s team and independent experts reviewed the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality to conduct a risk-versus-benefit analysis, the statement said.

“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.

A group of WHO immunization experts will meet on January 5 to lay out policies and recommendations for the vaccine’s use in populations. It will also help them set up cold supply chains, as the vaccine needs to be stored at 60-90 degrees Celsius.

While the Pfizer/BioNTech vaccine is the first to gain WHO approval, there are hopes that cheaper and easier-to-distribute options will be made available soon.

One such option is the Oxford/AstraZeneca vaccine, which was approved by UK regulators on Wednesday. The country will begin administering the shots from January 4.

AstraZeneca has promised to supply hundreds of millions of doses to low and middle-income countries, and to deliver the vaccine on a not-for-profit basis to those nations in perpetuity.