A dose of Pfizer vaccine, illustration – Esteban Felix / AP / SIPA
The World Health Organization on Thursday granted its first emergency approval since the start of the Covid-19 pandemic to the Pfizer-BioNTech vaccine. “This is a very positive step to ensure universal access to anti-Covid-19 vaccines,” said Mariangela Simao, director in charge of access to medicines at the WHO, quoted in a press release.
The emergency approval was based on the opinion of an expert in drug regulation from around the world as well as from the WHO, specifies the UN agency, which concluded that it met the criteria “of safety, efficiency and quality ”allowing its use. This advice is all the more crucial for countries that do not have significant resources as the Pfizer-BioNTech vaccine is based on the use of messenger RNA, a new method for teaching the immune system to fight a virus. Moderna’s vaccine, already approved in several countries, is based on the same principle.
Buy the vaccine for distribution in poor countries
This procedure, which WHO can use in health emergencies, allows countries that do not necessarily have the means to quickly determine on their own the efficacy and safety of a drug, to have faster access to therapy.
The procedure also allows Unicef, the UN agency in charge of an important part of the logistics of distributing anti-Covid vaccines around the world, and the Pan-American Health Organization to buy the vaccine for distribution in poor countries, said the press release. Dr Simao added, however, that “an even greater effort was needed to have enough vaccine doses available to meet the needs of priority populations around the world.”
The Pfizer-BioNTech vaccine has already been inoculated for several weeks in the United Kingdom, but also in the European Union, the United States or even in Switzerland for example. Several million people have already been immunized with this product estimated to be 95% effective but which requires ultra-low temperatures of the order of minus 80 degrees centigrade, which makes distribution and storage more difficult.
homologation is not a cheap procedure
WHO has also been committed there for several months to help member countries that so wish to set up vaccination plans. In its press release, the WHO insists on making it clear that approval is not a cheap procedure. It is based on data from phase II and III clinical trials (the last phase on a large cohort of several tens of thousands of patients in the case of the Pfizer-BioNTech vaccine).
Experts from various drug agencies around the world are invited to participate in the process, says the WHO.
