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The United Kingdom on Wednesday became the first country in the world to approve the vaccine developed by the Pfizer-BioNTech alliance against the COVID-19 disease.
In the United States and Europe, the competent authorities are analyzing several vaccines that are candidates for approval, reports AFP.
Following Wednesday’s announcement by British authorities, AFP journalists published a summary of the different procedures for approving COVID-19 vaccines in various regions of the world.
Continuous analysis in the UK
The British government has approved the use of the Pfizer-BioNTech vaccine following a recommendation from the Medicines and Healthcare Products Regulatory Agency (MHRA).
This agency has implemented an ongoing screening procedure, which is used to screen for promising treatments in the event of a medical emergency. Therefore, the British agency analyzed the data as it became available.
“Distinguished teams worked in parallel,” day and night, “including weekends, to examine various aspects of vaccine safety without waiting for one phase to begin another, said June Raine, MHRA director. She also questioned the claims by the British health minister that the MHRA had been able to act more quickly due to Brexit.
Unlike the European Medicines Agency (EMA), “the MHRA can ask a series of questions as it is answered, thus acting more quickly as one agency,” said Penny Ward, a physician at King’s College London.
Accelerated process in Europe
The EMA, based in Amsterdam, is responsible for the authorization and control of medicinal products marketed in the 27 Member States of the European Union. The EMA has also implemented an expedited procedure, called “continuous review,” in order to analyze data on the safety and efficacy of vaccines developed against COVID-19 as they become available.
All three vaccines created by Pfizer / BioNTech, Moderna and Oxford / AstraZeneca have been undergoing this process for several weeks.
The accelerated procedure is applied to evaluate those products that can provide a solution in cases of public health emergency.
In normal times, all data related to a vaccine must be collected and published before submitting an application for authorization.
The European Medicines Agency must rule “no later than December 29” on the Pfizer / BioNTech vaccine and on January 12 on the vaccine developed by the American company Moderna.
The final authorization for the commercialization of vaccines must be confirmed by the European Commission.
Advisory Council in the United States
In the United States, both Pfizer / BioNTech and Moderna have requested authorization for the emergency use of their COVID-19 vaccines from the Food and Drug Administration (FDA).
The American procedure is slower than the British one and involves a public consultation process.
Before making a decision, the US agency conducts an internal assessment and then addresses an external advisory board. “The FDA procedure is completely transparent, independent experts comment, ask questions, advise the agency and make recommendations,” said Moncef Slaoui, coordinator of Operation Warp Speed, which aims to distribute vaccines developed against COVID-19.
Pfizer’s vaccine advisory board is scheduled for December 10 and Moderna’s for December 17.
The FDA should make a final decision immediately after these meetings. If approved, the two vaccines could be available starting in December in the United States, the country that paid the greatest tribute to the COVID-19 pandemic, killing more than 270,000 people.
Russia: simplification of the procedure
In Russia, the evaluation of products under development is provided by the Scientific Center of Expertise on Medicines of the Ministry of Health.
According to the official vaccine website, “unlike in many countries, there is a state-coordinated study system in Russia that uses comparative drugs, the double-blind method, and other controlled tests without the involvement of developers.”
President Vladimir Putin ordered the government to simplify the procedure for the Russian state to register certain drugs in order to speed up the validation procedure for COVID-19 vaccines.
Evaluation of the Sputnik-V vaccine began in mid-February and Phases 1 and 2 of the clinical trials were completed on August 1.
On August 11, Russian authorities approved the vaccine before phase 3 began. Meanwhile, that phase of clinical trials has ended, but its results are not yet known.
Vladimir Putin on Wednesday ordered the Russian authorities to begin “large-scale” vaccination of “populations at risk” next week. Vaccination of the general public should begin in early 2021.
