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On Wednesday, the UK 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, regulatory authorities are analyzing several candidate vaccines for approval, AFP informs.
After the announcement on Wednesday by the British authorities, AFP reporters published a summary of the various procedures for approving COVID-19 vaccines in different regions of the world.
Analysis continues in the UK
The UK 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 examination procedure, used to review promising treatments in the event of a medical emergency. Therefore, the UK agency analyzed the data as it became available.
“Distinguished teams have worked in parallel,” day and night “, including weekends, to examine various aspects of vaccine safety without waiting for a phase to begin, explained another MHRA director June Raine, who also disputed the UK health minister’s claims that the MHRA had been able to act faster due to Brexit.
Unlike the European Medicines Agency (EMA), “the MHRA can ask a series of questions as they are answered, thus acting more quickly as one agency,” said Penny Ward, a doctor from the King’s College London.
Accelerated process in Europe
The Amsterdam-based EMA is responsible for the authorization and control of medicines marketed in the 27 Member States of the European Union. EMA has also implemented an accelerated procedure, called “continuous review”, in order to analyze data on the safety and efficacy of vaccines developed against COVID-19 as they become available.
The three vaccines created by Pfizer / BioNTech, Moderna and Oxford / AstraZeneca have undergone this process for several weeks.
The accelerated procedure is applied to evaluate those products that can provide a solution in the event of a 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 is expected to pronounce “by December 29” on the Pfizer / BioNTech vaccine and by January 12 on the vaccine developed by the American company Moderna.
The definitive authorization for the marketing of vaccines will then have to be confirmed by the European Commission.
Advisory Board in the United States
In the United States, both Pfizer / BioNTech and Moderna have applied for authorization for emergency use of their COVID-19 vaccines from the Food and Drug Administration (FDA).
The American procedure is slower than the British one, also involving a public consultation process.
Before making a decision, the US agency conducts an internal evaluation and then contacts an external advisory committee. “The FDA procedure is completely transparent, independent experts comment, ask questions, advise the agency and make recommendations,” Moncef Slaoui, coordinator of Operation Warp Speed, which aims to distribute vaccines developed against COVID-19, said Wednesday.
The Pfizer Vaccine Advisory Council is scheduled for December 10, and the Moderna Vaccine Advisory Committee is scheduled for December 17.
The FDA should make a final decision immediately following these meetings. If approved, the two vaccines could become available as early as December in the United States, the country that has paid the heaviest toll on the COVID-19 pandemic, killing over 270,000 people.
Russia: simplification of the procedure
In Russia, the evaluation of developing products is provided by the Scientific Center for Competence in Medicines of the Ministry of Health.
According to the official vaccine website, “unlike many countries, in Russia there is a state-coordinated study system that uses comparative drugs, the double-blind method and other controlled tests without the participation of developers.”
President Vladimir Putin has instructed the government to simplify the procedure for the registration of certain drugs by the Russian state in order to speed up the validation process of 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 1 August.
On 11 August, the Russian authorities approved the vaccine before the start of phase 3. That phase of clinical trials has meanwhile ended, but its results are not yet known.
Vladimir Putin on Wednesday ordered Russian authorities to begin “large-scale” vaccination of “at-risk populations” next week. Vaccination of the general public is expected to begin in early 2021.
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