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the vaccine anti Covid Pfizer / BioNTech was the first to obtain a license in United Kingdom by Mhra (Medicines and Health Products Regulatory Agency), the English institution is independent from the European Medicines Agency – Ema – and used an emergency clearance procedure, based on ongoing review (Ed.). The British temporary authorization is different from the one provided by the EMA, “The English procedure is emergency, so they only authorize the use of the experimental lot extending it to the general population, while the EMA sees the quality data potentially of the entire production plan (without prejudice to the control that is made in each batch, so for a few days of difference looking at all the data is certainly more reasonable and prudent – Indicates Guido Rasi, former executive director of the EMA -. If only I data partial how is he Mhra, you also run minimal risk. Fda it didn’t, and the vaccine is American. In this way the British – he adds – very few people get vaccinated but they do a lot of publicity. In twenty days they will have the work done by Mom. Personally, I would have expected a solid one. review of all the available data, that the British government did not do to be able to say that without Europe we are the first. While we, in Europe, in 25 years we have never had health problems due to quality (GMP standards, good manufacturing practices) ”.
GREAT BRITAIN EMERGENCY AUTHORIZATION (MHRA) – Temporary emergency authorization is a regulatory tool that allows some countries to supply and use an unauthorized drug (or a drug licensed in an unapproved indication) in some specific types of public health emergencies, such as Covid. It should be noted that the temporary authorization of the vaccine by the MHRA it is not a marketing authorizationIn fact, “continuous review is a review of data as it arrives,” he explains. Antonella Viola, an immunologist from the University of Padua – this speeds up the times because instead of waiting for the company to conclude everything and then send the data, the data is reviewed as soon as it is available – and concludes – Ema also did a continuous review but earlier to approve the drug with Cma (“conditional authorization”) and wants to review all the documents and take a few more days”.
The authorization procedure reduces time and has been specifically designed to allow temporary availability and use in emergency situations for the duration of the emergency. It can be revoked at any time if the situation evolves or when the Mhra (Medicines and Health Products Regulatory Agency) issues a standard marketing authorization, precisely because a different level of submitted evidence and controls required for marketing authorization is required. Emergency procedures are not always foolproof, for example, when shortcuts are taken there may be uncalculated risks: “If the shortcut means that you are not doing well in Phase 3 studies, there may be problems – Antonella Viola reminds us – China and Russia have registered vaccines without completing Phase 3 on efficacy and safety. This is very risky”.
THE DIFFERENCES WITH THE AUTHORIZATION OF THE EUROPEAN AUTHORITY (EMA) – Currently, Ema has received the “conditional” marketing authorization request for the vaccine developed by BioNtech and Pfizer (mRNA BNT162b2), and for the Modern Covid-19 vaccine (MRNA1273), on December 1. The European Agency issued an official statement, immediately after Great Britain authorized the vaccine, in which it clarifies its position “the conditional marketing authorization” (CMA) It is the most appropriate regulatory mechanism to use in the current pandemic emergency., to guarantee access to a vaccine for all citizens of the European Union and to support mass vaccination campaigns. A Cma application is supported by a large amount of data submitted by companies to demonstrate the quality of a vaccine, its proper functioning, and its safety. Provides a solid and controlled framework, which ensures that all pharmacovigilance controls, production controls, including vaccine batch controls and other post-approval obligations apply in a legally binding manner and are evaluated and implemented by EMA’s scientific committees on an ongoing basis. These are essential elements to guarantee a high level of protection to citizens during a mass vaccination campaign ”. Ema began reviewing vaccine data from Pfizer / BioNTech on October 6. The evaluation is ongoing and will conclude when the Scientific Committee for Medicinal Products for Human Use (CHMP) meets for an extraordinary meeting scheduled for December 29 at the latest.
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