“Well, we need more data”

Published on: 12/30/2020 6:38 PM

“Additional scientific information On issues related to the quality, safety and efficacy of AstraZeneca’s “anti-Covid” vaccine are it is considered necessary to support the rigor required for a conditional marketing authorization “in the EU” and this was requested from the company. “This was communicated by the European Medicines Agency Ema, officially clarifying where ‘process of the shield product in question, on the day in which the British regulatory body gave the go-ahead in GB. “We are aware – the EU authority notes in an update on the ongoing ‘continuous review’ of the AstraZeneca vaccine: the fact that the British agency Mhra has granted a temporary authorization for the supply of the vaccine in the context of emergency use, which is different from the marketing authorization. Ema, its European experts and the European Commission are working for a conditional marketing authorization for Covid vaccines, with all the guarantees, controls and obligations that this imposes ”.

The evaluation of the vaccine developed by the universities of Oxford and Irbm and produced by AstraZeneca “has been carried out in recent weeks – says Ema -“. More information from ongoing clinical trials is expected from January.. Interim data from a large study underway in the United States is expected in the first quarter of 2021. “The Agency is currently evaluating the vaccine data as part of an ongoing review.” So far, some tests on safety and security have been evaluated. efficacy from an interim pooled analysis of clinical data from four ongoing clinical trials in the UK, Brazil and South Africa. The last package was received on December 21 and is currently under evaluation. The CHMP technical committee has already evaluated the data from laboratory studies (non-clinical data) and is currently evaluating data on the quality of the vaccine (on its ingredients and on the way it is produced), ”the agency updates.

For the AstraZeneca vaccine “the evaluation will be completed according to the usual standards of quality, safety and efficacy”, underlines the European Medicines Agency. And it explains that the assurance that the shield product meets “strict EU standards” is ensured “through: full prescribing information and a package insert with detailed instructions for safe use, robust risk management and a safety control plan; production controls, including batch and storage conditions; a research plan for use in children; legally binding post-approval obligations and a clear legal framework to assess emerging efficacy and safety data “lists the body.

AstraZeneca’s Covid vaccine consists of a virus from the adenovirus family (which cannot reproduce and does not cause disease), modified to contain the gene for the production of the Sars-CoV-2 Spike protein, which is necessary to provoke an immune response of the body.

THE RESPONSE OF THE PHARMACEUTICAL COMPANY – A spokesperson, contacted by Adnkronos, explains that AstraZeneca has provided “a complete data package to support the request for a conditional marketing authorization for the Covid-19 vaccine made to the European Medicines Agency.” “It has submitted data on an ongoing basis and will continue to work closely with the EMA to support the initiation of a formal conditional marketing authorization application process,” Cma in technical jargon. “A similar approach has been taken of providing data on a continuous basis to regulatory agencies around the world.”

UNDER SECRETARY ZAMPA – “Good news. AstraZeneca has sent data on the” anti-Covid “vaccine to Ema. Undersecretary of Health, Sandra Zampa, writes on Twitter. We await the result of the evaluations” from the European Medicines Agency with fear. “A second piece of good news. The Moderna vaccine is already being tested by Ema.”

ASTRAZENECA IN USA – The United States plans to approve AstraZeneca’s Covid vaccine in April. US tests and evaluations will be completed for approval “in early April,” Moncef Slaoui, senior adviser to Warp Speed, the US military vaccine operation, told reporters. “If the data allows approval, tens of millions of doses will be produced,” he concludes.