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The European Medicines Agency (EMA) reports that it has started the approval process for the so-called Oxford vaccine, which is produced by the pharmaceutical giant AstraZeneca.
Evaluate the information continuously
This is done through a process they call “continuous review,” an ongoing evaluation, where the EMA continually assesses the information that comes from clinical trials.
Typically, the EMA does not begin evaluating results until pharmaceutical companies formally request approval of a drug.
– An “ongoing review” is one of the tools the agency can use to accelerate evaluations of a promising drug or vaccine during a public health crisis. Normally, all data on the efficacy, safety and quality of a vaccine, and all other necessary documents, will be provided at the beginning of an evaluation in the form of a formal application for marketing authorization. In an “ongoing review,” data is reviewed as it becomes available, before deciding if enough data is available, EMA writes.
It will start the process earlier to save time.
The purpose is simply to shorten the approval process, as those who must approve the vaccine can begin the work of familiarizing themselves with the documentation at an earlier stage.
– The decision to initiate this process is based on preliminary results from early clinical and non-clinical studies that suggest that the vaccine initiates the production of antibodies and T cells that attack the virus, EMA writes.
According to the EMA, more information about the large clinical trial, which is being carried out in several countries, will arrive in the coming weeks and months.
I don’t know when the final approval will come
They emphasize that this process does not mean that the vaccine is already approved and that the requirements for its approval are lowered.
– EMA will carry out the evaluations in accordance with the usual standards of quality, safety and efficiency. Currently, a timeline cannot be given for the entire process, but the process must be shorter than a normal evaluation. This process has previously been used to evaluate the covid-19 drug Veklury (remdesivir), EMA writes.
The AstraZeneca vaccine has always been the vaccine that has been at the forefront of the vaccine race, and the hope for the Norwegian health authorities is that the first doses of vaccine will arrive in Norway around the New Year.
