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The first results suggest that the vaccine works.
This Tuesday, the European Medicines Agency (EMA) announced that they have started the approval process for the corona vaccine from the pharmaceutical company BioNTech, which collaborates with the giant Pfizer. The vaccine has been given the resounding name BNT162b2.
This is the second vaccine that the EMA has begun to approve.
Also read: The EU has started the approval process for the first corona vaccine
The approval process is done through a “continuous review”, which means that the EMA assesses the company’s data on an ongoing basis.
Typically, the EMA does not begin evaluating results before pharmaceutical companies formally request approval of a drug, but the purpose of ongoing evaluation is that the approval process itself should take as little time as possible.
– The start of a continuous evaluation means that the committee has started the evaluation of the first part of the vaccine data, which comes from laboratory studies. This is not to say that a conclusion is drawn on the efficacy and safety of the vaccine, as much of the evidence has not been presented, EMA writes.
Signs that the vaccine is working
– The decision to initiate a continuous evaluation of BNT162b2 is based on preliminary results from early clinical and non-clinical studies in adults, which suggest that the vaccine triggers the production of antibodies and T cells that attack the virus, EMA writes.
Also read: The body can get two different types of immunity to covid-19: the difference between antibodies and T cells
Last week, BioNTech published a report in Nature describing positive results from phase 1/2 studies.
BioNTech’s vaccine is the so-called mRNA vaccine, which has never before been approved for use in humans. This vaccine does not supply parts of the virus to the body, but instead gives the body a prescription for how to do this.
– When a person receives the vaccine, the cells will read the genetic instructions and produce the coronavirus spike protein. The person’s immune system will treat this protein as an invader and produce the natural defenses: antibodies and T cells. If the person later comes in contact with the coronavirus, the immune system will recognize the virus and attack it, EMA writes:
Also read: Vaccine technology has never been used before, now it can save the world
No end date set
They say the evaluation will continue until there is sufficient evidence for the safety and efficacy of the vaccine.
The vaccine is one of several with which the EU has entered into procurement agreements and to which Norway will have access if approved.
In the United States, this is one of two vaccines that authorities have expressed in the hope that they will be ready by November.
Also read: The EU has started the approval process for the first corona vaccine
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