SECOND CONSECUTIVE EVALUATION OF A COVID-19 VACCINE IN THE EU BEGINS

Filenews 6 October 2020

The European Medicines Commission 's (EMA) Committee for Medicinal Products (CHMP) has launched a rolling review of a COVID-19 vaccine, known as BNT162b2, developed by BioNTch in collaboration with Pfizer.

The initiation of the ongoing evaluation means that the Commission has started to evaluate the first batch of vaccine data from laboratory studies (non-clinical data). This does not mean that a further conclusion can be drawn on the safety and efficacy of the vaccine, as many of the data have not yet been submitted to the Commission.

The CHMP's decision to initiate an ongoing evaluation of the BNT162b2 vaccine is based on preliminary results from non-clinical and early clinical studies suggesting that the vaccine activates the production of antibodies and T cells (immune cells, the body's natural defenses) targeted by the virus.

Large-scale clinical trials involving several thousand people are continuing and results will be available in the coming weeks and months. These results will provide information on how effective the vaccine is in protecting people from COVID-19 and will be evaluated when available. All available vaccine safety data resulting from these studies, as well as data on its quality (such as its components and how it is produced), will also be examined.

The ongoing evaluation will continue until sufficient evidence is available for the taxiing of the usual application for a marketing authorisation.

The EMA will complete its evaluation in accordance with the usual standards of quality, safety and effectiveness. Although the overall evaluation schedule cannot yet be foreseen, the process should be shorter than a normal evaluation due to the time gained during the continuous evaluation.

How the vaccine is expected to work:

BNT162b2 is expected to work by preparing the body to defend itself from infection with the SARS-CoV-2 coronavirus. The virus uses proteins on its outer surface, called spike proteins, to enter the body's cells and cause disease. BNT162b2 contains the genetic guidelines (mRNA) for these proteins and is covered by small fats (lipid particles) that prevent the degradation of mRNA. When a person receives the vaccine, his cells will read the genetic instructions and produce the protein. The person's immune system will then treat this protein as foreign and produce natural defenses - antibodies and T cells - against it. If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the virus and be ready to attack it: antibodies and T cells can work together to kill the virus, preventing cells from entering the body and destroying infected cells, thus helping to protect against COVID-19.

What is a rolling review:

Continuous evaluation is one of the regulatory tools the EMA uses to speed up the evaluation of a promising drug or vaccine during a public health emergency. Under normal circumstances all data on the efficacy, safety and quality of a medicinal product and all required documents must be submitted at the start of the evaluation for a formal marketing authorisation. In the ongoing evaluation, the CHMP of the EMA examines the data as they become available from continuous studies, even before a formal application is made. Once the CHMP has decided that sufficient data are available, the formal application must be submitted by the company. By examining the data as they become available, the CHMP may give an opinion earlier on whether the medicinal product or vaccine should be approved.

Source: eyenews