EMA Human Drugs Committee (CHMP) launches rolling review of Ad26.COV2.S, a vaccine COVID-19 by Janssen Vaccines & Prevention BV, announced the European Medicines Agency.
The CHMP decision to start the rolling review is based on preliminary results from laboratory studies and early clinical trials in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 virus.
As announced, “the company is currently conducting in-person testing to assess safety and immunogenicity (how well the vaccine elicits a response to the virus) and efficacy. The EMA will evaluate data from these and other clinical trials when available.
"The rolling assessment will continue until there is enough evidence for a formal marketing authorization application," it said.
The EMA will assess the vaccine's compliance with standard efficacy, safety and quality standards and states that "although the EMA cannot predict overall timing, it will take less rolling background ”.
The EMA notes in a written statement that "like other vaccines, Ad26.COV2.S is expected to prepare the body to defend itself against infection." "The vaccine contains genetic instructions for a protein known as spike protein (S) which is present on the surface of the SARS-CoV-2 coronavirus. When a person receives the vaccine, their cells will read the genetic instructions and produce the spike protein. The individual's immune system will treat this protein as foreign and will produce natural defenses - antibodies and T cells - against it. If later, the vaccinated person comes in contact with SARS-CoV-2, the immune system will recognize the virus and be ready to attack it. Antibodies and immune cells can work together to kill the virus, prevent it from entering the body's cells and destroy infected cells, helping to protect against COVID-19", He explains.
EMA explains that "a rolling assessment is a regulatory tool used by the EMA to accelerate the assessment of a promising drug during a public health emergency."
"Normally, all data on the efficacy, safety and quality of a drug or vaccine and all the required documents should be ready at the start of the evaluation in a formal marketing authorization application," he said.
"In the case of a rolling assessment, the EMA Human Medicines Committee (CHMP) is reviewing the data as it is available from ongoing studies," he said.
"Once the CHMP decides that there is sufficient data, the company should then submit a formal application. "Looking at the data as it is available, the CHMP can give an opinion on the approval of the drug earlier", concludes EMA
Source: KYPE