The European Medicines Agency (EMA) ended the continuous evaluation of the vaccine data against the COVID-19 developed by the German CureVac, after this pharmaceutical company communicated that it is abandoning the process to focus on another more advanced vaccine against the coronavirus.
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The entity received a notification from the German company communicating that it was withdrawing from the process that the Committee for Human Medicines (CHMP) initiated last February to review the data of the CVnCoV vaccine candidate as part of a real-time analysis, through which the pharmacist sends the data as it becomes available.
This process, known as “continuous review”, sought to accelerate the evaluation in order to a possible marketing license for the vaccine in the European Union (EU), in which for now Pfizer / BioNTech, Moderna, AstraZeneca and Janssen, from the American Johnson & Johnson, are already being administered in all member countries.
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The EMA had already received so far from CureVac lab data, from ongoing clinical studies, information on the quality and manufacturing process of the vaccine, and the risk management plan.
Although the EMA was accelerating its review of the data, some questions about the quality of the vaccine remained to be addressed, affecting the benefit-risk balance of the vaccine, added to the fact that the results of the main study showed only modest vaccine efficacy in adults, ”the agency noted.
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CureVac demonstrated an efficacy of 48%, according to results released last June from a clinical study conducted in 10 countries, including Peru.
In a letter sent to the Agency, the pharmacist explained that its withdrawal from the process is due to its decision to “Focus your efforts on a different COVID-19 vaccine development program,” which means that the EMA does not have to complete its CVnCoV review, unless the company requests a new assessment again in the future.
It is the first time since the pandemic began that a pharmacist retires of an evaluation process initiated with the EMA, and this decision leaves doubts for the people who have participated in the clinical trials carried out by CureVac, both about the current status of their vaccination and the recognition in the “covid passport”, associated with travel restrictions.
“They should contact the relevant authorities in their country of residence”, urges the EMA.
Last November, Brussels approved a contract with CureVac that provides for the purchase of 225 million doses, with the option to request up to an additional 180 million when the vaccine is approved, although it is not clear what will happen now with the acquired doses and if CureVac will try to replace them with another preparation.
CureVac is now working on a second-generation vaccine with the British company GlaxoSmithKline (GSK) and, calculating that this will be in an advanced stage when the previous EMA will comment on CVnCoV, the pharmaceutical company decided to close this process to focus on the other prepared, which is better suited to the “changing dynamics” of the pandemic.
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