Janssen’s Covid Vaccine, First Single-Dose, Approved in Europe: The European Medicines Agency (EMA) has officially approved Janssen’s Covid-19 coronavirus vaccine for the European Union this Thursday. It is the fourth against Covid-19 that receives the support of European scientists (after that of Pfizer, Moderna and AstraZeneca) and is the first that only needs one dose to immunize against this virus.
The Committee for Medicinal Products for Human Use (CHMP) of the EMA, made up of experts from the competent authorities of the different member states of the European Union, including the Spanish Agency for Medicines and Health Products (Aemps).
It has completed its scientific evaluation concluding by consensus that it has sufficiently robust data on the quality, safety and efficacy of the vaccine to recommend a conditional marketing authorization. In other words, the benefit-risk balance on which the evaluation of any drug is based is positive. In the United States, it was approved on February 27.
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Hours later, the European Commission has issued the marketing authorization of the vaccine. The conditional marketing authorization is an instrument contemplated in European legislation that allows authorization in the event of an unmet medical need, to the extent that the benefit for public health of its immediate availability is greater than the uncertainty derived from the limitation of the available data.
“The Commission has granted conditional marketing authorization for Johnson & Johnson’s vaccine. Four vaccines are now available for citizens of Europe and elsewhere. We will continue to work with the company to make deliveries as smooth as possible,” he announced. on the social network Twitter the Health Commissioner, Stella Kyriakides.
Janssen’s single-dose vaccine leverages the company’s ‘AdVac’ vaccine platform, which was also used to develop and manufacture the European Commission-approved Ebola virus vaccine and to develop its experimental vaccines. against Zika, RSV and HIV. It is stable in storage at 2/8 degrees Celsius for three months and -20 degrees for two years.
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