Thursday 11th March 2021 | translated by MIKE SMITH
The European Medicines Agency (EMA) has recommended that a conditional marketing authorization be granted for the COVID-19 vaccine developed by Janssen (a Johnson & Johnson company). This drug, which prevents the disease caused by SARS-CoV-2 in people over 18 years of age, will thus become the fourth vaccine to receive the approval of European regulators, after those promoted by BioNTech and Pfizer, Moderna and AstraZeneca. Of these, this is the only one that will be administered in a single dose.
On December 1st, COVID-19 Vaccine Janssen began the so-called rolling review, an exceptional mechanism activated by the EMA due to the health emergency, by which the data is evaluated as it is generated. This scientific evaluation has concluded today and has had the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the EMA, made up of experts from the competent authorities of the different EU Member States, among them the Spanish Agency for Medicines and Health Products (AEMPS). CHMP has concluded 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.
The European Commission (EC) will now be in charge of granting this conditional marketing authorization so that it can be distributed in all EU member states, as is the case with other medicines authorized by centralized procedure.
The conditional marketing authorization is an instrument contemplated in European legislation that allows an 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 data available. This type of authorization is not specific to this situation; it has been granted outside and inside the pandemic and requires more data than an authorization for emergency situations such as that granted in other regulatory regions.
A clinical trial with 44,000 participants
The COVID-19 Vaccine Janssen is composed of another virus (adenovirus) modified to contain the gene responsible for the formation of the SARS-CoV-2 spike protein. This protein is found on the surface of the SARS-CoV-2 virus, necessary for the virus to enter the cells of the body.
The results of the clinical trial carried out in the United States, South Africa and Latin America have shown that this vaccine complies with the guarantees of quality, safety and efficacy to prevent COVID-19 in people from 18 years of age. Around 44,000 people have participated in this study, which has been carried out with a double-blind design, in which the vaccine or a placebo is administered masked in a way that prevents its identification with the naked eye.
The clinical trial showed a 67% reduction in the number of symptomatic COVID-19 cases after two weeks in people who received the Janssen vaccine (116 cases out of 19,630), compared to those who received placebo (348 out of 19,691).
Adverse reactions were usually mild or moderate and disappeared within a couple of days after vaccination. The most frequent were pain at the injection site, headache, fatigue, muscle pain, and nausea.
The safety and efficacy of the vaccine is monitored among all Member States, through the pharmacovigilance system and additional studies to be carried out by the company and the European authorities.
Currently, Janssen is conducting two clinical trials in Spain with this vaccine, in phase 2 and phase 3, to determine the efficacy in adolescents and other populations that have not been included in the pivotal trial, as well as the efficacy of the administration. two doses instead of just one.
Press Release – Ministerio de Sanidad, Gobierno de España