The EMA begins the review of the CureVac vaccine, the first step for its approval

Brussels has signed a contract for the supply of up to 400 million doses.

Clinical trial of the CureVac vaccine at the university clinic in Tuebingen (Germany)

A new vaccine against Covid-19 it could soon enter the portfolio of the European Union and help alleviate the current situation of dose shortages. The European Medicines Agency (EMA) began on Friday the continuous review of CVnCoV, the antigen it is developing German biotech company CureVac. This procedure is the prelude to the rapid approval of the vaccine, once all the data from the clinical trials are available.

Brussels has already signed a contract with CureVac which provides for the purchase initial 225 million doses, in addition to the option to request up to 180 million additional doses, which will be delivered once the vaccine has been shown to be safe and effective against the coronavirus. Spain would account for around 10% of the total, that is, up to 40 million doses.

The EMA has decided to initiate continuous review of the CureVac vaccine based on the preliminary results of laboratory studies and the first clinical studies in adults. These essays they suggest that the vaccine triggers the production of antibodies and immune cells that attack SARS-CoV-2, the virus that causes COVID-19. CureVac’s antigen is based on the same messenger RNA technology as those from Pfizer-BioNTech and Moderna, which have already been authorized by the EU.

The company is currently conducting phase 3 trials in people to assess the safety, immunogenicity (how well it triggers a response against the virus), and effectiveness of the COVID-19 vaccine. The EMA will evaluate data from these and other clinical trials as they become available.. Ongoing review will continue until sufficient evidence is available for a formal application for marketing authorization.

In addition to the advance paid by Brussels after signing the contract (the amount of which is not public), the European Investment Bank granted on July 6 a loan of 75 million for the development and large-scale production of vaccines. A movement that occurred after the attempt of the former president of the United States, Donald Trump, to acquire the exclusivity of the CureVac vaccine against the coronavirus.

CureVac has reached an agreement with the pharmaceutical giant Bayer, which has not developed any antidote of its own, for manufacture your Covid vaccine in Germany. In total, Bayer plans to deliver 160 million extra punctures from CureVac through 2022.

So far, the EMA has given the green light to three vaccines: Pfizer, Moderna and AstraZeneca. The next one to be approved will likely be Janssen’s in the next few weeks.. In addition, the Agency has under continuous review the antigen from Novavax (a company with which Brussels negotiates a contract for 200 million doses) and from this Friday that of CureVac.

In contrast, the EMA has insisted this week that has not received any request to authorize the Russian Sputnik V vaccine, not even for continuous review. Furthermore, the European Commission has reiterated that it has no intention of adding it to its antigen portfolio, despite the fact that Hungary has started to use it on its own.

The President of the Commission, Ursula von der Leyen, has repeated this Friday that it maintains its objective that 70% of the adult population of the EU is vaccinated by the end of the summer, which would allow achieving group immunity and ending the pandemic. The end of summer is September 21, the president specified.