European regulator begins review of CureVac jab

By Busra Nur Cakmak

ANKARA (AA) – The European Medicines Agency (EMA) on Friday announced it has started a rolling review of German company CureVac’s COVID-19 vaccine.

The CHMP, the EMA’s human medicines committee, decided to begin the review of the CVnCoV vaccine “based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults,” the agency said.

“These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID‑19,” read a statement.

“The rolling review will continue until enough evidence is available for a formal marketing authorization application.”

CureVac said in a statement that the EMA will “assess CVnCoV’s compliance with standards for vaccine efficacy, safety, and pharmaceutical quality.”

“We are confident in the potential of our mRNA [messenger ribonucleic acid] technology to contribute to the fight against the global public health emergency that is COVID-19,” said Dr. Lidia Oostvogels, vice president area head for infectious diseases at CureVac.

“Working together with the EMA to initiate a rolling regulatory process is a critical step in enabling potential access to our vaccine by the many people who still need protection from this deadly disease.”

CureVac is among the six vaccine producers with whom the European Union, which has a population of around 450 million, signed advanced purchase agreements for about 2.3 billion doses.

The other five are Pfizer-BioNTech, Moderna, AstraZeneca, Johnson & Johnson, and Sanofi/GlaxoSmithKline.

On Wednesday, the bloc pushed forward its COVID-19 vaccination target date by three months, saying it now aims to vaccinate 70% of the adult population by the end of the summer instead of the beginning of the season.

The decision was announced by Ursula von der Leyen, president of the European Commission, who admitted that the EU had been “late to authorize vaccines” and was “too optimistic about massive production and expectations on timely delivery.”