ZAGREB, Dec 21, 2020 – The director of Croatia’s Agency for Medicinal Products and Medical Devices (HALMED) said on Monday the European Medicines Agency’s approval of the first COVID-19 vaccine confirmed that all Croatian citizens could be sure to have access to an effective vaccine whose benefits outweighed possible risks.
Earlier today, EMA recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent COVID-19 in people from 16 years of age.
EMA’s human medicines committee has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available, HALMED said in a press release.
HALMED evaluators have participated in this procedure from the start as members of EMA’s scientific commissions and working groups, Tomic said. “After the vaccine is put on the market, we will continue to intensively monitor the efficacy and safety of its application together with the Croatian Institute of Public Health and other regulators in the European Union.”
EMA’s scientific opinion will be submitted to the European Commission that will decide by tomorrow at the latest to grant marketing authorisation, which will be valid in all EU and European Economic Area member states, including Croatia.
The Comirnaty clinical trial involved around 44,000 people and showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine, HALMED said.
The trial also showed around 95% efficacy in the participants at risk of severe COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or a body mass index ≥ 30 kg/m2.
Comirnaty is given as two injections at least 21 days apart. The most common side effects were usually mild or moderate and got better within a few days after vaccination.
As Comirnaty is recommended for a conditional marketing authorisation, the company that markets it will continue to provide results from the main trial, which is ongoing for two years. This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.
The company will also carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine as the manufacturing continues to be scaled up. Comirnaty will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines.
Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated, HALMED said.
