Coronavirus: EMA gives positive opinion for Moderna vaccine

date: 06/01/2021

The European Medicines Agency (EMA) issued a positive opinion for “COVID-19 Vaccine Moderna”, making it the second COVID-19 vaccine to be authorised for marketing in the European Union. This recommendation still has to be confirmed by the European Commission. Belgium has purchased the vaccine and will use it in its vaccination campaign.

The Committee for Medicinal Products for Human Use (CHMP) of the EMA has thoroughly assessed data on the quality, safety and efficacy of the vaccine and recommended by consensus that a formal conditional marketing authorisation should be granted by the European Commission. EU standards are met and allow a vaccination campaign that is consistent with the requirements of the European Union.

A very large clinical trial showed that the Moderna vaccine was effective at preventing COVID-19 in people over 18 years old.

The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections. Efficacy was calculated in around 28,000 people from 18 to 94 years who had no sign of previous infection.

The trial showed a 94.1 % reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1 % efficacy in the trial.

The trial also showed 90.9 % efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection. The high efficacy was also maintained across genders, racial and ethnic groups.

COVID-19 Vaccine Moderna is administered as two injections into the arm, 28 days apart. The most common side effects of the COVID-19 Vaccine Moderna were usually mild or moderate and got better within a few days after vaccination. The most common side effects are pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU and the Member States' pharmacovigilance system and additional studies by the company and by European authorities.

How does the COVID-19 Vaccine Moderna work?
The COVID-19 Vaccine Moderna is a messenger RNA (mRNA) vaccine. These vaccines contain the genetic code (mRNA) of viral particles against which our immune system will react. The mRNA is encapsulated within lipid particles so that it reaches the body's cells more easily. Lipid particles are not toxic or harmful. Our body uses the messenger RNA to make some of the virus' proteins itself. Our immune system will react against these proteins. In the event of a subsequent infection, the body will remember these proteins. It will produce specific antibodies to destroy the virus in order to protect us from the disease.

Where to find more information?
The product information approved by the CHMP for COVID-19 Vaccine Moderna contains information for healthcare professionals, a package leaflet for members of the public and the conditions of the vaccine's marketing authorisation. This information will soon be available in Belgium's national languages.

An assessment report with details of EMA's evaluation of COVID-19 Vaccine Moderna, and the full risk management plan, will be published within a few days. Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency's clinical data website in due course.

More information is available in an overview of the vaccine in simple language, including a description of the vaccine's benefits and risks and why the EMA recommended its authorisation in the EU.

Conditional marketing authorisation with safety monitoring
A conditional marketing authorisation is one of EU's regulatory mechanisms for facilitating early access to medicines that fulfil a necessary medical need, including in emergency situations such as the current pandemic.

A conditional marketing authorisation is a formal authorisation of the vaccine, covering all batches produced for the EU and providing a robust assessment.

Moderna 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.

In line with the EU’s safety monitoring plan for COVID-19 vaccines, COVID-19 Vaccine Moderna 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.

Companies are required to provide monthly safety reports in addition to the regular updates required by the legislation and conduct studies to monitor the safety and effectiveness of the vaccines as they are used by the public. In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine's long-term safety and benefit in the general population.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health if needed.

Already purchased by Belgium
Subject to its marketing authorisation, the Moderna vaccine had already been purchased on 2 December 2020 by the Belgian authorities. Two million doses are reserved for 2021.

More information
COVID-19 vaccines
Questions and answers on COVID-19 vaccines (in Dutch or French)

Last updated on 06/01/2021