The green light for the Moderna vaccine from the European Medicines Authority (EMA) and the European Commission boosts Europe’s fight against the pandemic.
“With the Moderna vaccine, the second one now authorised in the EU, we will have a further 160 million doses. And more vaccines will come,” said Ursula von der Leyen, who heads the European Union executive.
The EMA granted conditional marketing approval two weeks ago for a similar vaccine from U.S. company Pfizer Inc and German partner BioNTech.
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA.
“It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.
“As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by scientific evidence and our commitment to safeguard the health of EU citizens.”
A very large clinical trial showed that COVID-19 Vaccine Moderna was effective at preventing COVID-19 in people from 18 years of age.
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 dummy injections.
Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of the 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 who received dummy injections 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 given as two injections into the arm, 28 days apart.
The most common side effects with COVID-19 Vaccine Moderna were usually mild or moderate and got better within a few days after vaccination.
How Moderna works
Moderna works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein.
This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein.
The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.
If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.
The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.
The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for COVID-19 Vaccine Moderna, allowing vaccination programmes to be rolled out across the EU.
Conditional marketing authorisation is one of EU’s regulatory mechanisms for facilitating early access to medicines that fulfil an unmet medical need, including in emergency situations such as the current pandemic.
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.