Less than a year since the WHO declared the COVID-19 pandemic, two vaccines have now been approved for us in the EU, with two more under active review.
For the second time in three weeks, the European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for the use of a COVID-19 vaccine in adults. The move follows a thorough assessment of data on safety, efficacy and quality.
📢 EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent #COVID19 in people from 18 years of age: https://t.co/l9KMZlx7wa pic.twitter.com/BdvXanjOHN
— EU Medicines Agency (@EMA_News) January 6, 2021
‘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.’
The approval was based on a large trial involving 30,000 people. Half were given the new vaccine and half were given dummy injections. People did not know whether they received the vaccine or the placebo.
Trial data shows the vaccine to be highly effective, with two doses given 28 days apart. The most common side effects were usually mild or moderate and got better within a few days of vaccination. (Read more)
Cooke said that, as for all medicines, the vaccines will be closely monitored during its use. The EMA will host a public meeting on 8 January to discuss COVID-19 vaccines. This follows an earlier public forum held on 11 December.
Now we are working at full speed to approve it & make it available in the EU.
— Ursula von der Leyen (@vonderleyen) January 6, 2021
The news was welcomed by experts and by politicians across Europe, including the President of the European Commission which has now formally endorsed the EMA’s recommendation. The Commission has agreed to purchase tens of millions of doses of the new vaccine, along with hundreds of millions of doses of other vaccines currently in development.
How the new vaccine worksThe first two COVID-19 vaccines approved in Europe are mRNA vaccines. When a person is injected with the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The spike protein is the part of the virus responsible for COVID-19 and considered to be the target for protection.
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. The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.
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.
Saving lives and fighting the pandemic is our number one priority.
— Stella Kyriakides (@SKyriakidesEU) January 6, 2021
How vaccines are developed
Vaccines are subject to strict rules on safety and efficacy. Large trials are required to demonstrate that vaccines are safe and that they work across the population. This can take several years.
However, for COVID 19 vaccines regulators accepted ‘rolling reviews’ before trials were completed and companies began manufacturing vaccines even before they were approved. This ensured that the normal timeline was accelerated without cutting corners.