Global scientific research efforts are focused on the development of COVID-19 vaccines to make them available as soon as possible.
Vaccines are only authorised in the EU once the safety, effectiveness and quality of the vaccine has been proven. These reviews are carried out by the European Medicines Agency (EMA).
Ireland’s national regulator, the Health Products Regulatory Authority (HPRA), participates in all EMA reviews of new medicines and vaccines. The HPRA will also be responsible for continuing to monitor the safety of vaccines in Ireland once in use.
To date, the European Commission has authorised the use of the Pfizer/BioNTech COVID-19 vaccine and the COVID 19 vaccine developed by Moderna.
Benefits of the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty) as shown in clinical trials
A clinical trial of around 44,000 people has shown that the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty) was effective at preventing COVID-19 in people from 16 years of age.
Half of the participants received the vaccine and half were given a dummy injection. People did not know whether they received the vaccine or the dummy injection.
was calculated in over 36,000 people from 16 years of age (including people over 75 years of age) who had no sign of previous infection.
The study showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (8 cases out of 18,198 got COVID-19 symptoms) compared with people who received a dummy injection (162 cases out of 18,325 got COVID-19 symptoms). This means that the vaccine demonstrated a 95% efficacy in the trial.
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.
Can people who have already had COVID-19 be vaccinated with the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty)
There were no additional side effects in the 545 people who received the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty) in the trial and had previously had COVID-19.
There were not enough data from the trial to conclude on how well the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty) works for people who have already had COVID-19. More information is available here.
Development and approval of other COVID-19 vaccines
The European Commission authorised the use of the Pfizer/BioNTech COVID-19 vaccine in December 2020. The Commission has also granted a conditional marketing authorisation (CMA) for the COVID 19 vaccine developed by Moderna, the second COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA).
There are also a number of other COVID-19 vaccines in development. The EMA is working closely with developers of these potential vaccines. This is to ensure that COVID-19 vaccines complete a robust assessment and approval process as soon as possible.
The COVID-19 EMA pandemic Task Force
is at the centre of the efforts to enable EMA, the European medicines regulatory network and the European Commission to take quick and collective action across all EU Member States.
A vaccine can only be approved for use once the necessary safety and efficacy data from clinical trials, involving thousands of people, are submitted to the EMA.
The safety requirements for COVID-19 vaccines are the same as for any other vaccine in the EU and will not be lowered as a result of the pandemic. What is different for COVID-19 vaccines is the level of funding available and the speed of the vaccine development.
The development and approval process is happening in parallel in a ‘rolling review process’ rather than through the usual process where one step has to be passed before the next step to approval is started.
The European Commission will use all existing resources to speed up the authorisation of any additional potential vaccines for use across the EU. But this will only be possible if the EMA receives the scientific evidence needed to show that a vaccine's benefits are greater than any risks.
The EMA has lots of information available on its website
about the assessment and approval of COVID-19 vaccines. You can also find more information on how vaccines and other medicines are evaluated and approved in the EU on: