[D66] Persbericht: Persconferentie Moderna-coronavaccin (5)

[Dr. Marc-Alexander Fluks]

Bron:  European Medicines Agency (EMA)
Datum: 6 januari 2021
URL:   
https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-moderna-authorisation-eu
Opm:   Vandaag nog zal de Europese Commissie het vaccin
       goedkeuren voor gebruik in de Europese Unie


EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU
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EMA has recommended granting a conditional marketing authorisation for 
COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in 
people from 18 years of age. This is the second COVID-19 vaccine that 
EMA has recommended for authorisation.

EMA's human medicines committee (CHMP) has thoroughly assessed the data 
on the quality, safety and efficacy of the vaccine and recommended by 
consensus a formal conditional marketing authorisation be granted by the 
European Commission. This will assure EU citizens that the vaccine meets 
EU standards and puts in place the safeguards, controls and obligations 
to underpin EU-wide vaccination campaigns.

'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 the 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 the dummy injections.

Efficacy was calculated in around 28,000 people from 18 to 94 years of 
age 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 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. 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 pharmacovigilance system and 
additional studies by the company and by European authorities.


Where to find more information

The product information approved by the CHMP for COVID-19 Vaccine 
Moderna contains prescribing information for healthcare professionals, a 
package leaflet for members of the public and details of conditions of 
the vaccine's authorisation.

An assessment report with details of EMA's evaluation of COVID-19 
Vaccine Moderna, and the full risk management plan, will be published 
within 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.
https://clinicaldata.ema.europa.eu/web/cdp/home

More information is available in an overview of the vaccine in lay 
language, including a description of the vaccine's benefits and risks 
and why EMA recommended its authorisation in the EU.
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/covid-19-vaccine-moderna


How COVID-19 Vaccine Moderna works

COVID-19 Vaccine 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.


Conditional marketing authorisation

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.

A 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.

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

As COVID-19 Vaccine Moderna is recommended for a conditional marketing 
authorisation, the company that markets COVID-19 Vaccine Moderna will 
continue to provide results from the main trial, which is ongoing, for 2 
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.


Monitoring the safety of COVID-19 Vaccine Moderna

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.


Assessment of COVID-19 Vaccine Moderna

During the assessment COVID-19 Vaccine Moderna, the CHMP had the support 
of EMA's safety committee, PRAC, who assessed the risk management plan 
of COVID-19 Vaccine Moderna, and the COVID-19 EMA pandemic task force 
(COVID-ETF), a group that brings together experts from across the 
European medicines regulatory network to facilitate rapid and 
coordinated regulatory action on medicines and vaccines for COVID-19.

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(c) 2021 EMA