[D66] EMA keurt Janssen vaccin goed (Wuhan Coronavirus 2019-nCoV #579, addendum)

[Dr. Marc-Alexander Fluks]

Bron:  European Medicines Agency
Datum: 11 maart 2021
URL:   
https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-janssen-authorisation-eu
WebTV: https://www.youtube.com/watch?v=lueDhuK1gto


EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU
-------------------------------------------------------------------

EMA has recommended granting a conditional marketing authorisation for 
COVID-19 Vaccine Janssen to prevent COVID-19 in people from 18 years of 
age.

After a thorough evaluation, EMA's human medicines committee (CHMP) 
concluded by consensus that the data on the vaccine were robust and met 
the criteria for efficacy, safety and quality. COVID-19 Vaccine Janssen 
is the fourth vaccine recommended in the EU for preventing COVID-19.

'With this latest positive opinion, authorities across the European 
Union will have another option to combat the pandemic and protect the 
lives and health of their citizens,' said Emer Cooke, EMA's Executive 
Director, adding, 'this is the first vaccine which can be used as a 
single dose'.

Results from a clinical trial involving people in the United States, 
South Africa and Latin American countries found that COVID-19 Vaccine 
Janssen was effective at preventing COVID-19 in people from 18 years of 
age. This study involved over 44,000 people. Half received a single dose 
of the vaccine and half were given placebo (a dummy injection). People 
did not know if they had been given COVID-19 Vaccine Janssen or placebo.

The trial found a 67% reduction in the number of symptomatic COVID-19 
cases after 2 weeks in people who received COVID-19 Vaccine Janssen (116 
cases out of 19,630 people) compared with people given placebo (348 of 
19,691 people). This means that the vaccine had a 67% efficacy.

The side effects with COVID-19 Vaccine Janssen in the study were usually 
mild or moderate and cleared within a couple of days after vaccination. 
The most common ones were pain at the injection site, headache, 
tiredness, muscle pain and nausea.

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 European authorities.


Where to find more information

The product information for COVID-19 Vaccine Janssen contains 
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 Janssen 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.

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.


How COVID-19 Vaccine Janssen works

COVID-19 Vaccine Janssen works by preparing the body to defend itself 
against COVID-19. It is made up of another virus (an adenovirus) that 
has been modified to contain the gene for making the SARS-CoV-2 spike 
protein. This is a protein on the SARS-CoV-2 virus which it needs to 
enter the body's cells.

The adenovirus passes the SARS-CoV-2 gene into the vaccinated person's 
cells. The cells can then use the gene to produce the spike protein. The 
person's immune system will recognise the spike protein as foreign and 
produce antibodies and activate T cells (white blood cells) to target 
it.

Later, if the person comes into contact with SARS-CoV-2 virus, the 
vaccinated person's immune system will recognise the spike protein on 
the virus and be ready to defend the body against it.

The adenovirus in the vaccine cannot reproduce and does not cause 
disease.

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 Janssen, allowing vaccination programmes to be rolled 
out across the EU.

Conditional marketing authorisation (CMA) is used as the fast-track 
authorisation procedure to speed up approval of treatments and vaccines 
during public health emergencies in the EU. CMAs allow authorisation of 
medicines that fulfil an unmet medical need on the basis of less 
complete data than normally required. This happens if the benefit of a 
medicine or vaccine's immediate availability to patients outweighs the 
risk inherent in the fact that not all the data are yet available.

A CMA guarantees that the approved medicine or vaccine meets rigorous EU 
standards for efficacy, safety and quality and is manufactured in 
approved, certified facilities in line with high pharmaceutical 
standards for large-scale production.

Once a CMA has been granted, companies must provide further data from 
ongoing or new studies within pre-defined deadlines to confirm that the 
benefits continue to outweigh the risks.


Monitoring the safety of COVID-19 Vaccine Janssen

In line with the EU's safety monitoring plan for COVID-19 vaccines, 
COVID-19 Vaccine Janssen 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 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 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 any necessary regulatory 
action to protect public health.


Assessment of COVID-19 Vaccine Janssen

During the assessment of COVID-19 Vaccine Janssen, the CHMP had the 
support of EMA's safety committee, PRAC, who assessed the risk 
management plan of COVID-19 Vaccine Janssen, 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.

--------
(c) 2021 EMA