|
31-12-2020 10:26 |
|
EMA’s assessment of the
COVID-19 vaccine being developed by AstraZeneca and Oxford University has
been progressing over the past weeks. The Agency is currently assessing data
on the vaccine as part of a rolling
review. So far, some evidence has been assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa. The latest clinical package was received on the 21 December and is currently being assessed. CHMP has already assessed data from laboratory studies (non-clinical data) and is currently assessing data on the vaccine’s quality (on its ingredients and the way it is manufactured). Additional
scientific information on issues related to quality, safety and efficacy of
the vaccine is deemed necessary to support the rigour required for a
conditional marketing authorisation and this has been requested from the
company. Further
information from the ongoing clinical trials is also expected from January.
Interim data from a large trial ongoing in the USA are expected in Q1 2021. EMA is
aware that the UK
MHRA has granted a temporary authorisation of supply of the vaccine in
the emergency use setting, which is distinct from a marketing authorisation.
EMA, its European experts and the European Commission are working towards
conditional marketing authorisation of COVID-19 vaccines, with all the
safeguards, controls and obligations that this imposes. It guarantees that
the vaccine meets rigorous EU standards for safety, efficacy and quality and
comes with:
EMA will
complete its assessment according to its usual standards for quality, safety
and effectiveness. A marketing authorisation ensures that COVID-19 vaccines
meet the same high EU standards as for all vaccines and medicines. More about the vaccine The
vaccine, called COVID-19 Vaccine AstraZeneca, is expected to work by
preparing the body to defend itself against infection with the coronavirus
SARS-CoV-2. This virus uses proteins on its outer surface, called spike
proteins, to enter the body’s cells and cause disease. COVID-19 Vaccine
AstraZeneca is made up of another virus (of the adenovirus family) that has
been modified to contain the gene for making the SARS-CoV-2 spike protein.
The adenovirus itself cannot reproduce and does not cause disease. Once it
has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the
body. The cells will use the gene to produce the spike protein. The person’s
immune system will treat this spike protein as foreign and produce natural
defences − antibodies and T cells − against this protein. If, later on, the
vaccinated person comes into contact with SARS-CoV-2, the immune system will
recognise the virus and be prepared to attack it: antibodies and T cells can
work together to kill the virus, prevent its entry into the body’s cells and
destroy infected cells, thus helping to protect against COVID-19. More about rolling review A rolling
review is one of the regulatory tools that EMA uses to speed up the
assessment of a promising medicine or vaccine during a public health
emergency. Normally, all data on a medicine’s effectiveness, safety and
quality and all required documents must be submitted at the start of the
evaluation in a formal application for marketing authorisation. In the case
of a rolling review, EMA’s human medicines committee (CHMP) reviews data as
they become available from ongoing studies, before a formal application is
submitted. Once the CHMP decides that sufficient data are available, the
formal application should be submitted by the company. By reviewing the data
as they become available, the CHMP can reach its opinion sooner on whether or
not the medicine or vaccine should be authorised. (MKY) |
