|
29-01-2021 18:11 |
|
EMA
recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU |
|
EMA has recommended granting a
conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to
prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age.
This is the third 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. “With this
third positive opinion, we have further expanded the arsenal of vaccines
available to EU and EEA member states to combat the pandemic and protect
their citizens,” said Emer Cooke, Executive Director of EMA. “As in previous
cases, the CHMP has rigorously evaluated this vaccine and the scientific
basis of our work underpins our firm commitment to safeguard the health of EU
citizens.” Combined
results from 4 clinical trials in the United Kingdom, Brazil and South Africa
showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing
COVID-19 in people from 18 years of age. These studies involved around 24,000
people altogether. Half received the vaccine and half were given another
control injection, either a dummy injection or another vaccine. People did
not know if they had been given the vaccine or the control injection. The safety
of the vaccine has been demonstrated across the four studies. However, the
Agency based its calculation of how well the vaccine worked on the results
from study COV002 (conducted in the UK) and study COV003 (conducted in
Brazil). The other two studies had fewer than 6 COVID-19 cases in each, which
was not enough to measure the preventive effect of the vaccine. In addition,
as the vaccine is to be given as two standard doses, and the second dose
should be given 4 to 12 weeks after the first, the Agency concentrated on
results involving people who received this standard regimen. These
showed a 59.6% reduction in the number of symptomatic COVID-19 cases in
people given the vaccine (68 of 5,494 got COVID-19 with symptoms) compared
with people given control injections (164 of 5,438 got COVID-19 with
symptoms). This means that the vaccine demonstrated around a 60% efficacy in
the clinical trials. Most of
the participants in these studies were between 18 and 55 years old. There are
not yet enough results in older participants (over 55 years old) to provide a
figure for how well the vaccine will work in this group. However, protection
is expected, given that an immune response is seen in this age group and
based on experience with other vaccines; as there is reliable information on
safety in this population, EMA’s scientific experts considered that the
vaccine could be used in older adults. More information is expected from
ongoing studies, which include a higher proportion of elderly participants. COVID-19
Vaccine AstraZeneca is given as two injections into the arm, 4 to 12 weeks
apart. The most common side effects with COVID-19 Vaccine AstraZeneca were
usually mild or moderate and got better within a few days after vaccination.
The most common side effects are pain and tenderness at the injection site, headache,
tiredness, muscle pain, general feeling of being unwell, chills, fever, joint
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 by
European authorities. Where to find more information The product
information approved by the CHMP for COVID-19 Vaccine AstraZeneca
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
AstraZeneca, 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
AstraZeneca works 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. 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
AstraZeneca, allowing vaccination programmes to be rolled out across the EU. EU
legislation foresees that conditional marketing authorisation (CMA) is used
as the fast-track authorisation procedure to speed up approval of treatments
and vaccines during public health emergencies. A CMA
guarantees that the vaccine meets rigorous EU standards for safety, efficacy
and quality and is manufactured and controlled in approved, certified
facilities in line with high pharmaceutical standards that are compatible
with large-scale commercialisation. CMAs allow for the 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. However, the data must show
that the benefits of the medicine or vaccine outweigh any risks. Once a CMA
has been granted, AstraZeneca must provide further data from ongoing studies
within pre-defined deadlines to confirm that the benefits continue to
outweigh the risks. The company will also carry out studies to provide
additional assurance on the pharmaceutical quality of the vaccine following
the scaling-up of the manufacturing. Monitoring the safety of
COVID-19 Vaccine AstraZeneca In line
with the EU’s safety
monitoring plan for COVID-19 vaccines, COVID-19 Vaccine AstraZeneca 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
AstraZeneca During the
assessment COVID-19 Vaccine AstraZeneca, the CHMP had the support of EMA’s
safety committee, PRAC, who assessed the risk management plan of COVID-19
Vaccine AstraZeneca, 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. (ΜΚΥ) EMA recommends COVID-19 Vaccine AstraZeneca
for authorisation in the EU EMA has recommended granting a conditional
marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent
coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is
the third 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. “With this third positive opinion, we have
further expanded the arsenal of vaccines available to EU and EEA member
states to combat the pandemic and protect their citizens,” said Emer Cooke,
Executive Director of EMA. “As in previous cases, the
CHMP has rigorously evaluated this vaccine and the scientific basis of our
work underpins our firm commitment to safeguard the health of EU citizens.” The safety of the vaccine has
been demonstrated across the four studies. However, the Agency based its calculation of how
well the vaccine worked on the results from study COV002 (conducted in the
UK) and study COV003 (conducted in Brazil). The other two studies had fewer
than 6 COVID-19 cases in each, which was not enough to measure the preventive
effect of the vaccine. In addition, as the vaccine is to be given as two
standard doses, and the second dose should be given 4 to 12 weeks after the
first, the Agency concentrated on results involving people who received this
standard regimen. These showed a 59.6% reduction in the number of symptomatic
COVID-19 cases in people given the vaccine (68 of
5,494 got COVID-19 with symptoms) compared with people given control
injections (164 of 5,438 got COVID-19 with
symptoms). This means that the vaccine demonstrated around a 60% efficacy in
the clinical trials. Most of the participants in these studies were between 18 and 55
years old. There are not yet enough results in older participants (over 55
years old) to provide a figure for how well the vaccine will work in this
group. However, protection is expected, given that an immune response is seen
in this age group and based on experience with other vaccines; as there is
reliable information on safety in this population, EMA’s scientific experts
considered that the vaccine could be used in older adults. More information
is expected from ongoing studies, which include a higher proportion of
elderly participants. COVID-19 Vaccine
AstraZeneca is given as two injections into the arm, 4 to 12 weeks apart. The most common side effects with COVID-19 Vaccine
AstraZeneca were usually mild or moderate and got better within a few days
after vaccination. The most common side effects are pain and tenderness at
the injection site, headache, tiredness, muscle pain, general feeling of
being unwell, chills, fever, joint 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 by
European authorities. Where to find more information The product
information approved by the CHMP for COVID-19 Vaccine AstraZeneca
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 AstraZeneca, 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 AstraZeneca works 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 cell
s, thus helping to protect against COVID-19. 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 AstraZeneca, allowing vaccination programmes to be
rolled out across the EU. EU legislation foresees that conditional
marketing authorisation (CMA) is used as the fast-track authorisation
procedure to speed up approval of treatments and vaccines during public
health emergencies. A CMA guarantees that the vaccine meets
rigorous EU standards for safety, efficacy and quality and is manufactured
and controlled in approved, certified facilities in line with high pharmaceutical
standards that are compatible with large-scale commercialisation. CMAs allow
for the 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. However, the data must show that the benefits of the medicine or
vaccine outweigh any risks. Once a CMA has been granted, AstraZeneca must
provide further data from ongoing studies within pre-defined deadlines to
confirm that the benefits continue to outweigh the risks. The company will also carry out studies to provide
additional assurance on the pharmaceutical quality of the vaccine following
the scaling-up of the manufacturing. Monitoring the safety of COVID-19 Vaccine
AstraZeneca In line with the EU’s safety
monitoring plan for COVID-19 vaccines, COVID-19 Vaccine AstraZeneca 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 AstraZeneca During the assessment COVID-19 Vaccine
AstraZeneca, the CHMP had the support of EMA’s
safety committee, PRAC, who assessed the risk management plan of COVID-19
Vaccine AstraZeneca, 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. |
