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01-12-2020 14:54 |
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EMA
receives application for conditional marketing authorisation of COVID-19 mRNA
vaccine BNT162b2 |
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EMA has received an application
for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA
vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will
proceed under an accelerated timeline. An opinion on the marketing authorisation
could be issued within weeks, depending on whether the data submitted are
sufficiently robust and complete to show the quality, safety and
effectiveness of the vaccine. Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. EMA also looked at results on the vaccine’s effectiveness and initial safety data emerging from a large-scale clinical trial as they became available. EMA will now assess the data
submitted as part of the formal application for conditional marketing
authorisation. The Agency and its scientific committees will continue working
on the assessment over the Christmas period. If the data submitted are robust
enough to conclude on the quality, safety and effectiveness of the vaccine,
EMA’s scientific committee for human medicines (CHMP) will conclude its
assessment during an extraordinary meeting scheduled for 29 December. These
timelines are based on the type of data assessed so far in the context of the
rolling review and may be subject to change as evaluation proceeds. EMA will
communicate on the outcome of its assessment accordingly. During the review, and
throughout the pandemic, EMA and its scientific committees are supported by
the COVID-19
EMA pandemic task force, 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. What is a conditional marketing authorisation? In the EU, 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. CMAs are being
used in the context of the pandemic to promptly respond to the public health
threat. However, the data must show that the benefits of the medicine or
vaccine outweigh any risks. 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. What may happen next? If EMA concludes that the
benefits of the vaccine outweigh its risks in protecting against COVID‑19, it
will recommend granting a conditional marketing authorisation. The European
Commission will then fast-track its decision-making process with a view to
granting a conditional marketing authorisation valid in all EU and EEA Member
States within days. As for all medicines, EU
authorities continuously collect and review new information on medicines once
they are on the market and take action when needed. In line with the EU safety
monitoring plan for COVID-19 vaccines, monitoring will take
place more frequently and will include activities that apply specifically to
COVID-19 vaccines. Companies for example will provide monthly safety reports
in addition to the regular updates required by the legislation and conduct
studies to monitor the safety and effectiveness of COVID-19 vaccines after
their authorisation. 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. Key
facts on COVID-19 vaccines and more information about how these vaccines
are developed, authorised and monitored in the EU can be found on the EMA
website. How is BNT162b2 expected to work? BNT162b2 is expected to work by
preparing the body to defend itself against infection with the coronavirus
SARS-CoV-2. The virus uses a protein on its outer surface called a spike
protein to enter the body’s cells and cause disease. BNT162b2 contains the
genetic instructions (mRNA) to produce the spike protein. The mRNA is covered
in small lipid (fat) particles that help deliver the mRNA into the cells and
prevent it from being degraded. When a person is given the vaccine, their
cells will read the genetic instructions and produce the spike protein. The
person’s immune system will then treat this protein as foreign and produce
natural defences — antibodies and T cells — against it. 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 prote ct against COVID-19. (MKY) |
