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EMA’s human medicines committee
(CHMP) has adopted several important recommendations that will increase
manufacturing capacity and supply of COVID-19 vaccines in the EU.
New manufacturing site for AstraZeneca’s COVID-19 vaccine
A new manufacturing site has
been approved for the production of AstraZeneca’s
COVID-19 vaccine active
substance. The Halix site is located in Leiden, the Netherlands, and will
bring the total number of manufacturing sites licensed for the production of
the active substance of the vaccine to four.
New manufacturing site and more flexible storage conditions for
BioNTech/Pfizer’s COVID-19 vaccine.
A new site has also been
approved for the production of Comirnaty,
the COVID-19 vaccine developed by BioNTech and Pfizer. The facility, which is
in the German city of Marburg, will produce both active substance and the
finished product. There are currently three active substance manufacturing
sites supplying the EU included in the marketing authorisation.
In addition to the new
manufacturing facility for this vaccine, the CHMP has also given a positive
opinion to allow transportation and storage of vials of this vaccine at
temperatures between -25 to -15˚C (i.e. the temperature of standard
pharmaceutical freezers) for a one-off period of two weeks. This is an
alternative to the long-term storage of the vials at a temperature between
-90 to -60˚C in special freezers. It is expected to facilitate the rapid
roll-out and distribution of the vaccine in the EU by reducing the need for
ultra-low temperature cold storage conditions throughout the supply chain.
New manufacturing site and scaled-up processes for Moderna’s
COVID-19 vaccine
Already last week, CHMP
recommended approving the addition of a new manufacturing site for the
production of active substance and finished product intermediates for
Moderna’s COVID-19 vaccine. The addition of the new manufacturing lines at
the Lonza facility, located in Visp, Switzerland, together with other changes
to the manufacturing processes that were greenlighted by the Committee are
intended to scale-up production capacity and increase supply of the vaccine
for the EU market.
The changes described will be
included in the publicly available information on these vaccines on EMAs
website.
EMA is in continuous dialogue
with the marketing authorisation holders of COVID-19 vaccines as they seek to
expand their production capacity for the supply of vaccines in the EU. The
Agency provides guidance and advice on the evidence required to support and
expedite applications to add new sites for the manufacture of high-quality
COVID-19 vaccines.
As for any medicine in the EU,
COVID-19 vaccines can only be manufactured in approved sites that are included
in the marketing authorisation following regulatory assessment.
This requires that a
manufacturer has a manufacturing licence from the national
competent authority of the Member State in which the pharmaceutical
manufacturing site is located to ensure that the production process complies
with the standards of good manufacturing practice (GMP). National competent
authorities carry out GMP inspections in coordination with
EMA to check that manufacturers comply with EU standards, the conditions
of their licence and the marketing authorisation if
obtained.
In addition, the marketing
authorisation needs to submit strong evidence to demonstrate that the site is
capable to consistently produce high-quality vaccines according to agreed
specifications.
Once the appropriate data are
available, the company applies to add the new manufacturing site to the
marketing authorisation. This is done via a variation application. EMA is
ready to assess such requests rapidly.
(ΜΚΥ)
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