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04-03-2021 11:30 |
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EMA’s Human Medicines Committee
(CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19
vaccine[1]
developed by Russia’s Gamaleya National Centre of Epidemiology and
Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH. The CHMP’s decision to start the rolling review is based on results from laboratory studies and clinical studies in adults. These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19. EMA will evaluate data as they
become available to decide if the benefits outweigh the risks. The rolling
review will continue until enough evidence is available for formal marketing
authorisation application. EMA will assess Sputnik V’s
compliance with the usual EU standards for effectiveness, safety and quality.
While EMA cannot predict the overall timelines, it should take less time than
normal to evaluate an eventual application because of the work done during
the rolling review. EMA will communicate further
when the marketing authorisation application for the vaccine has been
submitted. How the vaccine is expected to work: Sputnik V is expected to work
by preparing the body to defend itself against infection with the SARS-CoV-2
virus. This virus uses proteins on its outer surface, called spike proteins,
to enter the body’s cells and cause COVID-19. Sputnik V is made up of two
different viruses belonging to the adenovirus family, Ad26 and Ad5. These
adenoviruses have been modified to contain the gene for making the SARS-CoV-2
spike protein; they cannot reproduce in the body and do not cause disease.
The two adenoviruses are given separately: Ad26 is used in the first dose and
Ad5 is used in the second to boost the vaccine’s effect. 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 spike protein on 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. What a rolling review is: A rolling review is a
regulatory tool that EMA uses to speed up the assessment of a promising
medicine during a public health emergency. Normally, all data on a medicine
or vaccine’s effectiveness, safety and quality and all required documents
must be ready 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. Once the CHMP decides that sufficient data are available, the
company can submit a formal application. By reviewing the data as they become
available, the CHMP can come to an opinion on the medicine’s authorisation
sooner. During the rolling review, and
throughout the pandemic, EMA and its scientific committees are supported by
the COVID-19 EMA pandemic task force (COVID-ETF). This group brings together
experts from across the European medicines regulatory network to advise on
the development, authorisation and safety monitoring of medicines and
vaccines for COVID-19 and facilitate quick and coordinated regulatory action. [1]
Sputnik V is made up of two components comprising different viruses belonging
to the adenovirus family, Ad26 and Ad5. Separate submissions have been made
for each component. |
