European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adult...
19 November 2020 - 5:12AM
European Commission approves Supemtek® (quadrivalent recombinant
influenza vaccine) for the prevention of influenza in adults aged
18 years and older
European Commission approves
Supemtek® (quadrivalent
recombinant influenza vaccine) for the prevention of influenza in
adults aged 18 years and older
- First and only recombinant influenza vaccine approved in the
European Union
- Contains three times more antigen than standard-dose
vaccines
- Phase 3 efficacy trial demonstrated improved protection against
influenza compared to standard-dose influenza vaccine, and reduced
the risk of influenza by an additional 30% in adults aged 50 years
and older1,2
PARIS – November 18, 2020 – The
European Commission has granted a marketing authorization for
Supemtek®, a quadrivalent (four-strain) recombinant influenza
vaccine, for the prevention of influenza in adults aged 18 years
and older. Supemtek is the first and only recombinant influenza
vaccine now approved in the European Union.
Supemtek is produced using recombinant
technology, which allows an exact match to the key component of the
influenza strains recommended by the World Health Organization,
avoiding the risk of viral mutations. Supemtek also contains three
times more antigen than both egg-based and cell-based standard-dose
vaccines. This increased amount of antigen and the use of
recombinant technology provide improved protection against
influenza, particularly in those aged 50 and older. In comparison
with a standard-dose egg-based quadrivalent influenza vaccine,
Supemtek reduced the risk of influenza by an additional 30% for
adults aged 50 years and older1,2.
The authorization is based on clinical data
demonstrating safety, immunogenicity and efficacy of Supemtek in
two Phase 3 randomized controlled trials1,2 involving more than
10,000 patients in total. Specifically, the relative efficacy of
Supemtek was demonstrated in a Phase 3 multicenter (40 outpatient
centers in the US, involving more than 9,000 adults), randomized
controlled efficacy trial1,2.
“In the context of the COVID-19 pandemic,
preventing influenza remains a public health priority,” said Thomas
Triomphe, Head of Sanofi Pasteur. “Today’s approval of Supemtek
supports our strong commitment in advancing influenza vaccine
technology. With Supemtek, we provide European health authorities
with an additional innovative solution that has demonstrated
increased ability to prevent influenza and its potentially severe
complications, as well as the burden this causes on healthcare
systems.”
Each year, influenza-associated deaths range
from 290,000 to 650,0003,4 globally, and the burden on hospitals is
around 10 million of influenza-related hospitalizations5. Recent
data also show that influenza can multiply the risk of heart attack
by up to 10 times, and the risk of stroke by up to 8 times, in the
week after influenza infection6 – demonstrating that the burden of
influenza goes beyond its well-known respiratory complications.
The first European launches are expected for the
2022/2023 influenza season, with a possibility of accelerating the
availability of doses as early as the 2021/2022 season in certain
countries. Outside of the EU, Supemtek is also approved in the U.S.
under the tradename Flublok Quadrivalent®. About the
recombinant technology
The recombinant technology is a new way of
producing influenza vaccines which differs significantly from the
two other technologies currently in use (egg-based and cell-based
technologies) as it avoids the risk of viral mutations that can
lower vaccine efficacy. It ensures the exact match to the key
component of the influenza strains recommended by the World Health
Organization every year for producing influenza vaccines.
In an independent systematic review7 published
in October 2020, the European Center for Disease Prevention notes
that “the recombinant haemagglutinin was found to provide a greater
protective effect against overall influenza compared with no
vaccination and with traditional influenza vaccination […] this
effect may be attributable to either the restriction of mutations
seen with egg-based vaccines or the higher dose of antigen seen in
this type of influenza vaccine”.
The recombinant technology is also used for the
development of one of Sanofi’s vaccines against COVID-19, developed
in partnership with GSK and with the support of US Biomedical
Advanced Research and Development Authority (BARDA). The Companies
announced the start of the Phase 1/2 clinical trial for their
adjuvanted recombinant COVID-19 vaccine candidate in September and
anticipate first results in December 2020, to support the
initiation of a pivotal Phase 3 study before the end of the year.
If these data are sufficient for licensure application, Sanofi and
GSK plan to request regulatory approval in the first half of
2021.
Increased production of seasonal
influenza vaccines in the unique context of the COVID-19
pandemic
As the leading manufacturer of influenza
vaccines, Sanofi Pasteur, the vaccines global business unit of
Sanofi, is supporting health authorities in their efforts to
strengthen influenza vaccination campaigns in the unique context of
COVID-19. For the 2020/2021 influenza season, the Company is
delivering globally 20% more doses of flu vaccines, reaching an
unprecedented production level of 250 million doses, across its
influenza vaccine portfolio which includes a wide range of vaccines
(standard doses and differentiated vaccines) that are proven to
protect people of all ages from the risks of influenza.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe. Sanofi, Empowering Life |
Media Relations Contact Nicolas Kressmann Tel.: +1
(732) 532-5318 Nicolas.Kressmann@sanofi.com |
Investor Relations Contacts Paris Eva
Schaefer-Jansen Arnaud DelepineYvonne Naughton
Investor Relations Contacts North America Felix
LauscherFara BerkowitzSuzanne Greco IR main line:Tel.: +33
(0)1 53 77 45 45 investor.relations@sanofi.com |
Sanofi Forward-Looking StatementsThis press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words “expects”,
“anticipates”, “believes”, “intends”, “estimates”, “plans” and
similar expressions. Although Sanofi’s management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in
Sanofi’s annual report on Form 20-F for the year ended December 31,
2019. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements. |
1 Dunkle LM, Izikson R, Patriarca P, et al. 20172 Dunkle LM,
Izikson R, et al. 2017a3 Centers for Disease Control and
Prevention. Flu symptoms and complications4 WHO factsheet5 Lancet
Respir Med 2019; 7: 69–896 Warren-Gash C, et al. Eur Respir J.
2018:517 Systematic review of the efficacy, effectiveness and
safety of newer and enhanced seasonal influenza vaccines. ECDC. Oct
2020
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