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Sanofi's (SNY) Meningitis Vaccine MenQuadfi Wins EU Approval

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Sanofi (SNY - Free Report) announced that the European Commission (EC) has approved its fully-liquid meningococcal vaccine MenQuadfi for the active immunization of individuals, aged 12 months and above against meningococcal meningitis, which is a rare and deadly bacterial infection.

The nod in Europe was based on data from seven pivotal phase II and III studies, which evaluated the immunogenicity and safety of MenQuadfi in more than 6,300 healthy individuals. Data from the same showed that treatment with MenQuadfi demonstrated a good safety profile and led to a high immune response against four of the major meningococcal disease serogroups (A, C, Y, W) in patients, aged 12 months and above.

Per the company, more than 3,000 cases of meningococcal disease are reported in Europe every year. Following this nod, MenQuadfi becomes the first fully-liquid quadrivalent meningococcal conjugate vaccine in Europe.

Notably, in April 2020, MenQuadfi was approved in the United States for the prevention of meningococcal meningitis in patients, aged two years and above.

We note that additional phase III studies on MenQuadfi are currently ongoing for the prevention of meningococcal disease in infants from six weeks of age.

Shares of Sanofi have lost 0.7% so far this year compared with the industry’s decrease of 0.2%.

Price chart for SNY


We remind investors that Sanofi possesses one of the world’s leading vaccine operations. Apart from the meningitis vaccine, the company’s portfolio includes pediatric vaccines, influenza vaccines, adult and adolescent booster vaccines plus travel and endemic vaccines. Sanofi also holds a strong position in both seasonal and pre-pandemic influenza vaccine spaces. The company is actively engaged in developing a vaccine for the deadly COVID-19 disease.

Sanofi along with GlaxoSmithKline (GSK - Free Report) is developing an adjuvanted COVID-19 vaccine in a phase I/II clinical study. Data from the same is expected in December. The companies plan to produce 1 billion doses of the adjuvant vaccine in 2021.

Meanwhile, Sanofi and Translate Bio, Inc. (TBIO - Free Report) are jointly developing a novel messenger RNA (mRNA) vaccine candidate MRT5500 for COVID-19. The candidate demonstrated a favorable immune response against SARS-CoV-2 in pre-clinical studies. A phase I/II study on MRT5500 is expected to begin in the fourth quarter of 2020.

We note that currently, Pfizer/BioNTech’s mRNA-based coronavirus vaccine candidate BNT162b2 proved to be 95% effective in its final analysis. Meanwhile, Moderna’s (MRNA - Free Report) mRNA-based coronavirus vaccine candidate mRNA-1273 demonstrated a vaccine efficacy of 94.5% in the first interim analysis.

Zacks Rank

Sanofi currently has a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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