CueVac and GSK launch Phase 1 trial of mRNA-based flu vaccine

CureVac (NSDQ:CVAC) and GSK (NYSE:GSK) have announced the dosing of the first participant in a Phase 1 study of a multivalent influenza vaccine built on a second-generation mRNA backbone. The study is based in Panama and will enroll approximately 240 subjects.

CVAC shares increased 2.27% to $19.34 in mid-day trading.

At various points last year, however, the company’s stock was trading over $100 per share on enthusiasm about the company’s first-generation COVID-19 vaccine. However, the shares later tanked after the company announced that interim vaccine efficacy was 47% in the Phase 2b/3 study.

The company’s second-generation COVID-19 vaccine remains in pre-clinical development.

Its influenza vaccine candidate has multiple non-chemically modified mRNA constructs related to four different influenza strains.

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are also developing mRNA-based influenza vaccines.

Investors were dis…

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Moderna doses the first patient with its mRNA Epstein-Barr virus vaccine candidate

Moderna (NSDQ:MRNA) has dosed the first volunteer in the Phase 1 Eclipse study of mRNA-1189, an Epstein-Barr virus vaccine candidate.

The study will take place at roughly 15 sites in the U.S. and involve approximately 272 healthy adults between the ages of 18 and 30.

The study will be randomized, observer-blind, placebo-controlled and involve a range of doses.

Epstein-Barr virus (EBV) is one of the most common viruses, representing one of the viruses that cause infectious mononucleosis (mono). EBV is also linked to a heightened risk of multiple sclerosis and some cancers and autoimmune diseases.

EBV seroprevalence tends to rise with age, affecting 90–95% of adults.

“Adolescents who develop infectious mononucleosis are frequently absent from school for weeks and even months at a time, impacting the quality of their education and their families,” said Stéphane Bancel, Moderna CEO, in a press release.

Pfizer (NYSE:PFE) and BioNTech (NSD…

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Pfizer and BioNTech set their sights on developing mRNA-based shingles vaccine

Pfizer Inc. (NYSE:PFE) and mRNA vaccine specialist BioNTech SE (NSDQ:BNTX) will collaborate to develop an mRNA-based vaccine to prevent the herpes zoster virus (shingles).

Roughly one million people in the U.S. get shingles each year, according to the CDC.

Currently, the two-dose Shingrix shingles vaccine from GSK (NYSE:GSK) is the only such product available in the U.S. market. Shingrix won FDA approval in 2017.

In 2020, Shingrix generated £1.99 billion ($2.55 billion) in sales internationally.

Pfizer and BioNTech began working together on an mRNA vaccine for influenza in 2018. Two years later, the two companies began work on a COVID-19 vaccine, which has since become one of the bestselling pharmaceutical products in the world.

The shingles mRNA vaccine collaboration will bring together Pfizer’s antigen technology and BioNTech’s mRNA platform.

The two companies will split development costs and plan on beginning clinical trials in th…

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Moderna debuts fellowship program for young researchers focusing on mRNA therapies

Messenger RNA (mRNA) therapeutics and vaccines may offer significant promise, but few scientists specialize in the technology.

Moderna (NSDQ: MRNA) is looking to inspire a new generation of scientists and clinicians to focus on mRNA research with a new fellowship program. The program will support a range of applications within domains such as medicine, basic research, epidemiology, pharmacology and nursing.

For the first year of the program, which will launch in 2022, the company is aiming to select roughly 50 fellows from around the world to focus on mRNA-based treatments of infectious diseases.

Individuals selected for the program will receive guidance from a supervisor and fellow.

The term of fellowship will range from one to three years. The program also will provide a salary of up to $75,000 and annual expenses of up to $100,000.

“We’re at a critical moment for mRNA vaccine development,” said Dr. Greg Poland, director of Mayo Clinic’s …

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Sanofi completes Translate Bio acquisition

Sanofi (NSDQ:SNY) announced today that it has completed the purchase of its mRNA partner Translate Bio.

The previously announced deal, according to Sanofi, accelerates the French pharma giant’s efforts to develop transformative vaccines and therapies using mRNA technology.

The deal comes during a year in which mRNA-based Moderna (NSDQ:MRNA) and Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccines are generating tens of billions of dollars.

Sanofi generated $41 billion in revenue last year.

As of today, Translate Bio is now an indirect, wholly-owned subsidiary of Sanofi. All Translate Bio shares not validly tendered in the tender offer have been converted into the right to receive the same $38 per share in cash.


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FDA signs of on extended shelf life for J&J vaccine

FDA has agreed to extend the shelf life of the Johnson & Johnson COVID-19 to six months. The previous shelf life was four and a half months.

The regulatory agency based its decision on data from ongoing studies involving vaccine doses stored at the previously indicated storage temperature of 2–8°C (35.6–46.4°F).

There is currently a stockpile of J&J viral-vector vaccine across the U.S. Vaccination rates in the U.S. have slumped in recent months. The rare possibility of blood clots stemming from the vaccine has contributed to diminished demand. And the mRNA vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) continue to be the most popular options. More than 150 million Americans have received two doses of the mRNA vaccines from Pfizer and Moderna, while some 13 million have received the single-dose J&J vaccine.



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Projecting future of mRNA-based COVID-19 vaccines remains difficult

Nanotechnology-enabled mRNA vaccines are having a banner year in 2021. That much is clear. But making sense of the long-term prospects of the nascent market for mRNA therapeutics remains challenging. 

Global Data projected that sales of leading nanotechnology-enabled mRNA vaccines could hit $17 billion this year, in its January “The State of the Biopharmaceutical Industry” report.

But the sales of mRNA vaccines from mRNA vaccine leaders Pfizer and Moderna are on track to eclipse that figure. In February, Pfizer projected its COVID-19 vaccine sales for 2021 would be $15 billion. But additional orders for its vaccine, jointly developed with BioNTech, could boost that figure to at least $20 billion.  

Moderna anticipates that its vaccine 2021 sales will hit $18.4 billion. 

Drug companies are developing more than 150 mRNA-based candidates for a variety of therapeutic uses encompassing not just infectious diseases but areas such as …

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