In the midst of a global pandemic, Pfizer, under the leadership of its chief digital and technology officer Lidia Fonseca, achieved what was once thought impossible. The company, with the partnership of BioNTech, developed a COVID-19 vaccine in only 269 days, a process that traditionally would have taken 8 to 10 years. While prior research…
Can BioNTech’s BNT165b1 malaria vaccine stand up to Oxford’s R21?
The mRNA vaccine company BioNTech (Nasdaq:BNTX) has begun a Phase 1 study of BNT165b1, a multi-antigen malaria vaccine candidate that belongs to its BNT165 malaria program. Researchers at Oxford University are farther along with their R21/Matrix-M vaccine. A recently completed Phase 3 trial focused on R21. It could win licensure in 2023. In a Phase…
Why BioVectra has big mRNA biomanufacturing ambitions
Founded in 1970, BioVectra is a CDMO with specialties in microbial fermentation, complex chemistry and biologics. The company is looking to bolster its mRNA manufacturing capability. In November 2021, the Canadian company announced its intent to build a new $79.6 million facility dedicated to producing and manufacturing mRNA vaccines and therapeutics. The initiative resulted from…
Amazon Web Services is powering medtech innovation: Its chief medical officer explains
It doesn’t get any bigger than Amazon in the world of cloud computing. The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google. Dr. Taha Kass-Hout, the…
BioNTech 2021 revenue surges 39x year over year
The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021. Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth. Net revenues of the vaccine between Pfizer and BioNTech surpassed $59 billion. In 2020, BioNTech’s revenues were €482.3 million. “Looking back, 2021 was…
NIH to launch clinical trial of three mRNA HIV vaccines
The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences. The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA. The three HIV vaccine…
CureVac 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,…
7 potential applications of mRNA-based therapies
Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…
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.…
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) aims 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 medicine, basic research, epidemiology, pharmacology, nursing…
India’s Gennova developing mRNA COVID-19 vaccine
India is vying to create domestic mRNA COVID-19 vaccines, with Gennova Bio (Maharashtra) emerging as a frontrunner. The company’s investigational HGCO19 vaccine will be the focus of a Phase 2/3 study. The vaccine, developed in collaboration with privately-held Seattle-based HDT Bio, has received funding from India’s Department of Biotechnology and Ministry of Science and Technology.…
CDC analysis finds COVID-19 boosters generally elicit mild-to-moderate side effects
Most third doses of mRNA COVID-19 vaccines elicit side effects in line with that of the second dose, according to a CDC report. The study analyzed immunocompromised recipients of the Pfizer-BioNTech and Moderna COVID-19 vaccine recipients eligible for a third dose. It pulled data from 22,191 V-safe registrations. V-safe is a CDC-created smartphone-based system for tracking…
Mix-and-match COVID vaccines attract support and backlash
Several countries have embraced the idea of using distinct COVID-19 vaccines for the first and second doses. But a death in Korea is fueling concerns about the strategy, and some public authorities have warned against the practice. Canada, Korea, Thailand and Germany have authorized the use of a heterologous prime-boost COVID-19 vaccination strategy to manage…
Sanofi to spend nearly half a billion dollars a year on mRNA vaccine research
Sanofi (NYSE:SNY) announced today that it plans to invest approximately $476.3 million (€400 million) per year on mRNA vaccine development. Paris-based Sanofi’s intends for its annual investment to go toward a first-of-its-kind vaccine “mRNA Center of Excellence” to accelerate the development and delivery of next-generation vaccines. Approximately 400 employees will integrate end-to-end mRNA vaccine capabilities…
BioNTech and Moderna set their sights on treating cancer
COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company. BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different…
What made rapid mRNA COVID-19 vaccine development possible
A segment of the population is wary of COVID-19 vaccines. One of the main reasons why is the rapid pace at which they were developed. But the mRNA vaccines FDA was able to authorize in late 2020 were years in the making, stressed Kizzmekia Corbett of the NIH at CDC’s National Forum on COVID-19 Vaccine…
How Dolly Parton helped support Moderna’s COVID-19 vaccine
Buried in a preliminary report on Moderna’s COVID-19 vaccine is a list of financial backers that includes the famed singer Dolly Parton. Parton was unaware that her $1 million donation to COVID research at Vanderbilt University in April would be used to advance the vaccine candidate from Moderna (NSDQ: MRNA), according to CNN. The singer…