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Tuesday, February 25, 2020

Moderna to Use New mRNA Technology to Develop Coronavirus Vaccine

Moderna to Use New mRNA Technology to Develop Coronavirus Vaccine


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Story Highlights
  • In light of the coronavirus outbreak, three research teams have been awarded grants by the Coalition for Epidemic Preparedness Innovations to develop a vaccine for the novel coronavirus.
  • In a public-private partnership with NIH, Moderna, Inc. is using an experimental mRNA technology to develop a vaccine.
  • Johnson & Johnson and other drug companies are shipping different drugs, such as HIV therapies, to China to treat coronavirus infected patients.
The recent outbreak of a novel coronavirus that originated in Wuhan, China has driven pharmaceutical and biotechnology companies to begin developing a vaccine for the mutated virus.

Three Companies Awarded Funding for Coronavirus Vaccine Development

Three research teams have received funding from the Coalition for Epidemic Preparedness Innovations (CEPI), a global public-private partnership launched at the Davos World Economic Forum in 2017, to develop a vaccine for the new strain of coronavirus (2019-nCoV).1
The first grant was awarded to Moderna, Inc., which has partnered with the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH) to develop a vaccine for the Wuhan strain of coronavirus.1 Some researchers believe that an experimental vaccine previously designed to combat severe acute respiratory syndrome (SARS), which was never licensed, as well as vaccine platforms using messenger RNA (mRNA) technology, which has not yet been approved by the FDA for vaccine production, are likely to shorten the time needed to fast track a 2019-nCoV vaccine to market.2
Andrew Pekosz, PhD, professor of molecular microbiology and immunology at Johns Hopkins University’s Bloomberg School of Public Health told MarketWatch, “There’s been some really good work on SARS and MERS that is educating this process.”2 He added:
You assume that everything that works for SARS and MERS will work for this virus, therefore you just plug in the very specific pieces of the new coronavirus into these vaccine platforms [and] you should be able to get vaccine candidates very quickly.2
Anthony Fauci, MD, director of NIAID said during an interview with the Journal of the American Medical Association (JAMA) he is confident that within three months or less, an experimental coronavirus vaccine will be in a Phase 1 clinical trial.2 Some experts say an emergency-use coronavirus vaccine could be ready within one year.2
The second CEPI grant was given to Inovio Pharmaceuticals, Inc. headquartered in Pennsylvania. The drug company received a grant of up to $9 million to develop a 2019-nCoV vaccine.3
The third CEPI grant was given to the University of Queensland in Australia. Paul Young, PhD, head the university’s school of chemistry and molecular biosciences, said the university has novel technology for the rapid generation of new vaccines using knowledge about a virus’s genetic sequence information.4

Moderna Developing Vaccine Based on mRNA Technology

On Jan. 23, 2020, Moderna announced that it “will manufacture an mRNA vaccine against 2019-nCoV, which will be funded by CEPI. The Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, collaborated with Moderna to design the vaccine. NIAID will conduct IND-enabling studies and a Phase 1 clinical study in the U.S.”5
Moderna is using a new technology known as Messenger RNA (mRNA) to develop a vaccine for the novel coronavirus. Moderna’s website states:
mRNA medicines aren’t small molecules, like traditional pharmaceuticals. And they aren’t traditional biologics (recombinant proteins and monoclonal antibodies) – which were the genesis of the biotech industry. Instead, mRNA medicines are sets of instructions. And these instructions direct cells in the body to make proteins to prevent or fight disease.6
What are RNA vaccines? Unlike a traditional vaccine, RNA vaccines introduce an mRNA sequence (the molecule which tells cells what to build), which is coded for a disease specific antigen. Once produced within the body, vaccine developers say the antigen is recognized by the immune system and stimulates a strong inflammatory response to produce antigens to fight the pathogen.7
Messenger RNA vaccines are faster and cheaper to produce than traditional vaccines and do not utilize any parts of the pathogenic virus or bacteria. Researchers believe that the lab production of messenger RNA vaccines will speed up new vaccine development and responses to disease outbreaks and epidemics, with the potential to scale and standardize the vaccine manufacturing process.6
In a scholarly article published in 2018 in Nature Reviews Drug Discovery, Norbert Pardi, PhD and his colleagues wrote that, while pre-clinical studies have shown optimism about the prospects of mRNA-based vaccines, two recent clinical reports revealed less than optimal vaccine effectiveness.. In both trials, immunogenicity was lower in humans than was expected based on animal models, a phenomenon also observed with DNA-based vaccines, and side effects experienced by participants were not trivial.8
According to Stephane Bansel, Moderna’s Chief Executive Officer:
Once we have managed to master the technology that works on humans, things could go very quickly because it is always the same manufacturing process … for messenger RNA against the flu or against the coronavirus, it is the same method of manufacturing, the only difference is the order of letters that code the proteins.9

Johnson & Johnson and Other Drug Makers to Ship Therapies to China

Johnson & Johnson is the latest pharmaceutical corporation to begin working on a vaccine for the new strain of coronavirus.10 Johnson & Johnson said its vaccine program would use the same technologies used to make its experimental Ebola vaccine, which is currently being administered in the Democratic Republic of Congo and Rwanda.9
Johnson & Johnson’s Chief Scientific Officer Paul Stoffels said Johnson & Johnson agreed to a recent request by Chinese health authorities to ship its HIV drug Prezcobix for potential treatment of coronavirus infections.11
Dr. Stoffels said, “Industry can take different steps to combating this epidemic as fast as possible.”10 He added that studying Prezcobix in patients who test positive for the coronavirus would not harm them, and could help authorities find a treatment that works.10
Merck & Co. has also assigned a team of scientists to assess whether any of the company’s drugs might be effective against the Wuhan coronavirus.10
Gilead Sciences, a biotechnology company based in California is having discussions with researchers and clinicians in the United States and China about using its experimental antiviral therapy, Remdesivir, to treat coronavirus patients. Remdesivir has not been licensed yet by the FDA for public use inside or outside the United States.10

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