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– MRNA-1273 was sent from the company to the National Institute of Allergy and Infectious Diseases -NIAID in 42 days from sequence selection
Minapim by Hernan Valenzuela: Moderna, Inc., a clinical stage biotechnology company that pioneered messenger RNA (mRNA), announced today that it has launched the first batch of mRNA-1273, the company’s vaccine against the new Coronavirus COVID-19, for human use. The vials of mRNA-1273 were sent to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institute of Health (NIH) to be used in the planned Phase 1 study in USA.
MRNA-1273 is an mRNA vaccine against the new Coronavirus COVID-19 that codes for a stabilized form of preference for the protein Spike (S), which was selected by Moderna in collaboration with researchers at the NIAID Vaccine Research Center (VRC). The manufacture of this lot was financed by the Coalition for innovations in preparation for CEPI epidemics.
Moderna’s vaccine against Coronavirus COVID-19 was developed in record time because it is based on a relatively new genetic method that does not require the increase of large amounts of viruses. Instead, the vaccine is packed with mRNA, the genetic material that comes from DNA and makes proteins. Moderna carries its vaccine with mRNA that encodes the right coronavirus proteins, which are injected into the body. The immune cells in the lymph nodes can process this mRNA and start making the protein in the right way for other immune cells to recognize it and mark it for destruction.
“I want to thank all Moderna for their extraordinary effort in responding to this global health emergency at record speed. The collaboration between Moderna, NIAID and CEPI has allowed us to deliver a clinical batch within 42 days of sequence identification” , said Juan Andres, Director of Technical Operations and Quality at Moderna. “This would not have been possible without our local Norwood manufacturing facility, which uses state-of-the-art technology to enable flexible operations and ensure high quality standards for clinical-grade materials. ”
The drug test is the first to be carried out for the treatment of Coronavirus COVID-19 and will be led by a team from the University of Nebraska Medical Center. The first patient to volunteer for the groundbreaking study is a passenger who was brought back to the USA after testing positive for the disease on board the Diamond Princess. Other patients diagnosed with Coronavirus COVID-19 who were hospitalized will also be part of the study.
The Company’s plant in Norwood, MA manufactures Moderna’s portfolio of candidates for mRNA development, including vaccines and therapeutics. To date, the Company has produced and released more than 100 batches of Norwood for clinical trials in humans. MRNA-1273 is part of the Company’s main prophylactic vaccine modality, which has had six positive Phase 1 clinical readings on six different vaccines in the past four years.
About mRNA-1273
MRNA-1273 is an mRNA vaccine against the new Coronavirus COVID-19 that codes for a stabilized form preferably of the protein Spike (S), which was designed by Moderna in collaboration with NIAID. The protein S complex is necessary for membrane fusion and infection of host cells and has been the target of vaccines against coronaviruses responsible for Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
About Coronavirus
The new Coronavirus COVID-19 coronaviruses are a family of viruses that can lead to respiratory diseases, including MERS and SARS. Coronaviruses are transmitted between animals and people and can evolve into strains not previously identified in humans. On January 7, 2020, COVID-19 was identified as the cause of pneumonia cases in Wuhan, China’s Hubei Province.
About the modality of prophylactic vaccines from Moderna
At Moderna, scientists design the company’s prophylactic vaccine modality to prevent infectious diseases. Over 1,000 participants were enrolled in Moderna’s clinical trials of infectious disease vaccine under the country’s health authorities, USA, Europe and Australia. Based on clinical experience in six Phase 1 studies, the Company designated prophylactic vaccines as an essential modality and intends to accelerate the development of its candidates for vaccines against infectious diseases.
The potential benefits of an mRNA approach to prophylactic vaccines include the ability to mimic the natural infection to stimulate a more potent immune response, combining multiple mRNAs in a single vaccine, rapid discovery to respond to emerging pandemic threats and nature-derived agility in manufacturing the platform. mRNA vaccine design and production. Modern built a factory fully integrated factory in Norwood, MA, which makes the promise of the technological platform possible.
More than 80,000 people have been infected globally by the viral outbreak that started at the end of last year in China. A total of 35 cases have been reported in the United States.
More than 2,600 people died of the virus in mainland China, including a US citizen.
The shares of Moderna Inc., based in Cambridge, Massachusetts, jumped nearly 16%, or $ 2.92, to $ 21.51 in pre-market trading.
The stock began trading in late 2018 and set a record price of $ 29.79 last April, according to FactSet.
Modern Currently, it has nine candidates for development in its prophylactic vaccine modality, including:
Vaccines against severe respiratory infections
- Vaccine against respiratory syncytial virus (RSV) for the elderly (mRNA-1777 and mRNA-1172 / V172 with Merck)
- RSV vaccine for young children (mRNA-1345)
- Human vaccine against metapneumovirus and parainfluenza virus type 3 (hMPV / PIV3) (mRNA-1653)
- New vaccine against coronavirus (mRNA-1273)
- H7N9 flu (mRNA-1851)
Vaccines against serious infections transmitted from mother to baby
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
- Zika vaccine (mRNA-1893) with the Advanced Research and Development Biomedical Authority (BARDA)
Vaccines against common viral infections
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive readings of Phase 1 data for six prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV / PIV3 and CMV). Moderna’s CMV vaccine is currently in a Phase 2 dose selection study. The experimental Zika vaccine from Moderna (mRNA-1893), currently in a Phase 1 study, received the designation Fast Track from the FDA.
Source: Moderna Inc.
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