Massachusetts-based biotechnology company Moderna, Inc (NASDAQ: MRNA), is currently testing the safety and efficacy of an mRNA vaccine for the SARS-CoV-2 coronavirus that causes COVID-19. This article provides an updated timeline of the vaccine’s development.
- January 2020: Moderna Announces Partnership with CEPI and NIAID VRC
- February 2020: mRNA-1273 Shipped to the NIH for Human Trials
- March 2020: First Dose of Moderna Vaccine Administered in Phase 1 Human Trial
- April 2020: Moderna Receives Up to $483 Million from BARDA and Submits IND to FDA for Phase 2 Clinical Trials of Coronavirus Vaccine
- May 2020: Moderna Announces 10-Year Manufacturing Collaboration with Lonza Ltd. and Announces Interim Results of Phase 1 Clinical Trial
January 2020: Moderna Announces Partnership with CEPI and NIAID VRC
On January 23rd, 2020, Moderna announced a partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a messenger RNA (mRNA)-based vaccine for the severe acute respiratory syndrome 2 (SARS-CoV-2) virus, which causes the coronavirus disease COVID-19.
According to the agreement, Moderna will manufacture the vaccine with funding from the CEPI and design the candidate in collaboration with the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID will conduct a phase 1 clinical trial of the vaccine in the United States.
CEPI CEO Dr. Richard Hatchett, MD, stated, “Moderna’s commitment to global public health is aligned with CEPI’s vision of creating a world in which epidemics are no longer a threat to humanity. We are pleased with the pace of our combined response to the emerging threat of the novel coronavirus. Through our partnership with Moderna and the NIH, we hope to speed the development of a vaccine against the coronavirus and help to alleviate the burden of disease.”
Moderna CEO Dr. Stéphane Bancel stated, “We believe our mRNA vaccine technology offers potential advantages in the speed of development and production scalability, which positions Moderna to potentially develop a vaccine against coronavirus, 2019-nCoV. Advances in global public health require the collective effort of public-private partnerships – no organization can act alone.”
“We are honored to be supporting NIH and CEPI in their mission to identify a potential vaccine to prevent infection. It is impressive that CEPI was able to commit to this grant in a matter of days. We are thankful for the financial support from CEPI and the multi-year scientific collaboration we have with the NIH,” Dr. Bancel continued.
According to Moderna, advantages of its mRNA vaccine include “the ability to mimic natural infection to stimulate a more potent immune response,” the possibility of presenting multiple targets in the same vaccine by including multiple distinct mRNAs, and “manufacturing agility.”
February 2020: mRNA-1273 Shipped to the NIH for Human Trials
On February 24th, 2020, Moderna shipped the first batch of its mRNA vaccine mRNA-1273 to the NIAID for use in phase 1 human clinical trials in the United States. mRNA-1273 encodes a “prefusion stabilized” form of the coronavirus spike (S) protein, a component of the virus that, when targeted by the immune system, could effectively prevent COVID-19. The target was chosen by scientists at Moderna in collaboration with those at the VRC.
Moderna’s Chief Technical Operations and Quality Officer Dr. Juan Andres stated, “I want to thank the entire Moderna team for their extraordinary effort in responding to this global health emergency with record speed. The collaboration across Moderna, with NIAID, and with CEPI has allowed us to deliver a clinical batch in 42 days from sequence identification. This would not have been possible without our Norwood manufacturing site, which uses leading-edge technology to enable flexible operations and ensure high quality standards are met for clinical-grade material.”
At the time of the press release, the Norwood manufacturing plant had produced over 100 batches of Moderna’s vaccine candidates for use in human clinical trials.
March 2020: First Dose of Moderna Vaccine Administered in Phase 1 Human Trial
Moderna’s Chief Medical Officer Dr. Tal Zaks, M.D., Ph.D., stated, “This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase 2 study under our own IND.”
“We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak,” Dr. Zaks continued.
The phase 1 study will enroll 45 healthy adults and evaluate the immunogenicity and safety of the vaccine over the course of a year after the completion of vaccination, which involves two doses administered 28 days apart. The trial will involve three doses levels (25, 100, and 250 micrograms).
According to Moderna, the primary objective of the trial is to assess the “reactogenicity and safety” of the dose schedule, and the secondary objective is to determine whether the SARS-CoV-2 spike protein, the target of the vaccine, elicits a robust anti-viral immune response in humans.
April 2020: Moderna Receives Up to $483 Million from BARDA and Submits IND to FDA for Phase 2 Clinical Trials of Coronavirus Vaccine
On April 16th, 2020, Moderna announced that the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), has committed up to $483 million to accelerate the development of the coronavirus mRNA vaccine candidate mRNA-1273.
According to the agreement, the BARDA will provide funding until mRNA-1273 is licensed by the FDA. The vaccine is currently being evaluated in phase 1 human trials by the NIH. In addition to the original cohort of 45 healthy adults between the ages of 18 and 55, the trial has been expanded to include three additional cohorts of older adults between the ages of 56 and 70 and three cohorts of elderly adults 71 and older.
If the safety data from the phase 1 study fulfill expectations, Moderna intends to intiate a phase 2 trial of the vaccine under an Investigational New Drug (IND) application during the second quarter of 2020. A phase 3 trial could start as early as the fall of 2020.
CEO of Moderna Dr. Stéphane Bancel stated, “We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2. Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.”
BARDA Director Dr. Rick Bright, PhD, stated, “Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus. Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action. BARDA’s goal is to have vaccine available as quickly as possible and preparing now for advanced stage clinical trials and production scale-up while the Phase 1 is underway could shave months off development of COVID-19 vaccines.”
On April 27th, 2020, Moderna announced its submission of an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) to evaluate mRNA-1273 in phase 2 and later trials.
Dr. Tal Zaks, MD, PhD, stated, “Submitting this IND is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency. We look forward to launching this Phase 2 study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273.”
A phase 2 study evaluating the safety, reactogenicity and immunogenicity of the vaccine is expected to be intiated in the second quarter of 2020. Each participant will receive either a placebo, a 50 μg vaccine dose, or a 250 μg vaccine dose during two injections 28 days apart and be assessed over the course of a year after the administration of the second dose. The trial is intended to enroll 300 healthy adults between the ages of 18 and 55 and 300 adults older than 55.
Acting Director of BARDA Dr. Gary Disbrow, PhD, stated, “Safe, effective vaccines are critical to ending this pandemic and preventing future outbreaks of SARS-COV-2. The next steps announced today for this particular vaccine highlight the value of collaboration among government agencies including BARDA and NIAID, and the private sector, to move vaccines and other medical countermeasures forward as rapidly as possible.”
May 2020: Moderna Announces 10-Year Manufacturing Collaboration with Lonza Ltd. and Announces Interim Results of Phase 1 Clinical Trial
On May 1st, 2020, Moderna announced a 10-year strategic collaboration with Switzerland-based Lonza Ltd. (SIX: LONN) to support the large scale manufacture of mRNA-1273 and additional Moderna products, such as the cytomegalovirus vaccine currently being evaluated in phase 2 clinical trials.
According to the agreement, Lonza’s facilities in the United States and Switzerland will be established as Moderna manufacturing sites and used to produce the vaccine. The first batches of mRNA-1273 are expected to be produced in July 2020.
Dr. Stéphane Bancel stated, “We are very pleased to partner with Lonza, which shares our commitment to rapidly addressing this pandemic which has created a global health crisis. This long-term strategic collaboration agreement will enable Moderna to accelerate, by 10-times, our manufacturing capacity for mRNA-1273 and additional products in Moderna’s large clinical portfolio. Lonza’s global presence and expertise are critical as we scale at unprecedented speed. Our common goal is to potentially enable manufacturing of up to 1 billion doses of mRNA-1273.”
Lonza Chairman and CEO ad interim Dr. Albert M. Baehny stated, “Moderna’s technology represents a significant opportunity to change the way we protect people against disease. The current pandemic illustrates the need to combine the best science with resilient supply chains that can scale. We are fully committed to leveraging our global network and experience in manufacturing technologies to support Moderna’s manufacture of mRNA-1273 as well as collaborating on future Moderna products.”
On May 18th, 2020, Moderna announced interim results of a phase 1 human trial of their coronavirus vaccine. The data indicated that the vaccine is “generally” safe, with only a few adverse events primarily among patients that received the highest dose (250 micrograms). Furthermore, the vaccine was found to elicit anti-coronavirus binding antibody in all participants, and protective neutralizing antibody was identified in the eight patients assessed for this marker of humoral immunity.