Long before the COVID-19 presented itself as a threat to the United States, biotech giant Moderna was working behind the scenes to develop a vaccine for the novel virus. By May 18, Moderna announced positive interim phase 1 data for its mRNA vaccine, reinforcing hope that a COVID-19 vaccine may soon be on the horizon.
Moderna’s Timeline to Clinical Testing
Moderna’s work began on January 11, when Chinese authorities shared the genetic sequence of the novel COVID-19. Only two days later, the National Institutes of Health (NIH) and Moderna’s infectious disease research team finalized the sequences for a COVID-19 vaccine candidate, mRNA-1273.
The NIH announced its intent to run a Phase 1 clinical study using mRNA-1273 in response to the growing threat posed by COVID-19. In just 25 days, the first clinical batch of mRNA-1273 was completed and sent for analytical testing.
After Moderna supplied the first batch of mRNA-1273 to the NIH for use in their Phase 1 clinical study, the FDA approved the NIAID’s request, which allowed the study to proceed to clinical trials with human participants.
Clinical Testing in Humans
About 63 days after Moderna first sequenced the mRNA-1273 vaccine, the NIH announced that the first human participant in its Phase 1 Clinical trial was dosed with the vaccine.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a statement at the time that finding a safe and effective vaccine “is an urgent public health priority. This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
Enrollment for this Phase 1 trial lasted through April 16 During Phase 1, 45 men and non-pregnant females between the ages of 18 and 55 received two doses of mRNA-1273 in the upper arm. The first and second doses occurred about 28 days apart, with the participants split into three cohorts of 15 people each. Eventually the Phase 1 study expanded to an additional six cohorts to study older adults (ages 56-70) and elderly adults (age 71 and above).
Moderna requested FDA approval for a Phase 2 study of mRNA-1273 on April 27, shortly before Moderna and Lonza Bioscience announced a global strategic partnership to manufacture up to 1 billion doses of the vaccine per year.
Positive Phase 1 Results
On March 18, Moderna announced positive interim Phase 1 clinical trial data for its mRNA-1273 vaccine.
According to Moderna’s press release, mRNA-1273 is generally safe and well tolerated. The only adverse reaction was redness around the injection site, which occurred only in 4 participants and self-resolved quickly.
Just as importantly, the vaccine appeared to successfully elicit neutralizing antibodies and provide full protection against viral replication in the lungs.
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna.
“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies,” Zaks continued, “these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
Moderna’s mRNA Vaccine Receives FDA Fast Track Designation
The FDA Fast Track is “a process designed to facilitate the development, and expedited the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier,” according to the FDA.
Moderna received approval for its Phase 2 clinical trial on May 6, followed by an FDA Fast Track designation for mRNA-1273 on May 12. Phase 2 is expected to begin soon with 600 healthy participants in order to evaluate the safety, reactogenicity and immunogenicity of the two vaccinations of mRNA-127 given 28 days apart. Phase 3 is planned for early summer of 2020.
“As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2,” explained Zaks in a statement.
Sources
- https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna
- https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine
- https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19
- https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
- https://www.modernatx.com/sites/default/files/RNA_Vaccines_White_Paper_Moderna_050317_v8_4.pdf