Blog Post

Moderna Launches Phase 3 Testing for COVID-19 Vaccine

Rafiq Heigler • Sep 24, 2020

Development of mRNA-1273

On July 27, Moderna launched its Phase 3 efficacy trial for the investigational vaccine, mRNA-1273. This places Moderna ahead of competing pharmaceutical powerhouses, Johnson & Johnson and Pfizer, in the race to bring an effective COVID-19 vaccine to market.

During the Phase 3 trials, the vaccine candidate will be tested on 30,000 adult volunteers at 89 clinical research sites across the United States (1).

Development of mRNA-1273

Moderna’s mRNA-1273 was the first of over 20 vaccine candidates to enter clinical trials. The vaccine is based on messenger RNA (mRNA) to develop viral proteins in the body.

After the coronavirus was sequenced, scientists at the National Institutes of Health (NIH) and Moderna identified the sequence for a surface-level spike protein as a good vaccine candidate. The spike protein was then encoded into an instruction molecule called mRNA. When the mRNA vaccine is injected into patients, it travels to immune cells and instructs them to make copies of the spike protein. Other immune cells can then learn about the spike protein and protect the person if they come into contact with the coronavirus.

Since this method does not require scientists to replicate the virus in order to create the vaccine, scientists were able to save time and move from sequence to a vaccine ready for Phase 1 testing in a record 42 days (2).

Scientists began human trials back in March and yielded promising results. All 45 subjects who received the vaccine produced antibodies that can neutralize the novel coronavirus.

Operation Warp Speed

On August 11, The Department of Health and Human Services (HHS) and the Department of Defense (DoD) finalized an agreement with Moderna to take ownership of 100 million doses of the company’s COVID-19 vaccine candidate (3). This agreement was an essential component of the U.S. government’s Operation Warp Speed.

Operation Warp Speed is a collaborative effort between the HHS and the DoD. Together, they are working with private firms and other government agencies to expedite the manufacturing and distribution of a COVID-19 vaccine. The project includes fill-finish manufacturing in US-based facilities in order to ensure the vaccine can be packaged and shipped immediately upon FDA approval. The government-purchased vaccines would be available to the public at no cost.

Moderna’s Next Steps

The Phase 3 trials are designed to evaluate several effects of the vaccine:

If the vaccine can prevent symptomatic COVID-19 after two doses
If the vaccine can prevent severe COVID-19
If the vaccine can prevent death caused by COVID-19

Trial volunteers in the blind study will receive two injections of either the mRNA-1273 vaccine or a saline placebo 28 days apart. Scientists will then examine the volunteers’ blood samples in order to detect immune responses (1). Anyone 18 years of age or older interested in joining the study can contact the COVID-19 Protection Network (4).

Moderna will manufacture the vaccine while clinical trials are underway in order to expedite distribution to the public once the vaccine receives FDA approval.

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