Moderna Launches Study of COVID-19 Vaccine in Adolescents

December 15, 2020 - Moderna recently announced that the first adolescent patients have been dosed in the Phase 2/3 study of its mRNA-based COVID-19 vaccine, mRNA-1273.

The randomized, controlled Phase 2/3 study will evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 in 3,000 participants aged 12 to under 18 years of age. The two vaccinations will be given 28 days apart. 

“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy adolescents in the U.S. Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

In mid-November, Moderna reported that mRNA-1273 proved 95 percent effective in a Phase 3 clinical trial. Specifically, the candidate met the primary endpoint of the trial, referred to as COVE.

The first analysis was based on 95 cases and showed a point estimate of vaccine efficacy of 94.5 percent. The second endpoint analyzed was severe COVID-19 cases; there were 11 severe cases. 

All 11 cases occurred in the placebo group and not in the group that received the mRNA-1273 injections. 

Later, a December analysis found that mRNA-1273 was over 94.1 percent effective against the coronavirus. The results were based on a total of 196 cases, of which 185 were in the placebo group and 11 were in the mRNA-1273 group.

A secondary endpoint analyzed 30 severe COVID-19 cases of COVID-19, all of which occurred in the placebo group and none in the group that received the mRNA-1273 injections. 

Overall, COVE has enrolled over 30,000 participants in the US and is based on the analysis of COVID-19 cases confirmed and adjudicated two weeks after the second dose of a vaccine. 

“We are encouraged by the interim and primary analyses of the Phase 3 COVE study in adults ages 18 and above and this adolescent study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population. We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting,” Bancel said in the recent announcement. 

The Phase 2/3 study is being conducted with the Biomedical Advanced Research and Development Authority (BARDA).

By the end of 2020, Moderna expects to have nearly 20 million doses of mRNA-1273 ready to ship in the US. So far, the company is on track to manufacture 500 million to 1 billion doses globally by next year.

HHS and the Department of Defense (DoD) will manufacture and deliver 100 million doses of mRNA-1273. Additionally, the federal government will own the doses and will be able to acquire up to an additional 400 million doses of the vaccine candidate. 

Since the start of the pandemic, pharmaceutical companies have been racing to develop a COVID-19 vaccine.

Similar to Moderna’s mRNA COVID-19 vaccine, Pfizer’s and BioNTech’s mRNA-based COVID-19 vaccine, BNT162b2, was 95 percent effective in preventing coronavirus in participants without prior evidence of SARS-CoV-2 infection in a Phase 3 study.

But there are major storage differences between the two similarly structured vaccines, which must be addressed before FDA approval. 

Moderna’s vaccine can be stored at 36 to 46 degrees Fahrenheit and can last nearly 30 days in the fridge. Specifically, the vaccine can remain stable at four degrees Fahrenheit for nearly six months, at refrigerated conditions for up to 30 days, and at room temperature for up to 12 hours.

But Pfizer’s product must be at -112 Fahrenheit to remain effective, which requires special freezers usually found in research labs and hospitals. 

Although Pfizer is developing deep freeze “suitcases” that can be sealed and are safe for shipment in non-refrigerated trucks, these suitcases could create challenges for hospitals, pharmacies, and outpatient clinics that have to administer the vaccines to US citizens.