Moderna Increases Global 2022 COVID-19 Vaccine Capacity to 3B

Moderna recently announced that it will increase global 2022 capacity for its COVID-19 vaccine to up to 3 billion doses, boosting production at its owned and partnered manufacturing facilities.

The global capacity will be dependent upon the mix between Moderna’s FDA-approved COVID-19 vaccine at the 100-microgram level and the potentially lower doses of the company’s variant booster candidates and pediatric vaccines, if authorized.

At the same time, Moderna raised its 2021 manufacturing supply forecast to between 800 million to 1 billion doses.

“As we follow the rapid spread of SARS-CoV-2 variants of concern, we believe that there will continue to be significant need for our mRNA COVID-19 vaccine and our variant booster candidates into 2022 and 2023,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.

“We are hearing from governments that there is no technology that provides the high efficacy of mRNA vaccines and the speed necessary to adapt to variants, while allowing reliable scalability of manufacturing,” Bancel continued.

Recent studies have predicted that decreasing immunity will impact vaccine efficacy within 12 months, while other studies have found that variants of concern have lower starting neutralizing antibody titers and may lead to breakthrough infections in those individuals already vaccinated.

This indicates a significant need for booster vaccinations in 2022 and beyond.

Moderna will begin making investments at its owned and partnered manufacturing facilities this year, including Spain, France, Belgium, Switzerland, and the US. These investments will allow the company to deliver the 3 billion doses in 2022.

In December, Moderna’s mRNA-based COVID-19 vaccine was 94.1 percent effective against COVID-19 in a Phase 3 study.

And most recently, the New England Journal of Medicine released antibody persistence data six months following the second dose of the COVID-19 vaccine. Specifically, the antibodies elicited by the vaccine persisted through six months after the second dose.

In the study, researchers found that nearly all participants had detectable activity in pseudovirus neutralization assay. 

The ongoing development data of Moderna’s COVID-19 vaccine could support a three-month refrigerated shelf life for the vaccine in alternative formats. This would allow for easier distribution in doctor’s offices and other clinics, the company explained.

And results from ongoing variant clinical trials will help to fully develop the company’s booster product strategy and better estimate supply ranges for 2022.

Moderna stated that it believes that mRNA is the best-positioned technology platform to meet the global need for ongoing vaccination against COVID-19.

The company’s belief is based on observations that mRNA vaccines have the highest published efficacy among authorized vaccines, as well as the demonstrated ability of mRNA platforms to quickly respond to the coronavirus, including variants of concern.

Additionally, mRNA technology also has the ability to produce multi-valent vaccines. To date, Moderna has entered 14 different mRNA vaccine candidates into clinical trials.

Last month, Moderna announced updates from clinical trials testing its RSV and mRNA vaccine candidates.

In a Phase 1 study of its RSV vaccine, mRNA-1345, a single dose vaccination of 50 micrograms or 100 micrograms of the vaccine was generally well-tolerated in younger adults. mRNA-1345 also increased RSV neutralizing antibodies in seropositive younger adults.

And a Phase 2 study found that Moderna’s candidate, mRNA-1647, which combines six mRNAs in a single vial, was generally well tolerated at 50 micrograms, 100 micrograms, and 150 micrograms.

Based on these results, the 100-microgram dose has been chosen for the Phase 3 pivotal study, which will evaluate the prevention of primary CMV infection in seronegative women aged 16 to 40 years. 

Additionally, Moderna’s mRNA-1644 is a novel approach to HIV vaccine strategy in humans designed to elicit neutralizing HIV-1 antibodies.

A Phase 1 study for mRNA-1644 will use human testing to validate the approach and antigens, and multiple novel agents will be used for germline-targeting and immuno-focusing. The trial will begin in 2021.