Moderna Ships Doses of Variant-Specific COVID-19 Vaccine to NIH

Moderna recently announced that it has shipped doses of its variant-specific COVID-19 vaccine candidate to the National Institutes of Health (NIH) for a Phase 1 clinical trial.

NIAID will conduct the trial to determine if Moderna’s candidate, mRNA-1273.351, can boost immunity against the SARS-CoV-2 variant known as B.1351, which was first identified in South Africa.

Moderna will provide doses of mRNA-1273.351 to the NIH and NIAID will initiate the study after receiving safe-to-proceed authorization from the FDA. 

“We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration to combat this pandemic,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

“As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge. Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic,” Bancel continued. 

Initial data confirmed that mRNA-1273 provides neutralizing activity against variants of concern. But Moderna is pursuing two additional strategies against these variants, subject to FDA review.

In the first strategy, Moderna will evaluate three approaches to boosting vaccine doses to increase neutralizing immunity against the variants of concern. 

The first approach the company will take is to leverage a variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant at the 50-microgram dose level and lower.

Second, the company will use a multivalent booster candidate, mRNA-1273.211, which is authorized against ancestral strains, as well as mRNA-1273.351 in a single vaccine at the 50-microgram dose level and lower. 

Finally, Moderna will use a third dose of mRNA-1273, the Moderna COVID-19 Vaccine, as a booster at the 50-microgram dose level. The company has already begun dosing the cohort with a booster.

In the second strategy, Moderna will evaluate mRNA-1273.351 as a primary vaccination series for those who are seronegative. A seronegative individual does not have the same antibodies that a person who is “seropositive” has.

These candidates will be evaluated in a two-dose series at the 100µg dose level and lower, the company said. 

Moderna will evaluate immunogenicity and safety in participants who have not received a COVID-19 vaccine, as well as participants in clinical studies who previously received the mRNA-1273 vaccine.

NIAID will provide additional information when the trial begins and details will also be available on clinicaltrials.gov. Additionally, Moderna will conduct its own clinical studies to support regulatory filings for any booster vaccine or updated primary vaccine.

The studies will inform the company’s regulatory strategy with FDA and regulatory agencies outside of the US, Moderna said. The current Moderna COVID-19 Vaccine calls for 100-microgram doses.

“Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control. We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary,” Bancel said.  

Last week, FDA issued three guidance documents for COVID-19 vaccine developers and other medical product creators to address the current and potential future emergence of variants of SARS-CoV-2. 

In the first guidance, FDA updated its October 2020 guidance to include that for clinical data, the effectiveness of a vaccine should be supported by data from clinical immunogenicity studies. 

In the second guidance, FDA provides information on evaluating the potential impact of emerging and future viral genetic mutations. These genetic mutations could be the basis of viral variants on COVID-19 tests. 

Lastly, FDA provided new recommendations for test developers that addressed the impact of emerging variants of SARS-CoV-2 on the development of monoclonal antibody products targeting the virus.