Moderna sends variant-specific vaccine to NIH for clinical study
Click Here to Manage Email Alerts
Moderna said it has modified its COVID-19 vaccine to target the B.1.351 variant and shipped doses to the NIH for phase 1 testing.
The original vaccine, mRNA-1273, has been shown to be highly efficacious against wild-type SARS-CoV-2 and is one of two messenger RNA-based COVID-19 vaccines already authorized for use in the United States. The vaccine also protected against emerging variants in lab experiments, although it demonstrated reduced activity against the B.1.351 variant first identified in South Africa.
Moderna said it was exploring several strategies to address emerging variants “out of an abundance of caution.”
The trial to test the B.1.351-specific booster will be led and funded by the National Institute of Allergy and Infectious Diseases, which codeveloped the original vaccine.
“I think it makes sense to begin phase 1 dose ranging trials of the B.1.351 variant ... in case the variant resists vaccine-induced immunity,” Paul A. Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told Healio.
Moderna said it is pursuing three different approaches to boosting:
A variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant originating in South Africa. This would be at 50 µg per dose or less.
A multivariant booster candidate, mRNA-1273.211, which would combine mRNA-1273, Moderna’s authorized vaccine against the wild-type strain of SARS-CoV-2, and mRNA-1273.351 in a single vaccine of 50 µg per dose or less.
A third dose of the authorized mRNA-1273 vaccine as a 50 µg booster dose.
An additional strategy includes assessing mRNA-1273.351 and mRNA-1273.211 as a primary vaccination series for people who are seronegative in a two-dose series at a 100 µg doses or less.
Moderna noted that all strategies are subject to FDA review.
The company said it will evaluate immunogenicity and safety in participants who have not received a COVID-19 vaccine, as well as participants in clinical studies who have received the mRNA-1273 vaccine.
“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,” Moderna CEO Stéphane Bancel said in a statement. “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.”
Perspective
Back to Top
To me, the trigger for modifying the vaccines in the face of variants is when people acquire breakthrough infections that are serious enough to require hospitalizations. That really has not occurred yet. However, it is important to have various strategies to deal with the variants. One is to reformulate vaccine in the event that occurs. I do think it’s prudent to have modified vaccines available and, as the FDA has correctly decided that only small trials will be needed for updates, having them poised to go as Moderna’s proactive action illustrates will minimize the time needed if a vaccine update is needed.
Perspective
Back to Top
This is exciting news. Moderna has prepared new vaccines based on the emerging SARS-CoV-2 variants, and these are being sent to the NIH for them to undergo testing in individuals who have had previous SARS-CoV-2 vaccines and in those who have not been previously immunized.
Other vaccine manufacturers are preparing similar vaccines against the variants and will also be testing them in a similar manner. This is a little like the production and testing of influenza strains each year that match the strains that are projected to circulate. Manufacturers and the FDA have experience with this procedure and have issued guidelines for testing of the variants. It is important that scientists continue to study the variants and measure the impact of the existing and new vaccines on the disease burden.
Collapse
Moderna. Moderna announces it has shipped variant-specific vaccine candidate, mRNA-1273.351, to NIH for clinical study. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-it-has-shipped-variant-specific-vaccine. Accessed February 25, 2021.
Read more about
Click Here to Manage Email Alerts