Infectious Disease

Moderna is sending a variant-specific vaccine to NIH for scientific analysis

February 25, 2021

2 min read

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Disclosure:
Bancel works at Moderna. Offit does not report any relevant financial information.

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Moderna said it modified its COVID-19 vaccine to target variant B.1.351 and was supplying doses to the NIH for Phase 1 testing.

The original vaccine, mRNA-1273, has been shown to be extremely effective against wild-type SARS-CoV-2 and is one of two messenger RNA-based COVID-19 vaccines already approved in the United States. The vaccine also protected against emerging variants in laboratory experiments, although it showed reduced activity against variant B.1.351, which was first identified in South Africa.

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Moderna said strategies are being explored to “cautiously” address emerging variants.

The study to test the B.1.351-specific booster is led and funded by the National Institute for Allergies and Infectious Diseases, which helped develop the original vaccine.

Paul A. Offit

“I think it makes sense to start with Phase 1 dose finding studies of variant B.1.351 … if the variant resists vaccine-induced immunity.” Paul A. Offit, MD, Director of the Vaccination Education Center at Philadelphia Children’s Hospital, said Healio.

Moderna said it has three different approaches to funding:

A variant-specific booster candidate, mRNA-1273.351, based on variant B.1.351 from South Africa. This would be 50 µg per dose or less.

A multivariate booster candidate, mRNA-1273.211, would combine mRNA-1273, Moderna’s approved 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 approved mRNA 1273 vaccine as a 50 µg booster dose.

An additional strategy involves evaluating mRNA-1273.351 and mRNA-1273.211 as the primary series of vaccinations for individuals seronegative in a two-dose series at a dose of 100 µg or less.

Moderna determined that all strategies are subject to FDA review.

The company said it would evaluate immunogenicity and safety in subjects who did not receive the COVID-19 vaccine, as well as those in clinical trials who received the mRNA-1273 vaccine.

“We look forward to starting the clinical trial of our variant booster and are grateful for the NIH’s continued collaboration to fight this pandemic,” said Moderna CEO Stéphane Abort said in a statement. “We are taking advantage of the flexibility of our mRNA platform and are quickly testing vaccine updates to address emerging variants of the virus in the clinic.”

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Amesh A. Adalja, MD

Amesh A. Adalja

For me, the trigger to modify the vaccines in the face of variants is when people get breakthrough infections severe enough to require hospitalizations. It really hasn’t happened yet. However, it’s important to have different strategies for dealing with the variants. One is to reformulate the vaccine in case it does occur. I feel it is advisable to have modified vaccines available, and since the FDA rightly ruled that only small studies are needed for updates, the time it takes to update vaccines will be minimized when they are ready as Moderna’s proactive measures show.

Amesh A. Adalja, MD

Senior Scholar

Johns Hopkins Center for Health Safety

Disclosure: Adalja does not report any relevant financial information.

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