Moderna has developed an updated version of its Covid-19 vaccine to help it fight the South African coronavirus variant, the company announced on Wednesday.
Initial doses were sent to the US National Institutes of Health for a clinical study.
The new vaccine, called mRNA-1273,351, will be evaluated as a booster injection for people who have already been vaccinated against coronavirus and as a primary vaccine for people who have not had coronavirus and have not yet been vaccinated.
Moderna said it will also evaluate a “multivalent” booster injection that combines the new vaccine formulation with the current vaccine.
In addition, the company said it has started testing whether a lower third dose of its current Covid-19 vaccine can boost immunity against coronavirus variants of concern, with some study participants already receiving the third dose.
On Monday, the Food and Drug Administration issued a new guideline to vaccine manufacturers to address the emergence of coronavirus variants. The agency recommended that data from clinical immunogenicity studies be used to support any changes or updates to vaccines. These studies would be smaller and take less time than large-scale clinical trials.
“It will be in the order of a few hundred individuals in terms of size and we hope it will take a few months,” said Dr. Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, during a call with reporters on Monday.
Moderna said it plans to “assess immunogenicity and safety in participants” according to the recently updated guidance.
“We are moving quickly to test updates to vaccines that address emerging variants of the virus in the clinic. 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 dosage levels, which will allow us to deliver many more doses to the global community in late 2021 and 2022, if necessary, “said Stephane Bancel, CEO of Moderna, in a press release on Wednesday market.
Moderna did not say how long the studies are waiting or when the new vaccine will be available, if authorized.