Moderna to soon release bivalent COVID-19 vaccine

Effective against subvariants

A combo vaccine that targets Omicron BA 1 subvariant… will soon apply for approval

“Showed effect in BA 4 and 5 subvariants as well… can supply bivalent vaccine from the end of August”

Moderna emphasizes the need for Korea to use bivalent vaccine

Moderna is determined to promptly commercialize its new bivalent COVID-19 vaccine “mRNA-1273.214 (214)” in Korea.

 

On the morning of the 19th, Moderna held a “Moderna’s mRNA technology and strategy in the endemic era” press conference at JW Mariott Hotel.

 

At the conference, the company stated that it can “supply the 214 globally by the end of August, and plans to submit data for its approval in a few days.”

(From the left) Hee Soo Kim, Medical Director at Moderna Korea; Paul Burton, Chief Medical Officer at Moderna Global ; Ji-Young Sohn, General Manager of Moderna Korea; Francesca Ceddia, Senior Vice President of Respiratory Vaccines at Moderna Global

The 214 that was developed by Moderna combines a vaccine that targets the original strain and the Omicron variant BA.1.

 

The vaccine achieved superior neutralizing geometric mean titer ratio (GMR) over the current vaccine against the original virus as well as Omicron subvariants BA.4/5.

 

Specifically, GMR of the 214 was 1.24 against the original virus, and 1.78 against BA.1.

 

The GMR against BA 4/5 was relatively lower at 1.68.

 

Even so, Moderna explained that this demonstrates a superior protective effect compared to the current vaccine.

 

Francesca Ceddia, Senior Vice President of Respiratory Vaccines at Moderna Global, said, “ A GMR of 1 or higher means it has a superior effect over its comparator.

 

In this sense, the 214 has demonstrated a superior effect against BA.4/5.

 

We plan to submit data for its approval to the Ministry of Food and Drug Safety, and will work closely with the regulatory authorities to supply our vaccine by end of August.” However, one obstacle that remains to its use is the FDA’s position.

 

The US FDA had recently requested vaccine manufacturers Moderna and Pfizer to add omicron BA.4/5 spike protein component to the current vaccine composition in the development of their vaccine combos.

 

In consideration of the additional time required for clinical trials, the FDA also emphasized that it will accept animal testing data for approval.

 

Moderna’s position is that its bivalent vaccine, the 214, also shows superior effect against Omicron compared to the current vaccine and should be first administered.

 

The company referred to how other countries and the World Health Organization requested the company to add a BA.1 component to the company’s bivalent vaccine.

 

SVP Ceddia explained, “Moderna is working to take into account the different requests made by each country.

 

The important matter is that our bivalent vaccine is an effective solution.

 

If supplied, the 214 will also provide protection against the BA.4/5 subvariants." Ji-Young Sohn, General Manager of Moderna Korea, said, “The MFDS is also known to be positively reviewing 214.

 

I believe it is important to receive vaccination with a certain vaccine at a certain period according to virus variants.

 

Therefore, rather than waiting several more months for the release of a vaccine against BA.4/5, it would be more beneficial to use a readily available vaccine and protect public health.”