Moderna tackles the Omicron variant with booster shots

Development of booster shots is imminent

Randall Hyer, Moderna's senior vice president, explains the companies' measures to respond to the Omicron variant

Higher dose, partial variant, Omicron-specific booster shot in development

“Vaccine’s risk of myocarditis in younger population is very low… people of all ages should be vaccinated.”

” We are developing three vaccine strategies to rapidly respond to the much-concerned Omicron variant.

 

We plan to soon release a booster shot that is most appropriate for the Omicron variant.” Randall N.

 

Hyer, senior vice president of Global Medical Affairs at Moderna, replied so to an inquiry about the company’s plans on responding to the Omicron variant at a press conference that was held at the Somerset Palace in Jongno-gu, Seoul, on the 2nd.

 

According to SVP Hyer, Moderna is preparing three different strategies to respond to the Omicron variant: ▲high dose booster shot; ▲new booster shot to respond to the Omicron and other emerging variants; and ▲an Omicron-tailored booster shot.

 

For the first option, a high-dose booster shot, the company has already completed safety and immunogenicity tests on 306 adults with a 100μg dose that is twice the dose currently in use.

 

As the second option, the company is testing 2 multivalent booster candidates – one that added the Beta variant to the existing vaccine (mRNA-1273.211), and the other that combined the beta and delta variant (mRNA-1273.213).

 

The two candidates include the 4 and 8 variants found in the Omicron variant.

 

As the third option, Moderna is developing the vaccine candidate mRNA-1273.529 that specifically targets the Omicron variant.

 

The development is expected to take 2-3 months.

 

Randall N.

 

Hyer, Senior Vice President of Moderna Inc.

i2Hyer said, “We have been developing various booster shots since earlier this year to respond to anticipatable variants.

 

We are reviewing which strategy is most effective among the three.

 

We will be able to identify the effect of the high-dose booster shot within a few weeks.” However, it would take some time for a booster shot that can prevent the Omicron variant to be available for inoculation in the field, as it requires clinical trials and approval by the regulatory authorities.

 

Moderna believes that the benefits of vaccination outweigh the risk even in young adults and children.

 

There were concerns over the risk of myocarditis in young adults with the Moderna vaccine, however, the company says its data demonstrates the fact that its vaccine’s risk is no different than that of Pfizer’s.

 

Some Northern European countries have only allowed the use of Pfizer’s vaccine to children and young adults due to the risk of side effects such as myocarditis and pericarditis among youths and young adults.

 

Korea has also made the same recommendation.

 

Also, the US Food and Drug Administration has deferred extending approval of Moderna’s vaccination to those aged 12-17, saying that the risk of myocarditis in teenagers needs to be reviewed.

 

On this, Hyer said, “The absolute risk of myocarditis after vaccination is very low.

 

Some monitoring results showed that Moderna’s vaccine had a higher risk than Pfizer’s vaccine, but others have also shown that there was no difference at all between the two.

 

The incidence of myocarditis and pericarditis in those 30 years or less who were vaccinated were no different for the two - 0.45(0.45 per 100,000) for Pfizer and 0.49(0.49 per 100,000) for Moderna.” He added, “Please bear in mind that the risk of myocarditis is higher if you are unvaccinated and confirmed with COVID-19 rather than from vaccination with COVID-19 vaccines.

 

Of course, we fully understand the concerns of the health authorities as the results vary by each dataset.

 

Moderna is also conducting its safety investigations to examine the association between myocarditis and mRNA vaccines.” Moderna also stressed the need for smooth communication with the Korean government.

 

That day, Moderna had also announced that it had appointed Ji-young Sohn, former general manager of CSL Behring Korea, as its new general manager for its Korean subsidiary.

 

Hee-Soo Kim, Country Medical Director of Moderna Korea, said, “After the Korean subsidiary was established in May, the general manager and medical director joined the company in November, and various departments have also been established since then.” Kim added, “We are hiring many employees now.

 

Although we had issues communicating with Korean government authorities before, we hope that the establishment of our Korean subsidiary may contribute in various ways, including facilitating the smooth supply of vaccines and R&D partnerships.” As part of such efforts, Moderna has started a fellowship program under which young researchers can learn about the development of mRNA therapeutics, and encouraged active participation of Korean researchers.

 

Hyer said, “We are pleased that 2 Korean professors have joined our Fellowship Promotion Committee.

 

We hope many young researchers in Korea would join us to study mRNA-based therapeutics."