Moderna’s omicron-combo booster outperforms the current booster

Extend / A vial of the current Moderna COVID-19 vaccine.

A combined COVID-19 booster dose that targets the ancestral strain of SARS-CoV-2 and the initial omicron variant, BA.1, appears to outperform the current booster against both versions of the virus, Moderna reported Wednesday. fair.

Specifically, Moderna says that the combined booster increased neutralizing antibodies to omicron 8-fold, while the original booster alone increased antibody levels by about 4.4-fold.

The vaccine maker is trying to make this bivalent injection — dubbed mRNA-1273,214 — the booster for seasonal injections this fall. The company will submit its data to the Food and Drug Administration in the coming weeks and says it expects to have the bivalent booster available in late summer, if not early fall.

Moderna says this dose is the second bivalent design that can outperform its current booster. In April, the company released data that a bivalent booster targeting the ancestral strain and the beta variant (booster mRNA-1273.211) could also outperform the current booster. This data solidified the company’s path to focus on bivalent drivers in the future.

“We are excited to share the analysis of preliminary data from mRNA-1273.214,” Moderna CEO Stéphane Bancel said in a statement Wednesday. “Looking at this data along with the durability we saw with our first bivalent booster candidate, mRNA-1273.211, we predict more durable protection against variants of concern with mRNA-1273.214, making it our top candidate for a fall booster. 2022”.

increased uncertainty

There’s still a lot of uncertainty about a fall booster campaign – including which boosters will be offered and to whom. It is also not yet clear whether SARS-CoV-2 will become a seasonal virus. But given the continuing waves of variants and subvariants, along with waning immunity from current vaccines and boosters, vaccine manufacturers, regulators and experts have largely accepted the idea of ​​a fall booster campaign for this year.

The FDA will convene its panel of independent expert advisors on June 28 to plan for the fall and future reinforcements. Specifically, advisors will discuss “whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.” The panel – the Vaccines and Related Biological Products Advisory Committee (VRBPAC) – will not evaluate specific products, but will help establish guidelines for updating COVID-19 vaccines, as well as guidelines for deciding formulas for annual flu vaccines. Moderna said it will present some of its data at the meeting.

The meeting is already shaping up to be remarkably challenging. If vaccine manufacturers are to have booster shots made, distributed, and ready to go into arms for the fall, they need to have the design selected and manufacturing underway as quickly as possible. But the data that drives design decisions will be extremely limited. For example, Moderna’s latest bivalent booster is based on the BA.1 omicron subvariant, which is no longer circulating in the US. In fact, two subvariants – BA.2 and BA.2.12.1 – have already reached dominance since the BA.1 wave in January. And two additional subvariants – BA.4 and BA.5 – appear to be on the cusp of overtaking the current version of omicron, BA.2.12.1.

Variant variants

Preliminary data suggest that newer subvariants may prevent antibody responses generated by a BA.1 infection, raising concerns that a BA.1-based vaccine design may be less effective in current subvariants.

Moderna did not provide data on the performance of its bivalent vaccine targeting BA.1 against newer omicron subvariants. But it’s not even clear whether this data would be relevant for the fall, given how quickly the subvariant waves emerged this year. In winter, variants or subvariants yet to be identified could be circulating.

In a webcast on Wednesday, Moderna president Stephen Hoge addressed this deficiency, essentially saying that the antibody levels they see with the new omicron-based bivalent booster are high enough that even if the effectiveness is undermined by new subvariants, reinforcement will still be protective.

“We feel strongly that the data we have shows that it is appropriate” to update the booster with this bivalent design, said Hoge. “Actually, we think [it’s] It is highly desirable to update the vaccine sequence with an omicron-containing variant due to the ability to achieve significantly higher titers, which we think will correlate with better durability and better protection against omicron subvariants during winter.”

So far, Moderna has no data to back this up. But the data he has seems strong so far, at least in protecting against BA.1 and outperforming the original booster.

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