A combined COVID-19 booster dose targeting the progenitor strain of SARS-CoV-2 and the original Omicron variant, BA.1, appears to outperform the current booster dose against these two versions of the virus, This was reported by Moderna on Wednesday.
Specifically, Moderna says that the combination booster increased neutralizing antibodies against Omicron by 8-fold, while the original booster only increased antibody levels by 4.4-fold.
The vaccine maker is aiming for this bivalent injection – dubbed mRNA-1273.214 – to be the top choice for seasonal injections this fall. The company will file its data with the Food and Drug Administration in the coming weeks and hopes to have the bivalent booster available in late summer, if not early fall.
According to Moderna, this dose is the second bivalent design that can outperform its current booster. In April, the company reported 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 course to focus on bivalent boosters going forward.
“We are thrilled to share the preliminary data analysis on mRNA-1273.214,” Moderna CEO Stéphane Bancel said in a statement on Wednesday. “When we consider this data along with the durability we have seen with our first bivalent booster candidate, mRNA-1273.211, we expect more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a booster in the autumn 2022.”
There’s still a lot of uncertainty about a fall booster campaign — including which boosters will be offered and to whom. It is also still unclear whether SARS-CoV-2 will become a seasonal virus. But with waves of variants and subvariants continuing, and immunity to current and booster vaccines flagging, vaccine manufacturers, regulators and experts have largely accepted the idea of a fall booster campaign for this year.
The FDA will Its panel of independent technical advisers convened on June 28th to plan for fall and future boosters. Specifically, the advisors will discuss “whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.” The body — the Vaccines and Related Biological Products Advisory Committee (VRBPAC) — will not consider specific products but will help establish guidelines for updating COVID-19 vaccines, much like the guidelines for setting the formulas for annual flu shots . Moderna said it will present some of its data at the meeting.
The meeting is already developing into a remarkable challenge. If vaccine manufacturers are to make booster doses, distribute them, and have them ready for the fall, they need to pick the design and start manufacturing as soon as possible. But the data guiding 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 in circulation in the US. In fact, two subvariants – BA.2 and BA.2.12.1 – have already achieved dominance since the BA.1 wave in January. And two other sub-variants – BA.4 and BA.5 – seem poised to overtake omicron’s currently incumbent version, BA.2.12.1.
Preliminary data suggest that the newer subvariants can bypass antibody responses generated by BA.1 infection, raising concerns that a BA.1-based vaccine design might be less effective against the current subvariants.
Moderna did not provide data on how well its BA.1-targeted bivalent vaccine performs against newer Omicron subvariants. But it’s not even clear if such data would be relevant for fall, given how quickly subvariant waves have come this year. By winter, unidentified variants or subvariants could possibly be in circulation.
in the a webcast WednesdayAddressing this deficiency, Moderna President Stephen Hoge essentially said that the antibody levels they are seeing with the new Omicron-based bivalent booster are high enough that the booster is still protective even if the potency is replaced by new ones Subvariants is affected.
“We strongly believe that the data we have shows it is appropriate” to update the booster with this bivalent design, Hoge said. “In fact, we think so [it’s] It is highly desirable to update the sequence of the vaccine with an omicron-containing variant as this will allow significantly higher titers to be achieved, which we believe will correlate with better durability and better protection against omicron subvariants during the winter.”
So far, Moderna has no data to back this up. But the data it has looks strong so far, at least in protecting against BA.1 and outperforming the original booster.
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