- Six months put up the booster vaccination with ABNCoV2, the neutralization antibody titers in opposition to Wuhan and the Omicron variant remained excessive and at ranges related to a larger than 90% efficacy.
COPENHAGEN, Denmark, October 17, 2022 – Bavarian Nordic A/S (OMX: BAVA) introduced as we speak the outcomes of a six-month follow-up evaluation from a Phase 2 medical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.
Previously reported outcomes from the trial confirmed, that vaccination with 100ug ABNCoV2 in 103 seropositive topics was capable of show a robust boosting impact, growing the prevailing ranges of SARS-CoV-2 neutralizing antibodies in opposition to each the Wuhan variant and variants of concern (Alpha, Beta, Delta and Omicron) to ranges reported to be extremely efficacious (>90%) in opposition to SARS-CoV-21.
A cohort of 41 topics have been adopted for six months put up vaccination. From this cohort, two topics with confirmed COVID-19 illness have been excluded from the immune evaluation. Six months put up vaccination, neutralization titers have been six occasions greater than pre-boost titers in opposition to Wuhan and practically 10 occasions greater than the pre-boost titers for Omicron BA.1. This represented lower than a 50% decline within the peak neutralizing titers after six months and in comparison with the information printed for mRNA vaccines2,3,4, the antibody decay seems much less sharp, indicating a probably longer length of safety throughout variants of concern.
Paul Chaplin, President and CEO of Bavarian Nordic mentioned: “It is highly encouraging that the strong booster responses we have reported for ABNCoV2 against all variants of concern are maintained after six months post vaccination at levels associated with a high degree of efficacy. These latest data further support the concept that ABNCoV2 could be a universal booster vaccine inducing strong and durable immune responses against all major variants of concern, including Omicron, without the need to modify the vaccine. We look forward to generating further data in the ongoing Phase 3 trial that will shortly open sites in Denmark.”
About ABNCoV2
ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac, Denmark, utilizing their proprietary capsid virus like particle (cVLP) expertise. Bavarian Nordic has licensed the worldwide commercialization rights to the vaccine and has assumed the accountability for additional medical growth in the direction of licensure.
ABNCoV2 has proven to be extremely immunogenic in related preclinical fashions inducing a sturdy and extremely protecting response from a COVID-19 problem. Results from a Phase 2 trial in beforehand vaccinated topics has confirmed the flexibility of ABNCoV2 to considerably enhance antibody titers to ranges reported to be extremely efficacious (>90%) in opposition to SARS-CoV-2, together with variants of concern.
A worldwide Phase 3 trial assessing the non-inferiority of ABNCoV2 in comparison with Comirnaty® when it comes to neutralizing antibodies in opposition to the SARS-CoV-2 index virus was initiated in September 2022. The double-blind, managed trial will enroll two teams of a complete of roughly 4,000 grownup topics who both beforehand accomplished main vaccination or have already obtained one booster dose of a licensed COVID-19 vaccine. The first group, which is presently enrolling within the U.S., will consider the security and tolerability of the vaccine in 3,000 topics receiving a single 100 µg dose of ABNCoV2. The second group will begin enrollment of 1,000 topics in Denmark and Belgium later in October. Subjects on this group shall be randomized to obtain both a single 100 µg dose of ABNCoV2, or a single 30 µg grownup booster dose of Comirnaty.
About Bavarian Nordic
Bavarian Nordic is a completely built-in vaccines firm centered on the event, manufacturing and commercialization of life-saving vaccines. We are a worldwide chief in smallpox vaccines and have been a long-term provider to the U.S. Government of a non-replicating smallpox vaccine, which has been authorized by the FDA, additionally for the safety in opposition to monkeypox. The vaccine can also be authorized in Europe and Canada. Our industrial product portfolio moreover comprises market-leading vaccines in opposition to rabies and tick-borne encephalitis. Using our stay virus vaccine platform expertise, MVA-BN®, we’ve got created a various portfolio of proprietary and partnered product candidates designed to save lots of and enhance lives by unlocking the ability of the immune system, together with an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are additionally dedicated to the event of a subsequent era COVID-19 vaccine. For extra data go to www.bavarian-nordic.com.
Forward-looking statements
This announcement consists of forward-looking statements that contain dangers, uncertainties and different components, a lot of that are outdoors of our management, that would trigger precise outcomes to vary materially from the outcomes mentioned within the forward-looking statements. Forward-looking statements embody statements regarding our plans, aims, objectives, future occasions, efficiency and/or different data that isn’t historic data. All such forward-looking statements are expressly certified by these cautionary statements and some other cautionary statements which can accompany the forward-looking statements. We undertake no obligation to publicly replace or revise forward-looking statements to replicate subsequent occasions or circumstances after the date made, besides as required by legislation.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, [email protected], Tel: +1 781 686 9600
Company Announcement no. 38 / 2022
1 P. B. Gilbert et al., Science 10.1126/science.abm3425 (2021)
2 Bellusci et al. Antibody affinity and cross-variant neutralization of SARS-CoV-2 Omicron BA.1, BA.2 and BA.3 following third mRNA vaccination
3 Forgacs et al. The Effect of Waning on Antibody Levels and Memory B Cell Recall following SARS-CoV-2 Infection or Vaccination
4 Qu et al. Durability of Booster mRNA Vaccine in opposition to SARS-CoV-2 BA.2.12.1, BA.4, and BA.5 Subvariants (letter)
