Almost two years after the first COVID vaccine nabbed regulatory authorization, Daiichi Sankyo says its own shot is ready to join the list of options.
A booster dose of the company’s mRNA shot, DS-5670, increased neutralizing antibodies to higher levels than the shots already approved in Japan, the company reported Tuesday. Daiichi Sankyo says no safety concerns were identified and that more data would be presented at future conferences and in medical papers.
The company will now ask Japanese regulators for approval in January 2023. It's also gearing up for clinical trials of a bivalent vaccine, including strains of both the original virus and omicron variant. The company did not say whether it plans to ask other foreign regulators for booster consideration next year.
The phase 1/2/3 booster-focused trial launched in January with roughly 5,000 healthy Japanese adults and elderly people who had been fully vaccinated with other approved shots at least six months prior. The company also has ongoing trials testing DS-5670 as a primary vaccination series in adults and children.
Daiichi Sankyo is following in the footsteps of the two main mRNA vaccine makers, Pfizer and Moderna, who earlier this year started to reel in regulatory green lights for bivalent shots. On Monday, Moderna reported that its bivalent vaccine targeting specific omicron subvariants BA.4 and BA.5 elicited a “significantly higher” immune response. Earlier this month, Pfizer said its similar shot spurred a four-fold increase in antibody levels in people 55 or older compared to the original shot.