CONFLICT OF INTEREST STATEMENT
RBD, pain, coronavirus disease 2019, fever
ADVERSE REACTIONS, VIRUS, CORONAVIRUS DISEASE 2019, FOUNDER, ADVERSE EVENTS, PLAQUE, ADVERSE EVENT, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
Suad Hannawi and Rong‐Rong Zhang contributed equally to this work.Dear Editor,The coronavirus disease 2019 (COVID‐19) caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) continues to be prevalent worldwide. The development and global deployment of SARS‐CoV‐2 vaccines have reduced the burden of COVID‐19.Previously, we have developed a potent COVID‐19 mRNA vaccine (termed ARCoV) targeting the receptor‐binding domain (RBD) of the prototype strain of SARS‐CoV‐2, that has been licensed for emergency use in Indonesia.A total of 48 participants who had received two or three doses of inactivated COVID‐19 vaccines were enrolled from 277 volunteers (Figure Solicited adverse reactions within 7 days, unsolicited adverse events until Day 28, graded by National Medical Products Administration (NMPA) criteria.
The unsolicited adverse events reported by more than one participant were included.Feeling hot described the participants who felt the body temperature increase, but the measured temperature did not reach 37.3°C which was defined as Grade 1 fever by NMPA grading criteria.Unsolicited AEs within 28 days after the booster dose was reported by 26 (54.2%) participants. The most frequently unsolicited AEs were feeling hot, pain and blood triglycerides increased. No serious adverse event (SAE), AEs of special interest (AESI), or AE leading to study discontinuation was reported up to 28 days after the booster vaccination (Table Live virus nAb titers have been well deemed as the surrogate of protection.Immunogenicity of the booster with ABO1009‐DP in healthy adults. (A) The dots show the 50% Plaque reduction neutralization test (PRNTThis study has several limitations. First, data interpretation is based on a small sample size with an unbalanced ratio between race and sex. Secondly, Omicron variant BA.1 has continued to evolve into new sub‐lineages, including BA.2, BA.4‐BA.5, BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1, most of which showed significant immune escape capability from previous variants. The neutralization activity against these omicron sub‐lineages is yet to be carried out.In summary, ABO1009‐DP demonstrated a good safety profile and well tolerability administered as a booster vaccination. As an Omicron‐specific mRNA vaccine, a single dose of ABO1009‐DP booster induced excepted humoral and cellular immunity against Omicron variant BA.1. The findings of this study support further clinical trials to assay the efficacy of ABO1009‐DP.B.Y. is the founder of Abogen Bioscience. H.‐X.Z., D.‐F.W., D.‐D.Y., J.‐C.Y., D.Z., and R.L., are employees of Abogen Bioscience. The other authors declare no conflict of interest.