It has been just revealed the fact that Japan has given its green light to the world’s self-amplifying mRNA COVID-19 vaccine without any safety data. Check out the latest reports about this below.
Japan approves new vaccine
Meiji Seika Pharma, a Tokyo-based company, has received approval for manufacturing and marketing its Kostaive sa-mRNA COVID-19 vaccine.
According to a press release from November 28th, the vaccine uses self-amplifying mRNA that generates a strong immune response and has the potential for extended duration of protection. The vaccine is intended for primary immunization with two doses and for booster immunization in adults.
The press release claims that Kostaive is the world’s first approved product that applies self-amplifying mRNA technology.
Both mRNA and sa-mRNA are RNA vaccines that use the virus’s genetic code against it. When an mRNA vaccine is injected into an individual, it instructs cells to make a specific protein, stimulating an immune response.
An sa-mRNA vaccine goes further by making multiple mRNA copies, which generates more spike protein.
Toby Young, general secretary of the Free Speech Union, a public interest group, pointed out in a Nov. 30 X post that the sa-mRNA vaccine was approved in Japan “despite only testing it on 800 people, no control group and only checking antibody levels not infection rates. Medicine regulation died with Covid.”
In a phase 3 study, the Kostaive ARCT-154 vaccine was compared to Pfizer’s Comirnaty mRNA COVID-19 vaccine.
The study was funded by the Japanese Ministry of Health, Labour, and Welfare and followed a primary phase study that analyzed the safety and efficacy of the Kostaive vaccine. The results of the primary study are not yet available.
The phase 3 study was conducted among 828 people from December 2022 to February 2023, a much smaller number than Pfizer’s phase 3 study, which involved over 40,000 individuals.
The small scale of Kostaive trial has raised questions about its validity.
According to the pre-print study, Kostaive recipients reported a slightly lower number of localized reactions such as pain or swelling at the injection site compared to Comirnaty.
However, Kostaive recipients reported higher numbers of specific adverse events such as chills, diarrhea, dizziness, headache, malaise, nausea, and muscle pain.
Meiji Seika Pharma, a company that produces Kostaive, claims that the vaccine elicited higher and longer-lasting neutralizing antibody titers against the original strain and an Omicron subvariant compared to Comirnaty in phase 3 clinical trials for booster shots.