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Japan Grants AstraZeneca’s COVID-19 Vaccine Emergency Use
In other COVID news, Moderna’s COVID-19 vaccine was also granted special approval in Japan and the EMA issued positive opinion of GSK and Vir Biotechnology’s COVID-19 antibody.
AstraZeneca’s COVID-19 vaccine, Vaxzevria, was recently granted emergency use in Japan for active immunization of individuals 18 years of age and older.
The Japanese Ministry of Health, Labour, and Welfare granted the approval based on positive Phase 3 efficacy and safety data from the Oxford University-led clinical trial program in the UK, Brazil, and South Africa, as well as a Phase 1/2 trial in Japan.
The first doses are expected to be available in the coming weeks.
“We continue to expand global access to our vaccine and today’s approval brings us one step closer to providing Vaxzevria to the people of Japan who urgently need protection from coronavirus,” Mene Pangalos, executive vice president of biopharmaceuticals research and development, said in the announcement.
“We are proud to have produced a vaccine for the world, with more than 400 million doses now supplied by AstraZeneca and sub-licensees to 165 countries,” Pangalos continued.
Japan’s Pharmaceuticals and Medical Devices Agency recommended that Vaxzevria should be limited to adults and administered intramuscularly as two 0.5-millimeter doses gives four to 12 weeks apart.
An Interval between doses greater than eight weeks is preferable in order to maximize the vaccine’s efficacy.
In previous trials, this dosing regimen was shown to be well-tolerated and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalizations over 14 days after the second dose.
So far, Vaxzevria has been granted conditional marketing authorization or emergency use in over 80 countries across six continents and has also received emergency use listing from the World Health Organization (WHO).
These authorizations create the pathway for nearly 142 countries to access the vaccine through the COVAX Facility.
Moderna’s COVID-19 Vaccine Granted Emergency Use in Japan
Moderna recently announced that the Ministry of Health, Labour, and Welfare of Japan recently granted special approval under the Pharmaceutical and Medical Devices Act for emergency use of its mRNA COVID-19 vaccine in Japan.
Takeda Pharmaceuticals will begin distribution of the vaccine in Japan immediately.
“This is an important moment in Moderna’s history as it is the first approval for a Moderna product in Japan. We would like to thank the MHLW, the participants in the study and Takeda for helping to protect the Japanese population from COVID-19 with our vaccine,”
Stéphane Bancel, chief executive officer of Moderna, said in the announcement.
“We look forward to building our local team in Japan to continue to bring mRNA science to address additional unmet medical needs,” Bancel continued.
The approval is based on Moderna’s Phase 3 COVE study and positive initial clinical data from the Takeda Pharmaceuticals-led placebo-controlled Phase 1/2 study.
In the COVE trial, COVID-19 Vaccine Moderna was found to be 94.1 percent effective against the coronavirus.
In Takeda Pharmaceutical’s study, COVID-19 Vaccine Moderna was given at the 100-microgram dose level, 28 days apart in 200 participants. Binding and neutralizing antibody titers were elevated 28 days after the second dose of the vaccine candidate in 100 percent of participants.
These results are similar to results from the COVE trial.
Takeda Pharmaceuticals will distribute 50 million doses of Modera’s COVID-19 vaccine candidate throughout the first half of 2021. There is also potential supply of 50 million doses at the beginning of 2022.
EMA Issues Positive Opinion of GSK, Vir Biotechnology’s COVID-19 Antibody
GSK and Vir Biotechnology recently announced that the European Medicines Agency (EMA) Committee for Human Medicinal Products (CHMP) issued a positive scientific opinion of their COVID-19 antibody treatment.
The antibody, sotrovimab, is intended for adults and adolescents with the coronavirus who do not require oxygen supplementation and who are at risk of progressing to severe illness.
“As the COVID-19 pandemic continues and the virus generates new variants of concern, the need for therapies that can slow the progression of disease in patients who are at high risk for developing severe complications remains a top priority,” Christopher Corsico, senior vice president of development at GSK said in the announcement.
“Monoclonal antibody treatments are a critical part of a comprehensive solution to COVID-19. We are encouraged by this positive scientific opinion from the EMA, as it hopefully brings us closer to making sotrovimab available for patients across Europe,” Corsico continued.
The CHMP reached its opinion following a review of data, including an interim analysis of safety and efficacy data from the Phase 3 COMET-ICE trial.
In the trial, researchers evaluated sotrovimab as a monotherapy for the early treatment of COVID-19 in 583 adults at high risk of hospitalization.
Overall, the antibody elicited an 85 percent reduction in hospitalization or death in patients who received the antibody as a monotherapy compared to a placebo.
The CHMP opinion can now be considered by the national authorities in EU member states when making evidence-based decisions on the early use of the medicine prior to marketing authorization, a GSK spokesperson emphasized.
