MVC COVID-19 vaccine
The MVC COVID-19 vaccine (Chinese: 高端新冠肺炎疫苗; pinyin: Gāoduān xīnguàn fèiyán yìmiáo; Wade–Giles: Kaotuan hsinkuan feiyen imiao), designated MVC-COV1901 and also known as the Medigen COVID-19 vaccine, is a protein subunit COVID-19 vaccine developed by Medigen Vaccine Biologics Corporation in Taiwan, American company Dynavax Technologies, and the U.S. National Institutes of Health.[1][2]
Vaccine description
MVC-COV1901
- Full and emergency authorizations
Technology[edit]
This vaccine is made by the recombinant S-2P spike protein.[3][4] It is adjuvanted with CpG 1018 supplied by Dynavax, which was used in a previously FDA-approved adult hepatitis B vaccine.[3][5]
Controversies[edit]
In May 2021, when Taiwan experienced an outbreak of domestic cases, the government announced that the vaccine would be available in July despite the result of the phase 2 trial was yet to be announced. In June 2021, the vaccine had just completed the second phase clinical trial, but the vaccine was sent to Taiwan FDA for the application of EUA.[21] Seroconversion rate was used as the surrogate endpoint, though there was lack of evidence at that time. Compared to EUA of vaccine issued in the US, both Moderna and BNT/Pfizer vaccine finished interim analysis from Phase 3 study, which Medigen vaccine skipped.[22]
The controversy arose because immunobridging was not widely accepted as sufficient for EUA at the time. However, due to difficulty to conduct traditional, placebo-controlled efficacy trials in some countries, as few candidates are available or willing to participate, there were discussions to focus on immunobridging studies as an acceptable approach for authorizing COVID-19 vaccines by the International Coalition of Medicines Regulatory Authorities (ICMRA). As the result of the workshop convened in 24 June 2021, immunobridging has now been accepted by the UK, Australia, Canada, Singapore, and Switzerland among other countries.[15][23] US FDA also authorized Pfizer-BioNTech vaccine for children 5 to 11 years old based on immunobridging alone. [24][25]