Mozambique's National Health Institute (INS) will carry out research to investigate the effectiveness of mixing two approved Covid-19 vaccines.
A statement from the International Vaccine Institute (IVI) on 20 December announced that the INS-led Phase II trial will look at the safety and immunogenicity of a two-dose regimen using one dose of Sinopharm's VeroCell Covid-19 vaccine and one dose of the Johnson & Johnson vaccine administered 28 days apart. This will be compared with the effectiveness of the single source vaccines.
Both vaccines are approved and are part of Mozambique's COVID-19 vaccine rollout program.
There is evidence from around the world that mixing vaccines can produce a greater immune response. In addition, schedules where the second dose is not necessarily the same as the first allows for more flexibility in the event of vaccine shortages.
According to the deputy director of IVI, Doctor Florian Marks, "demonstrating the safety and efficacy of a mixed schedule of COVID-19 vaccines will have a significant impact on ensuring timely vaccinations and controlling the pandemic, particularly in the regions most affected by vaccine shortages".
She added, "amid an ongoing global pandemic with inequitable and interrupted access to vaccines, it is vital to make available a good, or potentially even better, alternative to the homologous dose schedules we have relied on so far".
The Phase II trial is an observer-blind and randomised study. A total of 360 participants will be enrolled in the study with follow-ups until 48 weeks after the second vaccination. It is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and is part of a US$12.7 million project for Expanding Access and Delivery of COVID-19 Vaccines in Africa (ECOVA).
Since it was launched in 2017, CEPI has focussed on developing vaccines against the Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus and has over twenty vaccine candidates against these pathogens in development. The organisation is a partnership between public, private, philanthropic, and civil organisations.
IVI is a non-profit intergovernmental organisation established in 1997 through an initiative launched by the United Nations Development Programme (UNDP).
The INS is the national public health and research institute in Mozambique, an autonomous public entity that functions under the umbrella of the Ministry of Health. Its mission is to improve well-being through the generation of scientific and technological solutions for public health problems in Mozambique.