Bharat Biotech’s nasal COVID-19 vaccine candidate BBV154 has led the world in the likely commercialization of an intranasal vaccine after the government gave the go-ahead to conduct combined Phase II and III clinical trials in India. Currently, of the 110 vaccines in clinical development worldwide, only eight are intranasal vaccines and three are oral vaccines. So far, none of these vaccines are in the final stages of trials and most are still in the first stage.
BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vector vaccine in-licensed from Washington University in St. Louis, USA. Nasal and oral vaccines are expected to be a groundbreaking second generation COVID-19 vaccine as they stimulate a broad immune response and prevent both infection and transmission. The non-invasive, needle-free vaccines do not require trained medical personnel to administer the vaccine, pose no risk of injury or infection, and are suitable for children and adults. Unlike Covaxin, which is difficult to make, manufacturing can be scaled up quickly and easily. Compared to injectable vaccines, nasal and oral vaccines are expected to provide long-lasting protection.
Bharat Biotech has not yet announced its plans and the timetable for future development of the nasal vaccine.
The Serum Institute of India and Codagenix have conducted a phase I clinical trial in the UK with 48 subjects for an intranasal COVID-19 vaccine COVI-VAC. This live attenuated vaccine is expected to have the potential to provide a broader immune response when compared to most COVID-19 vaccines that target only part of the virus. Codagenix recently completed dosing for its Phase I trials and the data is expected to be released in the third quarter of this year.
The US biopharmaceutical company Altimmune, listed on the Nasdaq, which was developing an intranasal vaccine candidate with three doses of AdCOVID, discontinued the project on July 29, because the first phases of the study did not stimulate an adequate immune response in healthy volunteers. « The top-line Phase 1 clinical data is disappointing given the encouraging preclinical data and our significant efforts to advance a differentiated intranasal vaccine candidate in the fight against COVID-19, » said Vipin K Garg, President and Chief Executive Officer of Altimmune in India .
The University of Hong Kong, Xiamen University, and Beijing Wantai Biological Pharmacy in China are attempting a Phase II clinical trial of a two-dose influenza virus vector COVID-19 vaccine as an intranasal spray (DelNS1-2019-nCoV-RBD-OPT1 ). The one-year second phase of the study with 240 volunteers is ongoing and will not be completed until mid-December 2021.
Oxford University is conducting a single-dose Phase I study of AstraZeneca’s ChAdOx1 nCOV-19 (Covishield in India and manufactured by the Serum Institute) administered intranasally to 54 volunteers in three groups. According to the study design, the study, which started in April, is not expected to complete the first phase until February 2022.
The Cuban Government’s Center for Genetic Engineering and Biotechnology, which developed Latin America’s first COVID-19 vaccine Abdala, is conducting a Phase I / II trial of an intranasal vaccine candidate with three doses of protein subunits Mambisa (CIGB-669). According to the research agency, Mambisa is based on the formulation of the RBD protein (Receptor Binding Domain) and an immune booster, the hepatitis B nucleocapsid antigen.
The Canadian Biotech-Symvivo Corporation has tested ‘bacTRL-Spike’ as an oral capsule DNA vaccine candidate for the prevention of COVID-19 in Australia in Phase I studies. The process only started in November last year. Global pharmaceutical company Merck, known outside the US and Canada as MSD, has acquired the exclusive license to Symvivo’s bacTRL platform for oral vaccines. Symvivo will receive approximately $ 4.57 million in funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to develop this vaccine.
US biotech Meissa Vaccines’ MV-014-212, a single-dose intranasal recombinant attenuated COVID-19 vaccine, is in Phase I trials and preliminary study data will be released by the end of this year. Another small US biotech company, Vaxform, and US Specialty Formulations LLC (USSF) are developing an oral COVID-19 vaccine, which is also in phase one. Similarly, another US small biotech company, CyanVac LLC, is attempting a COVID-19 vaccine based on an intranasal parainfluenza virus (CVXGA1), which is currently in the first phase and whose results are also not expected until the end of the year become.
The Mexican veterinary drug company Laboratorio Avi-Mex is testing a live vaccine based on an influenza virus, both as an intranasal spray and as an injection. It begins with Phase I trials and is funded by the Mexican State Department and the National Council of Science and Technology (Conacyt). Mexican authorities hope to commercialize this vaccine by the end of the year.
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