Bharat Biotech's nasal COVID-19 vaccine candidate BBV154 has become the front runner globally to likely commercialise an intranasal vaccine, following green signal from the government to conduct a combined Phase II and III final clinical trials in India. At present out of the 110 vaccines under clinical development globally, only eight are intranasal vaccines and three are oral vaccines. So far none of these vaccines have entered the final phase of trials and most are still in the first phase.
BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine, in-licensed from the Washington University in St Louis, USA. Nasal and oral vaccines are expected to be a game-changer 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 health care workers to administer the vaccine, have no risks of injuries and infections and is suited for children and adults. Unlike Covaxin, which is difficult to make, manufacturing can be scaled up fast and easily. Compared to injectable vaccines, nasal and oral vaccines are expected to provide long-lasting protection.
Bharat Biotech is yet to announce its plans and timeline for the nasal vaccine's future development.
Serum Institute of India and Codagenix have done a 48-subject Phase I clinical trial in the UK for an intranasal COVID-19 vaccine, COVI-VAC. This live attenuated candidate vaccine is expected to have potential to provide a broader immune response, in comparison to most COVID-19 vaccines that target only a portion of the virus. Codagenix has recently completed dosing for its Phase I trials and data is expected to come out in the third quarter of the year.
Nasdaq listed US biopharmaceutical company Altimmune, which was developing a three-dose intranasal vaccine candidate AdCOVID, discontinued the project on July 29, as its first phase trials did not stimulate an adequate immune response in healthy volunteers. “The top-line Phase 1 clinical data are disappointing given the encouraging preclinical data and our substantial efforts in advancing a differentiated, intranasal vaccine candidate in the fight against COVID-19,” said Vipin K Garg, Altimmune's India born President and Chief Executive Officer.
The University of Hong Kong, Xiamen University and Beijing Wantai Biological Pharmacy in China are trying a Phase II clinical trial of a two-dose influenza virus vector COVID-19 vaccine as an intranasal spray (DelNS1-2019-nCoV-RBD-OPT1). Its one year long second phase trial among 240 volunteers is going on and will conclude only by mid-December 2021.
The University of Oxford is conducting a single dose Phase I study of AstraZeneca's ChAdOx1 nCOV-19 (Covishield in India and manufactured by the Serum Institute) to be administered intranasal among 54 volunteers in three groups. According to the trial design, the study started in April is estimated to complete the first phase only by February 2022.
Cuban government's Center for Genetic Engineering and Biotechnology, which developed Latin America's first COVID-19 vaccine Abdala, is undertaking a Phase I/II study of an intra-nasal three dose protein subunit vaccine candidate Mambisa (CIGB-669). According to the research agency, Mambisa is based on the formulation of the RBD (Receptor Binding Domain) protein and an immuno enhancer, Hepatitis B nucleocapsid antigen.
Canadian biotech Symvivo Corporation has 'bacTRL-Spike', as an oral capsule DNA vaccine candidate for the prevention of COVID-19, is undergoing Phase I trials in Australia. The trial was started only in November, last year. The global drug major Merck, known as MSD outside the United States and Canada, has taken exclusive license of Symvivo’s bacTRL platform of oral vaccines. Symvivo has funding of about $4.57 million from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to develop this vaccine.
US biotech Meissa Vaccines’s MV-014-212, a single dose intranasal recombinant live attenuated COVID-19 vaccine, is undergoing Phase I trials and its interim trial data will come out by the end of this year. Another small US biotech, Vaxform and the US Specialty Formulations LLC (USSF) are developing an oral COVID-19 vaccine, which is also in its first phase. Similarly, another US small biotech CyanVac LLC is also attempting an intranasal parainfluenza virus based COVID-19 vaccine (CVXGA1), now in the first phase and its results are also expected only by the end of the year.
Mexican veterinary pharmaceutical company Laboratorio Avi-Mex is testing a live influenza virus based vaccine, both as an intranasal spray as well as an injection. It is starting Phase I trials and is funded by Mexico's foreign ministry and the National Council of Science and Technology (Conacyt). The Mexican authorities hope to commercialise this vaccine by the end of the year.
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