China’s proclivity toward a nasal-spray vaccine has been present since the onset of the pandemic, since the infections starting spreading in and around Wuhan, China. One of the early-on vaccine candidates, known as Ad5-nCoV with the trade name Convidecia, was developed by CanSino Biologics (CanSino) along with researchers from the Institute of Military Medicine under the Academy of Military Sciences. Now back together, they are jointly developing an inhaled nasal-spray COVID-19 vaccine a researcher at the Chinese Center for Disease Control and Prevention recently shared at a Chinese press conference. Apparently, the preclinical work has been done, and now the research team progressed into Phase 1 and Phase 2 trials. Ad5-nCoV is already approved in China and many countries around the globe. While not as effective as the Western vaccine products currently under emergency use authorization (EUA) in America, the Chinese operate under the premise that the nasal-spray version may end up working even better. TrialSite reminds that CanSino Biologics entered into a deal to supply America’s neighbor to the north, Canada, and ultimately failed to deliver the product, even though contractually obligated to do so. That scandal, fueled by geopolitical tension, highlighted the vaccine diplomacy now commonplace around the world. All along, TrialSite was one of the few clinical-research-focused media platforms to track this scandal. In the meantime, CanSino’s major markets are low- to middle-income countries (LMICs).
Current Ad5-nCoV Situation
Presently, CanSino Biologics’ Ad5-nCoV is approved in five countries, including China, Chile, Hungary, Mexico, and Pakistan. As TrialSite’s explained, the Western vaccine products are for the most part dominating the wealthy economies while the Russian and Chinese vaccines are marketed to the low- and middle-income countries (LMICs). The product is now progressing in some high-profile Phase 3 trials including one in Russia as well as another 40,000 subject Phase 3 trials in Argentina, Chile, and Mexico.
In September, CanSino initiated the Phase 1 nasal-spray study based in China targeting 144 participants in an effort to better determine the safety and immunogenicity of the treatment as compared to the traditional vaccine candidates necessitating intramuscular injection. China’s regulators authorized the study to proceed into expansionary trials while they apply for Emergency Use for the nasal spray.
Back in April, CanSino Biologics announced the commencement of clinical trials for this nasal-spray version. Yu Xuefeng, chairman and CEO of CanSino Biologics, reported to CNBC at the Boao Forum in China that this form of vaccine could offer an enhanced vaccine in terms of potency, acting more expeditiously by triggering antibodies in the airways where the disease is known to rapidly infect. Emphasizing this point, the CEO noted, “When the virus comes into the airway, you already have a layer of antibody, or T memory cells, which could be quickly activated…That’s why we are going through a mucosal route for immunization.”
Inferior Now But…
In the CNBC report, it was acknowledged that mRNA-based vaccines in the West are superior as measured in terms of efficacy rates; however, the planned nasal-spray vaccines in China could possibly perform better because of the body, according to Mr. Yu, as SARS-CoV-2 enters the human system via the airways.
Other Nasal-Spray Vaccines
Xiamen University, the University of Hong Kong, and Beijing Wantai Biological Pharmacy are also co-developing a nasal-spray based COVID-19 vaccine now under Phase 2 investigation. The researchers are now applying to take Phase 3 trials abroad.
The Phase 1 trial started in November 2020. According to a report, this partnership was the first in China to receive authorization from the China National Products Administration (CNPA).
Some analysts, such as GlobalData, suggested that this vaccine could become superior given its ease of mass production and distribution as its underlying technology is the same as its influenza vaccine.
Based on research from GlobalData drug’s database, by November 2020, five vaccines were in development for COVID-19 intranasal routes of administration, all targeting the spike protein.
Call to Action: TrialSite will monitor the nasal-spray candidates.