CanSino to release Phase III interim data soon
Amid a white- hot global vaccine battle, where a row caused by the EU and the UK, and US pharmaceuticals over the delayed delivery continues to flare, another Chinese vaccine, developed by CanSino Biologics, which guarantees dual protection after only one shot, received promising preliminary signs to continue its Phase- III trials on Monday.
China’s fast- pace development of COVID- 19 vaccines, and its generosity in offering assistance to other countries’ vaccination process, has propelled more countries like Hungary and Germany to cast their vote of confidence in Chinese vaccines. By shepherding vaccine R& D, China is injecting not only vaccines in people’s arms, but also new energy in the global fight against the virus, said Chinese experts.
New vaccine, different approach
The Ad5- nCOV vaccine candidate developed by CanSino Biologics has met its pre- specified primary safety and efficacy criteria at interim analysis, with no serious adverse events, and the company will continue to advance its Phase- III clinical trials of the vaccine.
The company is expected to obtain interim data of its PhaseIII clinical trials from across the world this week, the Global Times learned.
The Phase- III clinical trials of Ad5- nCoV saw more than 40,000 volunteers administered with the vaccine in 78 clinical trial sites across five countries in three con
tinents, according to a notice CanSino Biologics sent to the Global Times on Monday.
Distinct from inactivated vaccines, CanSino’s vaccine is effective in only one single dose and can bring dual protection.
Ad5- nCoV’s Phase- II and Phase- III trials have involved elderly participants, with no serious adverse reactions reported, the Global Times learned on Monday from a source close to CanSino.
The vaccine can be stored and transported at temperatures ranging from 2 to 8 C, and the vaccine production does not need the bio- safety level 3 laboratory as required by the manufacturing of inactivated vaccine, which experts said makes them more accessible to developing countries with limited facilities.
The upcoming interim results were collected from data at multiple centers of Phase- III trials across the world, including Russia, Mexico, Pakistan, Argentina, and Chile. It is a global multicenter clinical trial using uniform standards and organizational plans. Each center has a Principal Investigator ( PI) and Contract Research Organization ( CRO) partner.
CanSino said it has completed case accrual for the interim analysis of the Phase- III clinical trial of Ad5- nCoV, and data from these cases have been submitted to the Independent Data Monitoring Committee ( IDMC) for analysis and recommendation.
The Ad5- nCoV vaccine is a recombinant adenovirus vector vaccine jointly developed by CanSino Biologics and researchers from the Institute of Military Medicine under the PLA Academy of Military Sciences led by Chen Wei.
The COVID- 19 vaccines developed by Russia’s Sputnik V, British- Swedish pharmaceutical AstraZeneca and Johnson & Johnson use a similar approach.
There are 16 Chinese coronavirus vaccines undergoing clinical tests, among which seven has entered Phase- III tests, and one from Sinopharm has been granted conditional market approval, an official from the Ministry of Science and Technology said on Saturday.
Feng Duojia, president of the China Vaccine Industry Association, told the Global Times that China’s COVID- 19 vaccines are public goods, and China encourages Chinese vaccine producers to contribute to the global effort to battle the virus.
EU's vote of confidence
In sharp contrast to China’s generosity and selflessness to assist other countries’ vaccination, the EU has found itself stuck in speeding up the bloc’s mass vaccination, due to the delayed delivery of AstraZeneca and Pfizer vaccines.
After the spat caused tempers to flare, some EU members have given their vote of confidence to Chinese vaccines. After Hungary on Friday issued temporary authorization to Sinopharm, Germany’s Federal Health Minister Jens Spahn hinted on Sunday that vaccines from China and Russia could be used in Europe to overcome the current deficit of doses.
Vaccines developed by China will inject new energy to global efforts against the pandemic, Feng told the Global Times on Monday. Feng said that Europe will suffer a shortage in vaccines for a pretty long time, which has prompted those countries to find other sources of vaccines.