Experimental COVID vaccine gets patent

Awoman holds a small bottle labeled with a "Vaccine COVID-19" stickerand a medical syringe in this illustration taken on April 10, 2020.[Photo/Agencies]

China has recently granted its firstCOVID-19 vaccine patent for an experimental vaccine jointly developed by theAcademy of Military Medical Sciences and Chinese biotech company CanSinoBiologics, a decision that validates and protects the innovation of thecountry's vaccine development.

The adenovirus vector vaccine candidatewas found to be safe and able to trigger an immune response in the first andsecond stages of clinical trials. However, the vaccine, as well as a few otherpromising candidates, must complete the third and largest phase of trialsbefore gaining market approval, although some leeway will be offered to speedup the process, according to documents released last week by the NationalMedical Products Administration.

The application for the newly issuedpatent was submitted on March 18, and was approved on Aug 11, according to thepatent document published on the website of the National Intellectual PropertyAdministration.

Animal studies have demonstrated thevaccine's ability to reduce viral amounts in the lungs and to induce properimmunity. In addition, "the vaccine can be manufactured in a rapid andconvenient manner and can be mass produced in a short span to cope with suddenoutbreaks", the document said.

Ma Yide, an intellectual propertyprofessor at Zhongnan University of Economics and Law in Wuhan, Hubei province,said: "Patent approval is meant to protect the creativity of a new productor technology. Winning a patent means the development of the experimental vaccinehas achieved substantial progress in terms of innovation."

"The move will also help preventinfringement, misuse and imitation of the latest scientific progress in vaccineresearch under the legal framework, and curb the negative influence of such behavioron battling the epidemic," he added.

According to Ma, China has been focusingon manufacturing generic drugs for a long time, resulting in fewer patents inthe biomedicine sector compared with drug research powerhouses worldwide.

"The development of a homegrownvaccine against the novel coronavirus is a landmark action, and this time, thetop intellectual property regulator has acted very rapidly and forcefully tooffer legal protection," he said.

The vaccine in the spotlight, Ad5-nCoV,was the first to enter first-stage clinical trials in China in March and thefirst to begin second-stage trials worldwide on April 12. It uses a weakenedcommon cold virus to introduce genetic material from the novel coronavirus intothe human body and train the body to produce antibodies that can fight off thevirus.

According to a study published in themedical journal The Lancet on July 20, the phase-two clinical trial involving508 participants shows that the vaccine is safe and generates antibodies innearly all people who received effective doses.

The phase-three clinical trial will beconducted overseas and is currently in the pipeline, but developers of theexperimental vaccine have yet to announce a specific timetable or location forthe trial.

Human trials

As of June, China had five experimentalvaccines against the novel coronavirus in human trials and more in the initialstages of research.

Wang Huaqing, chief expert of theimmunization program at the Chinese Center for Disease Control and Prevention,said all novel coronavirus vaccines must pass evaluations for their safety andefficacy in large-scale, third-phase trials before public use, except foremergency use authorization.

"The main obstacles during thethird-phase trials are whether the protection can last longer than six months,as well as whether adverse reactions can be monitored sufficiently and whetherthe observed reactions correlate with the injection," he was quoted assaying in a report in Health News, a newspaper run by the National Health Commission,on Sunday.

In a trial guideline released by theNational Medical Products Administration on Saturday, the top drug regulatoralso stressed that the protective effects of novel coronavirus vaccinecandidates should be evaluated based on results from the third-phase humantrials.

In order to receive approval for publicuse, an experimental vaccine must confer protection for at least six months andideally, for a year or longer.

However, during the final-stage trial,if a vaccine demonstrates obvious and acceptable levels of protection and riskassessment determines that its benefits far outweigh the potential risks, thelengthy process can be cut short and the remaining steps can be completed afterthe vaccine is released to the market, the document said.