Tech2 news teamAugust 02, 2021 07:57:55 am
After publishing the results of phase 2 human trials of its COVID-19 Covaxin vaccine in India, Bharat Biotech has started testing an intranasal vaccine in different parts of the country. The Phase I trial, according to the company, will take place in Patna, Chennai, Hyderabad and Nagpur. The intranasal vaccine, called BBV154, it is being tested to prevent infection and transmission of COVID-19. If the vaccinated individual is infected, the vaccine is also intended to prevent the progression of the COVID-19 disease. Only time will tell if this vaccine will be successful with Bharat Biotech’s other COVID-19 vaccine, Covaxin, which was found to be 80.4 percent effective in preventing COVID-19 disease.
While trials have begun, here is what you need to know about this new form of vaccine.
Bharat Biotech Nasal Vaccine
Hyderabad-based Bharat Biotech is working on the first intranasal vaccine for COVID-19 in India, in collaboration with Precision Virologics, a startup incubated at Washington University School of Medicine in St Louis, USA. The vaccine was developed by University of Washington professors David Curiel, a cancer biologist, and Michael Diamond, a viral immunologist, according to a St Louis Post Shipping report.
The phase I trial was conducted by the American startup at the University’s Vaccine and Treatment Evaluation Unit in St Louis. Once this is complete, Bharat Biotech will also conduct tests in India. If both trials yield favorable results, Bharat Biotech Later it will manufacture the vaccine, having bought the rights to distribute the vaccine to all world markets except the US, Japan and Europe.
The results show that BBV154 provided “unprecedented levels of protection in mouse studies.”
BBV154 intranasal vaccine
The most common way that COVID-19 is spread is through the air, either by larger droplets through close contact or by smaller droplets called aerosols. The SARS-CoV-2 virus usually enters the body through the nose. Intranasal vaccines are given through the nose rather than injected into the skin. When vaccinating in this way, the vaccine targets the virus present in the mucosa of the nose, where the highest loads of the SARS-CoV-2 virus are likely to be present as well.
The nasal vaccine can be given by spray, needleless syringe, or nasal drops. According to a Times of India report when the vaccine is given with a nasal spray, it intercepts the virus locally (in the nose) and stimulates the immune system to produce proteins in the blood known as antibodies that can fight an infectious organism.
The Bharat Biotech nasal vaccine is an adenovirus vector vaccine, made from a weakened version of the common cold virus that was originally obtained from chimpanzees. It has been modified to look like and attack the coronavirus. Along with the Covishield vaccine that is being developed by AstraZeneca and the University of Oxford and manufactured by the Serum Institute of India, Covaxin is being administered to Indians under a phased vaccination campaign, the largest in the world.
According to the Nature reportDuring animal testing, mice that received a single dose of the nasal vaccine were “completely protected from SARS-CoV-2 with virtually no sign of the virus in their upper or lower respiratory tract.”
On the other hand, the mice injected with the vaccine were only partially protected.
The nasal vaccine has many advantages over an injection, requiring a single dose that is much smaller than for an injection, according to one St louise post report. A nasal vaccine will also be “easier to administer” as it involves minimal spraying and training. It will also be beneficial for both children and adults who may be afraid of needles.
Clinical trials in India
India’s main drug regulator, the Comptroller General of Drugs of India (CDSCO), passed The Phase I and Phase II trials of the nasal vaccine planned by Bharat Biotech last month. CDSCO’s subject matter expert committee (SEC) added a recommendation that the company produce safety and immunogenicity data from a phase I trial in 75 volunteers. That said, other reports have cited a higher number, around 150–175 – volunteers in the phase 1 study.
“A nasal vaccine candidate has been identified. It has come to be considered for phase 1 and phase 2 trials. If it works, then it could be a game changer,” said VK Paul, member of Niti Aayog (health) He said the indian express.
Forty-two days after the administration of the nasal spray, an interim analysis of the results will be performed. To participate in the vaccine trials, the volunteer must be a healthy adult, without comorbidities and must not have been infected with COVID-19.
Trials have already started in hospitals in Hyderabad, Nagpur, Patna and Chennai, sources said. The Hindu commercial line.
Other nasal vaccines in development
Three other countries around the world are also conducting intranasal vaccine trials. Along with India, an American company called Altinmune is developing a nasal spray called AdCOVID. It states that the vaccine will be effective in preventing COVID-19 transmissions, especially in children. Trials have started with a group of 180 volunteers aged between 18 and 55 years.
In the United Kingdom, Codagenix’s The nasal vaccine, COVI-VAC, has entered phase 1 clinical trials and 48 volunteers are being evaluated. The vaccine recognized the whole virus and not just the spike proteins. This vaccine is being developed in collaboration with the Serum Institute of India.
Not one to be left behind, China is also working on an intranasal vaccine. Beijing Wantai Biological Pharmacy Enterprise together with Xiamen University and Hong Kong University are working together. The phase I trial of this vaccine was approved and started in November 2020. The intranasal spray is composed of weakened influenza viruses such as H1N1, H3N2, and B with genetic segments of the COVID-19 Spike protein. 100 volunteers were enrolled in phase 1 and it was supposed to take a year to complete.
Editor’s Note: This article was originally published on March 12, 2021, when Bharat Biotech began testing an intranasal vaccine in different parts of the country. On August 1, an expert panel from India’s central drug authority recommended approval of Bharat Biotech to conduct a study on the interchangeability of its Covaxin and the candidate intranasal vaccine BBV154 under test.