Bharat Biotech's nasal COVID-19 vaccine receives drug regulator's nod
The nasal vaccine for immunization against COVID-19, developed by Hyderabad-based vaccine maker Bharat Biotech, has received the approval of the Central Drugs Standard Control Organisation (CDSCO). The Indian drug regulator on Tuesday reportedly cleared the COVAXIN manufacturer's nasal vaccine for "restricted use" in adults, i.e., only people aged 18 years and above, in the country. Here are more details.
Why does this story matter?
- The approval of India's first COVID-19 intranasal vaccine comes as the nation's vaccination coverage crossed the 213cr mark.
- While the virus has seemingly mellowed, India has been reporting around 5,000-7,000 cases daily.
- The current active caseload is 52,336, per the Union Health Ministry.
- The intranasal vaccine could help fight vaccine hesitancy and serve as a new weapon in India's arsenal against the deadly virus.
Union health minister made the announcement today
Union Health Minister Mansukh Mandaviya took to Twitter on Tuesday to announce that CDSCO has given its nod to the nasal vaccine. Terming it a "big boost" for India's COVID-19 fight, he wrote, "Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by [the CDSCO]." Notably, this is the first intranasal vaccine for COVID-19 in our country.
Take a look at what the health minister said
This step will further strengthen our collective fight against the pandemic.— Dr Mansukh Mandaviya (@mansukhmandviya) September 6, 2022
India has harnessed its science, RD, and human resources in the fight against COVID-19 under PM @NarendraModi Ji's leadership.
With the science-driven approach Sabka Prayas, we will defeat COVID-19.
Trials for primary and booster dose finished last month
The nod comes only a few weeks after Bharat Biotech completed its phase III trials for the vaccine as a primary and booster dose. Phase III trials for the primary dose were conducted for "safety and immunogenicity" in 3,100 participants across 14 trial sites. The trials for the booster dose were conducted among 875 people previously vaccinated with two doses.
What did the trial results reveal?
The phase III trial results termed the nasal vaccine to be "safe and well-tolerated." According to Bharat Biotech, "Being an intranasal vaccine, [it] may produce local antibodies [against COVID-19] in the upper respiratory tract." It is said to provide potential protection from infection and transmission of coronavirus. The vaccine was specifically formulated for intranasal delivery, which has proven to be cost-effective in many countries.
'Can become an important tool in mass immunization'
Bharat Biotech Joint MD Suchitra Ella earlier said that their offering can make it easier to deploy nasal vaccines in mass immunization campaigns with an easy-to-administer formulation and delivery device. "It can enable faster development of variant-specific vaccines and easy nasal delivery... It promises to become an important tool in mass vaccinations," she had said after the completion of the trials on August 15.