New Delhi, December 23
Adults inoculated with two doses of Covaxin or Covishield will be now able to take the world’s first intranasal Covid-19 shot manufactured by the Hyderabad-based Bharat Biotech as a booster dose from today with the Ministry of Health approving its inclusion in the national inoculation drive.
The approval comes amid a fresh surge of cases in China and other countries.
The two-drop intranasal shot iNCOVACC (BBV154) had on November 28 received the Central Drugs Standard Control Organisation (CDSCO)’s nod for restricted use in emergency situation for ages 18 and above.
Centre’s advisory: Test flu cases
- Step up surveillance and test patients of influenza-like illness and severe acute respiratory infection for Covid-19
- For the upcoming festive season, there is need to focus on test, track, treat and vaccinate
- Adhere to Covid-appropriate behaviour through use of masks, respiratory and hand hygiene and physical distancing
- Take stock of bed availability and keep health workers ready for any surge by conducting dry runs in hospitals
As of now, the booster will only be available at private centres at some nominal cost.
The shot was earlier approved for a primary two-dose schedule in September.
iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results.
We have few cases, we have had the XBB & BF.7 for a while and they have not driven an upsurge in India…. I do not expect a surge. —Gagandeep Kang, Vaccinologist
“iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries. It was developed in partnership with Washington University, St Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated it in preclinical studies for efficacy,” Bharat Biotech said.
Product development and clinical trials were funded in part by the government through the Department of Biotechnology’s Covid Suraksha Programme.
Krishna Ella, Chairman of Bharat Biotech said, “iNCOVACC is an intranasal vaccine for the primary 2-dose schedule, and a heterologous booster dose. This is a great achievement for us and the global scientific community to enable nasal administration of Covid vaccines. Despite the lack of demand for Covid vaccines, we continued to focus on intranasal vaccines to ensure that we were well-prepared with platform technologies for future infectious diseases.”
“Intranasal vaccine is easy to administer and builds up immune barriers in the respiratory tract through which respiratory viruses enter the body,” said chairman of the National Technical Advisory Group on Immunisation (NTAGI) NK Arora.
Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, and as heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid vaccines in India. Evaluation was also carried out to elicit responses against the ancestral and Omicron variants.
Meanwhile, vaccinologist Gagandeep Kang on Friday said India was doing fine as of now and no surge was expected. In a Twitter thread, she said that “as far as we know, there are no new variants” but advised surveillance of all acute respiratory infections — something the Centre has already ordered.
“The variants now circulating in China have been there in the rest of the world for months. The behaviour of the virus is not any different from the expected. In India, we already have XBB and BF.7 (the 2 being hyped as new monsters). They are, like all Omicron subvariants, very good at infecting people because they escape the immune response that prevents infection, but are not causing a more severe disease than Delta,” she said.
Advising against travel to China, Kang said India was doing fine. “We have few cases, we have had the XBB & BF.7 for a while and they have not driven an upsurge in India. In the absence of an even more highly infectious variant, I do not expect a surge.”
Kang said that India just needed to keep its surveillance up to detect any new variants.
Bharat Biotech’s intranasal Covid vaccine iNCOVACC has been approved by top drug regulator CDSCO as a booster dose for those aged 18 years and above | This booster can be given to adults who have been vaccinated with two doses of either Covishield or Covaxin.
BF.7: Variant behind China surge
It is a sub-lineage of BA.5 Omicron variant and transmits faster than other variants. It has shorter incubation period, and high capacity to infect people who have had previous Covid infection, or vaccinated, or both. BF.7 has already been detected in India, United States, UK, Belgium, Germany, France and Denmark.
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