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Clinical data disclosure critical for Bharat Biotech COVID-19 intranasal vaccine success in India: GlobalData

Even though intranasal vaccines can produce both local and systemic immunity, there can be challenges around long-lasting immunity, the company said.

Clinical data disclosure critical for Bharat Biotech COVID-19 intranasal vaccine success in India: GlobalData
Recently, the Drugs Controller General of India(DCGI) on Tuesday has given emergency use authorisation (EUA) to Bharat Biotech for the intranasal vaccine. (File)

GlobalData on Thursday said that as Bharat Biotech has not posted the clinical trial results of its COVID-19 intranasal vaccine BBV154, it is difficult to predict the success of the intranasal vaccine following its approval. Recently, Bharat Biotech completed the Phase III trials of its COVID-19 intranasal vaccine BBV154 and submitted the data to the Drug Controller General of India (DCGI) for approval both as a primary two-dose vaccine, and a heterologous booster dose. However, detailed clinical trial results are not yet available in the public domain.

BBV154 may become the world’s second approved intranasal vaccine for COVID-19. In April this year, the Russian Health Ministry approved Sputnik V nasal vaccine. Before this, Sputnik V was available as an intramuscular injection.

According to GlobalData’s ‘Pharmaceutical Intelligence Center’, as of 22 August 2022 there are currently nine COVID-19 intranasal vaccines in Phase I and later stages of clinical development in different parts of the world. However, only two COVID-19 intranasal vaccines, including Bharat Biotech’s intranasal vaccine, have reached Phase III.

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“It is very important that the clinical trial results for Bharat’s BBV154 be made available in the public domain to understand the overall efficacy. Moreover, sharing detailed results will improve transparency and overall credibility. There is no denying that intranasal vaccines are more convenient from logistics and administration perspectives and can be useful in the fight against COVID-19,” Prashant Khadayate, Pharma Analyst at GlobalData, said in a statement on Thursday.

Notably, none of the leading COVID-19 vaccine manufacturers like Pfizer and Moderna are involved in the development of intranasal COVID-19 vaccines. Historically, intranasal vaccines have been developed for influenza. However, they have generally demonstrated lower effectiveness compared to injectable flu vaccines, the GlobalData stated. Even though intranasal vaccines can produce both local and systemic immunity, there can be challenges around long-lasting immunity, the company said.

“Looking at the historical trends, intranasal vaccines have not performed as per the expectations in general. In the absence of detailed clinical data, it is difficult to predict the success of BBV154,” Khadayate said.

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