Govt rubbishes reports on approval for Covaxin due to political pressure


PTI, Nov 17, 2022, 2:02 PM IST

Image for representation

The Union Health Ministry on Thursday termed as ”misleading” and ”fallacious” media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.

It said scientific approach and prescribed norms were adhered to in approving COVID-19 vaccines for emergency use authorisation.

There have been media reports claiming that Bharat Biotech, manufacturer of the indigenous COVID-19 vaccine Covaxin, “had to skip certain processes” and “speed” up clinical trials due to political pressure, the ministry said.

The reports further claimed that there were several irregularities in the three phases of the clinical trials conducted for the vaccine.

”These media reports are completely misleading, fallacious and ill-informed.It is clarified that Government of India and the national regulator i.e. CDSCO have followed a scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorisation,” the ministry stated.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2, 2021 and after due deliberations made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Bharat Biotech. Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The SEC’s approval for commencement of phase 3 clinical trial of proposed dose of Covaxin was based on scientific data presented by Bharat Biotech and established practices in this regard, the ministry said.

Moreover, the purported ‘unscientific changes’ in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI.

Based on further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of COVID-19 vaccine in ‘clinical trial mode’ was removed on March 11, 2021, the ministry said.

Authorisation to COVID-19 vaccines including Covaxin for restricted use in emergency situation with various conditions and restrictions were granted by the national regulator only on the recommendations of the Subject Expert Committee of CDSCO. The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Aussies Hijikata, Kubler win Australian Open men’s doubles

Rashtrapati Bhavan’s Mughal Gardens renamed ‘Amrit Udyan’ to open for public from January 31

Sabalenka beats Rybakina for Australian Open women’s title

Grand inauguration of Kaustubha Residency – hotel & commercial complex at Katapady on Jan 29

Karnataka: Amit Shah takes part in road show in Kundgol, hits out at Cong and JD(S) for dynasty politics

DU forms 7-member panel to probe ruckus outside Arts Faculty over BBC documentary screening

One pilot killed in IAF’s Sukhoi, Mirage aircraft crash in MP


Related Articles More

Attempts being made to create differences among people, ‘mantra of unity’ is ultimate antidote: PM Modi

2 held for cheating people on pretext of selling iphones on discounted rates

BJP releases list of 48 candidates for Tripura Assembly polls

Counsel ‘decourted’ for donning jeans in Gauhati HC

Rashtrapati Bhavan’s Mughal Gardens renamed ‘Amrit Udyan’ to open for public from January 31

MUST WATCH

Villagers election boycott warning for road

Sand art | Malpe Beach Uthsava 2023 | Udupi – Udayavani

Various competitions, activities in Beach Utsava!

Melody King Rajesh Krishnan

Shakalaka Boom Boom Movie Review| |Premier Show Manipal


Latest Additions

Aussies Hijikata, Kubler win Australian Open men’s doubles

Attempts being made to create differences among people, ‘mantra of unity’ is ultimate antidote: PM Modi

2 held for cheating people on pretext of selling iphones on discounted rates

BJP releases list of 48 candidates for Tripura Assembly polls

Counsel ‘decourted’ for donning jeans in Gauhati HC

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.