Govt Slammed for‘Arbitrary Decision-making’on Using Corbevax to Vaccinate Children

As the Union Health Ministry rolls out the Corbevax vaccine for children, the All India People’s Science Network (AIPSN) has raised serious concerns over the modalities of its approval, deployment and decision-making processes. 

Corbevax is known as India's first indigenously developed RBD-protein subunit vaccine.The Centre had announced that vaccinations against COVID-19 for children within the age group of 12 to 14 years would start from March 16, 2022 using the Corbevax vaccine. The vaccine is manufactured in India by Biological E. Limited, based in Hyderabad, with license from BCM Ventures, USA, and set up by the vaccine developer, Texas Children’s Hospital.  

The AIPSN, a network of over forty peoples science organisations in the country, in a statement on Tuesday said, “While Corbevax undoubtedly expands the basket of vaccines available in India to combat the pandemic, the modalities of its approval, deployment and related decision-making processes raise many disturbing and recurring questions which have plagued India’s vaccine policies and the integrity of its regulatory institutions and mechanisms.”

Detailing its concerns, AIPSN mentioned, the government had stated that the decision to initiate vaccinations for the 12-14 years age group was taken “after due deliberations with scientific bodies.” However, the APISN noted that neither the National Technical Advisory Group on Immunisation (NTAGI) was consulted, nor was any recommendation obtained from the National Expert Group on Vaccination Administration for Covid-19 (NEGVAC) regarding the vaccination for this age-group, and that too with Corbevax as the only vaccine.  

 “It appears that the Government itself does not have confidence in its own expert bodies, which calls into question the very credibility of the decisions being made,” the AIPSN said in its statement, noting that “such non-transparent decision-making” contributes to vaccine hesitancy”.It  further said, “Once again, approvals in India for Corbevax for this age group have been granted without peer reviewed or even pre-published data and clinical trial data pertaining to this age group is not available in the public domain, whereas approval for adults were granted based on interim trial results.” 

Recalling the hurdles and delays faced by Covaxin in obtaining WHO approval due to inadequate data, the AIPSN warned that the Narendra Modi-led government would risk repetition of similar international embarrassment if it resorted to “short-cuts in India’s domestic scientific approvals and regulatory systems.” 

Slamming the Centre’s actions regarding vaccine approvals and policies during the COVID-19 pandemic, the AIPSN said, “India’s vaccine policy has been characterised by poor planning, arbitrary and non-transparent decision-making based on extraneous considerations rather than scientific evidence.” It also accused the government of arbitrarily dividing the market among different vaccine manufacturers by approving only specific vaccines for different age-groups instead of adopting a more equitable public vaccination programme. 

The AIPSN called upon the government to strictly follow regulatory procedures and scrutiny by scientific and expert bodies, and then formulate and implement evidence-based policies with transparent decision-making processes. “Only this will restore public confidence in India’s vaccination policy and obviate vaccine hesitancy,” it said,

The organisation also noted that “Corbevax is a protein subunit vaccine where the spike protein of SARS-CoV-2 is directly injected with stabilising chemicals and adjuvants in order to raise antibody levels in the recipient.” The body said that Corbevax was different from Covaxin which uses “full inactivated virus or Covishield which uses an adenovirus viral vector to introduce the DNA coding for the spike protein into cells.”