Centre places order for 300 mn Biological E vax
India has placed an advance order worth ₹1,500 crore with Biological E for 300 million doses of an unauthorised Covid-19 vaccine.
The order, announced Thursday, underscores the government’s efforts to overcome a severe shortage of vaccines in the world’s second-most populous nation that is battling a devastating second wave of the pandemic.
“These vaccine doses will be manufactured and stockpiled by Biological E from August-december 2021,” according to a government statement.
A spokesperson for Hyderabad-based Biological E was not immediately available for comment.
This is the first such contract with a vaccine maker in India, and marks a major shift from the government’s earlier stance of signing sourcing pacts only with companies with authorised vaccines.
Biological E has developed the vaccine with Baylor College of Medicine in Houston and California-based Dynavax Technologies Corp.this is the second vaccine to be developed in India after Bharat Biotech’s Covaxin.
Biological E’s vaccine is a protein sub-unit vaccine, which comprises of only spike proteins that are injected into the body to trigger an immune response. Protein subunit vaccines are considered by many experts to be one of the safest vaccine platforms as it is an old platform with known safety profile, unlike the relatively new messenger RNA technology, and also do not involve injecting a whole virus.
The vaccine is currently undergoing phase 3 trials and it is expected to be ready for regulatory authorisation and subsequent launch in August.
Biological E’s proposal was examined and recommended for approval after due diligence by the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), the government said.
NEGVAC chairman Vinod K. Paul said last month that the government expected 300 million doses of the vaccine from Biological E. Biological E had earlier received financial assistance from the department of biotechnology under the ministry of science and technology in terms of grant-in-aid of more than ₹100 crore for conducting human trials. Prior to that, it conducted animal trials at the government’s Translational Health Science Technology Institute in Faridabad.
While the government has previously helped companies with financial aid for vaccine development, it has steered clear of signing advance orders, stating that they would do so only when a particular vaccine receives regulatory approval.
This was in stark contrast with countries like the US, Canada, UK and even the Covax facility which have all signed significant advance purchase agreements worth billions of dollars months before the vaccines got authorisation in order to help them conduct research and scale up capacity and be ready for launch.