NEW DELHI, Dec 1: Despite a complaint from one of its volunteers for human testing, the Serum Institute of India (SII), licensed to manufacture Oxford University- AstraZeneca Plc developed Covishield against Coronavirus, on Tuesday claimed that its vaccine candidate was “safe and immunogenic”.
Even as the volunteer in his legal notice to the SII claimed that all tests had confirmed that the setback to his health condition was because of the vaccine candidate, the Pune-based company maintained that the incident with one of the volunteers during clinical trials was “no way induced by the vaccine”.
“All regulatory, ethical processes and guidelines were followed by the company. The principal investigator DSMB (Data and Safety Monitoring Board) and ethics committee stated it was non-related issue to vaccine trial,” media reports quoting a statement from the company said.
Pointing out that the company also had sent a legal notice to the Chennai-based volunteer, the statement said the “legal notice was sent to safeguard the reputation of the company which is being unfairly maligned.” The volunteer had served a legal notice on SII, claiming to have suffered a virtual neurological breakdown and impairment of cognitive functions, seeking Rs 5 crore in compensation and a halt to the trial.
Along with SII, the man also named vaccine’s one of the co-sponsors Indian Council of Medical Research (ICMR) and Chennai-based Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the volunteer. The man, according to the notice, suffered acute encephalopathy, a disease that affects the brain, following vaccination.
The Drugs Controller General of India (DCGI) had deployed an institutional ethics committee at the implementation site to investigate the adverse event.
In addition to Covishield, which was expected to get emergency-use approval by the year-end and roll out full production by February or March. India is also conducting a late-stage trial of Russia’s Sputnik V.
Moderna Inc applied for US and European emergency authorisation of its Covid-19 vaccine based on full results from a late-stage study showing its vaccine was 94.1% effective with no serious safety concerns. The trial data from Pfizer Inc with partner BioNTech SE, Moderna Inc and AstraZeneca Plc have shown their experimental vaccines are effective in preventing coronavirus.
China has not yet announced supply deals with Western drug-makers which have partnered with private companies, AstraZeneca’s vaccine may be approved in China by mid-2021 while Bangladesh has signed an agreement with the SII for art supply of its vaccine requirements. Japan is planning source its vaccine supplies from different companies including Pfizer, AstraZeneca as well as Johnson & Johnson. South Korea, Taiwan, Indonesia, Vietnam and several other Asian countries are also largely depending on Pfizer or Moderna dug manufacturing companies for the supply of the Corona vaccine, official sources said.
(Manas Dasgupta)
