NEW DELHI: As India prepares to deal with the surge in Covid-19 infections with booster vaccine doses amid anxiety over the highly infectious Omicron variant, it has added three more tools — two vaccines and a drug — to its armour.
The Drug Controller General of India on Tuesday gave emergency use authorisation (EUA) to Covid vaccines Covovax and Corbevax, apart from Covid drug molnupiravir, which will be manufactured by 13 companies locally.
The approvals came within hours of the subject expert committee on Covid-19 of the Central Drugs Standard Control Organisation recommending EUA for them.
Parallelly, the Centre ended a hassle of furnishing a medical certificate for the 60-plus with comorbidities for taking the booster shot, by dropping the clause.
It means all senior citizens with comorbidities are eligible for what the Centre calls is a precautionary jab.
Of the vaccines approved on Tuesday, Corbevax has been made by Hyderabad-based Biological E. Covovax is the Indian version of Novavax. (see box)
Molnupiravir is meant for restricted use for treating adult patients with blood oxygen levels at 93% and having a high-risk of progression of the infection, including hospitalisation or death. It should be taken twice a day for not more than five days.
Biological E conducted phase 1, 2 and 3 clinical trials of Corbevax in the country, apart from a phase 3 active comparator clinical trial to evaluate superiority against Covishield, the Centre informed. However, data from none of these clinical trials have yet been released in the public domain.
The Union health ministry said Covovax had shown efficacy of 90.4% and 86.9% respectively in the US and UK during phase 3 trials. It added that SII conducted phase 2/3 immuno-bridging clinical trails in the country for comparing safety and immunogenicity of this vaccine.
On molnupiravir, the regulator received applications from 22 manufacturers but approved only 13. Clearing the air on comorbidities, Union health secretary Rajesh Bhsuhan wrote to states saying anyone over 60, on their doctor’s advice, can now take the shot and will not be required to show the co-morbidity certificate at the vaccination centre.
The letter comes after a section of people, including doctors, had protested the requirement of doctors’ certificate.
“When there is no provision of such a certificate in India’s healthcare system to avail of any service, why create this hurdle?” said a senior medical professional at AIIMS, Delhi, who is a member of the ICMR advisory group on Covid-19 clinical management.
