China’s Shinopharm vaccine gets emergency use authorisation in NepalChina has decided to provide 500,000 doses of BBIBP-CorV vaccine, developed by Sinopharm, under grant assistance.
The Department of Drug Administration, the national drug regulatory authority, has granted emergency use approval to a Covid-19 vaccine developed by the Beijing Institute of Biological Products Co Ltd (BIBP) in China under Sinopharm.
A meeting of the drug advisory committee of the department on Tuesday decided to issue a conditional permission for emergency use authorisation to the vaccine.
By providing the emergency use authorisation, the department paves the way to bring Sinophrm’s vaccine in Nepal. China has decided to provide 500,000 doses of BBIBP-CorV vaccine, developed by Sinopharm, under grant assistance.
Sinopharm had applied for emergency use authorisation for its vaccine on January 13 with the department. Of the three applications—two from India and one from China’s Sinopharm—the department on January 15 had given emergency use authorisation to only Covishield vaccine developed by the University of Oxford and pharmaceutical giant AstraZeneca, which is produced in India by the Serum Institute of India. The department had demanded necessary documents with Sinopharm and Bharat Biotech.
Emergency use authorisation (EUA) is granted for some drugs and vaccines by authorities during a declared emergency when officials can make a judgment that the drug is worth releasing—even without all the evidence that would fully establish its eﬀectiveness and safety. Such a decision is taken when there’s enough evidence to suggest that patients have beneﬁted from the drug/vaccine.
On 30 December 2020, Sinopharm announced the vaccine's efficacy was 79.34 percent, which was lower than the 86 percent announced by the United Arab Emirates on December 9. The UAE had based its results on an interim analysis of Phase III trials conducted from July.
A report published in Lancet says the inactivated SARS-CoV-2 vaccine, BBIBP-CorV, is safe and well tolerated at all tested doses in two age groups. Humoral responses against SARS-CoV-2 were induced in all vaccine recipients on day 42. Two-dose immunisation with 4 μg vaccine on days 0 and 21 or days 0 and 28 achieved higher neutralising antibody titres than the single 8 μg dose or 4 μg dose on days 0 and 14.