The Drug Regulatory Authority of Pakistan (DRAP) on Friday has approved the emergency use of Chinese COVID-19 vaccine from CanSino Biologics.
According to the report, the registration board of the regulatory authority has greenlighted the manufacturer’s coronavirus vaccine which comprises a single dose.
A request for the approval of the vaccine for emergency use was submitted to DRAP’s registration board by AJM Pharma (Pvt) Limited, the report said, adding that the decision to approve it was taken during the third meeting of the authority’s registration board.
Pakistan is the second country to approve CanSinoBIO’s vaccine, the report said, adding that a day ago, Mexico had also approved it.
Clinical trials for CanSinoBIO’s vaccine were already going on in several countries, including Pakistan.
On Monday, Special Assistant to the Prime Minister on Health Dr Faisal Sultan had announced that China’s CanSinoBIO COVID-19 vaccine is nearly 75% effective against the virus in Pakistan.
Taking to Twitter, the special assistant had said that according to the vaccine’s phase-three trials data, it has turned out to be 74.8% effective against the virus, while it also showed 100% effectiveness in preventing severe disease.
Further citing the Independent Data Monitoring Committee’s report, he said that in multiple countries, the vaccine was 65.7% and 90.98% effective in preventing symptomatic cases and severe diseases, respectively.
The SAPM said that the IDMC did not report any “serious safety concerns” and that the data included as many as 30,000 participants and 101 people who had tested positive for coronavirus.
Earlier this month, China’s CanSino Biologics had said that an independent committee found the drugmaker’s COVID-19 vaccine met its pre-specified primary safety and efficacy targets under an interim analysis of Phase-three trial data.
No adverse events related to the vaccine have occurred and the findings of the IDMC means the company could go ahead with advancing its Phase-three clinical trial for the candidate, known as Ad5-nCoV or Convidecia, CanSinoBio said.
Back in November 2020, officials said Pakistan had inoculated about 7,000 of the 10,000 phase-three trial participants.
Pakistan has approved two coronavirus vaccines – AstraZeneca and Sinopharm — while the vaccination drive kicked off last week across the country.
Pakistan will administer the vaccine in three phases, starting with front-line healthcare workers.