Phase 3 clinical trials for potential coronavirus vaccine begin in Pakistan

The Ad5-nCoV trial will recruit around 8,000 volunteers, most of whom will be health workers. They will be recruited over a four-month period and be followed for 12 months after receiving the vaccine or placebo.

Phase 3 trials 

The phase 3 clinical trials for potential coronavirus vaccine, developed by China’s CanSino Biologics, have begun in Pakistan on Tuesday after the completion of tests of the first two phases in China.

Special Assistant to the Prime Minister on National Health Services, Dr. Faisal Sultan, shared the news in a media talk and congratulated his team over the launch of trials in the country. He hoped that the activity will also improve the health system.

National Institute of Health (NIH) Executive Director, Major General Amir Ikram, said the clinical trials have been launched with collaboration of China. 508 individuals participated in phase 2 trials while 8,000-10,000 Pakistanis will take part in phase 3 trials he said while adding that the vaccine has been approved for police and army in China.

On the other hand, Federal Minister for Planning and Development Asad Umar tweeted, “Just launched the phase 3 trials for a Covid19 vaccine in Pakistan. Vaccine has been developed by a chinese company. A total of 40,000 people will participate in this trial in 7 countries, of which 8 to 10, 000 will be Pakistani. Initial results expected in 4 to 6 months.”

 

Read More: Pakistanis to participate in clinical trials of ‘Made in China’ coronavirus vaccine

Pakistan gives go-ahead for Phase 3 trials 

Pakistan’s drug regulator last month gave the go-ahead for the country’s first Phase 3 clinical trial for CanSino’s candidate, Ad5-nCoV, which will be led by the government-run National Institute of Health (NIH) along with pharmaceutical company AJM – the local representative of CanSino.

“We are planning to launch the project on September 20, or at the latest within this month,” Hassan Abbas Zaheer, who is heading the trial for AJM, told Reuters earlier.

Daily positive cases in Pakistan peaked at more than 6,000 in June, but have since fallen sharply. The total reported cases have added up to 306,886 with 6,424 deaths.

Zaheer said the low positive rates did not indicate COVID-19 was no longer present in the country, and the potential for people vaccinated in the trial to be infected was still adequate for testing their immunity.

“We feel people are still getting infected but not getting tested, so the virus is still there,” he said.

COVID testing in Pakistan

Pakistan, a country of more than 220 million people, has been testing between 20,000 to 30,000 daily.

Aamer Ikram, Executive Director of the NIH, told Reuters that officials believed the prevalence of the virus in Pakistan was low, despite the low testing rate, but researchers had a plan in place for the trial.

“We have been strategizing with CanSino on how to make sure people who are more exposed to the virus are recruited for volunteers, so we will be targeting front-line workers who have more chances of exposure.” He said.

The Ad5-nCoV trial will recruit around 8,000 volunteers, most of whom will be health workers. They will be recruited over a four-month period and be followed for 12 months after receiving the vaccine or placebo.

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