Chinese vaccine Registration Soon As Trial Nears End

As the novel coronavirus continues to claim dozens of lives a day in Pakistan, the only hurdle in importing the Covid-19 Chinese vaccine from Chinese state-owned company Sinopharm will be removed soon with its Phase-I trial in Karachi reaching the final stage, it emerged on Tuesday.

Chinese vaccine registration soon as trial nears end

By Ikram Junaidi

In a separate development, the federal government has decided to implement the Medical Teaching Institutions (MTI) Ordinance in three major hospitals of Sindh and one major hospital of Punjab after it had been introduced in Pakis­tan Institute of Medical Sciences (Pims), Islam­abad, where employees have been protesting against the move for past several weeks.

Unlike clinical trial, Phase-I trial is requirement before administration of jabs in country

According to the National Command and Operation Centre, 2,408 more people tested positive for Covid-19 and 41 deaths were reported in a single day, while 320 ventilators are occupied across Pakistan. The data shows that 58 per cent ventilators in Multan are occupied, followed by Bahawalpur’s 50pc ventilators, Islamabad’s 36pc ventilators and Peshawar’s 32pc. The NCOC puts the number of active cases across the country at 34,007.

Explaining the current status of Chinese vaccine trial to Dawn, a member of Scientific Task Force on Covid-19 constituted in March last year, Dr Ghazna Khalid, said: “We have almost completed the trial, as only 10 volunteers have been left.”

She said that there was a requirement to hold a small Phase-I trial of the vaccine so it was decided to hold the trial at International Centre for Chemical and Biological Sciences (ICCBS), Karachi, with the collaboration of Indus Hospital.

“In the meantime the process of vaccine registration with the Drap is also going on and it is matter of days to get approval from Drug Regulatory Authority of Pakistan (Drap) for the emergency procurement of vaccine,” she said.

Asked about the sample size of the trial, she said it (Phase-I trial) should not be confused with clinical trial as so far vaccine had been administered to one million persons in China, Dubai and Abu Dhabi so there was the requirement of a small trial, which is called Phase-I trial. “Chinese vaccine has already been approved after clinical trial and it is easier to store. However we have nothing to do with the price so I am not aware about it,” she said while replying to another question.

Dr Ghazna said the efficacy of the vaccine was 86 percent and there was 100pc prevention of severe infections.

The Scientific Task Force on Covid-19, which is headed by renowned scientist Prof Dr Attaur Rehman and comprises Dr Ghazna Khalid, Prof Dr Javed Akram, Prof Al Fareed Zafar, Prof Iqbal Choudhary, Prof Dr Khalid Khan and Prof Mariam Riaz Tarar, was constituted by Minister for Science and Technology Fawad Chaudhry on March 24, 2020.

Later on December 30, 2020 a special cabinet committee for procurement of Covid-19 vaccine, chaired by federal Minister for Planning and Development Asad Umar, decided to procure 1.1 million doses of vaccine from the Chinese company, ‘Sinopharm’. It was also announced that the vaccine would be provided to 500,000 frontline healthcare workers as two doses would be given to each worker and the margin of spoilage was 10pc.

While talking to Dawn, ICCBS Director Prof Dr Iqbal Choudhary said the trial was being done on 150 healthy volunteers to see how vaccine reacts on different ethnic groups.

He said: “Drap will issue an emergency authorisation for the use of vaccine soon as the government has decided to import the vaccine but once the Phase-I trial, which is also called ‘Safety Trial’, will be completed it will become possible to start commercial import of the vaccine as well.”

Dr Choudhary said safety study was in final stage, and after completion, findings would be shared with both Drap and the Chinese company.

An official of Drap, requesting anonymity, said most of the requirements had already been fulfilled.

“We have demanded sale agreement of vaccine and data of Phase-I trial to place the cases in front of registration board. Once documents will be completed, approval for emergency procurement will be given,” he added.

Hospitals

Meanwhile, the federal government has decided to introduce MTI in four hospitals of Sindh and Punjab.

Promulgated by President Dr Arif Alvi in November 2020, the MTI Ordinance has already been implemented in Pims, Islamabad. It suggests that the hospitals will be run through Board of Governors (BoG).

According to the Ordinance, the BoG will deal with all affairs of the hospitals once they become MTI. The BoG will have overall superintendence and control over the functions of the hospitals and employees would lose status of civil servants.

However, employees of Pims believe that the hospital has been ‘privatized’ as it will have to generate its own revenue to meet expenses. They have been protesting against the Ordinance for several weeks.

According to a notification, issued by the Ministry of National Health Services and available with Dawn, as many as four hospitals have been added in the Schedule of the MTI Ordinance 2020.

Three hospitals —Jinnah Post Graduate Medical Center (JPMC), National Institute of Cardiovascular Diseases (NICVD) and National Institute of Child Health (NICH) — are located in Karachi (Sindh) and the fourth hospital — Sheikh Zayed Postgraduate Medical Institute — is located in Lahore (Punjab).

Originally published at Dawn

Leave a Reply