ISLAMABAD: The arrival of Pfizer vaccine has caught government officials unawares, with experts questioning its legality in the absence of necessary clearance and registration.

In the wake of this development, the Drug Regulatory Authority of Pakistan (Drap) has called a meeting of its registration board on June 1 (Tuesday) to register Pfizer vaccine.

A senior official of the National Health Services (NHS) ministry, on the other hand, claimed that approval to import the vaccine had been obtained from Drap on April 27.

When Minister for Planning, Development and Special Initiatives Asad Umar was informed about Pfizer doses reaching Pakistan, he said he was not aware of it.

The news of over 100,000 Pfizer vaccines reaching Pakistan had been announced by Unicef through a tweet on Friday.

“Over 100,000 doses of @pfizer #COVID19 vaccine via #COVAX have arrived in Pakistan. Shipments of @pfizer diluents and syringes will be arriving over the next two days. The vaccines will be used for @GovtofPakistan’s ongoing #COVID19 vaccination campaign,” the tweet said.

However no confirmation came from the government side. Some officials were of the opinion that the arrival of Pfizer vaccine was ‘illegal’ as Drap had not issued a clearance certificate or registered the vaccine.

They said only five vaccines — Sinopharm, Sinovac, Cansino, AstraZeneca and Sputnik-V — were registered and could be used in the country.

An official of Drap, requesting not to be named, said according to rules, no medicine or vaccine could be imported without it being registered by the regulatory authority or issuance of a clearance certificate.

“There are two statutory regulatory orders (SROs) under which import of medicines are allowed. The first SRO says that donated medicines can be brought to the country but a clearance certificate has to be obtained from Drap. The certificate is issued after getting an application along with certificate of analysis, quantity of medicine, batch numbers of medicines, etc. Under the second SRO, hospitals are allowed to import unregistered drugs but they too have to get clearance certificates after providing details of patients, certificate of analysis, quantity of medicine, etc,” he added.

“If the vaccine has arrived, the government will have to acquire a clearance certificate or get it registered. The meeting of the registration board has been called on June 1 (Tuesday) and registration of Pfizer vaccine is also included in the agenda item. I am sure the vaccine will be registered as all documentation was complete,” the Drap official said.

On the other hand, a senior NHS ministry official, requesting not to be named, said approval to bring 100,620 doses of Pfizer vaccine had been sought from Drap on April 27, therefore it could not be said the vaccine had been imported without seeking approval.

“We are not confirming the arrival as the vaccine has come in small quantity and there can be a huge demand of the vaccine. No one should try to stir a controversy,” he said.

When contacted, the NHS ministry spokesperson, Sajid Shah, said a number of vaccines would come through Covax, which had pledged free vaccines for 20 per cent of the country’s population.

“We are expecting millions of doses before June 30. This is the reason why walk-in vaccination facility has been introduced for citizens over 30 years and registration of those over 18 has been started,” he added.

Talking to Dawn, Asad Umar, who also heads the NCOC, said he was not aware of Pfizer vaccine reaching Pakistan.

When asked how could Unicef confirm its arrival instead of NCOC, the minister said he would look into it.

However, he said Prime Minister Imran Khan had been requested to chair a meeting of the National Coordination Committee (NCC) on May 31.

“We have requested Prime Minister Khan to preside over the NCC meeting on Monday as we want to take the vaccination to the next level. So far over 11.4 million people have registered themselves. Earlier the entire official machinery — federal and provincial governments, National Institute of Health, National Disaster Management Authority, hospitals and district administrations — was involved in the vaccination drive. Now we want to involve the entire nation to expedite the inoculation process and achieve herd immunity at the earliest,” he added.

According to a statement of the NCOC, the session was presided over by Asad Umar and National Coordinator Lt Gen Hamooduz Zaman Khan. Special Assistant to the Prime Minister on Health Dr Faisal Sultan participated via video link.

The meeting was held to review implementation of standard operating procedures (SOPs) and administration of vaccine.

“The forum expressed its general satisfaction on the overall situation in the country. However, it cautioned about the high disease prevalence in Sindh,” the statement said, adding that travelers from UAE will be required to bring negative PCR test results from authorised laboratories only.

“In case of violations, airlines will be fined for accepting passengers with PCR results of unauthorised laboratories. This is being done to ensure that no passenger with fake result enters the country. On arrival, passengers are again tested and in case of a positive result, strict mechanism of quarantine is in place,” it added.

“From June 1, no tourist above the age of 50 years will be allowed to stay in hotels without vaccination certificate in tourism districts of Khyber Pakhtunkhwa, Gilgit-Baltistan and Azad Jammu and Kashmir. Similar restrictions will be applied on tourists over 30 years from July 1 onwards,” the statement said.

The NCOC also approved compulsory vaccination of education staff which will be completed by June 10. Walk-in vaccination facility for all teachers and school staff above 18 years of age has been provided across the country. Exams for classes 10 and 12 will be held from June 23–29. For exam preparations, provinces may opt for staggered opening of classes 10 and 12 from May 31 with strict SOPs.

The statement said amusement and water parks as well as swimming pools would be allowed to reopen from May 30 in districts having positivity rate of 5pc or less. However, only 50pc occupancy will be allowed, again with the necessary health protocols, it added.

Meanwhile, according to the NCOC data, the country reported 2,455 new cases and 73 deaths in the last 24 hours with the positivity rate calculated at 4.42pc.

Published in Dawn, May 30th, 2021