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February 17, 2021

Sinopharm vaccine not to be given to immune-compromised persons: Drap

National

February 17, 2021

LAHORE: The Drug Regulatory Authority of Pakistan (Drap) has declared that Sinopharm vaccine against COVID-19 should not be administered to immune-compromised individuals.

The Drap, Ministry of National Health Services, Regulations and Coordination, directed that use of the vaccine in patients with comorbidities should be based on a favourable benefit/risk ratio.

The Sinopharm vaccine, manufactured by M/s Beijing Institute of Biological Products Co, Ltd, China, has been approved for grant of registration of SARS-CoV-2 Vaccine (Vero Cell) for emergency use authorisation for active immunisation of individuals between 18 to 60 years of age. The Registration Board, however, noted that the vaccine has already been granted market authorisations and emergency use authorisations in China, UAE and Bahrain.

As per recommendations of 5th meeting of Recommendations of Committee on Evaluation of Clinical Trials on 7.1.21 as discussed in 298th meeting of Registration Board, held on 18.1.21, the committee feels that, in case of any serious adverse events, disinformation campaign will be a very challenging issue and Drap should evolve an efficient mechanism of Post Marketing Surveillance/Adverse Events Following Immunisation (AEFI).

The Drap has directed the firm shall ensure the strict compliance of cold chain (2°C-8°C) during transportation, storage and distribution cycle. The shelf life shall be 12 months at 2°C-8°C. The Emergency Use Authorisation (EUA) shall be reviewed on quarterly basis keeping in view safety, efficacy and quality data of product.

It is also directed that the firm shall submit data of Adverse Events Following Immunisation (AEFI) to National Pharmacovigilance Centre, Pharmacy Services Division Drap as per their requirement. “The product shall be recalled in case of any quality issues or adverse reports regarding safety/efficacy or as decided by Registration Board”.

In case of Russian Sputnik-V vaccine, the committee expressed grave concern over vaccine’s side-effect with more than 20 percent contact dermatitis, which is significantly higher in vaccinated group.

Earlier, as per the minutes of 299th meeting of Registration Board, held on 22.1.21, the committee discussed clinical trial data of Sputnik-V vaccine, manufactured by M/s Gamaleya National Center of Epidemiology and Microbiology, Russia, reporting completion of trial. In response to health ministry’s inquiry to provide information on location of the contact dermatitis noted with their vaccine ie whether it was restricted to the site of administration only or affected other areas of body as well, the firm confirmed more than 20 percent contact dermatitis, which is significantly higher in vaccinated group.

Following this response, the health ministry sought complete/recent data of the trial and decided to hold Emergency Use Authorisation (EUA) till final report, which is to be published in next few weeks.