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.
In view of confusion among the healthcare workers and general public at large, especially above the age of 60, Pakistan Medical Association (PMA) believed that the vaccination drive, which started for healthcare workers in Pakistan from February 3, 2021, is moving at a very slow pace because of the confusion among the healthcare workers. “Same confusion persists among individuals older than 60 years,” said Dr SM Qaisar Sajjad, secretary general PMA (Centre). “The government must, therefore, remove all suspicions and fears about the vaccine”.
Meanwhile, in a notification on 2.2.21, Drug Regulatory Authority of Pakistan (Drap) exempted COV1D-19 vaccines, being imported for sale in hospitals and institutions, of fixed price cap for a period of six months or till the market prices of those vaccines become available. The Drap’s notification in this regard further says, “The vaccines shall be registered or approved for emergency use authorisation by Drap’s Registration Board; and the vaccines shall not be sold or distributed in the market. Drug Lawyers Forum Pakistan (DLFP) President Noor Mehr termed Drap’s decision not to fix prices of all imported vaccines for six months a free hand to pharmaceutical companies to rip off citizens without fear of accountability.