Sri Lanka regulator withdraws approval for emergency use of Sinopharma

By Chanka Jayasinghe

COLOMBO – The Sri Lanka National Medicine Regulatory Authority (NMRA) has withdrawn the approval it had previously given for the emergency use of the China-manufactured Sinopharm COVID-19 vaccine, officials said.

NMRA Chief Executive Officer Dr. Kamal Jayasinghe said the NMRA has waived off the registration requirement for the Sinopharma vaccine in order to receive 600,000 doses of the vaccine donated by the Chinese government. Permission for the emergency use will be given after further studies, he said

“This is a government to government donation. We have a list of guidelines we have to follow in such a case, according to which the NMRA gave the approval to bring in the donation,” he said.

Dr, Jayasinghe said in order to import a vaccine to any country, it must first be registered in that country. However, owing to the realities of the pandemic, vaccines are temporarily permitted to be brought without registration in order to release it from customs.

State Minister for Pharmaceutical Production, Supply and Regulation Prof Channa   Jayasumana said the NMRA approved the vaccine last Saturday (20) for emergency use along with the India-manufactured AstraZeneca Covishield and Russia’s Sputnik V vaccines. Jayasumana said the 600,000 doses of the Sinopharm vaccine will arrive in Sri Lanka soon.

“They have already confirmed the donation and we expect it to arrive in the next two weeks,” Jayasumana told reporters.

The vaccine is produced by Sinopharm, a State owned pharmaceutical manufacturer in China. The jab has shown 79% efficacy against the COVID-19 virus, lower than Pfizer, Moderna and Oxford COVISHIELD vaccines, international media reports show. Donations of Chinese vaccines have been made to several countries including Pakistan, Bangladesh, Congo Republic, Equatorial Guinea and Namibia.

However, Chief Epidemiologist Dr. Sudath Smaraweera said the Chinese vaccine will not rolled out without approval for emergency use.

“The NMRA should give written approval for any medicine to be imported that is not registered in Sri Lanka. In this case, permission has been given to import, but the permission for emergency use has been withdrawn,” said Samaraweera.

“The NMRA has not communicated with us or has given approval to include the vaccine in our vaccination programme,” he added.

The Sinopharma vaccine has yet to be approved by the World Health Organization (WHO). Despite this, however, said Samarweera, it can be used in Sri Lanka if the National Advisory Committee on Communicable Deceases (NACCD) approves it.

“Their immunization policy gives them the authority to decide on that. They should work together on this issue and decide whether to give the vaccine or not,” he said.

Samarawerea also said the Covishield vaccine got NACDD approval before receiving WHO approval.

The Chief Epidemiologist said that besides WHO approval, the committee considers other global factors when approving a vaccine – such as how many doses have been used in how many countries and the number of recipients who have experienced side effects. When Sri Lanka started rolling out Covishiled, he said, the Stringent Regulatory Authority (SRA) had approved the vaccine.

The SRA was developed by the WHO Secretariat and the Global Fund to Fight AIDS, tuberculosis and malaria to guide medicine procurement decisions and is now widely recognised by the international regulatory and procurement community.

Meanwhile, State Minister Sudarshini Fernandopulle told reporters on Sunday (21) that the Chinese donation will be used to vaccinate the Chinese people working in Sri Lanka as per a request by the Chinese Embassy in Colombo.

CEP of NMRA Dr. Jayasinghe said around 30,000 Chinese workers have already requested to get the vaccine.

“We considered the request and with the permission to bring in, we gave the permission for them to get the vaccine as well” Jayasinghe said.

Sri Lanka has so far vaccinated 815,585 with the Oxford Covishield jab.

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