- Cabinet Spokesman says regulator awaiting more trial data
- Use among general public only based on phase 4 data
Ahead of receiving 600,000 doses of the Sinopharm vaccine, the Government yesterday clarified that priority would be given to Chinese nationals residing in Sri Lanka and that shots could be approved for the general public once phase four data was evaluated by the local regulator.
Attempting to provide clarity over how the Sinopharm vaccine would be administered, Cabinet Co-Spokesperson and Plantations Minister Dr. Ramesh Pathirana told reporters at the weekly Cabinet briefing that the National Medicine Regulatory Authority (NMRA) was awaiting phase four trial data before making a decision.
“NMRA officials have requested to see the phase four clinical trial results in English before deciding on giving approval. Therefore, the initial use of the Sinopharm vaccine will only be for Chinese workers residing in Sri Lanka,” he said in response to questions.
He said the Government was working on obtaining approval from the NMRA. The 600,000-dose consignment will arrive in Sri Lanka today.
“Sri Lanka has vaccinated over 855,000 people and we also have another stock of AstraZeneca vaccines that is likely to arrive in Sri Lanka in May, so we are confident that we will be able to continue carrying out the COVID-19 immunisation campaign without any gaps.”
Sri Lanka was initially expected to receive 300,000 doses of Sinopharm, which was doubled upon a request by President Gotabaya Rajapaksa. However, the regulatory process ran into trouble after four members of the NMRA were controversially removed after they declined to approve the vaccine on the grounds that there was insufficient data on its effectiveness.
On Monday it was reported that the China National Pharmaceutical Group, which produces Sinopharm, would need to assess results from overseas Phase III clinical trials to decide whether its two-shot COVID-19 vaccine should be followed by a booster shot.
Regulators and vaccine developers are looking at whether booster doses are necessary amid concerns that emerging variants of the new coronavirus might weaken protection of vaccines designed against older strains.