Experts back Sinovac jab
(To watch the full media session with sign language interpretation, click here.)
The Advisory Panel on COVID-19 Vaccines has considered that under the current global epidemic situation, the benefits of authorising the use of the COVID-19 vaccine by Sinovac Biotech (Hong Kong) for protecting against COVID-19 outweigh the risks.
The advisory panel convened a meeting today to review the supplementary data and information submitted by Sinovac.
The company had earlier submitted supplementary information to the Department of Health to clarify that save for emergency situations, it is recommended that the first and second vaccine dose should be received with an interval of 28 days.
At today's meeting, the advisory panel reviewed the information submitted earlier and later supplemented by Sinovac on safety, efficacy and quality.
The panel considers that the relevant clinical information, based on the results of different situations such as the trial design, countries, target groups as well as the testing targets, indicated that the efficacy of Sinovac's vaccine was 50.65% to 91.25% for people aged over 18 and that the vaccine's safety was satisfactory.
The information on quality also indicated that the manufacturer has met the Good Manufacturing Practice standards, and has obtained approval for use from the National Medical Products Administration and other overseas drug regulatory authorities.
To ensure that the relevant vaccine continues to fulfil the requirements of safety, efficacy and quality, the advisory panel recommends attaching conditions to require the applicant to execute relevant risk management programme, and continue to provide the latest clinical data, laboratory analysis certificates for each batch of vaccines as well as timely update of quality reports.
The Government welcomes the advisory panel's recommendation on the authorisation application for the vaccine, adding that the Secretary for Food and Health will consider the relevant recommendation and come to a decision on the authorisation of the vaccine for emergency use as soon as possible.
The Government also reiterated that it will ensure vaccines satisfy the criteria of safety, efficacy and quality, and obtain emergency use approval in accordance with the relevant requirements as well as stringent approval procedures under the Prevention & Control of Disease (Use of Vaccines) Regulation, before arranging for the public to receive the vaccines.
Advisory Panel on COVID-19 Vaccines Convenor Prof Wallace Lau told reporters this evening after the meeting that the panel did not face any external pressure when making its recommendation.
“There is no pressure at all from anyone. Over the last few days I have actually more or less shut myself off from all the newspapers etc, and we have concentrated primarily on looking at the data, so there is no pressure from anyone at all on making the recommendation.”
Prof Lau noted that the panel made the recommendation based on clinical data submitted by Sinovac, adding that it had gone through all the necessary procedures.
“As to why we are not waiting for the World Health Organization’s (WHO) recommendation, as I mentioned the last time, this is about an emergency use of a vaccine that will hopefully help to protect the people of Hong Kong from COVID-19. And we have received the data from Sinovac Biotech (Hong Kong) and the data that we have looked at appeared to show that this vaccine is efficacious.
“And when we looked at the data last time and today, we have actually adopted the same attitude as how we normally would peer review a study report, a clinical trial report to be ready for publication in a learned journal. So we have actually gone through all the procedures as needed.
“We have been working, basically to be honest, since before the last meeting on February 10 and over the last week or so, almost one week. The secretariat will try to get the report done as soon as possible. Hopefully, it may be done shorter than one week.”