Vaccines meet safety requirements

March 17, 2021

The Government today pointed out that all COVID-19 vaccines used in Hong Kong are authorised for emergency use in accordance with the Prevention & Control of Disease (Use of Vaccines) Regulation to ensure the relevant vaccines meet the requirements of safety, efficacy and quality.

 

The Government said it has noticed that individual organisations used the name of medical professionals to claim that the Sinovac vaccine has insufficient data, thus shaking public confidence in vaccination.

 

It stressed that vaccination is an important public health measure to control COVID-19 effectively. The public health authorities have all along been implementing the vaccination programme based on scientific evidence and in adherence to the principles of openness and transparency, providing the public with the choice of vaccines from different technology platforms.

 

The Government emphasised that faced with the raging epidemic, the community should work together to fight the virus and it encouraged citizens to actively get vaccinated in order to protect themselves, their families, the healthcare system and even the whole population.

 

It pointed out that medical professionals should, following the spirit of protecting public health and the principle of adhering to medical evidence, explain to people the benefits and risks of getting vaccinated. No political considerations should be involved.

 

Individual organisations which used the name of medical professionals to, based on political stance, spread rumours to the public regarding vaccination and target individual vaccines attempting to smear the vaccination programme and mislead citizens to resist getting vaccinated are placing individual political gains on top of public health. The Government said such behaviour should be condemned.

 

In accordance with the regulation, the Secretary for Food & Health, after making reference to the advice of the Advisory Panel on COVID-19 Vaccines and having considered the threat to public health posed by COVID-19, considers that the authorisation of the Sinovac vaccine is necessary and in the public interest and has authorised the emergency use of the relevant vaccine in Hong Kong according to the regulation.

 

According to the information provided by Sinovac to the advisory panel, in the Phase 3 clinical trials conducted in Brazil, mainly targeting around 12,000 healthcare workers aged above 18, including around 600 seniors aged above 60 who have contact with COVID-19 patients, for the around 10,000 trial participants who received two doses of the Sinovac vaccine, the overall vaccine efficacy was 50.65% after 14 days.

 

The results indicated that, in the clinical trials, comparing subjects who received the vaccine and those who did not, receiving the vaccine could lower the risk of developing symptomatic COVID-19 by 50.65%. The above analysis encompassed only groups who experienced mild symptoms without the need for medical attention.

 

As regards the groups who experienced symptoms and required medical attention or had more severe conditions, the efficacy of the Sinovac vaccine was 83.7%. The efficacy for preventing hospitalisation and serious cases involving severe conditions or even death reached 100%.

 

However, the relevant case numbers are relatively fewer, hence further study would be necessary for confirmation.

 

The procedures for the advisory panel to examine the information and data and the Government to approve the authorisation are stringent and comprehensive. The procedures met all the relevant requirements under the regulation and were no different from those adopted for approving another vaccine for emergency use in Hong Kong, BioNTech, earlier.

 

As regards the use of Sinovac vaccine on people aged 60 or above, according to the information provided by Sinovac, the Sinovac vaccine was suitable for preventive vaccination for people aged 18 or above.

 

The Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging & Zoonotic Diseases under the Centre for Health Protection of the Department of Health and the Chief Executive's expert advisory panel examined the available information and data having regard to the information provided by Sinovac to the advisory panel.

 

They considered that the benefit of using the Sinovac vaccine generally exceeds the risk of not using any vaccines in people aged 60 or above.

 

According to the information provided by the drug manufacturer, so far over 40 million doses of the Sinovac vaccine have been administered around the world. According to statistics derived from the clinical trials of the Sinovac vaccine, so far there is no evidence indicating a direct causal relationship between receiving the relevant vaccine and a number of very severe adverse events such as death cases.

 

As regards the severe adverse events in Hong Kong which occurred after receiving COVID-19 vaccines, in accordance with the Department of Health’s pharmacovigilance system, the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation will conduct causality assessments on all important adverse events based on guidelines by the World Health Organization when necessary information for the cases is available.

 

So far, the expert committee’s assessment results have not indicated any causal relationship between death cases and the administration of vaccines.

 

The Government explained that from the medical professional and science perspectives, so far there is no evidence pointing to the need to cast doubt on the safety of the two COVID-19 vaccines now made available to citizens and emphasised that the relevant vaccines are effective and of good quality.

 

The Hospital Authority issued a statement regarding the dissemination of unfounded allegations towards the COVID-19 vaccination scheme by some healthcare workers.

 

It stated that while strongly refuting the unfounded allegations by some healthcare workers on the vaccination scheme, the authority strongly urges them to stop further promulgation of the information and avoid misleading the public.

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