Dear Allyson van de Pol,

Code on Access to Information
Re：Application No. DH DO/1-10/1 Pt 2 7/2021

Our department has received your application for access to information as
per email below.  Your application is now under processing.  According to
paragraph 1.16 of the Code on Access to Information, our department will
inform you of the latest progress of the case separately on or before
21.06.2021.  In the meantime, please contact me at 2961 8856 if you have
any enquiry.

(Mr. Shawn HUI)
for Director of Health

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Dear Allyson van de Pol,

Code on Access to Information
Re: Application No. DH DO/1-10/1 Pt 2 7/2021

I write further to my email to you dated 10 June 2021.

Please be informed that a longer processing time on your data access
request is required as we are now clarifying legal issues in connection
with your request.  We shall reply to you on or before 21 July 2021 in
accordance with Item 1.18 of the Code.

In the meantime, you may contact the undersigned at 2961 8856 if you need
further assistance.  

Thank you for your attention.

(Mr Shawn HUI)
for Director of Health

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Dear Allyson van de Pol,

Code on Access to Information  
Re:  Application No. DH DO/1-10/1 Pt 2 7/2021  

I refer to your email dated 1 June 2021 requesting the following types of
information –  
“(a)       Number of people who have died after taking a COVID-19 vaccines
by all causes;  
(b)        Cause of death per person;  
(c)        How long after taking the vaccine they died; and  
(d)        The post-mortem results.”   

Further to our email to you dated 10 and 21 June 2021, please find our
reply to your enquiry below.
 
The two COVID-19 vaccines being used in Hong Kong are authorized for use
under the Prevention and Control of Disease (Use of Vaccines) Regulation,
Cap. 599K. They have been rigorously evaluated by the Advisory Panel on
COVID-19 Vaccines established under this Regulation that they are safe,
effective and of good quality.
 
In accordance with Cap. 599K, the Department of Health (DH) has put in
place a pharmacovigilance system for COVID-19 vaccination, including
receiving reports of adverse events following immunization (AEFIs) related
to the COVID-19 vaccines reported voluntarily from healthcare
professionals and pharmaceutical industries. The DH also partners with the
University of Hong Kong to conduct an active surveillance programme for
adverse events of special interest (AESIs) related to COVID-19 vaccines,
i.e. the COVID-19 vaccines Adverse events Response and Evaluation
Programme (CARE Programme). The main purpose of the pharmacovigilance
system is to detect signals of possible side effects of the vaccines.
 
The Director of Health has appointed the Expert Committee on Clinical
Events Assessment Following COVID-19 Immunization (Expert Committee) to
provide independent assessment of potential causal link between the
clinical events (including AEFIs and AESIs) and COVID-19 vaccines used in
Hong Kong.  According to the World Health Organization, AEFI refers to any
untoward medical occurrence which follows immunization and which does not
necessarily have a causal relationship with the usage of vaccine while
AESI is a preidentified and predefined medically-significant event that
has the potential to be causally associated with a vaccine product that
needs to be carefully monitored and confirmed by further specific
studies.  The reporting of AEFIs is on a voluntary basis and the records
related to AESIs are kept by the University of Hong Kong.  As such, not
all death cases with history of COVID-19 vaccination would be reported to
the DH.  
 
Notwithstanding that the DH does not possess a complete set of the
information requested by you, the information of the reported death cases
with history of vaccination within 14 days and fall under the reporting
criteria of AEFIs endorsed by the Expert Committee is provided below for
your reference.
 
As at 30 June 2021, the Expert Committee had assessed a total of 23 death
cases with history of vaccination within 14 days and fulfilling the
criteria for reporting as serious AEFIs. Cases that fall outside the
reporting criteria would be captured and analysed by the University of
Hong Kong under the CARE Programme. The 23 cases involved 17 males and 6
females between 40 and 80 years old, 15 of them received CoronaVac vaccine
and 8 received Comirnaty vaccine. The autopsy/preliminary autopsy findings
included myocardial infarction, ischaemic heart disease, coronary artery
disease, aortic dissection, subarachnoid haemorrhage and brainstem
haemorrhage.  So far, none of these cases were found to be associated with
COVID-19 vaccine.  Specific report on the death cases can be found in the
report on Safety Monitoring of COVID-19 Vaccines in Hong Kong
([1]https://www.drugoffice.gov.hk/eps/do/en/...),
which will be updated regularly.

Thank you for your attention.

(Ms Teresa HO)
for Director of Health

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Dear Allyson van de Pol,

Code on Access to Information
Re：Application No. DH DO/1-10/1 Pt 2 8/2021

Our department has received your application for access to information as
per email below.  Your application is now under processing.  According to
paragraph 1.16 of the Code on Access to Information, our department will
inform you of the latest progress of the case separately on or before
4.8.2021.  In the meantime, please contact me at 2961 8856 if you have any
enquiry.

(Mr Shawn HUI)
for Director of Health

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Dear Allyson van de Pol,

Code on Access to Information
Re: Application No. DH DO/1-10/1 Pt 2 8/2021

I write further to my email to you dated 23 July 2021.

Please be informed that a longer processing time on your data access
request is required as we are now coordinating the reply within department
in connection with your request.  We shall reply to you on or before 3
September 2021 in accordance with Item 1.18 of the Code.

In the meantime, you may contact the undersigned at 2961 8856 if you need
further assistance.  

Thank you for your attention.

(Mr Shawn HUI)
for Director of Health

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Dear Allyson van de Pol,

Code on Access to Information
Re: Application No. DH DO/1-10/1 Pt 2 8/2021

Having received your first enquiry on 1 June 2021, we took some time in
retrieving, checking, verifying, and consolidating records and
information, and seeking legal advice.  Some cases were pending causality
assessment by the Expert Committee in the meeting held on 5 July 2021.
 Hence, interim replies were issued to you on 10 and 21 June 2021.  In the
second interim reply, you were provided with the reason that a longer
processing time on the data access request was required as we were
clarifying legal issue at that time.  Following the meeting, the
information consolidated up to 30 June 2021 was available and a reply was
given on 15 July 2021.  

Regarding your further questions, our replies are as follows:

Question 1

As mentioned in our reply dated 15 July 2021, the adverse event monitoring
system for COVID-19 vaccines is set up in accordance with the Regulation
on Prevention and Control of Disease (Use of Vaccine) Regulation (Cap.
599K) (the Regulation). Based on the recommendation given by the Expert
Committee, reference has been made to the World Health Organization (WHO)
manual on safety surveillance and taking into account of various factors
such as local healthcare system and regulatory regime for the vaccines for
setting up the system under the Department of Health (DH). The system
includes receiving reports of adverse events following immunization
(AEFIs) related to the COVID-19 vaccines reported voluntarily from
healthcare professionals and pharmaceutical industries. The DH also
partners with the University of Hong Kong (HKU) to conduct an active
surveillance programme for adverse events of special interest (AESIs)
related to COVID-19 vaccines, i.e. the COVID-19 vaccines Adverse events
Response and Evaluation Programme (CARE Programme). The reporting system
is a voluntary one and the DH does not have information on all the death
cases among those vaccinated in Hong Kong. Death cases falling outside the
reporting criteria, including those with history of vaccination more than
14 days, if captured, would be analyzed by the HKU under the CARE
Programme. DH does not have information on the total number of people who
died after receiving COVID-19 vaccination.  Pursuant to paragraph 1.14 of
the Code on Access to Information (the Code), it does not oblige
departments to acquire information not in their possession.  We are unable
to provide the relevant information as requested.    

Question 2

For those death cases with postmortem results being assessed by the Expert
Committee, they are all cases being handled by the Coroner's Court under
the Coroners Ordinance (Cap. 504). The postmortem results were obtained
under the permission of the Coroner. The DH is not in the position to
disclose such information. In the previous reply to you on 15 July 2021,
we have already specified the causes of death of 23 death cases as at 30
June 2021 based on the autopsy / preliminary autopsy findings with history
of vaccination within 14 days and fulfilling the criteria for reporting
deliberated by the Expert Committee detailed in the report of Safety
Monitoring of COVID-19 Vaccines in Hong Kong (the Report).  Other than the
information specified in the Report which is available in the public
domain, as DH does not have information on all the death cases among those
vaccinated in Hong Kong, the information you now requested are incomplete
statistics and / or analysis where disclosure could be misleading, or
could produce a misleading impression.  As the Code recognizes that
departments may withhold information relating to incomplete analysis,
research or statistics where the incompleteness could produce a misleading
impression, accordingly, we are unable to provide the other information
requested for the reason set out in paragraph 2.13(a) of the Code.

Questions 3 and 5

According to the Regulation, before the Secretary for Food and Health (the
Secretary) authorizes a vaccine, the Secretary must, having regard to the
advice of the Advisory Panel on COVID-19 Vaccines (Advisory Panel), take
into consideration the safety, efficacy and quality of the vaccine.
Details about the authorizations and reports on the evaluation of the two
vaccines are available at the website of Food and Health Bureau (FHB)
(Health Portfolio - Food and Health Bureau
([1]https://www.fhb.gov.hk/en/our_work/healt...)).        

Clinical trials conducted by the vaccine suppliers were carried out
outside Hong Kong and provided only to support the authorization under the
Regulation. The DH is responsible for providing professional and
secretariat support to the Secretary and the Advisory Panel on the
authorization of the vaccines. The protocols, including information about
follow up of test subjects and details of control group, are not possessed
by the DH, even the applicants have submitted those clinical trials
information to the Secretary’s approval based on Advisory Panel’s
recommendations.  Pursuant to paragraph 1.14 of the Code, we are unable to
provide the relevant information as requested.        

As the information required is under the purview of the FHB, I hereby
write to seek your consent to refer your application to the FHB for
further handling.

Questions 4 and 6

So far, the DH has received more than 5,000 reports of AEFIs related to
COVID-19 vaccination.  Each AEFI report may involve different types of
investigations.  Depending on the circumstances of the case, an AEFI
report received may involve more than one investigations covering either
primary research or desk research or both.  All serious cases would be
investigated and essential information, e.g. signs and symptoms, clinical
diagnosis, laboratory finding, etc., provided by healthcare professionals
is one of the prerequisites for AEFI causality assessment. The DH does not
keep statistics on the number of investigations conducted. Once all
relevant information and evidence is available, the DH and the Expert
Committee would conduct causality assessment of AEFI based on WHO
algorithm. More information about the WHO algorithm is available at:
new-aide-mem-causal-assmt.pdf (who.int). As indicated in the WHO's
aide-memoire, when concluding the causality assessment of an AEFI,
including death cases, factors like temporal relationship, alternate
explanations, proof of association, prior evidence, population-based
evidence and biological plausibility would be taken into consideration.

The Expert Committee has already considered various options of accepting
reports and recommended to receive reporting from healthcare professionals
and pharmaceutical industries.

If you believe that the DH has failed to properly apply any provision of
the Code of Access to Information, you may complain to The Ombudsman. The
Ombudsman's address is -        

30/F, China Merchants Tower
Shun Tak Centre
168-200 Connaught Road Central
Hong Kong

Telephone: 2629 0555
Fax : 2882 8149

(Mr Shawn HUI)
for Director of Health

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I am out of the office from 25/08/2021 14:30 until 25/08/2021 17:30.

For urgent matters, please contactMiss Jackie LAM, CO(Per)4 at 3107 2571 /
&DH/CO[Per]4.

Note: This is an automated response to your message "Re: Fw: Internal
review of Freedom of Information request - Please Advise The Number of
People That Have Died After Taking a Covid Vaccine" sent on 25.08.2021
03:00:43 PM.

This is the only notification you will receive while this person is away.