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Information Given to Covid 19 Vaccine Patients

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Allyson van de Pol

Dear Department of Health,

Can you please advise the information provided/ paperwork that each patient has to sign in order to be given either a Sinovac or Pfizer Covid 19 vaccine in Hong Kong.

Thank you,

Yours faithfully,

Allyson van de Pol

Department of Health

Dear Allyson,
We have received your application dated 5 April 2022 seeking access to
information.  As we are unable to provide you with the information sought
at this stage, pursuant to paragraph 1.16 of the Code on Access to
Information, you will be advised further in relation to your request on or
before 25 April 2022.  Should you have any questions in the meantime,
please contact me at 2125 2215.

Stephen Lowe
for Director of Health

show quoted sections

Allyson van de Pol

Dear Department of Health,

Thank you!

Yours faithfully,

Allyson van de Pol

Department of Health

Dear Allyson,

I refer to your email dated 5 April 2022 asking for the information /
paper that each recipient has to sign in order to receive COVID-19
vaccination in Hong Kong.

To safeguard public health and to allow the resumption of normal
activities of society gradually, the Government is implementing a
territory-wide COVID-19 vaccination programme free of charge for all Hong
Kong residents.  The COVID-19 Vaccination thematic website
[1]https://www.covidvaccine.gov.hk/en/ provides the most updated
information to the public regarding vaccination and the relevant
arrangements.

Members of the public may choose to book vaccination appointments to
receive vaccination at the website
[2]https://booking.covidvaccine.gov.hk/form... which provides the
following information:

Vaccination Fact Sheet - with information on the dosage and schedule from
the pharmaceutical company, contraindications, precautions and warnings,
possible side effects, as well as reporting of adverse events after
immunization (AEFI).
[3]https://www.covidvaccine.gov.hk/pdf/COVI...
[4]https://www.covidvaccine.gov.hk/pdf/COVI...

Supplementary information on additional doses -
[5]https://www.covidvaccine.gov.hk/pdf/Thir...
Supplementary information on fractional dose of BioNTech (for parents/
guardians whose children are receiving fractional dose of BioNTech) -
[6]https://www.covidvaccine.gov.hk/pdf/Comi...
       
Leaflets on eHR Sharing System (eHealth) enrollment -
[7]https://www.ehealth.gov.hk/filemanager/c...,
which is accessible at the eHealth
website:[8]https://www.ehealth.gov.hk/en/whats-new/...

Statement of Purpose of Collection of Personal Data -
[9]https://www.chp.gov.hk/files/pdf/cvc_bw_...

Members of the public who book the vaccination online is required to
provide in advance 1) consent to vaccination (required) and 2) consent to
eHealth enrollment (optional), which will be confirmed and documented
again at the point of service.

For minors or those who are mentally incapable, their parents or guardians
have to sign the following relevant Consent Form.
For Sinovac and for adult dose BioNTech:
[10]https://www.covidvaccine.gov.hk/pdf/Cons...
For fractional dose BioNTech:        
[11]https://www.covidvaccine.gov.hk/pdf/Cons...
Members of the public may also choose to receive vaccination from a
private doctor or private healthcare institution, through outreach
vaccination service to schools or residential care homes. Similarly,
vaccine recipients would be given the aforementioned information and their
informed consent would be documented.

For further information, you may watch the video of vaccination workflow
in CVC: [12]https://www.youtube.com/watch?v=jViPvl8H... which is available
in the CHP Youtube channel
[13]https://www.youtube.com/channel/UC5Ot-Vl....

Stephen Lowe
for Director of Health

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Allyson van de Pol

Dear Department of Health,

Thank you,

I have a few questions regarding the declared side effects:

-where can I find details on the numbers and severity of ALL side effects including death, experienced by patients, from the moment they are injected
-what follow up is conducted for each patient after being injected?
-why are the full side effects (as listed in Pfizer documentation- Cumulative Analysis of Post Authorization Adverse Reports) not listed and available for patients?

Yours faithfully,

Allyson van de Pol

Department of Health

   Dear Allyson,
Thank you for your application dated 27.4.2022 seeking access to
information related to the declared side effects of COVID-19 vaccines.

The Department of Health (“DH”) has put in place a pharmacovigilance
system for COVID-19 immunization, including receiving reports of Adverse
Events Following Immunization (“AEFIs”)  related to the COVID-19 vaccines
used in Hong Kong from healthcare professionals and pharmaceutical
industries. The Director of Health appointed the Expert Committee on
Clinical Events Assessment Following COVID-19 Immunization (“Expert
Committee”) to provide independent assessment of potential causal link
between AEFIs and COVID-19 vaccines used in Hong Kong. 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 main purpose of
the pharmacovigilance system is to detect signals of possible side effects
of the vaccines.

Upon receipt of serious or unexpected AEFI reports, the DH will contact
the healthcare professionals whom reported the AEFI for further
information. All serious or unexpected AEFI cases will be assessed based
on the causality assessment algorithm of the World Health Organization
(WHO).

According to WHO, AEFI refers to any untoward medical occurrence which
follows immunization and which does not necessarily have a causal
relationship with the usage of the vaccine, while AESI refers to
pre-identified 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. Both
AEFI and AESI may not be side effects of the vaccine. For further
information regarding AEFI and AESI, the enquirer may wish to refer to the
following website:
[1]https://www.drugoffice.gov.hk/eps/do/en/...

On the other hand, side effects (or adverse reactions) of the authorised
vaccines are available in the Vaccination Fact Sheets, which are available
online at the COVID-19 vaccine designated website at:
[2]https://www.covidvaccine.gov.hk/en/vaccine

Or in the package inserts of the vaccines, which are available online at
Food and Health Bureau's website at:
[3]https://www.fhb.gov.hk/en/our_work/healt...
The family doctor or doctor-in-charge provides clinical assessments and
follow-up as necessary for those who experienced side effects after
vaccination and sought medical attention. If necessary, the doctor will
report any AEFI that is deemed medically significant to Drug Office for
further action and assessment.

If we can be of any assistance in the provision of other information in
the future, please do not hesitate to contact us again.
(Stephen Lowe)
for Director of Health

show quoted sections

Allyson van de Pol

Dear Stephen Lowe

Thank you for your reply.

I have further questions:

1) As the vaccines are still under emergency use authorisation and therefore experimental and in phase 3 trials, with no long term safety or efficacy data, and given the number of known side effects as reported by Pfizer themselves (which exceed the limited number of side effects that you publish) , is each injected individual followed up at all post injection, to check for these known adverse effects at all? Or only if he/she reports a problem to a doctor?

2) Is there a way for individuals to report adverse effects directly, so that they can be monitored more closely? Given that doctors may be busy and may not report important information?

3) Further where can I find a complete list of all Adverse side effects that have been reported post injection?

4) Additionally, why are vaccines being pushed on under 16s when and I quote from the "Report on Evaluation of Safety, Efficacy and Quality of Comirnaty COVID-19 mRNA Vaccine (BNT162b2) Concentrate for Dispersion for Injection"

"The safety and efficacy of Comirnaty in children and adolescents aged less than 16 years of age have not yet been established. Limited data is available."

Please advise why children are being encouraged to take an experimental drug with limited safety and efficacy data?

Yours faithfully,

Allyson van de Pol

Department of Health

Dear Allyson van de Pol,

Code on Access to Information
Re:Application No. DO EC 0880/22

I refer to 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, we will inform you of the latest
progress of the case on or before 25.5.2022.  In the meantime, please
contact me at 2961 8856 if you have any enquiry.

(Mr. Shawn HUI)
for Director of Health

From:        Allyson van de Pol <[FOI #1035 email]>
To:        FOI requests at Department of Health <[Department of Health request email]>
Date:        05/05/2022 20:09
Subject:        Internal review of Freedom of Information request -
Information Given to Covid 19 Vaccine Patients

--------------------------------------------------------------------------

Dear Stephen Lowe

Thank you for your reply.

I have further questions:

1) As the vaccines are still under emergency use authorisation and
therefore experimental and in phase 3 trials, with no long term safety or
efficacy data, and given the number of known side effects as reported by
Pfizer themselves (which exceed the limited number of side effects that
you publish) , is each injected individual followed up at all post
injection, to check for these known adverse effects at all? Or only if
he/she reports a problem to a doctor?

2) Is there a way for individuals to report adverse effects directly, so
that they can be monitored more closely? Given that doctors may be busy
and may not report important information?

3) Further where can I find a complete list of all Adverse side effects
that have been reported post injection?

4) Additionally, why are vaccines being pushed on under 16s when and I
quote from the "Report on Evaluation of Safety, Efficacy and Quality of
Comirnaty COVID-19 mRNA Vaccine (BNT162b2) Concentrate for Dispersion for
Injection"

"The safety and efficacy of Comirnaty in children and adolescents aged
less than 16 years of age have not yet been established. Limited data is
available."

Please advise why children are being encouraged to take an experimental
drug with limited safety and efficacy data?

Yours faithfully,

Allyson van de Pol

show quoted sections

Department of Health

Dear Allyson van de Pol,

Code on Access to Information  
Re:  Application No. DO EC 0880/22

I refer to your email dated 5 May 2022 to our department requesting for
further information mentioned in your email.  

Please find our reply to your enquiry below.

Questions 1 to 3
 
The two COVID-19 vaccines authorised for use in Hong Kong have been
rigorously evaluated by the Advisory Panel on COVID-19 Vaccines
established under the Prevention and Control of Disease (Use of Vaccines)
Regulation (Cap. 599K) that they are safe, effective and of good quality.
 Current scientific evidence indicates that the benefits of the two
COVID-19 vaccines outweigh their risks for use as active immunisation to
prevent COVID-19 caused by SARS-CoV-2 virus.  The two vaccines not only
protect individuals from COVID-19 infection, available data also support
that the vaccines could reduce the seriousness of the illness even if
infected.  The rapid development of COVID-19 vaccines may require close
monitoring to ensure the safety and to identify potential signals that may
indicate causal association between previously unknown adverse events and
the vaccines.  Therefore, the Department of Health (“DH”) has put in place
a pharmacovigilance system for COVID-19 immunisation, including receiving
reports of Adverse Events Following Immunization (“AEFIs”) related to the
COVID-19 vaccines used in Hong Kong from healthcare professionals and
pharmaceutical industries.  The Director of Health appointed the Expert
Committee on Clinical Events Assessment Following COVID-19 Immunization
(“Expert Committee”) to provide independent assessment of potential causal
link between AEFIs and COVID-19 vaccines used in Hong Kong.  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.

AEFI should be reported to the DH by healthcare professionals (e.g.
doctors, dentists, pharmacists, nurses and Chinese medicine
practitioners).  Upon receipt of reports of serious and unexpected AEFI,
the DH will contact the healthcare professionals or pharmaceutical
industries who reported the AEFI for further information.  The DH will not
contact the vaccine recipients direct.  According to the established
mechanism, all the important cases will be considered by the Expert
Committee while all other serious or unexpected AEFI cases will be
assessed by DH based on the causality assessment algorithm of the World
Health Organization (“WHO”).

According to WHO, AEFI refers to any untoward medical occurrence which
follows immunisation and which does not necessarily have a causal
relationship with the usage of the vaccine, while AESI refers to
pre-identified 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.  Both
AEFI and AESI may not be side effects of the vaccine.  For further
information regarding AEFI and AESI, you may wish to refer to the
following website:
[1]https://www.drugoffice.gov.hk/eps/do/en/...

Regarding your request for “a complete list of all adverse side effects
that have been reported post injection”, please note that such list
contains information that involves incomplete analysis, and disclosure of
such information could be misleading.  Therefore, based on Clause 2.13(a)
of the Code on Access to Information as quoted below, the DH could not
provide the requested information –

“Information relating to incomplete analysis, research or statistics,
where disclosure could be misleading or deprive the department or any
other person of priority of publication or commercial value.”

Nevertheless, please kindly note that the Government releases relevant
statistics and information of AEFI received through the Government's
designated website and publishes the Report on Safety Monitoring of
COVID-19 Vaccines on the designated website regularly. You may wish to
refer to this information accordingly.

The latest report on safety monitoring of COVID-19 vaccines and the latest
statistics related to AEFI of COVID-19 vaccines are available at the
following websites respectively:

[2]https://www.drugoffice.gov.hk/eps/do/en/...

[3]https://www.covidvaccine.gov.hk/en/dashb...

Question 4

Taking note that the Advisory Panel on COVID-19 Vaccines has recommended
to lower the age limit for receiving the Comirnaty COVID-19 vaccine to
children and adolescents, the Scientific Committee on Vaccine Preventable
Diseases (“SCVPD”) and the Scientific Committee on Emerging and Zoonotic
Diseases (“SCEZD”) under the Centre for Health Protection of the
Department of Health (“JSC”) and the Chief Executive’s expert advisory
panel (“EAP”) made recommendations on the use of Comirnaty in this age
group.

Comirnaty COVID-19 vaccine has high efficacy against symptomatic COVID-19
disease, and lowers the risk of severe disease/death.  The JSC with EAP
considered that the benefits of Comirnaty vaccine in reducing deaths and
hospitalisations due to COVID-19 infection outweigh the risks in children
and adolescents aged below 16.

The proportion of paediatric patients markedly increased during the fifth
wave of COVID-19 in Hong Kong compared with the previous waves.
Vaccination remains an important public health tool to protect adolescents
against symptomatic COVID-19 disease and to reduce community transmission
of COVID-19, as well as to increase the overall community immunity.

You may ask the department to review the decision by writing to Deputy
Director of Health at 21^st Floor, Wu Chung House, 213 Queen’s Road East,
Hong Kong if you are not satisfied with the above decision.
 Alternatively, you may complain to The Ombudsman, whose address is –

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

Telephone: 2629 0555
Fax: 2882 8149
Email: [email address]

(Shawn HUI)
for Director of Health

From:        pharmgeneral/DH/HKSARG
To:        Allyson van de Pol <[FOI #1035 email]>
Cc:        Access to info/DH/[email protected]
Date:        13/05/2022 06:39 PM
Subject:        Fw: Internal review of Freedom of Information request -
Information Given to Covid 19 Vaccine Patients

--------------------------------------------------------------------------

Dear Allyson van de Pol,

Code on Access to Information
Re:Application No. DO EC 0880/22

I refer to 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, we will inform you of the latest
progress of the case on or before 25.5.2022.  In the meantime, please
contact me at 2961 8856 if you have any enquiry.

(Mr. Shawn HUI)
for Director of Health

From:        Allyson van de Pol <[FOI #1035 email]>
To:        FOI requests at Department of Health <[Department of Health request email]>
Date:        05/05/2022 20:09
Subject:        Internal review of Freedom of Information request -
Information Given to Covid 19 Vaccine Patients

--------------------------------------------------------------------------

Dear Stephen Lowe

Thank you for your reply.

I have further questions:

1) As the vaccines are still under emergency use authorisation and
therefore experimental and in phase 3 trials, with no long term safety or
efficacy data, and given the number of known side effects as reported by
Pfizer themselves (which exceed the limited number of side effects that
you publish) , is each injected individual followed up at all post
injection, to check for these known adverse effects at all? Or only if
he/she reports a problem to a doctor?

2) Is there a way for individuals to report adverse effects directly, so
that they can be monitored more closely? Given that doctors may be busy
and may not report important information?

3) Further where can I find a complete list of all Adverse side effects
that have been reported post injection?

4) Additionally, why are vaccines being pushed on under 16s when and I
quote from the "Report on Evaluation of Safety, Efficacy and Quality of
Comirnaty COVID-19 mRNA Vaccine (BNT162b2) Concentrate for Dispersion for
Injection"

"The safety and efficacy of Comirnaty in children and adolescents aged
less than 16 years of age have not yet been established. Limited data is
available."

Please advise why children are being encouraged to take an experimental
drug with limited safety and efficacy data?

Yours faithfully,

Allyson van de Pol

show quoted sections

We don't know whether the most recent response to this request contains information or not – if you are Allyson van de Pol please sign in and let everyone know.