Information Supplied to COVID-19 Vaccinators

Ross Francis made this Official Information request to Ministry of Health

The request was partially successful.

From: Ross Francis

Dear Ministry of Health,

I have the following information request regarding information supplied to vaccinators who are administering the COVID-19 vaccine in New Zealand:

1. Other than completing an online education course, what information is supplied to those tasked with administering the COVID-19 vaccine?

2. What new information, if any, has been added to the online education course for May 2021?

3. The (April 2021) online education course states that "a slightly increased risk of a severe allergic response in individuals who have had a previous anaphylaxis-type reaction needs to be balanced against the risk of SARS-CoV-2 exposure and severe COVID-19”. Unfortunately, the online course doesn’t specify the risk of the latter. In May 2021, what is the risk of someone in New Zealand, aged under 50, in excellent health and with no pre-existing conditions, being exposed to COVID-19?

4. In May 2021, what is the risk of someone in New Zealand, aged under 50, in excellent health and with no pre-existing conditions, dying from COVID-19?

5. Vaccinators are informed of the following: "To date, clinical studies have not investigated the mRNA vaccine in pregnancy...It is recommended to delay vaccination until after delivery". In New Zealand, how many pregnant women, despite being advised to delay vaccination, have received one or two doses of the Pfizer vaccine?

6. The online course states: "A few groups of people should not get the vaccine, and some others should consult with their doctor or follow special procedures". Which groups should not get the vaccine, and who should consult with their doctor or follow special procedures? What special procedures should be followed?

7. The online course states: “The safety and efficacy of the mRNA-CV in children and young adults aged less than 16 years of age have not yet been established". Has anyone under 16 received one or two doses of the Pfizer vaccine in New Zealand?

8. To date, what have been the most serious adverse reactions to the Pfizer vaccine, in New Zealand and overseas?

9. How many people have declined to be vaccinated because the vaccinator was unable to answer their question(s) about the vaccine?

10. The online course states: "Health professionals who are ambivalent about COVID-19 vaccination should endeavour to resolve their concerns before being involved in the community rollout". How many health professionals have expressed concerns about the COVID-19 vaccine or vaccination? How many health professionals have declined to be involved in the community rollout and how many have chosen not to be vaccinated against COVID-19?

11. The online course states: "A trusted health professional recommendation is the key to vaccine acceptance". Is a trusted health professional recommendation, with respect to vaccine acceptance, more important than informed consent?

12. Vaccinators are told: "Some [people] may be ambivalent or hesitant about the COVID-19 vaccine...If the person is clearly against vaccination there is usually little benefit in time spent arguing." If someone is hesitant about getting the vaccine, could they be asked to leave (without being vaccinated) because the vaccinator is uncomfortable answering their questions? How many people have declined to be vaccinated because they did not have the information necessary to make an informed decision?

13. The online course states: "We would expect COVID-19 vaccines to provide protection for longer than 2 months, although exactly how long for, remains unknown at this stage". What action, if any, does the Health Ministry intend to take in the event that the vaccine offers little or no long-term protection?

14. A recent report in The Lancet concluded:

“Publicly available data from the Pfizer-BioNTech and Moderna vaccine trials suggest an imbalance in the incidence of Bell's palsy following vaccination compared with the placebo arm of each trial. Combining data from both trials, among nearly 40000 vaccine arm participants, there were seven Bell's palsy cases compared with one Bell's palsy case among placebo arm participants…the observed incidence of Bell's palsy in the vaccine arms is between 3·5-times and 7-times higher than would be expected in the general population.”

https://www.thelancet.com/journals/lanin...(21)00076-1/fulltext

Are intended recipients of the vaccine in New Zealand routinely informed of possible side-effects or adverse reactions, or do intended recipients have to ask for such information? What information, if any, is being provided to recipients about the observed incidence of Bell’s palsy in vaccine trials?

Given that roll-out of the vaccine has begun, a prompt response to this request would be appreciated.

Yours faithfully,

Ross Francis

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Ross Francis left an annotation ()

The paper cited in question 14 is entitled: Bell's palsy and SARS-CoV-2 vaccines, by Al Ozonoff, Etsuro Nanishi and Ofer Levy.

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From: OIA Requests


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Kia ora

 

Thank you for your request for official information received 10 May 2021
for:

 

“1.      Other than completing an online education course, what
information is supplied to those tasked with administering the COVID-19
vaccine?

2.      What new information, if any, has been added to the online
education course for May 2021?

3.      The (April 2021) online education course states that "a slightly
increased risk of a severe allergic response in individuals who have had a
previous anaphylaxis-type reaction needs to be balanced against the risk
of SARS-CoV-2 exposure and severe COVID-19”. Unfortunately, the online
course doesn’t specify the risk of the latter. In May 2021, what is the
risk of someone in New Zealand, aged under 50, in excellent health and
with no pre-existing conditions, being exposed to COVID-19?

4.      In May 2021, what is the risk of someone in New Zealand, aged
under 50, in excellent health and with no pre-existing conditions, dying
from COVID-19?

5.      Vaccinators are informed of the following: "To date, clinical
studies have not investigated the mRNA vaccine in pregnancy...It is
recommended to delay vaccination until after delivery". In New Zealand,
how many pregnant women, despite being advised to delay vaccination, have
received one or two doses of the Pfizer vaccine?

6.      The online course states: "A few groups of people should not get
the vaccine, and some others should consult with their doctor or follow
special procedures". Which groups should not get the vaccine, and who
should consult with their doctor or follow special procedures? What
special procedures should be followed?

7.      The online course states: “The safety and efficacy of the mRNA-CV
in children and young adults aged less than 16 years of age have not yet
been established". Has anyone under 16 received one or two doses of the
Pfizer vaccine in New Zealand?

8.      To date, what have been the most serious adverse reactions to the
Pfizer vaccine, in New Zealand and overseas?

9.      How many people have declined to be vaccinated because the
vaccinator was unable to answer their question(s) about the vaccine?

10.     The online course states: "Health professionals who are ambivalent
about COVID-19 vaccination should endeavour to resolve their concerns
before being involved in the community rollout". How many health
professionals have expressed concerns about the COVID-19 vaccine or
vaccination? How many health professionals have declined to be involved in
the community rollout and how many have chosen not to be vaccinated
against COVID-19?

11.     The online course states: "A trusted health professional
recommendation is the key to vaccine acceptance".  Is a trusted health
professional recommendation, with respect to vaccine acceptance, more
important than informed consent?

12.     Vaccinators are told: "Some [people] may be ambivalent or hesitant
about the COVID-19 vaccine...If the person is clearly against vaccination
there is usually little benefit in time spent arguing." If someone is
hesitant about getting the vaccine, could they be asked to leave (without
being vaccinated) because the vaccinator is uncomfortable answering their
questions? How many people have declined to be vaccinated because they did
not have the information necessary to make an informed decision?

13.     The online course states: "We would expect COVID-19 vaccines to
provide protection for longer than 2 months, although exactly how long
for, remains unknown at this stage". What action, if any, does the Health
Ministry intend to take in the event that the vaccine offers little or no
long-term protection?

14.     A recent report in The Lancet concluded:

“Publicly available data from the Pfizer-BioNTech and Moderna vaccine
trials suggest an imbalance in the incidence of Bell's palsy following
vaccination compared with the placebo arm of each trial. Combining data
from both trials, among nearly 40000 vaccine arm participants, there were
seven Bell's palsy cases compared with one Bell's palsy case among placebo
arm participants…the observed incidence of Bell's palsy in the vaccine
arms is between 3·5-times and 7-times higher than would be expected in the
general population.”

[1]https://scanmail.trustwave.com/?c=15517&...

Are intended recipients of the vaccine in New Zealand routinely informed
of possible side-effects or adverse reactions, or do intended recipients
have to ask for such information? What information, if any, is being
provided to recipients about the observed incidence of Bell’s palsy in
vaccine trials?”

 

The Ministry's reference number for your request is: H202105506.

 

As required under the Official Information Act 1982 we will endeavour to
respond to your request no later than 8 June 2021, being 20 working days
after the day your request was received.  

 

If we are unable to respond to your request within this time frame, we
will notify you of an extension of that time frame.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngâ mihi

 

 

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [2][email address]

 

 

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1. https://scanmail.trustwave.com/?c=15517&...
2. mailto:[email address]

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From: OIA Requests


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Kia ora

 

Please find attached a letter regarding your request for official
information.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [email address]

 

 

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