GAAC's open letters to UK Civil Aviation Authority

FAO CAA Board: Covid-19 Vaccination and Class 1-3 Medical Certificate Holders

Update:

On 22/06/22 the CAA kindly replied.

Today, 06/07/2022 GAAC has replied to the CAA with further questions.

Scroll down to read the letters in order of recency. Click below to open the letters.

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220706 Gaac Uk Caa Ne

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July 6, 2022

Dear CAA Board Members,

Re: Covid-19 Vaccination and Class 1-3 Medical Certificate Holders

Thank you for your kind reply dated 22 June 2022, it is indeed helpful and greatly appreciated.

Further to that reply, please can you provide further insight into the following questions:

1. As you have advised us that the CAA defers to the MHRA in respect of Covid-19 vaccine safety and efficacy:

   • Does the CAA have any form of its own definition of “safety” or “efficacy” of the Covid-19 vaccines, outside of which it would independently withdraw their use by Class 1-3 medical certificate holders? If so, what are those definitions?

   • Is it possible to see the sources of “governmental guidance and scientific literature on Covid-19 “vaccines” that the CAA has specifically referred to/considered in any given period since January 2020?

   • Does the CAA's deference to the MHRA in this regard effectively mean that MHRA assessments, decisions, recommendations etc fully cascade, unimpeded, through the CAA and into its medical system?

   • By what means would any MHRA error or inappropriate determination of Covid-19 “vaccine” classification, safety, efficacy or suitability for use by Class 1-3 medical certificate holders, be avoided, trapped or mitigated by the CAA?

   • How does the MHRA's processes take specific account of aviation medicine when it comes to Covid-19 vaccines and, if the CAA defers to it, how has the CAA ensured that MHRA has fully accounted for all possible aviation medicine considerations/risks etc specific to the aviation environment?

   • What specific Covid-19 vaccine trial data has the CAA examined for each of the Covid-19 vaccines?

   • What specific Covid-19 vaccine surveillance data/evidence/reports does the CAA examine?

2. You refer to the “approval process for vaccines in the UK”. No Covid-19 vaccine has been fully approved. They are temporarily authorised under Regulation 174A(2) of the Human Medicine Regulations. Conditional Marketing Authorisations have been issued, which are not “approvals” and all the products are on the Black Triangle list of medicines requiring intensive monitoring. These MHRA Conditions of Authorisation state:

“This authorisation is not a marketing authorisation for the purposes of Part 5 of the HMRs or Chapter 4 of Title III to the 2001 Directive.”

What significance does such conditionality have on the CAA's view of medical products in use under CMA in the aviation industry?

1. Do CAA AMEs have the capability and/or remit to ascribe causality of injury to a vaccine independently or are they dependent upon that determination having been made by other clinician(s)? Conversely, could they independently override the clinical determination of another physician's determination?

2. In the CAA's opinion, is it possible for a Class 1-3 medical certificate holder to have suffered a vaccine-induced injury that, for some reason, is not formally attributed to a vaccine and therefore never recorded as such in the CAA medical system e.g. causal misdiagnosis, refusal by clinician to entertain a vaccine as a cause for some reason (including prejudice or lack of knowledge)? If so, could it be possible that the CAA might not ever know of or recognise such issues?

3. Is it fair to say that in order for the CAA to become aware of vaccine injury via its medical system, it requires:

   • causal certainty to have been recorded by a clinician who is not the AME; and

   • for the AME to agree; and

   • for the AME to enter that into the system?

4. We understand from your answer to question 5 that should a pilot choose to withhold information about an actual or suspected medical condition from the CAA, the CAA has no direct way of knowing unless the individual was effectively “found out” via involvement in incident, accident or third party reporting. Is this a fair understanding?

5. Should a Class 1-3 medical certificate holder wish to take part in a Covid-19 vaccine clinical trial of any kind, for example a booster “mix-and-match” trial, how would they have to interact with the CAA to do so legally and in conformance with their regulatory and licence obligations? Would they have to: declare their intent to do so to the CAA; be granted permission by the CAA? Would the individual be able to take part in such a trial and still continue to operate flights in accordance with their licence?

We thank you for your anticipated efforts in providing your insight into the above questions and look forward to receiving your reply by email in due course.

Yours sincerely,

GAAC

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Uk Caa Reply 220622

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Chair & Chief Executive’s Office

GAA Coalition

22 June 2022

Dear GAA Coalition

Thank you for your emails of 9 June to colleagues at the CAA regarding Covid-19 vaccinations and Class 1-3 medical certificate holders. I am replying on their behalf. Please see below for our response to each of your questions in turn.

1. Please explain how the Civil Aviation Authority assesses Covid-19 vaccines' suitability for use by Class 1-3 medical certificate holders since their roll out.

The approval process for vaccines in the UK, which includes a determination of their efficacy and safety, is undertaken by the Medicines and Healthcare products Regulatory Agency (MHRA). The CAA medical department continues to monitor governmental guidance and the scientific literature on Covid-19 vaccines. This includes the results of the COVID vaccine trial data and subsequent surveillance.

2. Does the Civil Aviation Authority collect reports of Covid-19 vaccine effects, side-effects and severe adverse events (including suspected or proven resultant death) occurring in any Class 1-3 medical holder and if it does please explain how this data is collected?

This data would normally be captured within the MHRA Yellow Card reporting system. There is a sub-section of the Yellow Card website for Covid-19 vaccines. The CAA does not specifically collect this data, however if an aeromedical examiner (AME) has made an individual unfit due to COVID vaccination effects, they will record this in the CAA medical records system.

3. Is the Civil Aviation Authority aware of any Covid-19 vaccine-induced adverse events in any UK Class 1-3 medical certificate holder? If so, how many such events is the Civil Aviation Authority aware of and how does the CAA categorise their severity?

Not directly. If an AME has made an individual unfit due to COVID vaccination effects, they will record this in the CAA medical records system. Severity would not be normally graded other than whether the applicant had been assessed as fit to fly or not.

4. Does the Civil Aviation Authority keep data relating to the numbers of Class 1-3 medical certificates that:

• are held;

Yes, but this will vary daily

• temporarily/permanently suspended; we do not suspend medical certificates.

Applicants are either fit or unfit.

• in any given year?

Yes, we hold data for the numbers of Class 1-3 medical certificate holders who were made unfit in each year dating back to 1999.

5. Holders of Class 1-3 medical certificates are expected to self-report medical issues to the Civil Aviation Authority, except where issues are actually detected during a Civil Aviation Authority medical examination. How and when does the Civil Aviation Authority, via its medical system, become aware of certificate holders' medical issues if they do not self-report those issues to the Civil Aviation Authority?

In accordance with the Aircrew Regulation and Air Navigation Order, applicants must declare medical history to their AME at the time of the medical examination and at other times when they know or suspect they are unfit to exercise licence privileges. On occasion, third parties make reports on individuals to the CAA which are investigated.

6. On an average, per yearly basis, approximately what proportion of all flights that the Civil Aviation Authority is responsible for regulating within UK airspace are conducted by multi-person crews and what proportion are conducted by single pilot?

You can find our available aviation data, statistics, and report here: Data and analysis | Civil Aviation Authority (caa.co.uk). We do not hold data for the number of general aviation flights operated by single pilots.

If you have any questions about our data sets, please contact enquiries@caa.co.uk.

7. Does the Civil Aviation Authority hold data documenting on a yearly basis passenger and crew medical:

• incidents;

• accidents; and

• diversions of any aircraft inside UK airspace and/or on G-registered aircraft globally?

For access to this data, you would need to complete an SRG1605 application. Please note this data can only be released if you can demonstrate that the information will be used to help to maintain or improve aviation safety (see section five of SRG1605).

8. How many Class 1-3 medical certificate holders has the CAA authorised to engage in:

• any phase 1, 2 or 3 clinical trial for any Covid-19 drug, treatment, therapy, protocol or

vaccine; and/or

• any form of trial, protocol or evaluation of "mix-and-match" Covid-19 boosters use

e.g. Pfizer vaccination followed by another manufacturer’s vaccine?

The CAA does not authorise medical certificate applicants to participate or not participate in vaccine research.

I trust this is helpful.

Yours sincerely

Philip Clarke

BUSINESS MANAGER TO THE CHAIR & CHIEF EXECUTIVE

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Update: 10/06/22

CAA have kindly acknowledged receipt of the letter and advised it will reply in due course.

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Click to download the GAAC open letter to the UK CAA Board.

Full text follows below.

Note: faulty question numbering is a substack artefact.

Gaac Uk Caa Ne 220609

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For the attention of:

Sir Stephen Hillier, CAA Chair;

Mr. Richard Moriarty, Chief Executive Officer;

Mr. Paul Smith, Group Director of Consumers and Markets;

Mr. Chris Tingle, Chief Operating Officer;

Mr. Rob Bishton, Group Director of Safety and Airspace Regulation;

UK Civil Aviation Authority

Westferry Circus

Canary Wharf

London E14 4HD

June 9th, 2022

From: Global Aviation Advocacy Coalition gaacoalition@protonmail.com

Sent by email

Dear CAA Board Members,

Re: Covid-19 Vaccination and Class 1-3 Medical Certificate Holders

The Global Aviation Advocacy Coalition (GAAC) comprises international aviation professionals, medical and scientific expert groups from the UK, USA, Canada, Australia, France, Germany, Austria, Netherlands and Switzerland, as well as passengers. We unite in the the pursuit of safe flying across the globe and so we share and endorse the CAA's goal of ensuring “aviation meets the highest safety standards” from both consumer and professional perspectives.

As UK and international aircrew and citizens who fly within and through UK airspace and on UK carriers, we write to you to ask the following questions of the Civil Aviation Authority:

1. Please explain how the Civil Aviation Authority assesses Covid-19 vaccines' suitability for use by Class 1-3 medical certificate holders since their roll out.

2. Does the Civil Aviation Authority collect reports of Covid-19 vaccine effects, side-effects and severe adverse events (including suspected or proven resultant death) occurring in any Class 1-3 medical holder and if it does please explain how this data is collected?

3. Is the Civil Aviation Authority aware of any Covid-19 vaccine-induced adverse events in any UK Class 1-3 medical certificate holder? If so, how many such events is the Civil Aviation Authority aware of and how does the CAA categorise their severity?

4. Does the Civil Aviation Authority keep data relating to the numbers of Class 1-3 medical certificates that:

   • are held;

   • temporarily suspended;

   • permanently suspended;

in any given year?

If so, how many years of such data does the Civil Aviation Authority hold?

1. Holders of Class 1-3 medical certificates are expected to self-report medical issues to the Civil Aviation Authority, except where issues are actually detected during a Civil Aviation Authority medical examination. How and when does the Civil Aviation Authority, via its medical system, become aware of certificate holders' medical issues if they do not self-report those issues to the Civil Aviation Authority?

2. On an average, per yearly basis, approximately what proportion of all flights that the Civil Aviation Authority is responsible for regulating within UK airspace are conducted by multi-person crews and what proportion are conducted by single pilot?

3. Does the Civil Aviation Authority hold data documenting on a yearly basis passenger and crew medical:

   • incidents;

   • accidents; and

   • diversions of any aircraft inside UK airspace and/or on G-registered aircraft globally?

4. How many Class 1-3 medical certificate holders has the CAA authorised to engage in:

   • any phase 1, 2 or 3 clinical trial for any Covid-19 drug, treatment, therapy, protocol or vaccine; and/or

   • any form of trial, protocol or evaluation of "mix-and-match" Covid-19 boosters use e.g. Pfizer vaccination followed by another manufacturer’s vaccine?

We thank you for your anticipated efforts in providing your insight into the above questions and look forward to receiving your reply by email in due course.

Yours sincerely,

Gaac Uk Caa Ne 220609

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