Request

I am requesting information under the Freedom of Information Act 2000 of detailed information regarding the AstraZeneca (AZ) COVID-19 vaccine in relation to the Vaccine Damage Payment Scheme (VDPS). Specifically, I request the following information:

Adverse Effects Reported:

Question 1. Adverse Impacts on Physical and Mental Health and when these were first reported, i.e. how soon after receiving the vaccine were adverse effects apparent?

Comprehensive data on all reported adverse impacts of the AstraZeneca COVID-19 vaccine on both physical and mental health. Breakdown of the number of cases reported for each type of adverse impact.

Question 2. Claims Data:

Total number of claims submitted to the VDPS for adverse impacts related to the AstraZeneca COVID-19 vaccine.

Breakdown of claims by category (physical health and mental health). Age and gender demographics of claimants.

Number of claimants with a previous mental health history versus those with no prior mental health history.

Question 3. Successful Claims:

Number of successful claims in each category (physical health and mental health).

Detailed criteria used to assess and approve these claims.

Question 4. Demographic and Clinical Data:

Detailed demographic data of all claimants (age, gender, pre-existing health conditions, etc.).

Analysis or correlation observed between specific demographics (including previous mental health history) and the severity of adverse impacts.

Question 5. Assessment Criteria:

Specific criteria and guidelines used by the VDPS to assess claims related to the AstraZeneca COVID-19 vaccine.

Response

I can confirm that the NHSBSA holds some of the information you have requested.

Please be advised that we do not collect data about vaccine manufacturers as part of the claim form, as this is not a requirement of the scheme. An independent medical assessor reviews a claimant’s full medical records and prepares a medical assessment report which is then shared with the claimant along with the outcome of their claim. At this stage in the process, we do hold information about vaccine manufacturers. We are therefore only able to disclose data about vaccine manufacturers for claims where an independent medical assessment has been carried out and the outcome has been communicated to the claimant.

Question 1: Adverse Impacts on Physical and Mental Health

Q1(a): When these were first reported, i.e. how soon after receiving the vaccine were adverse effects apparent?

I cannot confirm or deny that the NHSBSA holds information meeting the description specified in your request as we estimate that the cost of compliance with the request would exceed the appropriate limit under section 12 of the FOIA.

We estimate that the cost of complying with your request would exceed the non-central Government limit of £450. The limit has been specified in The Freedom of Information and Data Protection (Appropriate Limit and Fees) Regulations 2004 https://www.legislation.gov.uk/uksi/2004/3244/contents/made and represents the estimated cost of one person spending 18 hours in determining whether the NHSBSA holds the information, and locating, retrieving, extracting and checking the information.

The reasonable estimate is as follows:

There are 7,591 COVID-19-related claims that have not reached an outcome and therefore we do not know which manufacturer these claims relate to yet.

As part of the process of the scheme, a medical assessment can only commence once we receive full medical records for each claimant, and it can take time for the claimant’s healthcare providers to gather and securely supply copies of these records.

In addition, the claimant can tell us what happened after vaccination on the claim form. At the medical assessment stage, the independent medical assessor provides a description of the assessed conditions they have been able to identify from the claimant's medical records. The condition recorded against each claim may therefore be different to the condition initially stated by the claimant on their original claim form.

We estimate it will take approximately:

• 15 minutes per claim form to check whether the claimant has told us which manufacturer their claim relates to on their claim form; and • one hour per claim for each person’s medical records to be reviewed by a clinician to categorise what happened after the vaccine and how soon any report was made to a person's healthcare provider.

3,198 assessed claims relate to AstraZeneca. It is estimated it will take approximately one hour per claim for each person’s medical records to be reviewed by a clinician to categorise what happened after the vaccine and how soon any report was made to a person's healthcare provider.

Total 12,686 hours of clinician time.

Please be advised that due to the way that the information is held by the NHSBSA, it is not possible to submit a refined request under the appropriate limit.

Please see the following link to view the section 12 in full - https://www.legislation.gov.uk/ukpga/2000/36/section/12

Q1(b): Comprehensive data on all reported adverse impacts of the AstraZeneca COVID-19 vaccine on both physical and mental health.

Q1(c): Breakdown of the number of cases reported for each type of adverse impact. The claimant can tell us what happened after vaccination on the claim form. At the medical assessment stage, the independent medical assessor provides a description of the assessed conditions they have been able to identify from the claimant's medical records. The condition recorded against each claim may therefore be different to the condition initially stated by the claimant on their original claim form.

As such, as we do not categorise conditions into physical health or mental health and therefore, compliance with this request is out of scope of the FOIA 2000. This is because it requires the creation of new information by a clinician to categorise the conditions appropriately.

Question 2: Claims Data

Q2(a): Total number of claims submitted to the VDPS for adverse impacts related to the AstraZeneca COVID-19 vaccine.

We do not collect data about vaccine manufacturers as part of the claim form, as this is not a requirement of the scheme. The independent medical assessor reviews a claimant’s full medical records and prepares a medical assessment report which is then shared with the claimant along with the outcome of their claim. At this stage in the process, we do hold information about vaccine manufacturers. We are therefore only able to disclose data about vaccine manufacturers for claims where an independent medical assessment has been carried out and the outcome has been communicated to the claimant.

3,198 assessed claims relate to AstraZeneca.

Q2(b): Breakdown of claims by category (physical health and mental health).

The claimant can tell us what happened after vaccination on the claim form. At the medical assessment stage, the independent medical assessor provides a description of the assessed conditions they have been able to identify from the claimant's medical records. The condition recorded against each claim may therefore be different to the condition initially stated by the claimant on their original claim form.

As such, we do not categorise conditions into physical health or mental health and therefore compliance with this request is out of scope of the FOIA 2000. This is because it requires the creation of new information by a clinician to categorise the conditions appropriately.

Q2(c): Age and gender demographics of claimants.

Gender: Please be advised that we do not record gender as part of the claim form and therefore, to comply with this request, it would require reviewing each claimant’s record and is exempt under section 12 of the FOIA 2000 for the reasons set out in Q1(a) above.

Age: We can confirm that we do hold the requested information, but this information is exempt under section 40(2) of the FOIA (personal information).

Section 40(2) is an absolute, prejudice-based exemption and therefore is exempt if disclosure would contravene any of the data protection principles. In order for disclosure to comply with the lawfulness, fairness, and transparency principle, we either need the consent of the data subject(s) or there must be a legitimate interest in disclosure. In addition, the disclosure must be necessary to meet the legitimate interest and finally, the disclosure must not cause unwarranted harm.

As we do not have the consent of the data subject(s), the NHSBSA is therefore required to conduct a balancing exercise between legitimate interest of the applicant in disclosure against the rights and freedoms of the data subject(s).

The NHSBSA acknowledges that you have a legitimate interest in disclosure of the information in order to provide the full picture of the requested data held by the NHSBSA; however, we have concluded that disclosure of the requested information would cause unwarranted harm and therefore, section 40(2) is engaged. This is because there is a reasonable expectation that patient data processed by the NHSBSA remains confidential.

Please see the following link to view the section 40 exemption in full - https://www.legislation.gov.uk/ukpga/2000/36/section/40

In addition, we also consider this information exempt under section 41 of the FOIA (information provided in confidence). This is because the requested information was provided to the NHSBSA in confidence.

In order for Section 41 to be engaged, the following criteria must be fulfilled:

• the authority must have obtained the information from another person, • its disclosure must constitute a breach of confidence, • a legal person must be able to bring an action for the breach of confidence to court, and • that court action must be likely to succeed.

The NHSBSA can confirm that the information has been obtained from a third party and that subsequent disclosure of that information would constitute a breach of confidence. In addition, disclosure could result in a legal person being able to bring action for the breach of confidence to a court and that court action.

We can, however, provide the following age bands:

Vaccinated person's age range at the time of claim registration Number of claimants

0 - 29 153 30 - 39 411 40 - 49 753 50 - 59 1003 60 - 65 418 66+ 460

Q2(d): Number of claimants with a previous mental health history versus those with no prior mental health history.

Please be advised that that claimants do not have to provide information about their mental health as part of their claim form and therefore a manual search of all medical records would be required to confirm if any pre-existing health conditions are recorded. This information is therefore exempt under section 12 of the FOIA 2000 and the same calculations apply as Q1(a).

Question 3: Successful Claims

Q3(a): Number of successful claims in each category (physical health and mental health).

Please be advised that we do not categorise assessed conditions into physical health or mental health. As such, compliance with this request is out of scope of the FOIA 2000 as it requires the creation of new information by a clinician to categorise the conditions appropriately.

Q3(b): Detailed criteria used to assess and approve these claims.

Each claim is looked at by an independent medical assessor. They decide if a Vaccine Damage Payment is due based on whether:
• the vaccine, on the balance of probabilities, caused the disability • the level of disability is severe

Severely disabled means at least 60%, as defined by the principles for assessing the extent of disablement, set out in section 103 of the Social Security Contributions and Benefits Act 1992 and the Social Security (General Benefit) Regulations 1982.   https://www.legislation.gov.uk/ukpga/1992/4/contents  
Information about the medical assessment process, including guidance the independent assessor uses, is available on our website at: www.nhsbsa.nhs.uk/vaccine-damage-payment-scheme-vdps-claim-process 

Question 4: Demographic and Clinical Data

Q4(a): Detailed demographic data of all claimants (age, gender, pre-existing health conditions, etc.).

For age and gender, please see the response to Q2(c) above.

For pre-existing health conditions, please be advised that claimants do not have to provide information about any pre-existing health conditions as part of their claim form. We would there have to manually search all medical records to confirm if any pre-existing health conditions are recorded and this information is therefore exempt under section 12 and the same calculations apply as Q1(a).

Q4(b): Analysis or correlation observed between specific demographics (including previous mental health history) and the severity of adverse impacts.

I am writing to advise you that following a search of our paper and electronic records, I have established that the information you requested is not held by the NHS Business Services Authority. In any event, compliance with this request would require creating new information and is therefore, out of the scope of the FOIA 2000.

Question 5: Assessment Criteria

Q5(a): Specific criteria and guidelines used by the VDPS to assess claims related to the AstraZeneca COVID-19 vaccine.

Each claim is looked at by an independent medical assessor. They decide if a Vaccine Damage Payment is due based on whether:
• the vaccine, on the balance of probabilities, caused the disability • the level of disability is severe

Severely disabled means at least 60%, as defined by the principles for assessing the extent of disablement, set out in section 103 of the Social Security Contributions and Benefits Act 1992 and the Social Security (General Benefit) Regulations 1982.   https://www.legislation.gov.uk/ukpga/1992/4/contents https://www.legislation.gov.uk/uksi/1982/1408/made  
Information about the medical assessment process, including guidance the independent assessor uses, is available on our website at: www.nhsbsa.nhs.uk/vaccine-damage-payment-scheme-vdps-claim-process 

Reusing the data and copyright

If you plan on producing a press or broadcast story based upon the data please contact communicationsteam@nhsbsa.nhs.uk. This is important to ensure that the figures are not misunderstood or misrepresented.

The information supplied to you continues to be protected by the Copyright, Designs and Patents Act 1988 and is subject to NHSBSA copyright.

Should you wish to re-use the information you must include the following statement: “NHSBSA Copyright 2022” This information is licenced under the terms of the Open Government Licence:

http://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/

Failure to do so is a breach of the terms of the licence.

Information you receive which is not subject to NHSBSA Copyright continues to be protected by the copyright of the person, or organisation, from which the information originated. Please obtain their permission before reproducing any third party (non NHSBSA Copyright) information.