Chief Medical Officer stance on Covid-19 vaccine: FOI release

Information requested

1- Has Dr. Gregor Smith Chief Medical Officer for Scotland ever claimed COVID-19 vaccines were safe and effective?

2- If so, what is meant by 'safe and effective' and from what date and data was this claim based on?

3- Is Dr. Gregor Smith Chief Medical Officer for Scotland confident full informed consent has been applied to COVID-19 vaccinations within Scotland since December 8th 2020?

4- Has the Chief Medical Officer for Scotland considered that COVID-19 vaccines maybe responsible for some ongoing excess deaths in Scotland?

5- Does Dr. Gregor Smith Chief Medical Officer for Scotland possess any peer reviewed non pharmaceutical industry funded scientific evidence to show COVID-19 vaccines have saved lives in Scotland?

Response

By way of background you may find it of interest to note the history of the Chief Medical Officer (CMO). The CMO role as it currently stands is a role created by virtue of the Scottish Administration (Offices) Order 1999 (made under section 126(8)(b) of the Scotland Act 1998 “the 1998 Act”). That order makes clear that the office of the CMO is a non-ministerial office in the Scottish Administration (in addition to holders of non-ministerial offices, members of the Scottish Government, junior Scottish Ministers and members of staff of the Scottish Administration fall within the scope of the umbrella term “the Scottish Administration”). Legally the office of the CMO is not a Scottish Government department but is a separate office which forms part of the Scottish Administration in its own right. The CMO is responsible for providing policy advice to Scottish Ministers on healthcare and public health. In addition, the CMO seeks to achieve the best health and care outcomes for people by working with ministers and stakeholders to protect and improve public health, and to oversee the effectiveness of healthcare services in Scotland.

Therefore, while Professor Sir Gregor Smith is based in the Scottish Government and is supported by Scottish Government civil servants, ‘The Chief Medical Officer of the Scottish Administration’ is designated (at Part 2 of Schedule 1 of FOISA) as a wholly separate public authority from the Scottish Government. ‘The Scottish Ministers’ are designated at Part 1 of Schedule 1.

It should also be noted that requests for information submitted under FOISA cannot be transferred from one authority to another, therefore we cannot ask the Scottish Government, on your behalf, to respond. You can find out more information about how to request information from the Scottish Government here: Request information - gov.scot (www.gov.scot).

1. Regulation for the licensing, safety and efficacy of medicines, medical devices and vaccines is currently reserved to the UK Government and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has authorised each of the COVID-19 vaccines having independently considered and evaluated the safety, quality and efficacy data of each COVID-19 vaccine in an independent, robust and scientific way. In accordance with the usual requirements to support the authorisation of any new vaccine, tens of thousands of subjects have been included in trials and all were subject to very close safety follow-up over several months. As with the development of any new vaccine or medicine, the size of clinical trials invariably means that very rare side effects can only be identified and/or fully characterised when the vaccines are used in large populations. In addition, certain groups who may benefit from, and be recommended to receive a vaccine, such as those with underlying chronic illnesses, may have been excluded from clinical trials. As a result, post-authorisation, ‘real world’ safety vigilance of new vaccines is a crucial part of the process. As well as authorising the use of new vaccines and medicines, the MHRA has statutory responsibility for undertaking post-authorisation safety monitoring in the UK. The MHRA also oversees the manufacturers’ legal responsibilities to undertake such vigilance. Although this focuses on the post-marketing safety of the vaccines, the ‘real world’ effectiveness and population impact of the vaccine(s) are also key to overall continuing benefit-risk balance and will include longevity of protection, any need for boosters and evaluation of other vaccine characteristics such as prevention of viral transmission. This aspect is supported by the Joint Committee on Vaccination and Immunisation (JCVI). The JCVI is a statutory advisory committee and advises UK health departments on immunisation. The JCVI considers data on the impact of a disease, data from clinical trials and modelled data, and then advises on the best way to deliver vaccines to the public. They also look for any gaps in the information presented where further research or surveillance may be required. The Chief Medical Officer for Scotland, like the Chief Medical Officers for England, Wales and Northern Ireland, has received and accepted advice from both the MHRA and the JCVI on the safety and effectiveness of COVID-19 vaccines. Based on the expertise and authority of both the MHRA and the JCVI, the Chief Medical Officer for Scotland has advised that COVID-19 vaccines are safe and effective.

2. The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised each of the COVID-19 vaccines having independently considered the safety, quality and efficacy of each COVID-19 vaccine. The data includes results from laboratory and clinical trials in humans, manufacturing and quality controls, product sampling and testing of the final product. Once the MHRA has thoroughly reviewed the data, they seek advice from the Government’s independent advisory body, the Commission on Human Medicines (CHM). The CHM critically assesses the data before advising the UK Government on the safety, quality and effectiveness of any potential vaccine. The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness. It also has responsibility in law to continuously evaluate all products on the UK market. Following each COVID-19 vaccine authorisation, the MHRA has a robust and proactive safety monitoring strategy which allows for near real-time safety monitoring at population level. Data on the safety and efficacy of vaccines is also regularly updated. This link provides a comprehensive summary of all the guidance and advice issued by the MHRA, including regulatory flexibilities, clinical trials, vaccine approvals and vaccine safety. The Joint Committee on Vaccination and Immunisation (JCVI) is a statutory advisory committee constituted of independent experts who advise the UK health departments in the four UK nations on immunisation and the prevention of infectious disease. They also consider vaccine safety, efficacy and look at the impact and cost effectiveness of immunisation strategies. Once a vaccine has been authorised by the MHRA, the JCVI considers data on the impact of a disease, data from clinical trials and modelled data, and then advise on the best way to deliver vaccines to the public. They also look for any gaps in the information presented where further research or surveillance may be required. Each time the JCVI announces a new phase of the COVID-19 vaccine programme, or introduces a new vaccine to the programme, they release up to date data on safety and efficacy through statements and through the Covid-19 Green Book Chapter 14a. The Green Book chapter contains a comprehensive summary of the effectiveness and safety of each of the COVID-19 vaccines.

• COVID-19 vaccination of children aged 6 months to 4 years: JCVI advice, 9 December 2022 (updated 26 April 2023) - GOV.UK (www.gov.uk)
• JCVI statement on spring 2023 COVID-19 vaccinations, 22 February 2023 - GOV.UK (www.gov.uk)

3. All individuals, including parents, guardians and representatives, are provided with appropriate programme information and a leaflet describing the side effects when they are sent their invitations to book a vaccine appointment, (most in hard copy and some as digital links for those individuals who preferred alternative reading options, such as text messages or email). Individuals are also given a vaccine Patient Information Leaflet (PIL) at the vaccination clinic and are able to ask further questions of vaccinators and clinicians at the clinics. The Chief Medical Office is aware of the consent steps that have been taken and that they underpin a model of informed consent provided by professionals within their regulatory framework.

4. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for continuously monitoring the safety of all COVID-19 vaccines once authorised for use. To inform its decision making, the MHRA seeks independent expert advice from the Commission on Human Medicines (CHM). In May 2020, the CHM established an Expert Working Group (EWG), consisting of experts in medicine, infectious disease, pharmacoepidemiology and data analytics to provide the MHRA with independent oversight and advice on its COVID-19 vaccine vigilance activities. Based on the EWG advice, the MHRA developed, and has in place, a four-stranded approach to vigilance. The four strands to the MHRA’s proactive vigilance strategy are: 1) enhanced passive surveillance (‘observed versus expected’ analysis) using a dedicated COVID-19 interface to the Yellow Card scheme focused on the capture of suspected side effect reports for COVID-19 products, which includes vaccines; 2) rapid cycle analysis and ecological analysis using anonymised electronic healthcare records that are routinely collected in clinical practice; 3) targeted active monitoring of certain groups of vaccinees, focused particularly on those who may have been excluded or under-represented in clinical trials and done via a new platform, called the Yellow Card Vaccine Monitor, which the MHRA has developed; and 4) the use of formal epidemiological studies. The first three methods are essentially ‘signal detection’ and ‘signal strengthening’ tools and their main purpose is to quickly flag up whether there might be a new, rare side effect and to build the volume of data on safety. However, they cannot confirm if it is a side effect. Similarly, whilst these methods can provide some strong evidence to indicate if something is likely to be coincidental, they cannot always confirm this. The fourth method uses epidemiological studies, designed and powered specifically to test a given hypothesis in an unbiased way to confirm and quantify a suspected rare side effect. These studies are undertaken on an ad hoc basis should the need arise based on other vigilance activities. The MHRA works in close collaboration with public health partners across the UK, including Public Heath Scotland (PHS) and the respective public health authorities in England, Wales and Northern Ireland, and a range of other stakeholders. The MHRA has also incorporated scientific collaboration with the National Institute for Health and care Research (NIHR) funded Health Protection Research Unit, within the London School of Hygiene and Tropical Medicine. This collaborative approach harnesses collective expertise across the UK public health sector and enables the best use of the data sources and methodologies available, to implement a robust vigilance strategy. In addition, given the scale of the COVID-19 immunisation programme, with many millions of doses of one or more new vaccines administered across the UK over a relatively short time period, vigilance needs to be continuous, proactive and as near real-time as is possible. The importance of this is two-fold. Firstly, to rapidly detect, confirm, characterise and quantify any new risks that were not detected in clinical trials, to weigh these against the expected benefits and take any necessary action to minimise risks to individuals. Secondly, it needs to be very quickly established if any serious events which are temporally related to vaccination are merely a coincidental association, and to do this in a robust, evidence-based way so that public confidence in a vaccine is not eroded unnecessarily. Indeed, such associations may be more likely whilst we are still during a national epidemic, and because most of the millions of people offered the vaccine in the early phase of a vaccination campaign will be elderly and/or have underlying medical conditions, which increases the likelihood of unrelated illnesses occurring soon after vaccination. More generally, the Yellow Card scheme underpins medicines and vaccines safety monitoring in the UK. Through this scheme, members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA. Drug companies also submit such reports as part of their legal requirements. Safety scientists at the MHRA continuously evaluate Yellow Card reports to generate “signals” of potential safety issues. The MHRA encourages anyone to report any suspicion or concern they have – reporters do not need to be sure of a link between a medicine or vaccine and a suspected side effect and are encouraged to report if in doubt. Every report is reviewed and the MHRA may get in contact with reporters to obtain further information. As with any system of safety vigilance, the ability to detect a new safety concern very rapidly during a mass immunisation campaign is dependent on the early presentation and diagnosis of symptoms. The key strength of the Yellow Card scheme is that it allows any member of the public or health professional across the UK to immediately alert the MHRA to any concerns they have without a formal diagnosis. And because anyone across the UK can report to the MHRA at any time, unlike studies which are limited in size, the scheme is able to identify the rarest of side effects. A specific coronavirus yellow Card reporting site was introduced at the start of the COVID-19 pandemic. Scientific and clinical assessment are used to determine if an individual or series of reports indicate a new safety ‘signal’. Whilst Yellow Cards in isolation are sufficient to allow signal detection, the MHRA enhances the system by analysing reports in the context of near real-time information on the number of doses of administered at the relevant time point, stratified by age and gender, and the background rate of the event of interest in the absence of vaccination. This allows continuous evaluation of the ‘observed’ number of reports of a suspected serious side effect compared to ‘expected’ numbers – i.e. based on the naturallyoccurring rate that would normally happen in each time period in the same sized cohort and in the absence of vaccination. Because every passive surveillance system suffers from variable under-reporting, the MHRA also conducts sensitivity analyses based on a range of under-reporting assumptions. In addition, everyone receiving a vaccine should be provided with an information leaflet, which includes a link to the Yellow Card reporting site, and which should help to reduce any under-reporting. The MHRA takes all reports with a fatal outcome in individuals who have received a COVID-19 vaccine very seriously and every report with a fatal outcome is reviewed carefully. All reports with a fatal outcome regardless of the time period between receiving the suspect vaccine and the reported death are reviewed. All available information is assessed to consider whether the vaccine may have caused the reported death. Cumulatively, the Yellow Card data is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the reported death alongside data available from international sources. This is further considered by the Commission on Human Medicines and its Expert Advisory Groups. 

The Chief Medical Officer receives regular summary updates on the Yellow Card reports on coronavirus vaccine: Coronavirus_Vaccine-Summary_of_Yellow_Card_reporting_autumnupdate_DLP20230222.pdf (publishing.service.gov.uk)

5. There are many sources of data available to the Chief Medical Officer on the scientific evidence to show COVID-19 vaccines have saved lives. One of the key studies which demonstrates that since the start of COVID-19 vaccination in Europe , the lives of many older adults have been saved through immunisation. This study can be found at Eurosurveillance | Estimated number of deaths directly averted in people 60 years and older as a result of COVID-19 vaccination in the WHO European Region, December 2020 to November 2021. Public health Scotland (PHS) contributed to this study which demonstrated an estimated 86% of deaths had been averted, which equates to more than 27,000 lives saved in Scotland.

About FOI

The Scottish Government is committed to publishing all information released in response to Freedom of Information requests. View all FOI responses at http://www.gov.scot/foi-responses.