Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the covid-19 vaccine candidates for which the Government has provided funding, what the efficacy criteria are for each of those vaccine candidate trials; to what extent each of those efficacy criteria are required to be met in order that those vaccine candidate trials can be deemed by the Government to have achieved satisfactory outcomes; and by (a) what methods and (b) what number of people (i) in which locations and (ii) over what time periods those assessments on whether those safety criteria have been met are being made.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
There is broad agreement between international regulators on both the safety and the efficacy criteria that would be required for approval and authorisation of a COVID-19 vaccine. These criteria will apply to all COVID-19 vaccine candidates, irrespective of whether they receive funding from the United Kingdom Government.
The Medicines and Healthcare products Regulatory Agency (MHRA) will perform the assessment of the quality, safety and efficacy data submitted by developers of COVID-19 vaccines and will seek the advice of its independent expert advisors on the Commission on Human Medicines.
No approval will be given for any COVID-19 vaccine without robust evidence of efficacy and safety. The MHRA has teams of assessors available to review the submissions.
To expedite the review of COVID-19 vaccine applications, developers of COVID-19 vaccines can submit their Marketing Authorisation Applications in the form of a rolling submissions and do not need to wait to have a complete data package before submission.
The time taken for MHRA’s review will depend on what data will be submitted and when.
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the covid-19 vaccine candidates for which the Government has provided funding, what the safety criteria are for each of those vaccine candidate trials; to what extent each of those safety criteria are required to be met in order that those vaccine candidate trials can be deemed by the Government to have achieved satisfactory outcomes; and by (a) what methods and (b) what number of people (i) in which locations and (ii) over what time periods those assessments on whether those safety criteria have been met are being made.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
There is broad agreement between international regulators on both the safety and the efficacy criteria that would be required for approval and authorisation of a COVID-19 vaccine. These criteria will apply to all COVID-19 vaccine candidates, irrespective of whether they receive funding from the United Kingdom Government.
The Medicines and Healthcare products Regulatory Agency (MHRA) will perform the assessment of the quality, safety and efficacy data submitted by developers of COVID-19 vaccines and will seek the advice of its independent expert advisors on the Commission on Human Medicines.
No approval will be given for any COVID-19 vaccine without robust evidence of efficacy and safety. The MHRA has teams of assessors available to review the submissions.
To expedite the review of COVID-19 vaccine applications, developers of COVID-19 vaccines can submit their Marketing Authorisation Applications in the form of a rolling submissions and do not need to wait to have a complete data package before submission.
The time taken for MHRA’s review will depend on what data will be submitted and when.
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what estimate he has made of the proportion of positive covid-19 tests recorded in respect of patients tested 7-10 days after initial infection and who are no longer likely to be infectious.
Answered by Helen Whately - Minister of State (Department of Health and Social Care)
Current United Kingdom guidance is that testing should be undertaken for people who have a new onset of symptoms, and official advice is to get a test as soon as possible after the onset of symptoms. Data related to the time that a swab test is undertaken relative to the time of infection or the time of symptom onset is not routinely collected. Further information on testing is available at the following link:
https://www.gov.uk/guidance/coronavirus-covid-19-getting-tested
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the extent to which (a) polymerase chain reaction testing for covid-19 may identify non-infectious remnant RNA of the covid-19 virus as a positive test result and (b) positive tests for covid-19 reported in England would not indicate contagious cases of covid-19.
Answered by Helen Whately - Minister of State (Department of Health and Social Care)
The polymerase chain reaction (PCR) test is designed to detect viral RNA. Therefore, there will be cases where the PCR test is detecting remnants of viral RNA in the absence of infectious virus.
Public Health England (PHE) has not assessed the extent to which the PCR will pick up viral remnants rather than infectious virus.
An assessment of which positive cases do not reflect contagious virus would depend on individual case by case review. PHE has not performed such a review and therefore does not hold this data.
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential merits of using frequent rapid antigen tests to help slow the transmission of covid-19.
Answered by Helen Whately - Minister of State (Department of Health and Social Care)
We believe there are many potential merits of using frequent rapid antigen tests to help slow the transmission of COVID-19. The use of multiple new testing technologies could significantly improve our detection of positive cases, so that people can isolate themselves and prevent the spread of the disease. As part of the first deployment of whole city testing, residents and workers in Liverpool will for example be tested using a combination of existing swab tests, as well as new lateral flow tests which can rapidly turn around results within an hour without the need to be processed in a lab, as well as LAMP technology due to be deployed in Liverpool University Hospitals NHS Foundation Trust for National Health Service staff.
We have also started a number of pilots across schools, universities and workplaces to assess the use of rapid lateral flow antigen tests. This is in addition to ongoing pilots in Liverpool, Southampton and Salford using the LAMP no-swab saliva test and LAMP asymptomatic testing for NHS staff.
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment the Government has made of the potential effect of the (a) development and (b) authorisation of a covid-19 vaccine that doesn't prevent (i) transmission and (ii) fatalities on public confidence in (A) the Government response to covid-19, (B) public health programmes and (C) economic growth.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
A COVID-19 vaccine will only be deployed once it has been proven to be safe and effective through robust clinical trials and approved for use by the appropriate licensing authority. There are numerous potential vaccine candidates in development, which the United Kingdom will have access to. Once a vaccine is ready, it will be deployed to those most at risk, and then rolled out more widely. Regular testing of virus samples will be undertaken to assess any changes in the virus that may impact on vaccine effectiveness. Safe and effective vaccines rolled out to the population will form part of our overall recovery effort from the impact of this global pandemic.
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the covid-19 vaccine candidates for which the Government has provided funding, how much funding from the public purse has been allocated to the process of preparing each of those potential vaccines for (a) marketing, (b) manufacturing, (c) distribution and (d) administration.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
In terms of the six supply agreements that have and are being negotiated, these cannot be provided at this time due to commercial sensitivity. We are currently also unable to provide information on funding allocated to each potential vaccine for marketing, manufacturing, distribution and administration, as they have not yet been finalised.
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the (a) sensitivity and (b) specificity of the different methods and products used in testing for covid-19 infection; and by what methodologies each of those assessments were so made.
Answered by Helen Whately - Minister of State (Department of Health and Social Care)
On-going assessment of quality, sensitivity and specificity are monitored using quality control materials. Public Health England and the National Health Service have a national quality assurance network and issues with assay performance are managed through an alert system which may result in informing appropriate authorities such as the Medicines and Healthcare products Regulatory Agency.
When independently introducing new tests into service, laboratories assess the performance of assays including sensitivity and specificity according to the manufacturers stated performance in the Instructions for Use. The standard methodology is available at the following link:
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the operational false positive test rates are of PCR testing for covid-19 identified in quality assurance processes; and how such (a) quality assurance processes and (b) results have changed over time.
Answered by Helen Whately - Minister of State (Department of Health and Social Care)
In June 2020 the Scientific Advisory Group for Emergencies published a briefing paper on the impact of false positives and false negatives in the United Kingdom’s COVID-19 reverse transcription polymerase chain reaction testing programme, which is available at the following link:
https://www.gov.uk/government/publications/gos-impact-of-false-positives-and-negatives-3-june-2020
The briefing paper states that the UK operational false positive rate is unknown.
Asked by: Marcus Fysh (Conservative - Yeovil)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what proportion of patients reported as being covid-19 patients in intensive care have (a) had a positive covid-19 test result, (b) respiratory symptoms and (c) both, by (i) hospital trust and (ii) English region.
Answered by Edward Argar - Minister of State (Ministry of Justice)
Based on data from 15 March 2020 to week ending 1 November 2020 submitted to Public Health England’s Severe Acute Respiratory Infection-Watch, 30% of new admissions for acute respiratory infection (ARI) to any ward, including intensive care units, (ICU) and high dependency units (HDU), in hospitals in England had a laboratory confirmed COVID-19 test.
Over the same time period, 42% of new admissions to ICU/HDU for ARI had a laboratory confirmed COVID-19 test.
Further information on ICU/HDU admission rates by region and by trust in the weekly surveillance reports is available at the following link:
https://www.gov.uk/government/statistics/national-flu-and-covid-19-surveillance-reports