Written questions by Chope.

If he will take steps to provide (a) healthcare and (b) financial support to people whose applications to the Vaccine Damage Payments Scheme were rejected on the basis that they do not have a severe disablement that exceeds the 60% threshold.

We expect that individuals whose claims to the Vaccine Damage Payment Scheme (VDPS) have been rejected on the basis that they do not meet the 60% disability threshold would receive the same level of treatment and care from the National Health Service as those with any other long-term condition requiring support.The VDPS is not a compensation scheme. It does not prejudice the right of the disabled person to pursue a claim for damages through the courts. Other Government support remains open to claimants with a disability or long-term health condition, including Statutory Sick Pay, Universal Credit, Employment and Support Allowance, Attendance Allowance, and Personal Independence Payments.

What modifications have been made to existing Covid-19 vaccine products; for what reasons were those modifications made; and when those modifications were approved by the Medicines and Healthcare Products Regulatory Agency.

The Medicines and Health products Regulatory Agency may authorise a line extension, which is a new product authorisation linked to the original marketing authorisation. Various versions of the COVID-19 vaccines have been approved as line extensions to the original vaccines since the first COVID-19 vaccines were approved in December 2020. Variations may be requested to add an indication, dosage form, strength or pack size, which will make the vaccine available for a wider patient pool, whilst maintaining effectiveness and an acceptable safety level. For example, Pfizer, in late 2021, made an application to extend the indication of their vaccines to children between five and 11 years old in a smaller 10 micrograms per dose, and later, via the European Commission Decision Reliance Procedure, a new three micrograms per dose in infants and children between aged six months and four years old. New versions of the vaccine have also been introduced to adapt the vaccines to the new strains of the virus.

For what reason the MHRA uses observed analyses instead of expected analyses in assessing the safety of Covid-19 vaccines.

The Medicine and Healthcare products Regulatory Agency uses both observed and expected analysis in their assessment of safety signals for COVID-19 vaccines. Data obtained from the spontaneous Yellow Card reporting system, through which patients, public and healthcare professionals can report any incident associated with a medical product, was used to calculate ‘Observed’ figures. Estimated ‘Expected’ figures for pre-determined events were based on the total number of patients who had received the vaccine and the background rate of the event within a pre-pandemic period, using large electronic healthcare record databases. It should be recognised that the purpose of observed versus expected analyses is not to confirm the presence, absence, or magnitude of risks but to provide an alternative approach to rapid signal detection, in addition to disproportionality approaches, to maximise the value of spontaneous reports.