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To ask the Secretary of State for Health and Social Care, for what reason the Government's contract with Pfizer specified that any contractual dispute would be determined by three private arbitrators rather than a court.
To ask the Secretary of State for Health and Social Care, for what reason the Government's contract with Pfizer specified that any contractual dispute would be determined by three private arbitrators rather than a court.
It is standard practice for contractual disputes to be settled under the International Chamber of Commerce’s Rules of Arbitration.
To ask the Secretary of State for Health and Social Care, for what reason his Department paid a higher price for the Pfizer-BioNTech covid-19 vaccine for the booster campaign in winter 2021 than in 2020.
To ask the Secretary of State for Health and Social Care, for what reason his Department paid a higher price for the Pfizer-BioNTech covid-19 vaccine for the booster campaign in winter 2021 than in 2020.
We are unable to provide the information requested as it is commercially sensitive.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 16 November 2022 to Question 83513 on Coronavirus: Vaccination, for what reasons covid-19 vaccines which have a conditional marketing authorisation such as (a) Spikevax, Moderna, (b) Spikevax bivalent, Moderna, (c) Comirnaty bivalent, Pfizer-BioNTech and...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 16 November 2022 to Question 83513 on Coronavirus: Vaccination, for what reasons covid-19 vaccines which have a conditional marketing authorisation such as (a) Spikevax, Moderna, (b) Spikevax bivalent, Moderna, (c) Comirnaty bivalent, Pfizer-BioNTech and...
The granting of a full Marketing Authorisation for one product does not affect the Conditional Marketing Authorisations (CMA) of others. CMAs are used for products which prevent or treat serious and life-threatening diseases where no satisfactory treatment methods are available or where the product offers a significant therapeutic advantage. The Medicines and Healthcare products Regulatory Agency may grant a CMA where comprehensive clinical data is not yet complete although it is judged that such data will become available shortly.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 November 2022 to Question 88800 on Coronavirus: Vaccination, for what reason the marketing authorisation holder did not submit the six month safety follow-up data in subjects aged between five and 11 years old...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 November 2022 to Question 88800 on Coronavirus: Vaccination, for what reason the marketing authorisation holder did not submit the six month safety follow-up data in subjects aged between five and 11 years old...
Prior to the planned submission date, Pfizer-BioNTech advised the Medicines and Healthcare products Regulatory Agency (MHRA) that there had been delays in obtaining the data for the report and requested an extension. The MHRA assessed any potential risk to public health and considered the significant post-marketing safety data already available from the use of the Comirnaty vaccine in children, which did not indicate any new safety concerns in this age group. An extension was agreed and the MHRA continues to monitor the safety of Comirnaty in children and adults through its surveillance strategy and will act promptly to protect public health, should any new safety concerns arise.
To ask His Majesty's Government what cost is being charged by Pfizer for the Comirnaty Original/Omicron BA.1 medicine.
To ask His Majesty's Government what cost is being charged by Pfizer for the Comirnaty Original/Omicron BA.1 medicine.
We are unable to provide the information requested as it is commercially sensitive. However, the Government has ensured that the supply agreements for COVID-19 vaccines provide access to updated vaccines, such as the bivalent mRNA vaccines deployed during the current booster vaccination campaign.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 77274 on Coronavirus: Vaccination, if he has made an assessment of the potential impact of full marketing authorisation being granted to the Comirnaty covid-19 vaccine on Comirnaty's (a) indemnity...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 77274 on Coronavirus: Vaccination, if he has made an assessment of the potential impact of full marketing authorisation being granted to the Comirnaty covid-19 vaccine on Comirnaty's (a) indemnity...
Indemnities do not affect the routes available to an individual to pursue a legal claim against the manufacturer. It establishes that in certain circumstances, one party to the agreement will pay the other party’s losses arising from a claim.
Regulation 345 of the Human Medicines Regulations 2012 provides partial immunity from civil liability for suppliers when there is a temporary authorisation in place to supply a product under regulation 174. Supply of the vaccine was authorised under regulation 174 as a temporary measure before the Medicines and Healthcare products Regulatory Agency granted the conditional marketing authorisation. This partial immunity would only have applied in relation to the product supplied under the regulation 174 authorisation. It would not have applied in relation to the product that was authorised by the Conditional Marketing Authorisation. And the grant of a full Marketing Authorisation would not affect any partial immunity under the Regulations.
There are still conditions to be met for the bivalent Comirnaty products, where currently the target resolution dates are before the end of 2023. There are also post-approval measures relating to drug safety monitoring through the pharmacovigilance process, as for all licensed products on the market.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 16 November 2022 to Question 83513, which post-authorisation conditions relating to the conditional marketing authorisations of the Comirnaty products specified have been met; and if he will place in the Library a copy of...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 16 November 2022 to Question 83513, which post-authorisation conditions relating to the conditional marketing authorisations of the Comirnaty products specified have been met; and if he will place in the Library a copy of...
The Commission on Human Medicines considered that, based on the large body of clinical data now available on these vaccines from clinical trials and real-world experience, the safety profile and efficacy of the products are now considered comprehensively characterised and meet the requirements for conversion to a full Marketing Authorisation and that the remaining conditions could therefore be downgraded to Risk Management Plan or Post-Authorisation Measures. On 9 November, the Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection line extension application was also licensed and has a full Marketing Authorisation.
The following table shows the cumulative conditions during the Conditional Marketing Authorisations.
Description | Due date |
1. In order to complete the characterisation of the active substance and finished product, the Marketing Authorisation Holder (MAH) should provide additional data. | July 2021 Interim reports: 31 March 2021 |
2. In order to ensure consistent product quality, the MAH should provide additional information to enhance the control strategy, including the active substance and finished product specifications. | July 2021. Interim reports: March 2021 |
3. In order to confirm the consistency of the finished product manufacturing process, the MAH should provide additional validation data. | March 2021 |
4. In order to confirm the purity profile and ensure comprehensive quality control and batch-to-batch consistency throughout the lifecycle of the finished product, the MAH should provide additional information about the synthetic process and control strategy for the excipient ALC-0315. | July 2021 Interim reports: January 2021, April 2021 |
5. In order to confirm the purity profile and ensure comprehensive quality control and batch-to-batch consistency throughout the lifecycle of the finished product, the MAH should provide additional information about the synthetic process and control strategy for the excipient ALC-0159. | July 2021 Interim reports: January 2021, April 2021 |
6. In order to confirm the efficacy and safety of Comirnaty, the MAH should submit the final Clinical Study Report for the randomized, placebo-controlled, observer-blind study C4591001. | December 2023 |
7. In order to confirm the safety of Comirnaty in individuals aged 12 to 15 years of age, the MAH should submit six-month safety follow-up data in subjects aged 12 to 15 years from study C4591001. | October 2021 |
8. In order to confirm the efficacy and safety of Comirnaty, the MAH should submit the final Clinical Study Report for the randomized, placebo-controlled, observer-blind study C4591007. | July 2024 |
9. In order to confirm the safety of Comirnaty in individuals aged 5-11 years of age, the MAH should submit 6-month safety follow-up data in subjects aged 5-11 years from study C4591007. | July 2022 |
By the conversion of the Conditional Marketing Authorisations to full Marketing Authorisations, these conditions were all met with the exception of ‘6’ and ‘8’, which were converted to Risk Management Plan measures. Condition ‘9’ was converted to a Post-Authorisation Measure with an extension until 31 December 2022 to submit the data.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 77274 on Coronavirus: Vaccination, if he will make an assessment of the compatibility of the conditional marketing authorisation (CMA) for the Comirnaty vaccine with the requirement that such authorisations...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 77274 on Coronavirus: Vaccination, if he will make an assessment of the compatibility of the conditional marketing authorisation (CMA) for the Comirnaty vaccine with the requirement that such authorisations...
The post-authorisation conditions relating to any Conditional Marketing Authorisations (CMA) are only removed from the licence once these conditions have been met and a full Marketing Authorisation (MA) could then be considered. Where clinical studies are continuing, companies will update to the regulatory authorities through post-authorisation measures.
As there are no further specific obligations, the status changed from CMA to MA for the following Comirnaty products on 9 November 2022:
- Comirnaty 30 micrograms/dose Concentrate for Dispersion for Injection (PLGB 53632/0002);
- Comirnaty 30 micrograms/dose Dispersion for Injection (PLGB 53632/0004); and
- Comirnaty 10 micrograms/dose Concentrate for Dispersion for Injection (PLGB 53632/0006).
To ask the Secretary of State for Health and Social Care, when the NHS was made aware of the findings disclosed in July 2021 by the US Food and Drugs Administration of a potential increase in four types of serious adverse events in elderly people who had had the Pfizer...
To ask the Secretary of State for Health and Social Care, when the NHS was made aware of the findings disclosed in July 2021 by the US Food and Drugs Administration of a potential increase in four types of serious adverse events in elderly people who had had the Pfizer...
Following its initial findings in June 2021, the FDA issued a subsequent statement confirming that after detailed analysis, these events were not found to occur more frequently in the elderly people who received the Pfizer COVID-19 vaccine.
To ask the Secretary of State for Health and Social Care, whether there is a deadline by which the Medicines and Healthcare products Regulatory Agency is required to convert the Conditional Marketing Authorisation for the Pfizer Covid-19 vaccine for use in adults into a Full Marketing Authorisation; and whether there...
To ask the Secretary of State for Health and Social Care, whether there is a deadline by which the Medicines and Healthcare products Regulatory Agency is required to convert the Conditional Marketing Authorisation for the Pfizer Covid-19 vaccine for use in adults into a Full Marketing Authorisation; and whether there...
In general, the Conditional Marketing Authorisation (CMA) is valid for one year, where the Medicines and Healthcare products Regulatory Agency will evaluate whether the company has addressed the post-authorisation measures and CMA commitments. If this has been sufficiently addressed, the CMA can be converted to a full Marketing Authorisation (MA).
Where commitments need to be addressed, the CMA may be extended for further year before the conversion to a full MA can take place. It is not expected that there will be any major implications for patients from a change in the status of the Comirnaty vaccine’s authorisation.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 12 August 2022 to Question 40021 on Coronavirus: Vaccination for children, if she will take steps to remove Pfizer covid-19 vaccination is removed from the NHS.UK schedule.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 12 August 2022 to Question 40021 on Coronavirus: Vaccination for children, if she will take steps to remove Pfizer covid-19 vaccination is removed from the NHS.UK schedule.
The NHS.UK vaccination schedule sets out which vaccinations individuals are eligible to receive through the National Health Service, including COVID-19. However, the schedule does not specify which specific COVID-19 vaccine will be used. The Government continues to be guided by the expert independent Joint Committee on Vaccination and Immunisation on the deployment of COVID-19 vaccines.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 21 June 2022 to Question 17162 on Coronavirus: Vaccination for children, for what reason the covid-19 vaccination for five- to 11-year-olds was included in the NHS.UK vaccination schedule information for the purposes of raising...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 21 June 2022 to Question 17162 on Coronavirus: Vaccination for children, for what reason the covid-19 vaccination for five- to 11-year-olds was included in the NHS.UK vaccination schedule information for the purposes of raising...
While the Joint Committee on Vaccination and Immunisation’s one-off advice for a non-urgent offer of the Pfizer vaccine in this age group was publicised on NHS.UK to raise awareness, it does not reflect a change in policy.
COVID-19 vaccination is not included in the UK Health Security Agency’s routine childhood immunisation schedule, which provides immunisation information for health professionals and immunisation practitioners.
To ask Her Majesty's Government how many doses of the (1) Pfizer, and (2) Moderna, vaccines they have purchased for children under the age of five; and when such vaccines will be made available to those children.
To ask Her Majesty's Government how many doses of the (1) Pfizer, and (2) Moderna, vaccines they have purchased for children under the age of five; and when such vaccines will be made available to those children.
There are no Covid-19 vaccines for under 5s currently approved for use in the UK, and as such we have not specifically procured vaccines for this cohort. The Government will continue monitoring developments and seek the advice of the Joint Committee on Vaccination and Immunisation going forward.
To ask the Secretary of State for Business, Energy and Industrial Strategy, how many doses of (a) Pfizer and (b) Moderna Coronavirus Vaccines have been procured for under 5 year olds as of 15 June 2022.
To ask the Secretary of State for Business, Energy and Industrial Strategy, how many doses of (a) Pfizer and (b) Moderna Coronavirus Vaccines have been procured for under 5 year olds as of 15 June 2022.
There are no Covid-19 vaccines for under 5s currently approved for use in the UK, and as such we have not specifically procured vaccines for this cohort. The Government will continue monitoring developments and follow the advice of the Joint Committee on Vaccination and Immunisation going forward.
My Rt Hon Friend the Secretary of State for Health and Social Care (Sajid Javid) has made the following written statement:
The ability of bacteria - and other types of pathogen - to develop and propagate resistance to the available therapeutic drugs and medicines, such as antibiotics, used to treat them...
My Rt Hon Friend the Secretary of State for Health and Social Care (Sajid Javid) has made the following written statement:
The ability of bacteria - and other types of pathogen - to develop and propagate resistance to the available therapeutic drugs and medicines, such as antibiotics, used to treat them...
The ability of bacteria - and other types of pathogen - to develop and propagate resistance to the available therapeutic drugs and medicines, such as antibiotics, used to treat them is a significant and growing threat. Alongside extensive efforts to tackle this threat, as set out in the Government’s five-year...
The ability of bacteria - and other types of pathogen - to develop and propagate resistance to the available therapeutic drugs and medicines, such as antibiotics, used to treat them is a significant and growing threat. Alongside extensive efforts to tackle this threat, as set out in the Government’s five-year...
To ask the Secretary of State for Business, Energy and Industrial Strategy, whether the terms of the indemnity against product liability given to Pfizer for the manufacture and supply of covid-19 vaccines are conditional upon the provision of accurate information on the results of trials of that vaccine undertaken prior...
To ask the Secretary of State for Business, Energy and Industrial Strategy, whether the terms of the indemnity against product liability given to Pfizer for the manufacture and supply of covid-19 vaccines are conditional upon the provision of accurate information on the results of trials of that vaccine undertaken prior...
We are not able to disclose the details of some clauses of contracts between the Government and vaccine manufacturers as this information is commercially sensitive.
To ask the Secretary of State for Business, Energy and Industrial Strategy, how much his Department has paid on average for each vaccine dose purchased from (a) AstraZeneca, (b) Moderna and (c) Pfizer BioNTech.
To ask the Secretary of State for Business, Energy and Industrial Strategy, how much his Department has paid on average for each vaccine dose purchased from (a) AstraZeneca, (b) Moderna and (c) Pfizer BioNTech.
We are not able to disclose specific costs of individual vaccines procured to date, as details of contracts between the Government and vaccine manufacturers are commercially sensitive.
To ask the Secretary of State for Health and Social Care, what recent discussions he has had with relevant stakeholders on the availability of the Pfizer pill for covid-19 on the NHS.
To ask the Secretary of State for Health and Social Care, what recent discussions he has had with relevant stakeholders on the availability of the Pfizer pill for covid-19 on the NHS.
An updated interim clinical commissioning policy on the use of neutralising monoclonal antibody treatments and antivirals for non-hospitalised patients with COVID-19 was agreed by the United Kingdom Chief Medical Officers on 27 January 2022. This set out the intention to add PF-07321332+ritonavir (co-packaged as Paxlovid), manufactured by Pfizer, and remdesivir to the currently available treatment options for highest risk patients with COVID-19 from 10 February 2022.
NHS England has held webinars with stakeholders such as patient organisations, Royal Colleges, professional bodies and clinicians to support the introduction of the interim commissioning policy, with further engagement events and communications planned. Any decisions on deployment of community treatments, including Paxlovid, beyond the highest risk groups will be subject to the outcomes of the PANORAMIC study.