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To ask the Secretary of State for Health and Social Care, whether any of the vials of (a) Pfizer and (b) Moderna covid-19 vaccines supplied to patients in the United Kingdom contained (i) variable and (ii) excessive levels of residual plasmid DNA.
To ask the Secretary of State for Health and Social Care, whether any of the vials of (a) Pfizer and (b) Moderna covid-19 vaccines supplied to patients in the United Kingdom contained (i) variable and (ii) excessive levels of residual plasmid DNA.
All batches of the Pfizer and Moderna COVID-19 vaccines released in the United Kingdom to date have passed their release specifications for DNA levels. The specifications are set in line with their respective controlled manufacturing process and in accordance with, for example, World Health Organization guidance on the quality, safety, and efficacy of vaccines. No batches that have excessive levels of residual DNA have been released.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 November to Question 88800 on Coronavirus: Vaccination, if he will place in the Library a copy of the clinical data that has been submitted in relation to condition 7 in the table.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 November to Question 88800 on Coronavirus: Vaccination, if he will place in the Library a copy of the clinical data that has been submitted in relation to condition 7 in the table.
A copy of the table and documents that gives the clinical data which was submitted in relation to condition 7 will be deposited in the Libraries of both Houses.
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 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 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 Health and Social Care, when he first received information on the study by Public Health England that found that AstraZenica and Pfizer covid-19 vaccines are more effective in preventing hospitalisation from the delta variant than from other covid-19 variants; and what steps he...
To ask the Secretary of State for Health and Social Care, when he first received information on the study by Public Health England that found that AstraZenica and Pfizer covid-19 vaccines are more effective in preventing hospitalisation from the delta variant than from other covid-19 variants; and what steps he...
We received Public Health England’s full report on 12 June. The report was shared with all with all relevant Government departments and discussed with senior advisors.
Further work is underway to establish the level of protection COVID-19 vaccines provide against mortality from the Delta variant.