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420261000

Refrigerated Storage

MenveoGSK

GSK
Menveo
Powder and solution for injection

In the event of an inadvertent temperature excursion the following data may be used:

The vaccine components are stable at temperatures up to 25°C for a cumulative time of 120 hours.

Temperature excursions from 0°C to 2°C do not impact the quality of the product.

The product can be returned to the fridge and no change in expiry dates is required if exposed to the above conditions.

Contact GSK in cases where additional stability data is required. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

Public Health England has guidance on responding to errors in vaccine storage, handling and administration.

20 December 2021
London MI Service

NimenrixPfizer

Pfizer
Nimenrix
Powder and solvent for solution for injection in pre-filled syringe and vial

In the event of an inadvertent temperature excursion the following data may be used:

In-house stability data shows the product is stable when stored in the following conditions:

  • 25ºC ± 2ºC for 193 days
  • 2-8°C for 11 months followed by 1 month storage at 37°C, followed by 24 months storage at 2-8°C
  • 40ºC ± 2ºC for 1 month
  • Three cycles of 5 days at 25ºC ± 2ºC and 2 days at 5ºC ± 3ºC, followed by long-term storage at 5ºC ± 3ºC for 36 months
  • 1 month at 25ºC ± 2ºC followed by long-term storage at 5ºC ± 3ºC for 36 months.

Public Health England has guidance on responding to errors in vaccine storage, handling and administration.

25 February 2022
London MI Service

New Medicines

MenQuadfiMeningitis ACYW prevention in toddlers and above

Information

MenQuadfi
Vaccine
Sanofi
Sanofi

Development and Regulatory status

Launched
Licensed but not launched
Licensed but not launched
September 2021
Sep 21Available in the UK, Price 1x1 solution for injection vial = £31.50 [10,11].
Nov 20Company plans to make MenQuadfi available in several European countries from 2021 to help protect individuals 12 months of age and older. Phase 3 studies are ongoing to investigate the vaccine in infants from 6 weeks of age [9].
Nov 20The EC has approved MenQuadfi [8].
Sep 20Recommended for EU approval by CHMP - the full indication is "for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. The use of this vaccine should be in accordance with official recommendations" [7].
Apr 20Approved in US [6].
Oct 19Filed in EU via centralised procedure [5].
Jul 19Is now pre-registration in the US for use in children aged 2 years and over; EU filings for use in children aged 12 months and older remain planned for 2019 [4].
Feb 19EU submission expected 2019 [1].

Category

A quadrivalent meningococcal polysaccharide vaccine, conjugated to tetanus toxoid
UK cases of meningococcal meningitis occur mostly in younger people, and fatality rates have fallen in recent years due to the introduction of vaccination programmes covering infants and older children; annual incidence of invasive disease reported in 2012 was 2 per 100,000 [3].
Meningitis ACYW prevention in toddlers and above
Intramuscular

Trial or other data

Mar 19PIII trials show efficacy alone, and a series of further PIII trials is in progress to confirm efficacy when given concurrently with other paediatric vaccines (NCT03547271, NCT03691610, NCT03673462, NCT03537508) [2].