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Safety in Lactation: Vaccines and antisera

21 September 2020Although vaccines and toxoids (diphtheria and tetanus) are considered to be compatible with breastfeeding, their use should be limited to those situations where there is…
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Refrigerated Storage

DukoralValneva UK Limited

Valneva UK Limited
Dukoral
Oral suspension

In the event of an inadvertent temperature excursion the following data may be used:
Product in the unopened bottle and sachet, stored in the outer carton, is stable at temperatures up to 25°C for a period of 14 days. At the end of this period the product should be used or discarded.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

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

Reduce to 14 days as above
13 October 2020
London MI Service

New Medicines

Vaxchora Cholera

Information

Vaxchora
Vaccine
Emergent BioSolutions
Emergent BioSolutions

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Feb 21Has been available in the US since Oct 16 [12].
Jan 21Use from age 2 recommended for EU approval by CHMP - the amended indication is "for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older" [11].
Apr 20Marketing authorisation issued by EC [10].
Jan 20recommended for EU approval by CHMP - the full indication is "active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 6 years and older. This vaccine should be used in accordance with official recommendations” [7].
Dec 19Emergent BioSolutions plans to launch PXVX in European countries in 2020 [6].
Oct 18PaxVax has been acquired by Emergent BioSolutions [6].
Jun 16Approved in US for the prevention of cholera caused by serogroup O1 in adults aged 18 to 64 years traveling to cholera-affected areas [5].
Dec 14PaxVax plans to file in the US in mid 2015 [4].
Dec 13PXVX0200 has been granted Fast Track designation in the US [2].

Category

Live cholera vaccine. Vaxchora will be available as an effervescent powder and a powder for oral suspension. It contains live attenuated cholera bacteria (V. cholerae O1 classical Inaba strain live attenuated CVD 103-HgR).
Cholera is prevalent in areas with poor sanitation and poor food and water hygiene and constitutes a major global public health problem. The disease is not endemic to the UK and is rarely imported from abroad (an average of only 10 cases of cholera are imported into the UK annually) [8].
Cholera
Oral

Trial or other data

Dec 14Paxvax´s cholera vaccine meets its primary outcome in a PIII trial designed to evaluate the safety and ability to induce an immune response of three consecutive lots of the vaccine candidate. In 3,000 subjects in the Australia and the U.S., each of the three lots met a pre-set immunological endpoint for consistency of manufacture [4].
Jan 14Interim data from a PIII cholera challenge study reported. In participants challenged at 10 days post vaccination with wild type, fully pathogenic cholera bacteria the rate of diarrhoea was reduced in the vaccine group: 20/33 participants who received placebo experienced moderate-to-severe diarrhoea vs 2/35 of 35 who received PXVX0200. A second, separate group of volunteers will be challenged at 90 days post vaccination to further evaluate duration of vaccine protection. The co-primary endpoint will combine both challenge time points [3].
Dec 13PaxVax has raised $22m which will be used to continue to fund the recently initiated PIII clinical trial program for PXVX0200 as a traveler´s vaccine. Approximately 3,000 participants will be enrolled in this pivotal international programme, which comprises cholera challenge, safety, and immunogenicity studies. Studies are being conducted in the US, Australia, and Canada [2].
Dec 13NCT01895855 is a PIII randomized, double-blind, placebo-controlled, trial of a single dose of PXVX0200 in preventing cholera following challenge with vibrio cholera O1 El Tor Inaba. The co-primary outcomes are protection afforded at 10 and at 90 days post-vaccination. The study plans to enrol 210 healthy volunteers aged 18-45 from Sep 13. Estimated date of study completion is Jul 14 [1].