5_Dr Balasegaram_Roundtable_Ensuring appropriate vaccines, improving product thermostability

Ensuring appropriate vaccines, improving product thermostability

Dr Manica Balasegaram, Executive Director MSF Access Campaign Oslo, 14th of October, 2013

To expand access to immunisation, better adapted vaccines are needed • Needle-free administration • Multi-antigen vaccines (fewer visits) • Dose-reduced schedules (fewer visits) • Antigens adapted to local strains of pathogens • More thermostable vaccines

Cold chain bottlenecks: MSF’s experience Ice packs require 24 hours in the freezer then 30 minutes to 2 hours outside the freezer (to reach >0°C), before being used.

MSF vaccination campaign in Chad (2010): - 570,000 people vaccinated for measles, - 21,500 ice packs frozen in 11 days, -18 freezers and 3 freezer rooms were needed.

Without ice packs: - Capacity of vaccine carriers doubled - Weight reduced by half -20.6L cold box: 15.9kg vs >30kg -2.6L vaccine carrier: 2.3kg vs >5kg - No risk of accidental freezing vaccines

Freezing ice packs on a boat (!)

Malemba DRC (2010)

Cold chain burden: developing country experience • Newer vaccines require 5x more cold chain storage capacity than traditional • ~50% of facilities in GAVI-eligible countries have effectively no electrical supply / 10% have reliable electrical supply • In MSF projects, 70% of vaccine wastage is due to cold chain ruptures during storage of vaccines, mainly at peripheral level • Tip of the iceberg: US$ 1,500,000 -worth of vaccines wasted in W&C Africa in just five months (UNICEF audits)

Measles vaccination campaign Don Bosco refugee camp, DRC (2012)

Flexible cold chain: what would it mean in practice?

No or little changes in supply chain from manufacturer to district store

Flexibility at latest stages of supply chain

Heavy and cumbersome frozen icepacks could be removed from insulated boxes and vaccine carriers

Peripheral health centers without electric supply could store some vaccines for a certain period of time

Dual agenda: what needs to happen?

• Short-term: relabelling existing vaccines for a flexible cold chain (‘controlled temperature chain’ - CTC) • Medium/long-term: Developing more thermostable new vaccines

Existing vaccines: best potential for a flexible cold chain?

VVM 2

Moderately good candidates for CTC

VVM 7

VVM 14

Yellow Fever

Measles

Cholera

Penta valent

Best candidates for CTC

Tetanus toxoid

VVM 30

HBV

SOURCE: Temperature sensitivity of vaccines – Feb2013 - PATH

HPV

PCV

Existing vaccines: what needs to happen?

• Companies to release ALL their thermostability data and seek re-registration w/ flexible cold chain in developing countries – Labels of HPV & PCV13 in USA / EU / Canada already mention possible use outside cold chain under certain conditions. This should happen in tropical developing countries, too!

• Regulatory requirements to re-register vaccines with new heat stability range need to be clarified – Simplified and standardized WHO-coordinated process needed to fast-track re-registration w/ flexible cold chain

New vaccines: guiding the development of more thermostable vaccines • Preferred product profiles (PPP) / Target Product Profiles (TPP) – WHO PPP PCV (2008): "Vaccines with increased thermostability are desirable“.

– Draft WHO PPP malaria vaccines (2013): “preferably ambient, minimally 2°-8°C” >> Too vague and based on a simplistic dichotomy (no need of cold chain versus need of cold chain) • A broader range of precise thermostability preferences, linked to different operational strategies in developing countries, is needed – “strict cold chain 2°-8°C all the way through – outside of the cold chain for up to one week at 40°C – outside of the cold chain for up to 45 days at 40°C – (…)

– outside of the cold chain all the way through”

Adapting existing and pipeline vaccines: who can stimulate it?

• Donors that support developing country immunisation programmes • GAVI and UNICEF to incentivise development of more adapted vaccines and thermostable vaccines through market power: – GAVI: value of GAVI-funded vaccines increased 10x since its start ($921m 2011-2015) – Institute specific reward policy in favour of vaccines with higher thermostability; ex AMC PCV: no increased market share in case of higher stability •

WHO to develop TPPs that prioritise thermostability & define prequalification process

• Manufacturers to initiate re-licensing process for vaccines with known thermostability and prioritise stability for pipeline products

Vaccines with most potential for flexible cold chain: PQ-ed producers per product Cholera

HBV

HPV

Measles

Penta valent

PCV

Tetanus toxoid

Yellow Fever

NB: Sanofi-Pasteur and Shanta are grouped under Sanofi

Thermostability agenda: what is MSF doing?

• Study on use of the tetanus toxoid vaccine with a flexible cold chain in Chad (with Optimize); similar studies to come • Forthcoming landscape report on the vaccine adaptation pipeline, including thermostability • Advocacy towards pharmaceutical companies,R&D funders, regulators and vaccine procurement agencies for more scaled up adaptation agenda, and increased thermostability

Thank you for your attention