Prequalification to make high-quality, safe and affordable vaccines

April 2013

WHO’s vaccine prequalification programme ensures that the vaccines received by two thirds of the world’s babies are high-quality, safe and affordable.

Every year, more than 2.5 billion doses of vaccines are used globally to immunize children under 10 years old. Immunization is key to protecting children from many deadly diseases, including polio, measles, diphtheria, and tetanus. But it only works if vaccine quality and safety can be assured and consistent, and it can only be carried out if vaccines are affordable. So in 1987, WHO introduced a vaccine prequalification programme, initially as a service to UNICEF and other UN purchasing agencies. Today, that programme is the only one in the world to facilitate international harmonization of vaccine production standards.

Why vaccine prequalification is necessary

Quality testing of locally produced vaccines in Thailand.
Ministry of Public Health, Thailand

Currently, 65% of all babies worldwide are immunized using WHO prequalified vaccines. As more countries begin to routinely immunize children and develop more ambitious national vaccination programmes, demand for quality products grows. At the same time, new funding, notably from the GAVI Alliance – which funds country immunization programmes – has encouraged new entrants into the vaccine market, which in 2013 was worth US$ 24 billion. The need for prequalification becomes even more pressing.

“It is critical that GAVI funds only be used to purchase vaccines that meet international expectations of assured quality,” says GAVI Alliance Executive Director Seth Berkley. “WHO prequalification gives assurance that the vaccines we buy are safe, effective and suit the needs of developing countries.”

Prequalifying pentavalent vaccine

“WHO prequalification gives assurance that the vaccines we buy are safe, effective and suit the needs of developing countries.”

Seth Berkley, GAVI Alliance Executive Director

Between 2005 and 2010, global demand for the pentavalent vaccine increased rapidly. This combination “five-in-one” vaccine protects children from diphtheria, pertussis (whooping cough), tetanus, hepatitis B and Haemophilus influenzae type b (Hib) which causes pneumonia and meningitis. It is less traumatic for babies to receive and easier for programmes to administer than previous formulations.

By the end of 2010, a GAVI-subsidized programme had approved 61 countries for funding for pentavalent vaccine. The programme assures a sustainable market, encouraging manufacturers to increase supply. This has, in turn, spurred greater competition – a virtuous cycle where manufacturers have to make increasing investments in quality to compete effectively.

The Indian company Biological E is part of a group of emerging economy manufacturers – including Brazil, Bulgaria, Cuba, Indonesia, Russia, Senegal and Thailand – that are joining industrialized countries as major manufacturers of vaccines, including pentavalent.

Pentavalent’s journey to prequalification

Vaccine vials.
iStockphoto

In 2012, Biological E prequalified its single-vial, liquid formulation of pentavalent, an easier product to transport and administer than the earlier version in two vials (one liquid, one powder, to be mixed).

India’s National Regulatory Authority licensed the formulation, and the application was then submitted to WHO. Involving government regulatory authorities in the process is part of the programme’s effort to strengthen national capacity. The Organization assessed the vaccine as “high-priority” (priorities for vaccines are set every two years by WHO and UN procurement agencies, to obtain a consensus view of global public health vaccine needs for the next two years).

Biological E submitted to WHO a “product summary file” (PSF), a dossier that provides information that matters to the populations that will use the vaccine, such as stability at different temperatures and potential interaction with other vaccines. The dossier was examined by reviewers from within and outside WHO. They also reviewed the product itself, sending samples to a range of reference laboratories and carrying out site inspections. Evaluation of pentavalent was further complicated because not all the components were manufactured at the same sites. The vaccine was prequalified in less than the 12-month target period for the process.

“WHO’s ultimate goal is for countries to be self-reliant – able to regulate the safety and quality of their own products. ” says Dr Mahima Datla, Senior Vice President of Biotechnology and Projects at Biological E. “But sometimes it takes an external organization to make sure these are harmonized with global standards. WHO plays that role – levelling the playing field so kids everywhere can receive the same quality vaccines."

Share