by MICHAEL WOODHEAD
The expired vaccine 'shame' originating in Shandong has caused a huge outcry of concern in China and has prompted angry reactions from the very top leaders, including Li Keqiang.
Here's what we know so far:
1. More than 2 million doses of expired or spoiled vaccine worth $88 million have been sold by a rogue Shandong wholesaler since 2011.
2. Between 12 and 25 different vaccine products were involved. They were Class 2 (non-essential/optional) vaccines such as rabies and Japanese encephalitis, which are distributed via private wholesalers rather than though the centralised buying system used for Class 1 (essential/state-funded vaccines). The vaccine products affected are said to include:
- Rabies, Rabies immune globulin
- Haemophilus influenza B (Hib),
- Pneumococcal polysaccharide vaccine (23-valent)
- Meningococcal A/C vaccine
- Influenza vaccine,
- Hepatitis B vaccine
4. The National Health and Family Planning Commission and the China FDA say they are now "resolutely investigating the relevant departments" and actively tracking down where the vaccines have been sold to 24 provinces. Officials say each vaccine and recipient should be traceable by barcode and batch number. Authorities are now investigating the case at the behest of Premier Li Keqiang, who has called in law enforcement authorities and said there were obvious loopholes in the regulatory system for the supply and distribution of Class 2 vaccines.
5. The WHO say that there should be no major adverse effects in recipients of vaccines that have expired or not been handled according to the cold chain procedures - however the recipients may not have received an adequate immune response and would not be protected against the infections for which the vaccine was given. The WHO has urged the Chinese public to maintain faith in the immunisation system and it emphasises that vaccination programs have helped reduce China's high burden of infectious diseases.
6. The NHFPC says there have not been any notable spikes in vaccine related adverse effects but it is now checking figures - particularly for the Shandong area.
7. Chinese netizens are asking why the information was only brought to light in February 2016 when the authorities became aware of the problem in April 2015. This raises obvious questions of whether vaccines could have been traced and recalled before being given to unsuspecting patients.
8. There has been public outrage and 'vaccine panic', with many Chinese expressing scepticism about the quality of Chinese made and distributed vaccines and anger about the integrity of the medical safety surveillance and regulatory system. There are fears for vaccination rates may fall as the public lose faith in public vaccine programs.
9. Some of the more open media outlets have blamed China's lax approach to food and medicine safety on the authorities' lack of accountability and transparency and also the routine censorship of and control of 'bad' news. Caixin magazine ran a feature that harked back to a previous hepatitis B vaccine adverse events scandal from 2013, but the article was later deleted.
10. Some analysts have said that the Class 2 non-essential vaccine distribution system is ripe for corruption. It has minimal regulation and there are strong financial incentives for unscrupulous wholesalers and local disease control departments to collude to make commissions and backhanders off sales of unreliable vaccines.
11. China CDC director Wang Huaqing says that after a full investigation some children and adults may need to undergo repeat vaccinations to ensure they are covered against certain diseases. However he says the more widespread impact is likely to be on herd immunity levels in the population rather than individual risk of infection.