11 things we know about the expired vaccine scandal

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
• Varicella, 
• Haemophilus influenza B (Hib), 
• Pneumococcal polysaccharide vaccine (23-valent) 
• Meningococcal A/C vaccine 
• Influenza vaccine, 
• Hepatitis B vaccine

3. The mother and daughter team of rogue sellers have been arrested, along with 37 other suspects in Shandong. They are believed to have bought cheap vaccines that had expired or had not been stored or transported according to cold chain methods to ensure they remained viable. Three pharmaceutical companies have been investigated and one has had its manufacturing and distribution suspended. A further nine wholesalers are under investigation.

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.

My weekly news blog for 1 Feb

The medical news in China has been dominated this week by the death of a doctor at a Luoyang hospital after a brawl with a drunken patient. Both fell down a lift shaft and were killed. It's just the latest in a long line of violent incidents against medical staff. Each time one occurs there are protest by staff, stern editorials in the media and vows to crack down on such incidents. There have even been gimmicks, including plans to have 'volunteers' or police patrols in hospitals to defend doctors from violence and defuse violent situations And yet still they continue. I can't understand why Chinese hospital don't have 'crash' alarms like they do in western countries, that trigger lockdowns and mutual protection protocols.

On a more positive note, Chinese drug makers have registered the world's first Sabin-inactivated poliovirus vaccine (S-IPV). The vaccine, developed by the Chinese Academy of Medical Sciences is being produced by the Institute of Medical Biology within the Kunming Hi-Tech Zone. It is said to be more effective than the current oral polio vaccine and also inexpensive.

Such a vaccine may have a role in remote parts of China such as Xinjiang, which recently reported an outbreak of polio. After more than a decade being polio free, in 2011 there were 23 polio cases reported, 55% of which were in young adults.  The polio was presumably brought in from the neighbouring Muslim state of Pakistan, where polio has not been eradicated due to the Taliban.

Another first for China this week was the first patient to be treated - and survived - a new H5N6 strain of avian influenza. The patient treated by well-known specialist Dr Zhong Nanshan at Guangzhou hospital after contracting the infection from - guess where - a live poultry market (why don't they just shut them down for good?). Dr Zhong said this was the second patient to contract the dangerous infection - the first one died. he said the second patient had been treated with high doses of antivirals and was in a stable condition. China is also struggling with a winter outbreak of H7N9 avian flu, with 30 cases so far around Guangdong.

In the healthcare reforms, some healthcare managers have said that hospital reforms should focus on the model of funding, and switch to an 'activity based funding' system to reward outcomes. At a meeting of the Beijing Chinese Peoples Consultative Committee they said that the funding system based on "diagnosis-related groups" (DRG)  would "break the link between doctors' incomes and prescriptions, thereby preventing excessive medical treatments and over-prescription of drugs." Hospital managers complained that they were underfunded because fees had been fixed at low prices set in 1999 whereas costs (and incomes) had risen considerably since then.

Well, fees may be too low according to hospital managers, but some patients still can't afford them. A woman has made news in Kunming by dressing up in a wedding gown and offering herself for marriage to any man who will pay her brother's medical fees. Her brother has leukaemia and she says he needs 300,000 yuan for treatment. China is supposed to have a public health fund for people with catastrophic illness, but it obviously hasn't trickled don to this young man.

Resisting the Japanese invader: the China success story against Japanese encephalitis

by Michael Woodhead
 As China cranks up its media hate campaign against its former enemy Japan, the country can actually celebrate victory in its war against another 'Japanese' invader from the 1940s: Japanese encephalitis. 

This mosquito borne viral disease used to cause about 200,000 cases of severe neurological illness in China every year at its peak in the 1960s and 70s - with about 30% patients dying and many of the survivors  left with lasting neurological disability as a result of the infection.

The name is misleading - the disease did not originate in Japan, but was first identified there in the 19th century. The infection was first recorded in China in the 1940s and became widespread in the 1960s - partly because of the breakdown in public health preventive activities during the chaos of Mao Zedong's Cultural Revolution.

A vaccine against the virus was developed in Japan in 1965, and China started manufacturing its own vaccine a few years later.  Writing in the journal PLOS Neglected Tropical Diseases, Dr Gao Xiaoyan and colleagues at the Chinese Centre for Disease Control and Prevention, Beijing, describe how Japanese encephalitis was brought under control in China.

The initial Chinese vaccine was only available in limited quantities and required many doses. It was expensive and was only available to privileged cadres and Party members, not to the peasants who were most at risk of the disease. With more than half the cases of Japanese encephalitis in the world, China continued to work on improving the vaccine and eventually developed one in 1988 that was more convenient and could be mass produced at relatively low cost, to make it affordable for public health use.

This vaccine was gradually made available at a cost of 1 yuan to rural residents, and was fully subsidised as a free vaccine after the year 2005. Since it was included in the "Expanded Program of Immunisation" this cheap and effective vaccine had reduced the incidence of Japanese encephalitis in China from 21/100,000 people to just a fraction of 1 per 100,000 - a remarkable achievement.

But the vaccine is not the only reason for the drastic reduction in Japanese encephalitis in China. Other public health measures were implemented by local health authorities to reduce mosquito breeding and transmission:  pig farms were moved away from villages,  sewage disposal was improved to reduce mosquito breeding, and mosquito breeding grounds in areas of static water were eliminated.

The threat from Japanese encephalitis has now been markedly reduced in the more prosperous eastern provinces of China but it remains a problem in the poorer parts of southwest China. Nevertheless, Chinese researchers say other developing countries can copy the Chinese model for eliminating Japanese encephalitis: low cost programs using inexpensive vaccine and anti-mosquito measures.

HPV vaccine delay | Baidu medical fraud | Malaria system success | Gassers in short supply | GSK case won't stop bribery

1. China may be delaying approval of HPV vaccines made by foreign companies until the country has a homegrown competitor, according to Global Times. The HPV vaccines Gardasil and Cervarix are still not available in China despite 30,000 women dying in China every year of HPV-related cervical cancer. Some Chinese doctors and officials claim there are ethnic differences in vaccine responses between Chinese and Europeans, and clinical trials that in Chinese people are needed to ensure of the vaccines' safety and efficiency on Chinese.

2.  Baidu earns its fortune by promoting fraudulent medical information at the cost of health and even lives, critics say. The search engine site is the main avenue used by illegal drug manufacturers and illegal hospitals to advertise in China, they claim. Many drugs that are explicitly banned by the China Food and Drug Administration (CFDA) are still on promotion on Baidu, an article in Daily Kos says.

3. A '1-3-7' system of dealing with malaria cases that is very successful and could be a model for other countries, researchers from the Jiangsu Institute of Parasitic Diseases claim. The system is based on case reporting within one day, case investigation within three days. and focus investigation and action within seven days.Since the system was implemented in 2012 the proportion of cases investigated in 3 days has reached 100%, and seven-day action rates are 50% and rising.

4. China has a shortage of 200,000 anesthesiologists as doctors avoid the speciality due to low salaries, heavy workloads and lack of a strong training system, experts say. A conference was told that China has only 100,000 anesthesiologists but needs 300,000. Eight anesthesiologists died of overwork last year, according to Yu Weifeng, head of the anaesthesiologist branch of the Chinese Medical Doctors Association.

5. A cure for the endemic corruption in China's healthcare system is still far away despite the scare campaign against executives of British pharma company GSK, the online magazine Caixin says. While the crackdown makes the authorities look like they are being tough on bribery for prescribing, the reality is that doctors still accept commissions and there is no fix for the 'demand side' of the bribery equation, the magazine says. The health ministry cannot afford to alienate doctors, who are central to the problem, it concludes.

Eight medical stories from China you should read

by Michael Woodhead

1. Beijing will start to enforce new anti-smoking laws with 200 yuan on-the-spot fines (up from 10 yuan) for people who smoke in public indoor shared areas, and institutional fines of 30,000 yuan (up from 5000 yuan). Cameras will be used to compensate for the lack of enforcement officers, especially after hours, the city government says.

2. The Chinese government has been accused of withholding medical care from dissidents. An article by Sophie Richardson in the WSJ says civil rights campaigner Cao Shunli is now in intensive care because she was denied access to medical care while detained for her efforts to promote a civil society.

3. A link has been found between damp housing in Shanghai and rates of asthma in children. Researchers from the University of Shanghai for Science and Technology say asthma symptoms could be reduced by 25% by simply keeping a child's window open at night.

4. A vaccine against enterovirus 71 developed by Sinovac Biotech has proved effective against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children, according to a study in 5000 children done by the Jiangsu Provincial Center for Disease Control and Prevention, published in the New England Journal of Medicine.

5. Eating shark fin is not only cruel and bad for the environment, it is also a health hazard because of high mercury levels in the product, researchers from Zhejiang have shown. After testing samples of shark fin they found that up to 33% contained toxic levels of mercury.

6. Antibiotics are widely overused by parents in rural China, with more than 60% dosing their children with antibiotics bought over the counter, Shanghai researchers have found. Most parents were ignorant about how antibiotics worked and had little idea hat they do not help viral infections.

7. Migrant workers have little access to healthcare and many of them put off seeing a doctor for illness, a survey in Shanghai has found. Two thirds of migrant workers said they had never had a medical check up and nearly 40% said they had ignored symptoms because they couldn't get to see a doctor.

8. Health workers in Guangdong have completed a successful pilot trial of a cervical cancer screening program using the ThinPrep cytological system. The program offered Pap test cancer screening to more than 40,000 women, and found that improvements are needed in basic education regarding cervical cancer screening for young and poorly educated women.

Hepatitis B vaccine in China: the unanswered questions

Commentary by Michael Woodhead

The deaths of 17 Chinese infants reported as having have followed hepatitis B vaccination are a tragedy that needs to be be fully investigated. When the first deaths occurred, the suspicion lay with a vaccine made by Shenzhen BioKangtai, with reports that certain batches of the vaccine were linked to the deaths of newborns in several provinces who had received vaccines with the specific batch number. Matters then became confused when reports were made of deaths of infants who had received other vaccines, including one made by a company called Beijing Tiantan. In all, 17 deaths have been officially reported in relation to hepatitis B vaccine.
When the first deaths were reported, the China Food and Drug Administration (SFDA) and the National Health and Family Planning Commission (NHFPC) ordered a halt to the use of the Biokangtai vaccine in China's newborn vaccination program and an investigation into the vaccine used.

After a rapid investigation of less than two weeks it has been announced that no problems have been found with the batches of Biokangtai's vaccine reportedly involved in the deaths and adverse reactions. The SFDA has also found no problems in the manufacturing, storage, transport or injection of the vaccine. Nevertheless, manufacturing permissions have been suspended for the three major manufacturers of hepatitis B vaccine, on the grounds that their facilities had not met the new GMP criteria for vaccine prodiction that came into effect on 1 January.
Post-mortem investigations into the infant deaths have also excluded the vaccine in nine cases, so far, and the other eight cases are waiting for autopsy results. Thus the hepatitis B infant vaccination campaign has quickly been given the all clear by the various authorities, and this verdict has been endorsed by the local branch of the WHO. The WHO representative rightly pointed out that the hepatitis B program was based on a good vaccine and prevented many cases of diseases and death every year. However, the announcement about the vaccine being safe was met with anger from some of the families of the children who died, and there has been disbelief on online forums about the "all clear" verdict from netizens who have little faith in monitoring of safety and quality of foods and medicines in China.

Despite the endorsement of WHO, there are still areas of doubt and unanswered questions in relation to the safety of China's hepatitis B vaccine and other child vaccine programs. First of all, if a vaccine was not responsible for the infant deaths, what was or were the real causes? With millions of newborns being vaccinated it is statistically probable that some natural infant deaths will co-incide with the time of vaccination. But the reports of 17 deaths in association with hepatitis B vaccination require in-depth investigation. Another question is whether it is possible to confidently rule out the vaccine as a possible factor in the cause of death. The investigations into the child deaths and into the vaccine quality and usage were done very quickly, raising questions about how thorough and comprehensive they were. There was also little transparancy about the process.
By comparison, when a similar series of vaccine-linked adverse events was seen in Australian infants given flu vaccine in 2010, authorities followed this up with several major inquiries. One inquiry was overseen by an independent clinician who examined the timeliness and appropriateness of the responses to the events. A second inquiry looked at the systems in place to monitor vaccine adverse events. A third inquiry looked into the vaccine manufacturing and quality issues. These separate inquires continued for months and in one case extended for more than a year. They concluded that a manufacturing anomaly had caused the vaccine batch for that year to be more 'reactive' than usual and to provoke more adverse effects. As a result, flu vaccine made by this manufacturer was banned from use in children, while products from other manufacturers continued to be allowed to be used. The other inquiries found that vaccine event monitoring and responses could have been better, and that information sharing had been poor and could be improved.

The recommendations from these inquiries were accepted by the Australian government, which has started to implement new vaccine monitoring and oversight systems. China could learn much from the Australian response to a series of vaccine related adverse events, to improve vaccine safety monitoring and response systems and to improve transparency in the whole process.
A clear and open response on the issue is needed from the Chinese authorities to maintain confidence in the safety of vaccination programs for children. It is not enough to point out that 15 million children receive the hepatitis B vaccine each year with the vast majority showing no ill effects and that the vaccine program prevents millions of cases of severe illness and death. Given the previous food and drug quality safety scandals seen in China - and the lack of public faith in the responses from the authorities - it is not surprising that there is now a crisis of confidence in the quality of China's food and drug products. Let us hope that vaccines do not become like milk powder, with parents only having faith in imported foreign brands for their newborns.

China's top 3 hepatitis B vaccine makers ordered to stop production because of GMP failings

by Michael Woodhead
China's three major manufacturers of hepatitis B vaccine have been ordered to suspend production because they have failed to meet new stringent GMP criteria that came into effect in 1 January.
The order from the Chinese Food and Drug Administration (SFDA) applies to Shanzhen Biokangtai, whose hepatitis B vaccine has been linked to a string of deaths among newborns in recent weeks. It also applies to Dalian Hanxin and Tiantan Biologicals.
According to a report from Xinhua, the vaccine manufacturers knew in advance that they had to meet the new GMP criteria by 1 January but failed to do so. The report says the new GMP criteria apply to all aseptic manufacturing plants, of which there are 1319 in China. It says two thirds have already met the new GMP requirements and others are working towards them. However, the three hepatitis B vaccine manufatcurers have not met the criteria and have been told that any further products produced from 1 January will not be accepted for use in China.
The Xinhua report notes that the three manufacturers account for about 80% of hepatitis B vaccine producetion in China. other manufacturers such as Hualan and Huabei have achieved GMP licencing but produce only about 10% of the vaccine supplies.
The SFDA says new GMP criteria apply to all manufacturers, and they estimate that there are GMP-compliant manufacturers for all 171 essential medicines. Mannufacturers who have not yet met the criteria have stockplied supplies of essential medicines, Xinhua notes.
The SFDA empahises that the move is only a temporary suspension of manufacturing and it is not ordering the  manufacturers to shut down the production facilities. Production may be resumed once the manufacturers show they are meeting GMP requirement, the SFDA says.

Tiantan hepatitis B vaccine maker bosses resign

The makers of one of China's hepatitis B vaccines has seen several of its top executives resign in the wake of the recent spate of deaths of babies who received hepatitis vaccinations. However, the resignations are from the Tiantan Biological company, whose vaccine has been linked to few if any of the recent reports of deaths of newborns after receiving hepatitis B vaccine. The 12 deaths reported so far have mostly been linked to the rival Shenzehn Bio-Kangtai vaccine.
Caixin reports that several board members of Tiantan have offered their resignations, apparebtly becaus the recent investigations into manufacturing processes at vaccine makers have exposed sub-standard practices, especially in relation to meeting GMP requirements. The board members of Tiantan include the financial manager and auditors. The lack of GMP certification meant the company was unable to expand its production and thus has been unable to meet the shortfall created by the ban on use of BioKangtai vaccine, which  accounted for about a quarter of the market.

Experts defend hepatitis B immunisation programme after deaths

The hepatitis B vaccination program for newborns should stay in place despite the recent deaths of eight babies, medical experts said.
But expectant mothers are worried about the quality of vaccines as authorities investigate the cause of the deaths.
Jia Jidong, who leads the Liver Research Center at the Beijing Friendship Hospital, cited China's relatively high prevalence of the viral infection as a major reason for keeping the immunization program.
China reported a hepatitis B prevalence of more than 7 percent.
"We would have seen a relapse of the epidemic if the program was not well implemented,” he warned.

Hepatitis B vaccine death toll rises to seven, questions asked about slow recall

Seven children have now died in China since November following hepatitis B vaccination, raising questions of the effectiveness of the emergency response.
To date, four infants have died in south China's Guangdong Province after hepatitis B vaccinations with products made by Biokangtai,a Shenzhen drug manufacturer, the Provincial Disease Control and Prevention Center said on Monday. The four deaths in Guangdong occurred in Zhongshan, Jiangmen, Shenzhen and Meizhou, but the Zhongshan case was not related to the vaccine. The baby in that case died of pneumonia, according to the center. Autopsy results have not yet been released for the other three cases. Cause of the death can only be confirmed after autopsies which normally take 30 working days. Two babies in neighboring Hunan Province and another in the southwestern province of Sichuan died in similar circumstances, according to the National Health and Family Planning Commission. A circular on Friday ordered suspension of Biokangtai vaccinations,two weeks after the first Biokangtai link was established on Dec. 6. Babies died in Hunan on Dec. 9 and in Shenzhen on Dec. 17.

More details released on hepatitis B vaccine deaths and recall

An infant who became sick just minutes after a hepatitis B vaccination and died an hour later may be the fourth victim of vaccines produced by China’s largest hepatitis B vaccine supplier in the southern city of Shenzhen.
The deaths have triggered a nationwide suspension.
An official investigation is underway, while Biokangtai has not said where vaccines from the same batch as the Shenzhen baby received may have been sold.
Last Tuesday, the boy, born at 10:31am and apparently healthy, was given a vaccination six minutes later. At 10:39am, his face turned blue, his cries became faint and his breathing became rapid due to a lack of oxygen, Dr Yang Jinmin at the Nanwan People’s Hospital in Shenzhen, Guangdong Province, said.

Shenzhen Kangtai Hepatitis B vaccine withdrawn after four infant deaths

by Michael Woodhead
The China Food and Drug Administration (SFDA) has suspended the use of recombinant hepatitis B vaccine for children manufactured by Shenzhen Kangtai Biological Products (Shenzen Kangtai Shengwu Zhipin, 深圳康泰生物制品股份有限公司) after the four deaths were reported among children who received the vaccine. According to an announcement by the SFDA on 20 Dec, the four deaths were reported following vacination with batches of the company's vaccine in Hunan, Guangdong and Sichuan. The SFDA says an investigation into the cause of death is still underway and until the results of this investigation are available, the use of all batches of the vaccine is being suspended immediately, in the interests of child safety and safety of the infant vaccination program.

Hunan investigates hepatitis batches after two deaths

Health authorities of Hunan, central China, are investigating three cases of adverse reactions to hepatitis B vaccination, including two deaths.
A one-month-old boy died on December 6 in Hengshan County, two days after being vaccinated. Another eight months old died in Changning City on December 9, one day after vaccination for both hepatitis B and flu. A third newborn in Hanshou County showed a severe adverse reaction after being vaccinated on November 25, the Hunan Provincial Center for Disease Control and Prevention said Monday.

Vaccine effective against China’s avian influenza A (H7N9)

by Michael Woodhead
A vaccine has been shown to be effective in humans against the new avian-origin influenza A (H7N9) virus that has already caused 137 cases and 45 deaths in China.

Australian and US researchers developed an A/Anhui/1/13 (H7N9) viruslike particle (VLP) vaccine that combines the HA and neuraminidase (NA) of A/Anhui/1/13 with the matrix 1 protein (M1) of A/Indonesia/5/05.

Writing in the NEJM they say avian influenza viruses have acquired mutations that could facilitate infection in mammals, which could pose a pandemic threat if the viruses become readily transmissible in humans. They have previously shown the efficacy of the vaccine in mice, and in a new study they have demonstrated the efficacy of the VLP vaccine in humans.

In a randomized, placebo-controlled clinical trial of the vaccine in 284 Australian adults two identical doses were given 21 days apart.

When followed up after a month, a strong immune response was seen in 81% of partcipants receiving 5 μg of vaccine with adjuvant. Significant increases in N9 neuraminidase-inhibiting antibodies occurred in 97.2% of recipients of vaccine with 60 units of adjuvant.

The VLP vaccine with adjuvant was associated with increased local and systemic reactions, but few of the reactions were severe, and no body temperatures exceeded 38.5°C.

The researchers from Novavax say the vaccine appears to be a good candidate for prevention of a pandemic  avian-origin influenza A (H7N9).

See the full report in: NEJM DOI: 10.1056/NEJMc1313186

China medical news roundup for Monday 18 November

Thousands of fake rabies vaccine doses may still be on the market

Almost 11,000 fake rabies vaccines brought into the eastern Shandong Province have yet to be found, some 10 days after the case was busted, Qilu Evening News reported yesterday.

According to the Ministry of Public Security, the suspect bought 12,000 fake rabies vaccines in the central Henan Province, and since 2009 has sold 10,800 in Shandong.

The fake shots are made from distilled water and vitamin K1.

Police say the suspect, surnamed Liu, bought vaccines at 0.8 yuan (13 US cents) each and resold them for 1 yuan to vendors in Shandong. In turn, they sold them to patients for 26 yuan each.

Health and drug authorities in Shandong Province started an investigation earlier this month after the suspect was held.

However, they don’t know where the fake rabies vaccines have gone.

Insiders warned they could flood the market as vaccination units are allowed to buy stocks independently.

This increases the risk of buying fake vaccines, compared to unified provincial-level purchases in the past.

As inspectors didn’t find fake rabies vaccines in legal vaccine trade companies, there is speculation that they were bought by unlicensed vaccination units or licensed vaccination units that didn’t check certification, said Zhang Jun, who works in the industry in Jinan, capital of Shandong.

There have been fake rabies vaccine cases across the country since 2005.

In 2009, a five-year-old boy in the Guangxi Zhuang Autonomous Region died 21 days after he was injected with a rabies vaccine which was later discovered to have been a fake.

Source: Shanghai Daily

Adenovirus implicated in severe infant pneumonia

Adenovirus is a critical pathogen that can cause severe respiratory infections even in immunocompetent children, researchers from Hangzhou have found.

In a study of children hospitalised with acute lower respiratory tract infection from 2006 to 2012 they found that infection due to adenovirus infection was infrequent but often caused severe outcome. In an analysis of 479 children with adenovirus infection, the incidence rate of adenovirus-associated acute lower respiratory tract infection peaked in the second six months of life.

Children with pneumonia accounted for 74% of the patients, and more than one-third developed severe pneumonia. Features of severe adenovirus-associated lower respiratory tract infection included persistent high fever with serious infective symptoms, and hepatic dysfunction was one of the most common complications. Mixed infection of atypical pathogens was common (19%).

 The researchers from concluded that “co-infection of adenovirus with atypical pathogens is common and that antibiotic treatment with azithromycin or erythromycin is necessary in patients with mixed infection of atypical pathogens.”

Full study at World Journal of Pediatrics

H6N1 poultry flu reported in humans for first time

The first report of human infection with a wild avian influenza A H6N1 virus has ben published by clinicians from Taipei.

Writing in the Lancet, researchers from the Taiwan Centres for Disease Control say the virus is one of the most common viruses isolated from wild and domestic avian species, but human infection with this virus has not been previously reported.

They publish a case history concerning a 20-year-old woman with an influenza-like illness who presented to a hospital with shortness of breath in May, 2013. An unsubtyped influenza A virus was isolated from her throat-swab specimen and was transferred to the Taiwan Centres for Disease Control (CDC) for identification.  The virus was identified as the H6N1 subtype, but the source of infection was not established. Sequence analyses showed the human case was very similar to chicken H6N1 viruses.

“These viruses continue to evolve and accumulate changes, increasing the potential risk of human-to-human transmission,” they comment.

“Our report highlights the continuous need for preparedness for a pandemic of unpredictable and complex avian influenza.”

Read the full study in The Lancet.

 

Chinese women fare worse after stroke compared to males

Neurologists in north east China have shown that women fare worse than men after a stroke.

Health-related quality of life was significantly worse for  adult females compared to males, according to a study carried out by Dr Wu Xiaoning and colleagues at the First Affiliated Hospital of Liaoning Medical University.

More than 400 stroke survivors were followed up six months after discharge from hospital.

Following stroke, improvements in physical functioning, bodily pain, vitality, social functioning, emotional role, and mental health in the SF-36 survey were significantly higher for men than woman.

Regression analyses confirmed that female sex was adversely associated with overall health status at discharge.

Female stroke patients were older than male stroke patients and were more likely to have transient ischemic attack and hypertension. Male stroke patients were more likely to have a history of smoking, heart disease and dyslipidemia, while female patients were less likely to achieve daily living independence.

“Our results demonstrate that sex has a significant impact on stroke outcome in Chinese individuals, wherein female stroke survivors are more likely to live a life of profound disability with poor self-care ability compared to male survivors,” the researchers concluded.

Read full study at: Journal of Clinical Neuroscience

Lung cancer increase seen in Beijing

Beijing municipal health authorities said on Friday that the number of lung cancer patients in the city has been rising over the last decade, without elaborating on what might have caused the rise.

The number of lung cancer patients per 100,000 people was 63.09 in 2011, compared with 39.56 registered in 2002, according to the Beijing Municipal Health Bureau, citing figures from the city's tumor prevention and treatment office.

In 2011, Beijing reported a total of 7,999 new lung cancer cases, accounting for 20.8 percent of the malignant tumor cases that year.

The bureau said lung cancer is the most common disease among male malignant tumor patients.

The statistics also showed that the lung cancer incidence rises as people age, and male patients outnumber female patients after the age of 35.

Health experts with the Beijing Cancer hospital said lung cancer is highly linked to lifestyle, noting that smoking is the top reason for the disease, followed by passive smoking and environmental pollution, such as air pollution.

People with respiratory diseases are more likely to contract lung cancer, the experts added.

Source: Xinhua

China medical news roundup for Wednesday 13 November

China alliance hopes to boost vaccine access

Eleven civic societies, including the China Medical Association, the China Medical Doctor Association, and the China Medical Women's Association, launched the China Alliance for Vaccines & Immunization on Friday to enhance Chinese and foreign children's access to vaccinations.

Despite tremendous progress in immunizing children worldwide, more than 20 million children do not receive essential vaccines globally, according to the World Health Organization.

China has a unique role to play in supporting global immunization efforts, said Lei Zhenglong, deputy director of the Bureau of Disease Prevention and Control at National Health and Family Planning Commission.

“Immunization requires continuous commitment and there are still challenges that we need to address for China’s immunization program”, he said, adding that immunization needs a joint effort beyond just government.

“Civic societies can leverage their diversity and flexibility to play a bigger role in the future,” he noted.

The alliance includes community organizations, professional associations, academic institutions and organizations representing affected population groups and will work to cultivate greater partnership in China and other countries, said Cheng Feng, vice-president of the Global Health Strategies initiative.

“The global community has a responsibility to reach all children, everywhere, with the vaccines they need, and China is an important part of such efforts,” he said.

Given its experience and expertise in immunization, China has an opportunity to draw from its success and help the world achieve goals for universal access to immunization, he added.

The alliance will also explore opportunities to promote the adoption of quality and affordable vaccines made in China, he said.

Last month, the first Chinese-made vaccine achieved WHO pre-qualification and met international standards for quality, safety and efficacy.

That status allows the Chinese manufacturer to sell its vaccine against Japanese encephalitis to international agencies to be used in low-income countries.

Source: China Daily

Infectious diseases kill 1200 Chinese a month

A total of 1,272 people died of infectious diseases on the Chinese mainland in October, the National Health and Family Planning Commission announced on Monday.

A total of 549,135 infectious disease cases were reported on the Chinese mainland last month, it said.

Among them, five cases of cholera were reported, but none resulted in death. Plague and cholera are categorized as Class A infectious diseases, the most serious category.

In addition, about 285,020 cases were identified as Class B infectious diseases. Hepatitis, tuberculosis, syphilis, dysentery and gonorrhea accounted for 95 percent of the cases in this category, the statement said.

It added that category C infectious diseases claimed 10 lives in October, with foot-and-mouth disease, infectious diarrhea and mumps reported most frequently.

Source: Xinhua

China’s family planning policy has improved child and maternal health 

On the 40^th anniversary of China population control program, National Health and Family Planning Commission spokesman Mao Qun-an said family planning had reduced population growth by 400 million people, greatly reducing stress on environment and society.

Family planning has ensured our rapid population growth has been effectively controlled, he said. China's birth rate has fallen from 33% in 1970 to 12% in 2012, half of the world average. Over the same period, women's total fertility rate dropped from 5.8 in 1970 to 1.6, reaching the same level of developed countries.

"China's population reproduction pattern has changed from a traditional high birth rate and infant mortality to a low birth rate and low infant mortality, Mao said.

Family planning effectively alleviated the pressure of population on resources and the environment. 

“If we had not implemented our family planning policy, China's population would by now have reached 1.7 to 1.8 billion, with a higher pressure on arable land, grain, water resources and energy,” he added.

Family planning also improved womens’ and childrens’ health and improved child development, Mao said. The policy improved prenatal and postnatal care, reproductive health services, universal adolescent sexual and reproductive health knowledge, and protected baby girl survival as well as promoting development rights and gender equality.

China had achieved outstanding results in terms of maternal and infant mortality, with mortality rates dropping significantly from 80 and 50 per 100,000 in 1991 to 24.5 and 10.3 per 100,000.

"The success of China's family planning practices, has ensured that the world 7,000,000,000 Population Day has been postponed for five years," said Mao. China family planning policy set an example for other developing countries to address population and development issues, and established China as a responsible populous country.

Source: Xinhua 

Two out of three Chinese don’t trust doctors

According to a survey published on Tuesday, 67 percent of people do not trust doctors' professional diagnosis and treatment

The survey, which sampled 252,283 people and was conducted by the survey center of the China Youth Daily, also showed that more than 87 percent of respondents expected to rebuild doctor-patient trust following recent assaults on medical workers in China..

Some 30.4 percent of respondents attribute current medical disputes to a lack of public welfare services, which should be provided by public hospitals, and 27.4 percent said negative news reports worsened such disputes, according to the survey.

Other reasons ranging from uneven distribution of medical resources, intensive physical workload, and the knowledge gap between patients and doctors are blamed for the loss of doctor-patient trust, the survey said.

On Oct 25, a doctor was stabbed to death and two others injured by a dissatisfied patient at a hospital in East China's Zhejiang province.

In the same week, a doctor in Guangzhou, capital of South China's Guangdong province, was beaten up by a patient's family members.

Violence against medical staff is on the rise, according to a previous sample survey by the Chinese Hospital Association conducted from Dec 2012 to July 2013.

The annual average number of assaults on doctors per hospital increased from 20.6 in 2008 to 27.3 in 2012, according to the survey, which polled staff and patients at 316 hospitals.

"Courses in medical colleges focus more on medical techniques, but there are few courses on communication," Wang Zhong, vice-head of Tsinghua University Hospital, was quoted by the newspaper as saying, adding that inadequate communication is the root of a majority of medical disputes.

Wang said that the assault of medical staff destroys hospital order and should be curbed and condemned as it brings panic to doctors, which ultimately results in decreased service by doctors.

Chinese Vice-Premier Liu Yandong pledged to curb assaults on medical workers at a meeting last week, noting that the government will launch a year-long campaign to enhance security arrangements at hospitals and improve coordination between hospitals and police.

Source: China Daily

What hope for preventing cervical cancer in China with no access to Pap tests or HPV vaccine?

An inflatable uterus in a Shanghai park aims to raise awareness of women's health

by Xuyang Jingjing
As World Cancer Day is celebrated on February 4, it is a sad reality that potentially life-saving cervical cancer vaccines are being kept from the Chinese mainland due to tight import restrictions and testing requirements. 


HPV types 16 and 18 are responsible for about 70 percent of cervical cancer cases. 

HPV vaccines have been available in Hong Kong, Macao and Taiwan since late 2006. But for vaccines, or any new imported drugs, to be sold in the mainland, new clinical trials have to be performed on mainland residents. Then the drugs are re-evaluated and reviewed by the State Food and Drug Administration before they can be imported, according to regulations.

 Some women who are aware of the vaccines and have the means to do so choose to get inoculated in Hong Kong. There are also many agencies that help mainland women book appointments in Hong Kong hospitals. Such procedures usually come in at around HK$3,000.

 Both Gardasil and Cervarix are given in a series of three shots over the span of six months, which means women have to travel back and forth. They could also take the other two shots back home and get injected at a local clinic, but strictly speaking this is illegal since the vaccines are not yet approved for the mainland. 


Zhou Zijun, professor with the School of Public Health of Peking University, said the purpose of such barriers is to protect the Chinese people while noting that every country has its own set of standards and procedures when approving imported drugs. This also serves to protect domestic pharmaceutical companies. 

But many doctors argue that these regulations are too stringent and may be keeping some good medicines out. The tests done in Hong Kong and Taiwan should have been sufficient, said Gong Xiaoming, a gynecologist at Beijing Union Medical College Hospital.

 He gave another example of an overseas pharmaceutical company that estimated it would cost around 100 million yuan ($16 million) to do all the clinical trials and evaluations to introduce a drug for ovarian cancer to the mainland, ultimately deciding it wasn't worth it and shelving the launch. 


"We should have standards when importing new drugs, but right now it seems the threshold is too high and is preventing us from using some good drugs," said Gong.

 The two vaccines started clinical trials in China around 2007. The first two stages of clinical trials have been concluded and have proven the safety of the vaccine. The third stage has been going since 2009, aiming to test the efficacy of the vaccines. But it could still take years, experts say.

 In the meantime, Chinese pharmaceutical companies have also started clinical trials for domestically-produced HPV vaccines. But it is unclear when any of these will start to be sold on the mainland.
Statistics from the Ministry of Health in 2011 showed over 130,000 new cases of cervical cancer in China each year, accounting for about one-fifth of all new cases worldwide. This translates to about 30,000 women in China dying of cervical cancer each year.

 n China, cervical cancer usually occurs among women over 35 years old, especially between the ages of 45 and 49, according to research carried out by Qiao Youlin, a leading oncologist and a professor at the Cancer Institute and Hospital of the Chinese Academy of Medical Sciences.

 Worryingly, recent years have seen reports indicating that the disease is becoming increasingly prevalent among women in their 20s.

 Most cervical cancer cases occur in central and western areas such as Shanxi, Shaanxi and Hunan, and more so in rural areas than in cities, according to a report released by the Center for Cancer Registry in January.


Besides vaccination, regular screenings are crucial for the early detection and treatment of cervical cancer. However, the biggest problem at the moment is that the general public, especially those in rural or poverty-stricken areas, lack awareness about the disease and the importance of getting regularly tested, said Gong. 


Chinese authorities have also been trying to raise awareness of breast and cervical cancer and have launched programs to promote screening. 

Between 2009 and 2011, China invested over 350 million yuan to screen for breast cancer and cervical cancer among women aged between 35 and 59 in rural areas. Over 11 million rural women were tested for cervical cancer and the country aimed to screen another 10 million in 2012. Whether this program was successful remains unknown.

 Despite the government's effort to promote screening, not enough is being done to ensure that the hundreds of millions of women who need the test are all able to receive it.

 The commonly used screening technique, the pap smear test, detects pre-cancerous and cancerous processes in the cervical canal. It requires skilled doctors to analyse cells for cancerous changes and is therefore more suited to developed countries where medical staff have decades of experience. 

It takes over 10 years to train a doctor qualified to diagnose the disease from the test, but China lacks both the training system and qualified doctors, according to Qiao. 

In 2008, Qiao and scientists from other countries announced in a paper published in The Lancet Oncology that they had developed a new test, named careHPV, to detect 14 high-risk types of HPV in about 2.5 hours.

 It took the team five years to develop the new test, which is considerably cheaper and faster than the currently used pap smear or HPV DNA tests. It is also much easier for medical workers to master. The new test, based on the Hybrid Capture 2 technology, is designed for low-resource areas and works in environments that lack water, electricity or modern equipment.

Qiao said that the new test has just been approved by the State Food and Drug Administration last year and will enter mass production soon. 

In 2011, the Cancer Foundation of China launched a research program that aims to prevent cervical cancer in ethnic minority areas. An ethnic minority county would be chosen respectively from Inner Mongolia, Yunnan and Sichuan where about 6,000 girls between 13 and 15 years of age would be inoculated with HPV vaccines.

 Qiao is hoping that the medical community in China could push for the vaccines to get approved as early as possible. "We are already seven years late. Who knows how many people have been affected during that time?" said Qiao.
Source: Global Times

Hepatitis E vaccine available in China

Hecolin, the world’s first hepatitis E vaccine, is now available in Xiamen, China, to protect against the liver-damaging virus that affects approximately 20 million people around the world.
Hecolin was developed by researchers from Xiamen Innovax Biotech Co., Ltd., and Xiamen University.
Gao Yongzhong, the general manager of Xiamen Innovax, said that Hecolin is available at Xiamen’s centers for disease control and prevention, community clinics, hospitals and other medical organizations for approximately $22.50, Xiamen Daily reports.
“I have participated in the whole research and development process of the vaccine,” Yongzhong said, according to Xiamen Daily. “The vaccine is just like our child, and we witnessed it grow up from the test tube to finally becoming a product for sale. We were so excited when the vaccine was finally launched.”
The vaccine was approved for production in December 2011 and went to market in China late last year after 14 years of research, clinical trials and development. Xiamen Innovax is now working with the Chinese government to offer the vaccine to high-risk members of the public. It is also working with international organizations to distribute the vaccine to countries in need.
On January 19, the Chinese Academy of Sciences and Chinese Academy of Engineering recognized the vaccine as one of the top 10 advancements in domestic technology and science for 2012.
Source: Xiamen Daily

Enterovirus vaccine safe and effective against hand foot and mouth disease, Chinese trial shows

A trial conducted in Jiangsu has provided major step forward in the development of  a vaccine against enterovirus 71 - a member of the Picornaviridae family of viruses associated serious and fatal outbreaks of hand, foot, and mouth disease across Asia.
Published in The Lancet,  the results of a phase 2 trial of an enterovirus vaccine in more than 1100 infants and children in Jiangsu found that the vaccine had good immunogenicity and a low incidence of adverse effects.
The inactivated EV71 vaccine developed by Beijing Vigoo Biological used the EV71 strain was given in two doses a month apart, injected intramuscularly into the deltoid region in children aged 12—36 months and into the anterolateral side of thigh in infants aged 6—11 months.
The trial compared four different doses of vaccine, and all procuced  good antibody responses, with the best seen with an adjuvant 320 U formulation.
Antibody titres had significantly declined by eight months, suggesting a need for a booster shot. Generally, the vaccine had a good safety profile in all participants. Most reactions were mild or moderate and severe adverse reactions were uncommon.
Researchers say an enterovirus  vaccine is a public health priority because mortality rates with enterovirus 71 are as high as 82—94% in severe cases and the incidence of hand, foot, and mouth disease seems to be increasing across the Asia region
As a result of our findings, the adjuvant 320 U formulation has been selected for larger multicentre, randomised, double-blind, placebo-controlled trial in about 10 000 participants aged six—35 months.
Source: Lancet

Parents angry as children used in secret trial of vaccine for hand foot and mouth disease

Angry parents have accused a township health service center in Taixing, Jiangsu Province, of using their children as guinea pigs after it was found to have injected more than 100 of them with vaccines still under clinical trial.
Both the health center in Fenjie Town and the Taixing City Disease Control Center admitted that the vaccine was not yet on the market but insisted that the trial had been approved by parents, the Modern Express reported yesterday.
However, parents said they had no idea it was a trial when their children took part in January last year.
Li Wei said the center had asked him to bring his two-year-old daughter to have a free hand-foot-and-mouth disease vaccine a year ago. He understood that 200 children would be taking part in the inoculation program.
"I felt confused as I was told my daughter needed to have blood tests regularly after the inoculation," Li said.
Li told the newspaper that his daughter had tested positive in two blood tests, but the newspaper did not specify what the tests were for.
He told reporters he searched online and found that the vaccine had not been approved for use but was still under clinical trial.
Another parent, Fang Yun, told the newspaper that her daughter had contracted hand-foot-and-mouth disease two months ago and said a worker at the center had told her secretly that the vaccine had some problems.
"No one ever told me it was a trial," Fang said.
An official surnamed Gu at the center told the newspaper the program was nationwide and the center was just one of many places where it was carried out. The trial was conducted with the approval of parents, Gu added.
Yao Genhong, an official with the disease control center, said parents had all signed on agreements for the project, but he failed to provide any documentation when asked.
Source: china.org