Thursday, 6 October 2016

Dengue vaccine approved for use in Singapore on 4 Oct 2016; Drug giant Sanofi raises alert on harm from dengue vaccine, 29 Nov 2017

It works better for those infected before, and is less effective against common strains here
The Straits Times, 5 Oct 2016

The world's first dengue vaccine has been given the green light by the Health Sciences Authority (HSA), and will be available here in a few months.

The vaccine is most effective in people who have had dengue before and - underscoring the difficulty of vaccinating against a virus that has four distinct strains - is less effective against the two strains that are more common here.

But experts say it still holds promise against the mosquito-borne virus, which had infected 12,054 people (as of 3pm yesterday) so far this year, surpassing the number for the whole of last year.

The HSA, which has been studying the vaccine since March, fast-tracked its approval process because of public health concerns.

The decision to approve Dengvaxia was based on 24 studies conducted by vaccine manufacturer Sanofi Pasteur, which involved more than 41,000 people and showed the vaccine to be safe for use and effective against dengue.

Given in three doses over a year, the vaccine is approved for use in those aged between 12 and 45. Those outside this age group can be vaccinated if they so wish, but should seek a doctor's advice first.

Before the vaccine becomes available, the HSA will be embarking on efforts to educate doctors and the public on the benefits and limitations of the vaccine.

For people aged two to 16, Dengvaxia was shown to reduce the number of dengue cases by 60 per cent as compared with those who had not been vaccinated. This figure went up to 84 per cent when it came to preventing severe dengue infections in the same age group.

Additional studies showed that the vaccine was effective up to age 45, said the HSA yesterday.

But, though formulated against all four strains of the virus, the vaccine is less effective against the Den-1 and Den-2 strains, which account for three-quarters of the dengue cases here. Its efficacy is 50 per cent and 40 per cent respectively, compared with 75 per cent and 77 per cent for the other two strains.

Studies also showed that the vaccine provided better protection for those who had been exposed to the dengue virus than for those who had not, with efficacy at 81 per cent and 38 per cent respectively.

How much Dengvaxia reduces dengue infections will depend on how many people choose to be vaccinated, said Professor Ooi Eng Eong, deputy director of the emerging infectious diseases programme at Duke-NUS Medical School. "The larger this number, the greater impact vaccination would have on reducing the number of dengue cases in Singapore," said Prof Ooi, who is also a scientific advisory board member on dengue for Sanofi.

Professor Tikki Pang, a visiting professor at the Lee Kuan Yew School of Public Policy, said even if the vaccine is not as effective as hoped, it still presents a learning opportunity. "If you can prevent a certain number of cases, that, to me, is already worth it," he said.

Who should consider vaccination
By Linette Lai, The Straits Times, 5 Oct 2016

Should you be vaccinated against dengue? Here are some potential scenarios to help you decide.

If you are a 40-year-old man who has had dengue before: Yes, you could consider the vaccine. Although you have had dengue before - the strain you had should be in your medical records - you might still contract another strain. Getting vaccinated could protect against future infections and severe dengue.

If you are a 19-year-old woman who is not sure if you have had dengue before: You should talk to your doctor about potential risks and benefits, as the vaccine offers more protection to those who have been infected with dengue before.

Your doctor may recommend that you undergo a blood test to determine if you have had a previous dengue infection.

If you are a 25-year-old man who is very sure you have never had dengue: You should talk to your doctor about the potential risks and benefits of getting vaccinated, so you can make an informed decision. If you are a 34-year-old woman who lives in an active dengue cluster, and would like to get vaccinated to protect yourself against the outbreak: The vaccine is administered in three doses over a year, so you will not be able to get immediate protection against the dengue outbreak just by getting vaccinated.

However, you may still want to get vaccinated to protect yourself against future infections.

What you need to know about the new dengue vaccine
By Linette Lai, The Straits Times, 5 Oct 2016

Q Will the new dengue vaccine help to protect me against all the different strains of dengue?

A Yes, but to a different extent depending on the strain. Against Den-1 and Den-2, which are the more common dengue strains in Singapore, vaccine efficacy is 50 per cent and 40 per cent respectively. The figures are 75 per cent and 77 per cent for Den-3 and Den-4.

Q Why is the vaccine not recommended for children under 12?

A In clinical trials, children aged between nine and 11 were vaccinated against dengue.

Those who still contracted dengue infections afterwards had a 30 per cent higher risk of hospitalisation. Also, the children had three times the risk of developing severe dengue. These effects were not observed in those aged 12 and above. In fact, the risk of hospitalisation was reduced for the older age group after vaccination.

Q Why is vaccination not recommended for those aged above 45?

A A study conducted in Australia showed that people aged 46 to 60 had a very low antibody response to the vaccine, meaning that it is likely to be less effective at protecting people in this age group from dengue.

Q How much more effective is the vaccine in people who have had dengue before?

A If you have had dengue, the vaccine's efficacy is 81 per cent. However, if you have not been infected with dengue before, this figure is only 38 per cent.

Q What are the side effects of the dengue vaccine, and how long do they last?

A They include soreness at the injection site, a low-grade fever, headaches and muscle aches. These are similar to the side effects of other approved vaccines. The vaccine, which is administered in three doses over a year, is still being studied.

Results so far have shown that it is effective up to four years from the administration of the last dose.

Q When will Dengvaxia be commercially available, and how much will it cost?

A The Health Sciences Authority has said the vaccine will be made available in several months' time, although it did not give a specific timeline.

The maker, Sanofi Pasteur, has not disclosed how much it will cost. Its head of global medical affairs, Dr Su-Peing Ng, has said it will make the vaccine "as commercially accessible as possible".

Q Will the vaccine be subsidised when it becomes commercially available?

A No. The Health Ministry has said the vaccine will not be part of a national vaccination programme because it would not be a "clinically and cost-effective means to tackling dengue infection in Singapore". This means that the vaccine will not be subsidised, and you cannot use Medisave to pay for it.

* Dengue vaccine Dengvaxia can be dangerous for those not previously infected, says manufacturer, Sanofi
By Salma Khalik, Senior Health Correspondent, The Straits Times, 1 Dec 2017

Dengvaxia, a dengue vaccine available here since March, could prove harmful to people who have never been infected by dengue.

Sanofi Pasteur, which produces the vaccine, sent out an alert saying: "For those not previously infected by dengue virus, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection."

The French pharmaceutical giant said it will ask authorities in countries where it has been approved for use, such as here, to update their information on the vaccine, and to disseminate it to doctors and patients.

A spokesman for the Health Sciences Authority (HSA) said yesterday it is working with Sanofi Pasteur to "strengthen the package insert" to include the warning of an increased risk of hospitalisation for dengue and clinically severe dengue in vaccinated individuals not previously infected by dengue.

The insert will also contain advisories on an assessment of prior dengue infection in individuals before vaccination, and that vaccination should not be recommended in individuals who have not been previously infected with dengue.

The new findings come from six years of clinical data, said Sanofi Pasteur in a statement in Paris. However, for those who had been previously infected, it "provides persistent benefit against dengue fever".

Dr Ng Su Peing, global medical head of Sanofi Pasteur, said: "These findings highlight the complex nature of dengue infection."

Dengvaxia, the world's first dengue vaccine, was approved by HSA for use among patients aged between 12 and 45, and requires three doses to be administered over 12 months by injection. Sanofi expects the new information to impact its business to the tune of €100 million (S$160 million) after tax.

** Healthcare professionals in Singapore issued advisories on risk of dengue vaccine Dengvaxia: HSA
By Felicia Choo, The Straits Times, 7 Dec 2017

Healthcare professionals here have been issued advisories on a dengue vaccine which could be harmful to people not previously infected by the virus.

The Health Sciences Authority (HSA) said in response yesterday to queries from The Straits Times that all healthcare professionals here have been issued advisories on the vaccine, Dengvaxia.

The authority added that it will further strengthen the warnings and recommendations in the prescribing information of the vaccine, as well as closely monitor it to ensure its continued safety and efficacy.

The manufacturer, French pharmaceutical giant Sanofi Pasteur, said Dengvaxia was found to have a possible harmful effect when used on people who did not previously have dengue. Those who were vaccinated and later became infected could have "more cases of severe disease", Sanofi said last month.

When asked, HSA said there was one report of a male patient who developed a rash three days after being vaccinated, but he has since recovered. It has had no other reports of adverse reactions to Dengvaxia.

The world's first dengue vaccine, Dengvaxia has been available in Singapore since March, after HSA approved its use in patients between 12 and 45 years old in October last year.

Back then, HSA flagged the potential risk of severe dengue after reviewing data from Sanofi. It informed healthcare professionals of the risk and recommended that patients consult doctors before getting the vaccine. Educational materials and the package insert of Dengvaxia carried information on the risk.

Blood tests to identify previous dengue infection were also made available at major hospitals here.

HSA said it is now working with Sanofi to "strengthen the package insert" to include a warning of an increased risk of hospitalisation for dengue and clinically severe dengue in vaccinated people not previously infected by dengue.

However, in its alert, Sanofi had added that for those previously infected, Dengvaxia "provides persistent benefit against dengue fever".

HSA noted that dengue vaccination is not part of the national immunisation programme, meaning the vaccine is given to individuals only when the benefits outweigh the risk.

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