4/26/2016

Polio: Off-label use of IPV vaccine to tide over shortage

IPV vaccine
THE MANUFACTURERS HAVE CONFIRMED THAT THEY WILL NOT RAISE OBJECTIONS TO THE USE OF IPV OFF-LABEL FOR INTRADERMAL USE.
Due to shortage of Inactivated Polio Vaccine (IPV) globally, India and a few other countries are stretching the supply of the vaccine to cover all children. The IPV vaccine was introduced into the routine immunization programme in India from November 30, 2015.
To tide over the shortage, children in Puducherry and seven States (Andhra Pradesh, Karnataka, Kerala, Maharashtra, Odisha, Tamil Nadu and Telangana) will get two doses of 0.1 ml each at 6 and 14 weeks and administered intradermally. Children in the rest of the country will get 0.5 ml of the vaccine at 14 weeks administered intramuscular.
The vaccine has been licensed by the manufacturers only for intramuscular use and not for intradermal administration. The Global Polio Eradication Initiative (GPEI) has, however, permitted the use of the vaccine intradermally as only one-fifth of the vaccine will be required to vaccinate a child.
“The manufacturers have confirmed that they will not raise objections to use of their product off-label. The final decision, however, on the use of IPV intradermally will need to be made by each country and its respective regulatory agencies,” says an April 7 Information Note of GPEI. Both the companies have been “requested to fast-track their efforts to file for a licence revision to include a provision for intradermal use.”
The February 26, 2016 meeting of the mini India Expert Advisory Group (IEAG) recommended that in the absence of sufficient IPV supply, the Government of India “should consider implementing a routine immunisation schedule of two fractional doses [of 0.1 ml each] of IPV, administered at 6 weeks and 14 weeks, in six or seven of the high performing States/Union Territories”. The main objective of IEAG in using IPV intradermally was to ensure administration of IPV to all infants.
As of February 2016, Gavi has assured 28.14 million doses of IPV. Domestic procurement from the Hyderabad-based Shantha Biotechnics for the period October 2016 to March 2018 will provide another 24 million doses, leaving a shortfall of 23.42 million doses, notes the IEAG.
“India has no shortage of IPV vaccine but it is a hand-to-mouth supply,” said Dr. Pradeep Haldar, Deputy Commissioner – Immunisation, Ministry of Health and Family Welfare, Government of India. “The supply has to be managed properly till March 2018 by making sure that all 27,000 cold-chain points [across the country] have only one month’s supply”.
The “rapid scale-up of IPV production required has encountered multiple challenges, leading to a global shortage”, according to the Global Polio Eradication Initiative. As a result, about 20 countries that are at low risk for type 2 VDPV will get their first shipment only in the fourth quarter of 2017. And nearly 25 countries that have already introduced IPV and considered at low risk for type 2 VDPV outbreak will not receive additional supply before the fourth quarter of 2017.
The IEAG has recommended reassessment of the use of fractional dose of IPV in seven States and Puducherry after one year and take a decision to either continue in these States and Puducherry or expand it to more States based on the “lessons learnt from the experience and the supply position at that point in time.” It has also asked for studies to be carried out to understand the immunogenicity and protection conferred by two doses of 0.1 ml vaccine in the Indian setting and to guide future continuation or expansion of the use of fractional dose of IPV.

Post Polio Litaff, Association A.C _APPLAC Mexico

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Erradicación de La poliomielitis

Polio Tricisilla Adaptada

March Of Dimes Polio History

Dr. Bruno

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A 41-year-old man developed an acute illness at the age of 9 months during which, following a viral illness with headache, he developed severe weakness and wasting of the limbs of the left side. After several months he began to recover, such that he was able to walk at the age of 2 years and later was able to run, although he was never very good at sports. He had stable function until the age of 18 when he began to notice greater than usual difficulty lifting heavy objects. By the age of 25 he was noticing progressive difficulty walking due to weakness of both legs, and he noticed that the right calf had become larger. The symptoms became more noticeable over the course of the next 10 years and ultimately both upper as well as both lower limbs had become noticeably weaker.

On examination there was wasting of the muscles of upper and lower limbs on the left, and massively hypertrophied gastrocnemius, soleus and tensor fascia late on the right. The calf circumference on the right exceeded that on the left by 10 cm (figure1). The right shoulder girdle, triceps, thenar eminence and small muscles of the hand were wasted and there was winging of both scapulae. The right quadriceps was also wasted. The wasted muscles were also weak but the hypertrophied right ankle plantar flexors had normal power. The tendon reflexes were absent in the lower limbs and present in the upper limbs, although the right triceps was reduced. The remainder of the examination was normal.

Figure 1

The patient's legs, showing massive enlargement of the right calf and wasting on the left

Questions

1
What is that nature of the acute illness in infancy?
2
What is the nature of the subsequent deterioration?
3
What investigations should be performed?
4
What is the differential diagnosis of the cause of the progressive calf hypertrophy?

Answers

QUESTION 1

An acute paralytic illness which follows symptoms of a viral infection with or without signs of meningitis is typical of poliomyelitis. Usually caused by one of the three polio viruses, it may also occur following vaccination and following infections with other enteroviruses.1 Other disorders which would cause a similar syndrome but with upper motor neurone signs would include acute vascular lesions, meningoencephalitis and acute disseminated encephalomyelitis.

QUESTION 2

A progressive functional deterioration many years after paralytic poliomyelitis is well known, although its pathogenesis is not fully understood.2 It is a diagnosis of exclusion; a careful search for alternative causes, for example, orthopaedic deformities such as osteoarthritis or worsening scoliosis, superimposed neurological disorders such as entrapment neuropathies or coincidental muscle disease or neuropathy, and general medical causes such as respiratory complications and endocrinopathies.3

QUESTION 3

Investigations revealed normal blood count and erythrocyte sedimentation rate and normal biochemistry apart from a raised creatine kinase at 330 IU/l (normal range 60–120 IU/l), which is commonly seen in cases of ongoing denervation. Electromyography showed evidence of denervation in the right APB and FDI with polyphasic motor units and complex repetitive discharges, no spontaneous activity in the left calf and large polyphasic units in the right calf consistent with chronic partial denervation. Motor and sensory conduction velocities were normal. A lumbar myelogram was normal. Magnetic resonance imaging (MRI) scan of the calves is shown in figure2.

Figure 2

Axial T1 weighted MRI scan (TR 588 ms, TE 15 ms) of the calves, showing gross muscle atrophy and replacement by adipose tissue on the left, and hypertrophy of the muscles on the right, with only minor adipose tissue deposition

QUESTION 4

The differential diagnosis of the progressive calf hypertrophy is given in the box.

Causes of calf muscle hypertrophy

Chronic partial denervation

  • radiculopathy

  • peripheral neuropathy

  • hereditary motor and sensory neuropathy

  • spinal muscular atrophy

  • following paralytic poliomyelitis

    Neuromyotonia and myokymia

  • Isaac's syndrome

  • generalised myokymia

  • neurotonia

  • continuous muscle fibre activity due to: chronic inflammatory demyelinating polyradiculopathy, Guillain Barre syndrome, myasthenia gravis, thymoma, thyrotoxicosis, thyroiditis

    Muscular dystrophies

    Myositis

    Infiltration

  • tumours

  • amyloidosis

  • cysticercosis

    Link here