The Serum Institute of India has manufactured a
vaccine that can tolerate temperatures upto 40°C for upto 3 weeks. This
miraculous vaccine is called MenAfriVac and was developed for mass
immunization against Meningococcus A in Africa. The desperate need for
such a vaccine was felt when a massive epidemic of meningococcemia swept
Africa between 1996 and 1997 affecting more than 250,000 patients
annually, and killing up to 25,000 persons every year. Funded largely by
the Bill & Melinda Gates Foundation, and developed by Dutch and US
researchers, the Serum Institute of India was commissioned to
manufacture it.
This vaccine does not require the rigorous cold chain
that is vital for most vaccines. It uses a technology called controlled
temperature chain (CTC) that has been developed to provide vaccines in
remote areas where cold chain maintenance may not be possible due to
erratic electricity supply and lack of ice manufacturing capability.
Using a CTC, the MenAfriVac meningitis A vaccine and its diluent can be
removed from the 2-8°C cold chain for a single period of time not
exceeding four days. During this period, it can be stored, transported
and administered at temperatures up to 40°C. A peak threshold indicator
card, placed inside the vaccine carrier, will inform teams and staff if
peak temperatures of 40°C are reached. Because the health worker need
not return to the health center every night, more people in remote areas
can be reached. It is estimated that CTC approach can reduce the cold
chain-related campaign costs by 50 per cent. For the remaining
MenAfriVac campaigns between 2014 and 2016, the savings would translate
to over $12 million dollars. Since it is manufactured in India, the cost
of one dose is Rs 36/- or just 60 cents as against $5 for the
polysaccharide vaccine previously used. A trial comparing use of the
vaccine with CTC versus standard cold chain maintenance in rural
Benin has been recently published in the journal Vaccine. Neither
group had a case of meningitis A, and the vaccine remained viable at
temperatures as high as 39°C. (The Hindu 5 March 2014;
http://apps.who.int/iris/bitstream/10665/86018/1/WHO_IVB_13.04_eng.pdf)
The Quality of Indian Drugs
Surprise checks conducted by the Central Drugs
Standard Control Organisation (CDSCO) to test the quality of drugs on a
monthly basis last year has found that 2.3% of the drug samples were
sub-standard. No spurious drugs were detected. The surveillance report
was released by the central drug regulator possibly in response to
various reports in American media casting doubts on Indian drug quality.
Last month a group of US academicians and doctors briefed American
Congress on the perils of sub-standard drugs from India. The Indian
pharmaceutical industry has reacted strongly to these ‘sweeping
generalizations’, and asked that specific details of sub-standard drugs
– and the specific companies – be made public.
Of 1123 drugs tested by the DCGI (Drug Controller
General of India), 26 failed to qualify. Highest number of sub-standard
drugs were found in Jammu and Kashmir with 17% failing quality checks
and the next highest offender was Himachal Pradesh where 7% of drugs
were of inferior quality. (The Hindu 10 March 2014; The Economic
Times 20 March 2014)
Doubts About ‘Landmark’ Stem Cell Research Paper
Weeks after a landmark paper was published in Nature
in January this year, doubts about its authenticity began surfacing. The
paper described a simple acid bath method to reprogram mature mammalian
cells into pluripotent stem cells. The paper was criticized for
irregularities and apparent duplicated images. Numerous scientists also
had difficulty reproducing the supposedly simple method.
The lead author of the RIKEN Center for Developmental
Biology in Kobe, Japan is a lady scientist in Japan’s male-dominated
scientist community. The Nature paper was found to contain two
images apparently duplicated from Obokata’s doctoral dissertation. Her
thesis also reported experiments dealing with cells that were supposedly
in an embryonic state, but the cells reported in the Nature paper
were said to be derived from a different process in an altogether
different experiment. Nature has refused comment on the subject but is
conducting its own evaluation. The whole episode just highlights the
pressures for breakthroughs in this highly competitive field. (The
Hindu 3 April 2014).