A New Vaccine

What is the issue?

A new vaccine manufactured by Pune-based Serum Institute of India has shown 66.7% efficacy against severe rotavirus gastroenteritis among infants in Niger in West Africa. 

What is special about Serum Institute’s new rotavirus vaccine?

• Serum Institute of India is the world’s largest vaccine maker, producing and selling more than 1.3 billion doses globally every year.
• Rotavac, a rotavirus vaccine produced by Hyderabad-based Bharat Biotech, became part of India’s Universal Immunisation Programme (UIP) when it was introduced in 4 states in April 2016, and was subsequently extended to 5 more states last month.
• The key step forward in the manufacture of Serum Institute of India’s new BRV-PV vaccine — to be ultimately called Rotasiil — is that it does not, unlike Rotavac, require refrigeration, and is, therefore, easier to store in low-income countries where rotavirus poses the greatest threat to children.
• BRV-PV has completed Phase III trials in Niger, and shown good efficacy in heat-challenge conditions.
• This trial brings a vaccine which is adapted to African settings to those who need it most.
• The Institute had decided to develop a heat-stable vaccine to overcome the absence of cold chains in many poor countries.

What challenges does the global immunisation programme face?

• According to the World Health Organisation, vaccines prevent an estimated 2 million to 3 million deaths every year, but an additional 1.5 million deaths could be prevented if the global immunisation cover improved.
• In 2015, an estimated 19.4 million infants worldwide did not receive routine immunisation.
• A special supplement to Vaccine, a peer reviewed medical journal, noted with concern that outdated vaccine supply and distribution systems were delaying and limiting the impact that vaccines have in safeguarding people’s health.
• According to one study in the Vaccine collection, every year, 1 in 3 countries worldwide experiences a stockout of at least 1 vaccine for a minimum of 1 month, and the problem is most pronounced in sub-Saharan Africa.
• Many vaccines can lose potency if exposed for too long to temperatures outside the recommended range of 2 degrees to 8 degrees Celsius.
• The vaccine ‘cold chain’ strives to maintain proper temperatures for vaccines from manufacturing facilities to storage facilities, health centres, and immunisation clinics.
• Each year, rotavirus gastroenteritis is responsible for about 37% of deaths from diarrhoea among children younger than 5 years of age worldwide, with sub-Saharan Africa bearing a disproportionate burden. The BRV-PV vaccine has the potential to reduce this burden.

When will the vaccine be sold in India, and at what cost?

• The vaccine is already licensed in India, and is under the WHO pre-qualification process.
• Once approved, low-income countries will be able to procure the vaccine at an affordable price and make it available to their populations.
• Serum Institute plans to produce around 60 million doses to begin with, and hopes to roll out the vaccine in August- September this year.
• The cost is likely to be under $ 2 — between Rs 100 and Rs 120 — per dose.

Source: Business Standard