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The production process has begun in three Indian companies – Pune-based Serum Institute, Hyderabad’s Bharat Biotech and Delhi’s Panacea Biotech. All received vaccine seeds from the World Health Organisation (WHO). The Pune firm is in the most advanced stage as it has started the animal trials.
Pune firm ahead
Serum Institute is one of WHO’s accredited agencies to manufacture vaccines against H5N1 (avian influenza) as well. Its manufacturing capacity was upped with WHO finance.
A commercial Indian vaccine will take four to seven months to realise, said V M Katoch, Director General of ICMR.
Though a vaccine normally takes a minimum of one and a half to two years to go through the regulatory processes, considering the pandemic nature of the epidemic, a global debate is on to find ways to cut down the time required for regulatory approval without compromising on the safety and efficacy of the vaccine.
“By August end, the international guideline should be in place. Then we will modify our guidelines accordingly,” Katoch told Deccan Herald.
“Safety and efficacy of the vaccine will be tested both on animals and humans before the vaccine is released in the market,” he said, adding that the centre has already issued advertisements seeking healthy volunteers for H1N1 vaccine.
Influenza vaccines are one of the most effective ways to protect people from contracting illness during influenza epidemics and pandemics.
Making new influenza vaccines ready to immunise people typically takes five to six months after first identification of the pandemic virus. The virus causing the influenza (H1N1) pandemic virus was identified at the end of April 2009.
Internationally, the very first doses of influenza A (H1N1) vaccine usable to immunise people, from one or more manufacturers, are expected as early as September 2009. Three global players Sanofi-Aventis, Novartis and an Australian company named CSL have started human trials of their H1N1 vaccines.
Call it homestay!
The word ‘quarantine’ originates from the Italian quaranti giorni, meaning ‘forty days’. When plague broke out in the 13th century, it was declared as “Black Death”, which wiped out an estimated 30% of Europe’s population, as well as a significant percentage of Asia’s population. The Archieves of Dubrovnik from 1377, states that newcomers, before entering the city had to spend 30 days (a trentine) in a restricted location, mainly nearby islands, waiting to see whether the symptoms of plague would develop. Later, isolation was prolonged to 40 days and was called “quarantine”. Now, quarantine is used to describe isolation of H1N1 Influenza patients in hospital or at home for a mere 7 days. It should typically be called ‘homestay’ and not quarantine.
Second line of drug
There have been more than six cases around the world who developed resistance to Oseltamivir (Tamiflu) after being tested positive for H1N1 Influenza. This is when repeated throat swab samples show positive despite administering the antiviral drug. However, fortunately, there is a second line of drug zanamivir (Relenza) which is cheaper than Tamiflu.