Times of India: The Serum Institute of India (SII) has received permission from the Drug Controller General of India (DCGI) to market its injectable vaccine against the swine flu. The vaccine, to be marketed under the brand name Enzavac, is likely to be available in the market in a two weeks. A single dose vaccine can be administered to anyone above the age of three.
The intra-muscular H1N1 vaccine (injectable) passed the safety norms in the first phase of the human trial. In the second phase, the antibody-producing capacity of the vaccine in humans was evaluated and it was found to be good on that front as well. The reports of both trials were scrutinised by the DCGI. “We received the formal approval to market the injectable vaccine on July 23. The vaccine is likely to be available in two weeks,” said Prasad Kulkarni, additional director of SII.
The vaccine is a whole-virion inactivated vaccine. It is liquid of 0.5ml, is egg-based and a single intra-muscular dose is recommended for children above three years, adults and the elderly.
“The virus is killed and cannot cause any infection but at the same time retains its antibody-producing capacity,” said Kulkarni. “As a result, the vaccine induces systemic immunity (circulating antibodies in the blood) against the H1N1 virus in the majority of people,” he added.
In June, India unveiled its first-ever indigenous vaccine VaxiFlu against the H1N1 virus a multidose intra-muscular vaccine created by Ahmedabad-based pharmaceutical company Zydus Cadila. A few weeks later, the Serum institute launched its intra-nasal multidose vaccine, NasoVac.
“Unlike multidose vaccines, the intra-muscular vaccine will be a single dose vaccine,” said Kulkarni.
Inactivated vaccines are preferred in the case of immunocompromised people and pregnant woman and breastfeeding woman. People who are allergic to eggs should not take the shot.