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SEC recommends Serum Institute’s hexavalent vaccine for marketing authorisation

Our Bureau, New Delhi
Wednesday, June 22, 2022, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC) of the drug control organisation, which looks into the applications on vaccine approvals, has recommended grant of marketing authorisation permission of hexavalent vaccine of Serum Institute of India.

The company has presented its proposal for the grant of marketing permission of the hexavalent (DTwP-HepB-IPV-Hib) vaccine to the SEC earlier, along with the phase II/III clinical trial report.

After detailed deliberation, the committee recommended the grant of marketing authorisation of the vaccine, according to the minutes of the SEC meeting held earlier this month.

The vaccine is expected to address diphtheria toxoid (D) and tetanus toxoid (T) in combination with whole-cell Pertussis (wP), haemophilus influenzae type b conjugates (Hib), hepatitis B (HepB) and inactivated polio vaccine (IPV).

It may be noted that Serum Institute, in 2018, has entered into an agreement with Panacea Biotec to manufacture and sell a Hexavalent vaccine in this nature, a fully liquid whole cell Pertussis (wP) and salk based injectable polio vaccine (IPV) based hexavalent vaccine (DTwP-HepB-Hib-IPV) developed and commercialised by Panacea Biotec.

Serum has also received a favourable recommendation from the SEC, in the same meeting, for its quadrivalent Human Papillomavirus Vaccine (qHPV) to treat cervical cancer.

The company presented its proposal for grant of marketing authorisation permission for the recombinant qHPV vaccine along with phase II/III clinical trial report before the SEC. During the meeting, the committee also reviewed the prescribing information of the vaccine.

“After detailed deliberation, the committee recommended for the grant of marketing authorisation permission of quadrivalent Human Papillomavirus Vaccine (Recombinant) (qHPV) for the age group of 9-14 years, twos-doses schedule (0 and 6 months) and for age group of 15-26 years, three dose schedule (0, 2 and 6 months) with the condition to carry out Post Marketing Surveillance (PMS) study,” said the SEC minutes.

The vaccine, Cervavac, reportedly demonstrated robust antibody response above the baseline against all the HPV types which were targeted. Cervical cancer is one of the most prevalent cancers among women between the age of 15 and 44 years in the country.

The approval of the vaccine also gains significance as this is the first qHPV vaccine against cervical cancer, developed in the country, while there are drugs from international firms available in the country.


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