4. Handout_Anemia-Nutrition-HBV vaccine_Naowanit_24 June 2022 (1)

LG recombinant Hepatitis B vaccine  Approved in Korea in 1992, and supplied for 29 years and Pre-qualified by WHO in 1996  Supplied to UN agencies for over 20 years ; UNICEF & PAHO  Partnered with Sanofi Pasteur for distribution in 40 countries since 2001  >900M doses used in over 80 countries [ Countries where Euvax BTM, hepatitis B vaccine has been marketed ] Central & Eastern Europe (13 countries) Albania, Bosnia & Herzegovina, Bulgaria, Estonia, Latvia, Lithuania, Malta, Poland, Macedonia, Romania, Slovakia, Serbia, Montenegro Russia & CIS (11 countries) Armenia, Azerbaijan, Belorussia, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Turkmenistan, Ukraine, Uzbekistan Latin America (21countries) Argentina, Aruba, Bolivia, Brazil, Chile, Colombia, Costa Rica, Curacao, Dominican Republic, Ecuador, El Salvad, Guatemala, Haiti, Honduras, Jamaica, Mexico, Panama, Paraguay, Peru, Uruguay, Venezuela Asia (17 countries) Austrailia, Bangladesh, Brunei, Cambodia, India, Indonesia, Korea, Laos, Malaysia, Macao, Myanmar, Nepal, Pakistan, Philippines, Sri Lanka, Thailand, Vietnam Middle East (8 countries) Egypt, Iraq, Iran, Jordan, Morocco, Syria, Turkey, Yemen Africa (24 countries) Benin, Botswana, Burkina-Faso, Cameroon, Central African Republic, Chad, Congo, Democratic Republic of Congo, Ethiopia, Gabon, Guinea, Ivory Coast, Kenya, Madagascar, Mali, Mauritania, Mauritius, Niger, Nigeria, Republic of South Africa, Senegal, Tanzania, Togo, Tunisia, Uganda

HBV Vaccine in Thailand Trade name Euvax-B Engerix B Heberbiovac HB Bevac Hepatitis B vaccine Manufacturer LG Chem GlaxoSmithKline (GSK) Heber Biotec Pharmadica Biological E. Limited Serum Institute of India Distributor DKSH Zuellig Pharma (BE) (SII) Biogenetech Masu Country Korea Belgium Cuba India India Approved age Children ≤ 15 yr Children ≤ 19 yr Children ≤ 10 yr Children ≤ 10 yr Adult ≥ 10 yr Adult > 15 yr Adult >19 yr Adult > 10 yr Adult > 10 yr Presentation 0.5 ml x 1’s 0.5 ml x 1’s 0.5 ml x 10 × 1's 0.5 ml x 10 × 1’s 1 ml x 50 x 1’s 1 ml x 1’s 1 ml x 1’s 1 ml x 10 × 1’s; 1 ml x 10 × 1’s 1 ml x 25 × 1's Preservative Thimerosal-free Thimerosal-free Thimerosal Thimerosal Thimerosal Shelf life 3 years from date of 3 years from date of 4 years from date of 3 years from date of 2 years from date of manufacture manufacture manufacture manufacture manufacture Adjuvant Aluminium Hydroxide Aluminium Hydroxide Aluminium Hydroxide Aluminium Hydroxide Aluminium Hydroxide Yeast cells (Al3+) (Al3+) (Al3+) (Al3+) (Al3+) WHO Pre- qualified Saccharomyces Saccharomyces Pichia pastoris Pichia pastoris Hansenula polymorpha cerevisiae cerevisiae Yes Yes Yes No Yes

Clinical Data of LG Recombinant Hepatitis B Vaccine Evaluate the immunogenicity of 4 recombinant hepatitis B vaccine: LG HB, GSK HB, GreenCross HB and Butantan HB in Brazil during February 2001 to April 2002 A total of 316 students aged 17-19 years (LG HB = 71, GSK HB = 83, GreenCross HB = 85, Butantan HB = 77) on a 0-1-5 schedule Jose Luis da Silveira Baldy et.al. Rev. Inst. Med. trop. S. Paulo 46(2)_103-107_Mar-Apr2004

Clinical Data of LG Recombinant Hepatitis B Vaccine Seroconversion rate The GMT of anti-HBs after the third doses Percentage 97.6 96.2 mIU/mL 2009.09 2070.14 96.5 85.8 100 98.6 2500 1729.82 89.2 89.4 95 2000 91.6 1500 90 1000 727.78 85 500 80 GSK HB vaccine Greencross HB vaccine Butantan HB vaccine 0 GSK HB vaccine Greencross HB Butantan HB vaccine LG HB vaccine vaccine 75 LG HB vaccine  Similar seroconversion rate for 4 recombinant hepatitis B vaccines both normal criteria (anti-HBs > 10 mIU/mL) and good responders (anti-HBs > 100 mIU/mL).  The GMT of anti-HBs induced by the LG and GSK hepatitis B vaccines were higher than other hepatitis B vaccine  No spontaneous adverse effects attributable to the application of any dose of the four vaccines were reported. Jose Luis Da Silveira BALDY et. Al., Rev Inst. Med. Trop. S. Paulo 46(2):103-107, Mar-Apr 2004

Clinical Data of LG Recombinant Hepatitis B Vaccine  To evaluate the response to LG recombinant hepatitis B vaccine in hemodialysis patient and staff from April 1998 to November 1999 in Brazil.  The first group consisted of 42 chronic renal patient. The vaccine was administered in four consecutive doses of 40 ug at 0,1,2, and 6 months interval.  The other group was healthy staff (n=60). All of staff was vaccinated in three doses of 20 ug at 0, 1 and 6 months. S.A. Teles, et.al. European Journal of Epidemiology. 17:145-149,2001

Clinical Data of LG Recombinant Hepatitis B Vaccine Hemodialysis patients Staff 100 89.5 100 48.4 93.3 90 90 4th dose 80 2nd dose 3rd dose Rates of anti-HBs response*(%) 70 Rates of anti-HBs response*(%)80 60 50 70 40 60 57.5 30 20 50 10 3.3 0 40 30 23.8 1st dose 20 10 7.2 0 2nd dose 3rd dose 1st dose *anti-HBs > 10 mIU/mL  In this study, using four dose intervals of 40 ug, about 90% of the patients responded to LG recombinant hepatitis B vaccine. The 93.3% of the healthcare workers responded to the LG recombinant hepatitis B vaccine.  Mhaovset coofnthtreibpuatteiednttos awgeoroedonvahcecminoedrieaslypsoinsstereinatomuernhtefmoroldeisaslythsiasnp3atmieonnttsh. s. Thus, these conditions could S.A. Teles, et.al. European Journal of Epidemiology. 17:145-149,2001

Recommended Vaccines for Adults with CKD LG Recombinant Hepatitis B Vaccine Haddiya I. Current Knowledge of Vaccinations in Chronic Kidney Disease Patients. Int J Nephrol Renovasc Dis. 2020 Jul 27;13:179-185.

Outlines Hepatitis B virus (HBV) Hepatitis B immunization and recommendation LG Chem recombinant hepatitis B vaccine

Summary: “SET the Right Targeting” Supply from Plant to Patient Efficacy to achieve the WHO goal of immunization Trust in Safety Profile and rDNA technology

Thank You for Your Attention Lt. Col. Naowanit Nata, MD Nephrology Division, Department of Medicine Phramongkutklao Hospital & College of Medicine