Vaccine Storage & Stablity.

1. Rungta College of Pharmaceutical Sciences & Research.
Topic- Storage conditions & stability conditions of OfficialVaccines.
Presented By-
Abhimanyu Awasthi.
307204119301

2. List of various availableVaccines.
Available vaccines
•Cholera- Oral cholera vaccines (OCV): Dukoral®, Shanchol™,
and Euvichol®.
•Dengue- Dengvaxia (CYD-TDV) .
•Diphtheria- DTwP/DTaP.
•Hepatitis- HbV
•Haemophilus influenzae type b (Hib): HiB Conj-V
•Human papillomavirus (HPV): HPV recombinant vac.
•Influenza- Flu Shot.
•Japanese encephalitis- JEV(IXIARO)
•Malaria- Mosquirix
•Measles- MMR
•Meningococcal meningitis- MCV
•Mumps- MMR
•Pertussis- DPT
•Pneumococcal disease- PCV
•Poliomyelitis- Inactivated PV
•Rabies- Human DiploidCultureV
•Rotavirus- RotaTeq
•Rubella-MMR
•Tetanus- DPT
•Tick-borne encephalitis-TBEV
•Tuberculosis- BCG
•Typhoid-Vivotif (Ty-pills)
•Varicella-VV
•Yellow Fever-YF-VAX

3. Coronavirus/ COVID-19Vaccines
RNA vaccines
 Pfizer–BioNTech- Corminaty
 Moderna – mRNA 1273, Spikevax
Protein sub vaccines
 EpiVacCorona-Peptide BasedVaccine
 ZF2001-ZIFIVAX
Inactivated virus vaccines
 Sinopharm (BBIBP)-BBIBP-CorV
 CoronaVac- Sinovac
 Covaxin- BharatBioTech, ICMR
 Sinopharm (WIBP)-WIBP-CorV
 CoviVac- CHUMAKOV
 QazCovid-in- QazVac
Adenovirus vector vaccines
 Oxford–AstraZeneca – Covidsheild /Vaxzevira

single dose
SputnikV- Gamaleya
 Johnson & Johnson- Jansen covid-19 vaccine.

single dose
Convidecia- AD5-nCOV

single dose
Sputnik Light- AD26Vector.

4. List ofVaccines under Pipeline Development.
Pipeline vaccines
•Campylobacter jejuni
•Chagas Disease
•Chikungunya
•Enterotoxigenic Escherichia coli
•Enterovirus 71 (EV71)
•Group B Streptococcus (GBS)
•Herpes SimplexVirus
•HIV-1
•Human Hookworm Disease
•Leishmaniasis Disease
•Malaria
•Neisseria gonorrhoeae
•NipahVirus
•Nontyphoidal Salmonella Disease
•Norovirus
•Paratyphoid fever
•Respiratory SyncytialVirus (RSV)
•Schistosomiasis Disease
•Shigella
•Staphylococcus aureus
•Streptococcus pneumoniae
•Streptococcus pyrogenes
•Tuberculosis
•Universal InfluenzaVaccine

5. Storage Conditions for differentVaccines.
• Stand- alone units are recommended; self-contained units that only refrigerate or freeze, and are suitable for
vaccine storage.35° F and 46° F ( -2° C and 8 ° C)
• While CDC does not recommend specific brands of vaccine storage units, CDC does provide guidance on
types of storage units that offer greater assurance of proper temperatures for vaccine storage based on
equipment testing by the National Institute of Standards and Technology (NIST).
• CDC recommends stand-alone units, meaning self-contained units that only refrigerate or freeze, and are
suitable for vaccine storage. These units can vary in size, from compact, under-the-counter style to large,
stand-alone, pharmaceutical grade units.
• Have enough room to store water bottles (in the refrigerator) and frozen coolant packs (in the freezer) to
stabilize the temperatures and minimize temperature excursions that can impact vaccine potency. The
addition of water bottles in the refrigerator (not coolant packs) reduces the risk of freezing due to the
tremendous latent heat released from water prior to freezing;Have a calibrated thermometer inside each
storage unit.
• Reliably maintain the appropriate vaccine storage temperatures year-round;Be dedicated to the storage of
vaccines. Food and beverages should NOT be stored in a vaccine storage unit because this practice results
in frequent opening of the door and destabilization of the temperature.-50° F and – 15° F ( -58° C and + 5 °
C).

7. Refrigerator and FreezerVaccine Storage Guidelines
• Storing: Place vaccines in breathable plastic mesh baskets.
• Label each basket with vaccine type. Keep labeling methods consistent across all baskets.
• Store empty shelves and doors with full water bottles (refrigerator) or frozen packs (freezer)
and label as ‘DO NOT USE’. Place a recommended temperature monitoring device in the
unit.
• Place a warning sign on the storage unit that says, ‘Do not adjust refrigerator or freezer
temperature controls.’ Store vaccines with similar packaging and names (e.g., HB and Hib
orTdap andTd) in dierent locations of the unit. Keep vaccines in their original packaging to
protect against exposure to light.
• Always store foods in a separate unit. Frozen vaccines must be stored in a frost-free freezer.
• Do not use bar-style fridges or freezers and/or cyclic defrost freezers, as they can result in
significant temperature variations in the unit. Maintenance:
• Review expiration dates regularly and rotate vaccines with closer expiration to the front to
be used first.
• Remove expired vaccines from the unit and label them as expired. Monitor vaccine storage
to prevent shortage and over-ordering during low- and high-season demands.

9. Stability of vaccines.
Stability is the ability of a vaccine to retain its chemical, physical, microbiological and biological
properties within specified limits throughout its shelf-life.
Factor affecting stability of vaccines.
• Purity
• Formulation
• Stabilizers eg- Human Serum Albumin (HAS), recombinant human Albumin (rHA), Gelatine, Sugars,
SorbitolThiomersal AlOH,AlPO Ions (Buffer systems) .
• Pharmaceutical form Lyophylized versus liquid .
• Storage Frozen versus refrigerator.

10. Types of StabilityTesting.
• RealTime Stability-RealTime Stability:
• Long term: Long term stability under recommended storage stability under recommended storage
conditions for the shelf life proposed for the product.
• AcceleratedTesting Studies under exaggerated storage conditions.
• Stress studies- More severe conditions than those used for conditions than those used for
accelerated studies.

11. THANKYOU.