Quality Assessment of Some Brands of Tetanus Toxoids Marketed in Open Markets in South-Eastern Nigeria.
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Date
2014-07
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Abstract
Aims: This study was designed to verify the immunogenicity (potency) and the safety of
tetanus toxoid vaccines marketed in three large open drug markets in South-Eastern
Nigeria.
Methodology: Tests for Sterility, formaldehyde concentrations, specific toxicity,
endotoxin, and immunogenicity (potency) were conducted on three different brands of
tetanus toxoids (Brand α - from Ariaria Drug Market, Aba-Abia State; Brand β - from
Ogbete Drug Market, Enugu State; and Brand γ - from Bridge-Head Drug Market,
Onitsha-Anambra State).
Results: All vaccine brands studied passed the sterility testing, but did not comply with
the 2011 BP specifications on free formaldehyde concentration, which stipulates that the
free formaldehyde concentration should not exceed 0.02%. The three vaccine brands did not show specific, abnormal, or general toxicity, but contained different amounts of
endotoxins. The result of the potency testing showed that the three brands were
immunogenic and elicited specific antibodies against tetanus toxin; but brand γ was the
most immunogenic since it elicited the highest titers of total IgG, IgG1, and IgG2a followed
by brand α, and then brand β.
Conclusion: Generally, the quality control tests carried out on these three commercial
brands of tetanus toxoids marketed in Nigeria showed that they do not comply with all the
pharmacopeial standards on quality and safety required for vaccines of this nature.
Therefore, we conclude that some of the tetanus toxoids marketed in open drug markets
in Nigeria are substandard and may be responsible for the failures of these vaccines used
for immunization in the country.
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Keywords
Tetanus toxoid, vaccine, quality control, sterility test, endotoxin, immunization, potency, safety
Citation
Chigozie V U, Eze P M, Chukwunwejim C R, Abba C C, Nworu C S, Esimone C O. Quality Assessment of Some Brands of Tetanus Toxoids Marketed in Open Markets in South-Eastern Nigeria. British Journal of Pharmaceutical Research. 2014 July; 4(13): 1657-1667.