Proper Quality Control of Formulated Foot-and-Mouth Disease Vaccines in Countries with Prophylactic Vaccination is Necessary

Abstract

Vaccination is considered as an important tool to control foot-and-mouth disease (FMD). A good quality vaccine containing relevant serotypes and matching strains is a pre-requisite for vaccination to be effective. The present study investigated the quality of different brands of FMD vaccine available in Pakistan, including three locally produced and two imported products. All the vaccines were found free of bacterial or fungal contamination. No adverse effects were noted in suckling mice and buffalo calves inoculated with the vaccines, showing that the vaccines were sterile and safe. The humoral immune response to the FMD vaccines was determined in buffalo calves for 234 days post-vaccination. Very low humoral immune responses against FMD serotypes O, A and Asia 1 viruses were detected to the locally produced vaccines. The imported vaccines, however, elicited a higher antibody response which persisted for a long period in one of the 2 vaccines. The present study highlights the need of assessing an independent vaccine quality control of finished FMD vaccine products.

An Evaluation of Foot-and-Mouth Disease Outbreak in Relation to Vaccination in a Herd of Cattle and Buffaloes

“…This was also observed in our findings that animals were vaccinated three months ago. This finding was also coincides with Jamal et al, (2013) who reported very low humoral immune responses against FMDV by the locally produced vaccines. The failure of vaccination may be due to differences between the circulating field strains and the strains included in the vaccine.…”

Use of recombinant capsid proteins in the development of a vaccine against the foot-and-mouth disease virus

“…A manufacturer may produce a good vaccine but if it is stored poorly then it may not function well when it is used and thus there is a need to determine vaccine quality, at the point of production, and also efficacy during vaccination campaigns. 4 The text above indicates that there are a number of limitations and problems associated with current FMDV vaccines (eg, lack of cross protection, short duration of immunity, lability, requirement for high containment facilities to produce it) and thus there is interest in developing improved vaccines which address at least some of these shortcomings. It may well be that there will not be a single solution to these different issues and indeed the most important features of a vaccine …”

A Review of OIE Country Status Recovery Using Vaccinate-to-Live Versus Vaccinate-to-Die Foot-and-Mouth Disease Response Policies I: Benefits of Higher Potency Vaccines and Associated NSP DIVA Test Systems in Post-Outbreak Surveillance

“…Worldwide, at least two billion FMD vaccinations are applied in China, South America, parts of Asia and the Middle East (Paton et al., ) for routine prophylactic FMD control, but many are not tested to see whether they meet standard potency (≥ 3 PD 50 ) as defined in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (the Manual, OIE, ). A recent paper shows that many locally produced FMD vaccines do not meet the minimum OIE potency criteria of 75% protection (Jamal et al., ). In contrast, strategic reserves or antigen banks hold high‐quality, higher potency (≥ 6 PD 50 ) vaccine antigen concentrates (VACs) for emergency formulation to use as a temporary, targeted response measure as an adjunct to movement control and stamping out in countries with OIE status, FMD free country where vaccination is not practised .…”