Wednesday, July 23, 2014

Quinvaxem Vaccine IS SAFE TO USE as confirmed by WHO & UNICEF

The Safety of The Quinvaxem Vaccine

Quinvaxem vaccine is meant to prevent five common and potentially fatal infantile diseases: diphtheria (D), tetanus (T), pertussis (P, whooping cough), hepatitis B (HepB), and Haemophilus influenza type b (Hib). Besides its worldwide usage, it has been administered to more than 50 million children globally.

Till date, 61 children have died after being vaccinated using Quinvaxem since 2007. 2013 accounting for 15 alone. The joint investigation held by the 2 international giants has failed to find any evidence that links the Quinvaxem vaccine and the deaths, said WHO and UNICEF.

In a joint public statement made - the World Health Organization (WHO) and UNICEF (United Nations Children's Fund) have jointly confirmed that the 'Pentavalent' Quinvaxem vaccine use globally, suspected of playing a role in 61 children’s deaths post-vaccination, is in fact, safe to use.

The joint confirmation was issued on December 19 after the results of an investigation of the vaccine showed that it meets all of the highest international safety standards. They are still in fact trying to determine whether the adverse effects are due to localized foul-play or some other interference with administration.

The two international organizations have independently helped Vietnam conduct an investigation on the safety of Quinvaxem with independent technical assistance both locally and abroad.

The Quinvaxem vaccine was withdrawn for local use for about 5 months at the start of May 2013 after nine children passed away shortly post being vaccinated between December 2012 and March 2013.

It has been used again since October 2013 after investigations by the health authorities showed that there were no unsafe cases in relation to the use of the Quinvaxem Vaccine.

The vaccine was highlighted in the National Expanded Immunization Program in June 2010, and Vietnam as a country alone has administered 15.2 million doses of Quinvaxem across the country so far with no other accounts of fatalities.

Safety for use

Along with the confirmation of its safety, WHO and UNICEF also released Frequently Asked Questions (FAQs) for the Quinvaxem vaccine.

    For the question “Is Quinvaxem safe?,” the reply is: “Yes. There are strict quality controls at every step of the manufacturing and supply processes. Quinvaxem is prequalified by WHO to guarantee that the vaccine is of assured quality according to the highest global standards.”

Regarding the side effects of Quinvaxem, the two organizations said that like all vaccines, Quinvaxem can have some mild side effects. They include low grade fever, localized swelling, and general short term discomfort, possibilities of fatalities or adverse reactions have not been noticed so far.

In a very few number of cases – less than one per million – a child can have only a severe allergic reaction to the Quinvaxem vaccine. Health care providers are trained to respond and if prompt medical treatment is given, the child can make a full recovery.

Regarding the quality of Quinvaxem, WHO declared that there are no issues with the quality of the vaccines supplied to Vietnam. All GAVI supported vaccines procured through UNICEF Supply Division are prequalified by WHO which implies they are of confirmed quality.

    “This process is in addition to the work of the country of production’s National Regulatory Authority (NRA) and involves a review of the product’s clinical data, production process, and manufacturing facilities. WHO also visits the production sites and tests samples in addition to the testing requirements for sample batches produced.”

For the question about how UNICEF and WHO, as a major supplier of vaccines, can ensure the safety of vaccines, the two organizations replied that UNICEF only buys vaccines that have been pre-qualified by WHO and meet established international standards.

    “WHO follows a rigorous procedure to evaluate vaccine production facilities and quality standards. The quality of vaccines shipped to countries is regularly monitored through rounds of random testing performed at six-month intervals by WHO. In addition, a full re-evaluation of all pre-qualified vaccines takes place every two years.”

 Its time the local and international news agencies cease their endless campaigns in spreading fear amongst the general public.