International Drug Control Authorities in the UK, USA & European Drug Agency (EMEA) in the EU member countries, have released many information related to the safety of H1N1 vaccine, after its use over the last three months period from licensing. This is in response to the raised issue of vaccine safety which was subject to extensive discussion and questions at the public and local media (TV / Press) levels.
Statistics revealed that 75 million shots of the vaccine were distributed in Europe and 30 million people were vaccinated ( including 218 thousand pregnant ladies). The vaccine is registered in the European Drug Agency under three trade names: Pandemrix , Focetria, Clevapan, where Pandemrix vaccine is the only one registered in the Kingdom of Saudi Arabia to date.
The European Drug Alert Center ( EudraVigilance) received, during that period, about 8745 reported cases from member countries concerning suspected side effects of the vaccine. Most of the cases belonged to normal (unserious) side-effects that may occur with any other vaccine.
Out of these reported cases 13 were suspected for GBS syndrome registered against this vaccine but the diagnosis of 4 of these cases was not confirmed. These cases were registered in people between 24-72 years old and it took one day to one month to develop the syndrome, in which case it cannot be confirmed that the vaccine was the prime cause of the syndrome There are many factors that cause this syndrome such as viral infection, intestinal infection with C.jejuni bacteria, previous surgery, lymphatic tumors or Lupus erythematosus. It shall also be considered that swine flu vaccine was given, in one of its commercial licensed forms, to around 28 million people in Europe while GBS syndrome developed in 13 cases only. This ratio is by far less than expected. Studies expected one case in every one hundred thousand vaccinated people during in one year. It can be concluded that there is no evidence yet that swine flu vaccine causes GOB syndrome.
In the UK, two swine flu vaccines were registered: Pandemrix –the same vaccine registered in KSA- and Clevapan. 3.4 million people were given either of these vaccines- Pandemrix is the mostly used vaccine- at that time and up to the 29th. September 2009, the UK Drug & Health Products Regulation Authority received about 2534 reported cases concerning suspected side effects of the vaccine. As is the case in Europe, all the side effects were within the expected limits, i.e. they either consist of (pain, swelling reddening) at the spot of the shot, or general symptoms such as nausea, vomiting, fever, fatigue, headache or gland swelling, which are generally short - term unserious side effects. As for pregnant ladies vaccination, the reported cases did not exceed the expected limits based on registered rates. As it is the case in the European experience referred above, there is no evidence of any A-H1N1 vaccine hazards to pregnant ladies. With regard to GBS syndrome, only two cases were suspected, but as mentioned before, these could be due to other reasons such as viral infections, or due to unknown reasons, especially in winter. It worth mentioning that despite the normal seasonal flu vaccine does not cause GBS syndrome, yet the UK Drug & Health Products Regulation Authority received about 90 reported cases concerning suspected side effects of the vaccine over the last two decades. It worth mentioning here, that no new problems are observed about the safety of the vaccine, which were unseen before. In conclusion, if we compare the positive and negative effects of the vaccine, we will find that the positive effects win.
We would like to emphasize that the UK Drug & Health Products Regulation Authority has changed the A-H1N1 dose to one shot for children between the age of 6 months to 10 years, except of children with less immunity in the same category, who must take two shots according to previous recommendations.
In the USA, Disease Control and Protection Center mentioned that 95 million shots of swine flu vaccine were distributed, according to statistics up to 23rd. December 2009. However, the VAERS center received 6945 reports about suspected side effects of the vaccine. Most of these reports (95%) were found to be normal side effects (unserious) while only (5%) of the reported cases were serious, which are not different from the observed effects of normal seasonal flu vaccine. Also, as mentioned above, no new side effects are observed about the safety of the vaccine, which were unseen before. As for GBS syndrome, 32 cases were reported and their causes are being studied. However, about 80-160 GBS syndrome cases are reported every week regardless swine flu vaccine is used or not, as mentioned in the report.
As for the Kingdom of Saudi Arabia, the National Drug Safety & Alerts of SFDA received 81 cases about Swine Flu vaccine reported by the citizens over 2 months from licensing the vaccine in the Kingdom. All the received reports were found to be for normal side effects that did not those mentioned in the bulletin and which are familiar effects with any vaccine( e.g. pain in the place of the shot, bone and joints pain)
- If you have any questions about the vaccine, please contact the National Drug & Toxins Information Center at the Saudi Food & Drug Authority (SFDA)