In the light of the deployment of A/H1N1 vaccines to Viet Nam, the WHO Office of the Representative in Viet Nam hereby provides the following information:
1. Following the detection of a pandemic virus in April 2009, WHO launched an Initiative to ensure vaccine access to low- and middle-income countries.
2. In response to this, WHO received donation pledges for about 180 million doses. Of these, GlaxoSmithKline (GSK) pledged 50 million doses in May 2009 and Sanofi Pasteur pledged 100 million doses in June 2009. The current pledges would cover about 10% of total population in 95 low- to middle-income countries identified.
3. GSK signed with WHO the agreement for donation on 10th November 2009. ArepanrixTM, an adjuvanted vaccine produced at its Canada site is the subject for this donation. Canada authorized the use of Arepanrix vaccine on 21st October 2009. ArepanrixTM was prequalified by WHO based on a standard protocol and the information on vaccine safety and quality provided in the dossier.
4. 17 countries in the Western Pacific will receive vaccine from the WHO Initiative. Viet Nam is expected to receive 1.2 million doses of ArepanrixTM, which would cover about 2% of its population. WHO is expected to ship the vaccine between 9th December 2009 and February 2010.
5. Some concern has been raised after reports of severe adverse effects following immunization with Arepanrix in Canada on 24th November 2009.
6. GSK advised a voluntary hold of the Lot A80CA007A of Arepanrix (adjuvanted H1N1 pandemic vaccine) on 24th November 2009, following observation of higher than expected incidence of anaphylaxis associated with this lot.
7. A statement released by GSK on 24th November 2009, stated that approximately 15 million doses of Arepanrix have been distributed in Canada and, overall, the frequency of adverse allergic reactions following immunization is less than 1 event per 100,000 doses. This rate does not exceed the rates typically reported for other vaccines.
8. The vaccine surveillance report of the Public Health Agency of Canada, dated 4th December 2009, indicated that seven confirmed cases of anaphylaxis following immunization with vaccine from Lot A80CA007A have been reported. A total of 172,000 doses were distributed, but after placing its use on hold, over 14,700 doses were kept from use. With the doses not used being accounted, the frequency of anaphylaxis following immunization with vaccines from Lot A80CA007A was 4 per 100,000 doses distributed. This is higher when compared to the usual 0.1-1 per 100,000 doses. Pending further investigations, unused vaccines from this lot have been withdrawn from use.
9. WHO estimates that 150 million doses of pandemic H1N1 influenza vaccines have been distributed worldwide and 95 million administered, of which 30% are adjuvanted vaccines. Immediate hypersensitivity reactions have been reported following the use of all types of H1N1 pandemic vaccines. These events include urticaria, angioedema and anaphylaxis and would range from mild to serious. Anaphylaxis can be life-threatening in the absence of prompt medical treatment and although this is a rare event, authorities should be prepared to recognize and appropriately treat such reactions.
FAQs:
Q: Will all the information the Viet Nam's Ministry of Health has demanded about the vaccines, including its dosage and the number of allergic reactions to it in other countries, be clearly stated by the WHO? Why or why not?
A: Yes, all information about the administration of the vaccine as well as adverse reactions in other countries is made available to Member States by the WHO.
Q: Was the decision to provide Viet Nam with 1.2 million does of the Arepanrix vaccines made before or after Canada withdrew 170,000 doses last month? If before, how would the WHO guarantee the safety the vaccines to be imported to Viet Nam? If after, why did WHO think the vaccines are still necessary for Viet Nam?
A: Decision about the share each of the 95 eligible low and middle income counties would receive was based on assessments conducted in October this year, before the withdrawal of the batch of vaccine in Canada.
With a vaccine campaign of this size it is expected that a small number of adverse reactions will occur; some of these reactions are likely to be more severe. WHO (along with Member States regulatory authorities) are closely monitoring and investigating any adverse events associated with the vaccine.
To date, results from the tens-of-thousands of people vaccinated indicate that the Pandemic vaccine is as safe as the regular seasonal flu vaccination. There have not been deaths conclusively linked to the vaccine in any country.
Q: Is Arepanrix vaccines the only option for containing the H1N1 spread in Viet Nam? Is there any other alternative?
A: Vaccination is one effective way to protect individuals from the impacts of the influenza virus but once there is wide-spread transmission of the virus vaccination will only have minimal impact on slowing its spread in the community.
The primary benefit of vaccination is to target "at risk population" such as those with chronic conditions, pregnant women, persons living in remote and isolated communities and health workers. Vaccination in these groups will lessen the risk of transmission and complications and death from the disease.
In addition, the use of Oseltamivir (under medical supervision) is recommended for treatment of severe illness and at risk groups. Maintaining good basic hygiene practice such as washing hands with soap and water; covering ones' mouth when coughing or sneezing; and staying home if sick are effective ways to prevent the spread of the influenza virus.
Q: Some 800,000 women over four months pregnant will be given the vaccines from the 1.2 million doses pledged by the WHO. In case side effects caused by the vaccines happen, who would bear the main responsibility?
A: Vaccine safety must be ensured from the point of manufacture until it is administered to the patient. The National Regulatory Authority in a country registers vaccines according to the scientific evidence provided by the manufacturer. It shall ensure that vaccines meet the standards of quality and safety, and that these should be distributed and administered following strict standards and protocols. To date, the pandemic vaccine appears to be as safe as regular seasonal vaccine.
WHO reiterates that the risks posed by adverse reactions to the vaccines are still far smaller than the risks to at risk populations of serious illness from pandemic influenza.
Q: What can the Viet Nam's Ministry of Health and agencies concerned do to ensure the vaccinations benefit the right people at the right time? What is the role of the WHO in this vaccination campaign?
A: We know that vaccination is an effective way to protect people from the impacts of the influenza virus. We also know that supply of the vaccine is limited therefore governments have to be pragmatic in who they priorities to receive the vaccine.
WHO recommends that health care workers be the first group to receive the vaccine - this is to ensure that health care facilities remain safe and that patients (who are more likely to be susceptible to the virus) are protected.
After health care workers, WHO recommends immunizing pregnant women and then those with underlying medical conditions as both groups appear to be particularly vulnerable to the H1N1 strain of influenza.
WHO coordinates a global surveillance network that collects and respond to notices of adverse events following immunization. WHO will continue to provide the Government of Viet Nam with information about adverse vaccine events.