OFFICIAL STATEMENTS TO THE PRESS
MOST FREQUENTLY ASKED QUESTIONS (FAQs)
1. Who is responsible for the quality of the vaccine?
The immunization partners, such as WHO, UNICEF, other international organizations and national governments, are responsible for ensuring that the vaccine used in the immunization of children globally is effective and safe.
This starts with the manufacturer who is responsible for ensuring that the vaccine is produced according to international quality standards. For vaccines procured by UNICEF, WHO (together with the NRA of the country where the vaccines were manufactured) is responsible for ensuring compliance with international quality standards. UNICEF is responsible for overseeing the safe delivery of the vaccine from the manufacturer to the country that will be using it. WHO and UNICEF work jointly to ensure that the vaccine supplied to the country meets international expectations of quality standards and, if used properly, will be safe and effective.
Once the vaccines are actually in a country and the vaccine arrival report has been signed, the Ministry of Health is responsible for the quality of the immunization process. The Ministry of Health has to ensure that the vaccine is kept at recommended temperature conditions until it is used at every one of the more than 20,000 routine immunization posts in Ukraine.
The Ministry has to ensure that the vaccine is correctly and safely administered. The Ministry also has to ensure that any complications ensuing after the vaccine has been administered are correctly managed.
WHO and UNICEF have undertaken considerable training for health workers in order to assist the Ministry of Health and to ensure the safety of injection practices. They have supplied Ukraine with 9 million doses of vaccine with syringes, 20,000 vaccine carriers and 120,000 safety boxes.
2. How is quality assured?
WHO rigorously controls and monitors this programme at each and every step. WHO conducts rigorous assessments of producers around the world and, if satisfied with a producers’ processes, it pre-qualifies the vaccine.
Once WHO pre-qualified vaccines are tested for safety and effectiveness through clinical and field procedures, a controlled laboratory can license and released them for use, lot by lot. WHO regularly inspects the production facilities to ensure compliance with good manufacturing practices.
A quality control protocol for the vaccine concerned has been provided to the Ukraine Ministry of Health. This is the same procedure, applicable to all vaccines provided through UN programmes. (We do not discuss the procedure applied to vaccines purchased directly by governments.)
Prior to distribution to the sub-national level, the vaccine underwent a thorough potency and sterility test in a laboratory in the Ukraine.
To assure safety during the vaccination period, the Ministry of Health and WHO have put in place a mechanism for responding to adverse events following immunization. It uses standard operating procedures that enable vaccination teams to react rapidly to any potential case of adverse effect.
The vaccine has an excellent track record. Two thirds of children globally have been vaccinated by vaccines from the Serum Institute of India (SII), which are being used in the Ukraine.
Since 2001 the M-R vaccine has been used in many countries in Eastern Europe and Central Asia including: Albania, Armenia, Azerbaijan, Kazakhstan, Kyrgyzstan, Moldova, Turkey, Turkmenistan and Uzbekistan.
Altogether about 30 million doses of the M-R vaccine have been used in our region without a single lethal case or major AEFI occurring. Detailed reports on adverse reactions from all these countries were provided to the Ukraine MoH for review before the vaccine was imported into the country.
In most countries the vaccine has been used in the same age group as in the Ukraine, namely 15-30 year olds.
We urge the MoH to publish the results of the investigation. WHO experts have reviewed all available information from the medical investigations which show that no evidence exists of any causal link between this boy's fatal illnesses and the vaccine. However, evidence suggests that his death may have been caused by an unrelated infection. If that is the case, any further delay in publishing the results of the investigation may delay the implementation of the necessary public health actions to contain its spread.
The hospitalization of children for "preventive" reasons was an over-reaction. Not one of the "preventively hospitalized children" was found to be suffering from severe vaccine reactions. A few had mild, but predictable, vaccine reactions which required no treatment or hospitalization.
5. The Serum Institute of India M-R vaccine is produced on human diploid cells. Are cells of aborted embryos used for vaccine production?
Human cells have been used for the production of measles and rubella vaccines for more than 40 years when the vaccine was first produced. However, these are self-reproducing human cells cultivated in laboratory conditions without use of embryos. The rubella vaccine virus was first isolated from a foetus affected by rubella infections in utero in the U.S. This was done with the full consent of parents. It was then weakened (attenuated) by replication in human diploid cells in laboratory conditions with no use of new foetal/human cells.
Once the attenuated virus was isolated, vaccine production occurred by replicating the virus in laboratory conditions in self-reproducing human cells. This technology was then taken up by manufacturers in Belgium, France, India, Japan, Russia, South Korea and the U.S., as well as any other country where measles and rubella vaccines were produced.
6. If this live vaccine is produced from human diploid cells in India, how can you ensure that cells, containing Asian genotype DNA do not harm Ukrainians? Will this vaccine virus work against the measles virus in Ukraine?
The assumption behind this question is false. The cells used for vaccine production are derived from the UK. The measles vaccine being used in the Ukraine is from the same vaccine first produced in Zagreb by the Croatian Institute of Virology 40 years ago and that is still being used throughout the world. No other human cells have been used from any of the countries where the vaccine is produced.
The rubella vaccine being used in Ukraine is from the same vaccine which was first produced in the U.S. 40 years ago.
The vaccines won’t harm Ukrainians or anybody else. Vaccines don’t kill, viruses do.
This vaccine can protect Ukrainians effectively against viruses. The Serum Institute of India (SII) measles vaccine, which contains the Edmonston-Zagreb strain of measles-rubella vaccine, will halt the transmission of the D6 sub-type measles virus circulating in Ukraine. A case in point, the D6 measles virus was successfully eradicated from the Americas by vaccine derived from the Edmonston strain.
The boxes of vaccine vials were shipped with English and Russian-language instructions. The MoH decided to provide an additional translation of the instructions in Ukrainian. This Ukrainian translation contains some factual errors, including an erroneous description of the colour of the vaccine in the vial. This translation error has no implication on the use or the quality of vaccine. We wish to reiterate that the vaccine is of high quality and safe.
1. Who procured and paid for the vaccine?
The vaccine was procured by UNICEF Supply Division (SD) in Copenhagen on behalf of the Global Measles Partnership. SD procures vaccines for 40% of world’s children every year with the annual budget for vaccines of over US$ 500 million. Vaccines from the Supply Division are equipped by temperature monitors on each vial to help health workers to monitor storing temperatures easily. Vaccines from SD are bundled with safety syringes that can only be used once and that reduce risks for vaccine recipients.
SD also procures vaccines for GAVI, the Bill and Melinda Gates Foundation, the World Bank and number of countries and partnerships. Over one billion doses of vaccines, worth over USD 75 million, have been supplied to CEE/CIS countries since the early ’90s.
Funding for this vaccine campaign is coming from funds from the International Financing Facility for Immunization, through the UN Foundation. The tenders for procurement of vaccines at SD are public and transparent. The supply division procurement system operates on a non-profit basis.
2. Why was this specific vaccine chosen for Ukraine?
A consultation process with the MoH took place in the selection of this vaccine. The Global Immunization partners felt that, while Ukraine had sufficient resources to purchase vaccines for routine immunization, it needed support to conduct a major campaign. Also Ukraine has signed an agreement to eliminate measles from Europe by 2010 and time was running short. It still is. Another issue was the availability of vaccines. The M-R vaccine is in short supply globally. There is no other producer among WHO pre-qualified manufacturers, apart from SII, which was able to supply 9 million doses at the time.
3. Who is responsible for the registration and legal usage of the vaccine on the territory of Ukraine? (+clinical trials issue)
The international guidelines for procurement of vaccines for UN programmes have been set up at the global level to ensure that, in a case like this, the vaccine can be supplied swiftly and in line with highest quality standards, particularly in countries where the national regulatory authority has not been pre-qualified by WHO.
UNICEF was told that registration in Ukraine takes up to 12 months and that additional financial costs were involved that non-profit partners, such as UNICEF and WHO, could not meet. No other country that has conducted a campaign using measles-rubella vaccine has required registration of the product with clinical trials in the country before use.
Another critical factor was that time was running short and any further delay in vaccinations brought the risk of another outbreak of measles and rubella, similar to the one in 2005/06, where at least seven people were reported to have died (and hundreds likely died).
But as stated earlier, prior to receiving WHO pre-qualification, the vaccine goes through quality assurance procedures and various clinical trials.
1. Why was such a massive campaign in Ukraine conducted if no epidemic had broken out? Why was the decision to conduct the campaign made so fast?
Two years ago top WHO, ECDC and CDC experts undertook an epidemiological investigation, but the campaign was delayed several times for various reasons. There is now strong evidence that if the campaign is not done soon, further outbreaks are inevitable. The mass outbreaks in 2005/06 and earlier ones suggest that Ukraine is on the verge of another epidemic. A critical segment of the population is susceptible to measles and rubella infections due to the use of a sub-standard vaccine in the 1980s and early 1990s. The indigenous measles virus of genotype D6, which is still in circulation in Ukraine, is being exported to other countries in Europe, USA and former Soviet Union. Vaccines do not kill people, viruses do. In the last measles outbreak at least seven people were reported to have died (with likely hundreds actually having died based on other country experiences). With rubella outbreaks and the ongoing disease a number of children each year suffer lifelong consequences of congenital rubella syndrome.
2. Is Ukraine the source of infections in Europe, and therefore do you only want to protect Europeans?
We want to protect everyone, in particular those young people most at risk here in the Ukraine. Remember seven people died here just two years ago from measles. Viruses do not recognise borders. That is why we are all together in this cause of vaccinating children all over the world and trying to make Europe measles free, just like it is in the Americas. I would remind you that the issue is not just measles alone - every day, six Ukrainians in the age group of 15-29 are dying from preventable infectious diseases.
Measles and rubella are so easily preventable with two doses of a measles containing vaccine. We believe that today, when a good quality vaccine is available, no one should go through the pain of illnesses, or should suffer from the consequences of infections. No death caused by vaccine preventable diseases is acceptable in Ukraine or elsewhere. This campaign is not about protecting the rest of Europe from Ukraine, but about eliminating the measles virus in Ukraine and all of Europe before 2010.
3. Nobody proved that Ukraine was exporting the virus, as was the case with the 2006 outbreak affected regions of Ukraine close to the border. Could it be that the virus was imported to Ukraine?
III. TOPIC: Future Plans.
1. What are the implications of postponement or cancellation of the campaign?
Europe has set a goal of eliminating measles and rubella in the WHO European region by 2010. This goal was endorsed by Ministers of all 53 countries of the WHO EURO region, including Ukraine.
We still believe that Ukraine is fully committed to eliminating measles and rubella. There are no formal sanctions. The gravest sanction for Ukraine will be another outbreak of measles and rubella with all its devastating consequences for the health of Ukrainians.
The international community could, however, issue a travel advisory that travellers entering and leaving the Ukraine have to provide a record on recent M-R vaccination. Some international public events could be postponed to reduce risks of disease transmissions. The approach to public health overall could affect tourism.