European Medicine agency (EMA) has endorsed two statements about the importance, safety and effectiveness of vaccines published by the International Coalition of Medicines Regulatory Authorities (ICMRA).
International regulators from around the world have come together and jointly developed these statements for healthcare professionals and the general public to give assurance that the regulatory processes for the authorisation and safety monitoring of vaccines are robust, independent and focus firmly on public health.
‘The COVID-19 health emergency reminds us how important vaccines are to protect ourselves and our loved ones against infectious diseases,’ said Guido Rasi, Chair of ICMRA and EMA’s Executive Director. ‘In fact, vaccines are that one medical intervention that benefits not only those who receive it directly but also those who are too young, too old or too ill to be vaccinated themselves.’
The two ICMRA statements aim to reassure healthcare professionals and the public around the globe that medicines regulators only allow vaccines onto the market that fulfil the highest standards of safety, efficacy and quality.
Vaccination coverage has dropped In recent Years
In recent years, vaccination coverage has dropped to sometimes dangerously low levels in some countries, which increases the risk of the disease spreading and affecting the unvaccinated. The ICMRA statements reiterate that it is everyone’s responsibility to get vaccinated in order to protect not only themselves but also their friends, communities, vulnerable populations who cannot get immunised as well as the generations to come.
ICMRA statement about confidence in vaccine safety and effectiveness (for healthcare professionals)
Messages that may be used to support dialogue with other healthcare professionals and patients
Emphasise that vaccines prevent diseases:
- Vaccines prevent illnesses and deaths due to vaccine preventable diseases.
- Remind that if people are not vaccinated, harmful infectious diseases such as measles, pertussis, polio or influenza will continue to occur or spread. With vaccination, these diseases could be prevented.
- Vaccines that are available to the public have been assessed extensively for safety and shown to be effective. But for the unvaccinated, diseases such as cervical cancer, measles, pertussis, polio, tetanus or influenza can be fatal or have long-lasting effects on health.
Emphasise that the benefits of a particular vaccine outweigh potential risks that may be associated with it:
- Vaccines are usually given to large numbers of healthy people, mostly children, to prevent disease. Rigorous safety standards are in place to ensure that vaccines prevent disease while minimizing the potential risk of harm
- Emphasise that getting vaccinated is part of a wider social responsibility – a decision not to get vaccinated may be seen as a personal choice – but because of herd immunity it can seriously affect others.
Low vaccination rates can lead to an epidemic of preventable diseases
Low vaccination rates can lead to an epidemic of preventable diseases or to a breakdown of herd immunity because the exposure of the population to the disease increases. When this happens, vulnerable people such as infants who are too young to be vaccinated or immunocompromised people who cannot receive certain vaccines or who respond poorly to vaccination are more readily infected. For herd immunity to be effectively established and maintained, high vaccination coverage, up to 95% of the population for certain diseases such as measles is required.
Describe your own decision to vaccinate your family – personal stories are powerful.
Actively call out vaccine misinformation such as the false assertion about the link between the measles-mumps-rubella vaccine and autism. Because of vaccine misinformation, we are now seeing a rise in diseases that were previously almost eradicated, e.g., measles. WHO’s Vaccine Safety Net is there to help internet users find reliable vaccine safety information tailored to their needs.
Read More Here.
ICMRA statement about confidence in vaccines (for the general public)
Vaccines save lives
Vaccines protect you and the people around you from serious and life-threatening infectious diseases that used to kill millions of people every year. Diseases like the measles, whooping cough, polio, tetanus and influenza (the seasonal flu), are still killing many thousands of people in vulnerable populations every year and causing long lasting health problems in many more, where vaccines are not available.
Although we do not yet have a vaccine to prevent COVID-19, the development of such a vaccine is one of the highest public health priorities today, because it can help protect everyone against this major threat.
Getting vaccinated is an act of responsibility
There are some people in the community who cannot be vaccinated because they are too young, too sick or their immune systems are weakened. They may be family members or people you know – your grandparent, your neighbour’s newborn, a colleague with a chronic disease. If we are not vaccinated, diseases will spread to these people with potentially fatal outcomes.
In many countries, the Ministry of Health, in collaboration with the World Health Organization, decide which vaccines are added to the national immunisation program, taking into consideration multiple factors, including safety, quality, suitability, affordability and cost-effectiveness.
Vaccines undergo rigorous scientific evaluation by regulatory authorities
Vaccines are rigorously reviewed and tested to make sure there is evidence that they are safe, effective and high quality before they are approved for use and administered to the public. Regulators use the best available scientific evidence from clinical trials and manufacturing information to assess the benefits of each vaccine.
Regulators may decide to solicit independent expert advice from vaccine scientific committees. The decision of whether or not to approve each vaccine for use is made by the government regulator and is independent of the pharmaceutical industry.
Vaccines are medicines of continuously proven pharmaceutical quality
Vaccines are manufactured according to the same high standards as other medicines. Vaccine manufacturers are required to meet manufacturing quality standards, and as a further check, batches may undergo laboratory testing by individual national regulatory authorities before they can be supplied to the public.
Assuring vaccine safety is an extremely important part of their regulation
Regulators will only allow the use of a vaccine if its benefits outweigh potential risks, monitoring them for the whole lifecycle of vaccines. Vaccines are given to large numbers of people (including children and pregnant women), most of whom are healthy. Very high safety standards are essential to minimise any potential risk of harm.
Read more here.
ICMRA brings together 29 medicines regulatory authorities from every region in the world, with the WHO as an observer. Medicines regulators recognise the importance of facilitating access to safe, effective, high-quality products that are essential to human health and well-being.
This includes keeping the pace with advances in science needed to set standards and drive the decision-making process, as well as maintaining efficient regulatory processes that support the development and delivery of innovative medicinal products while ensuring that benefits of these products outweigh any associated risk.