CFI welcomed the launch of the Government’s vaccination roadmap on Tuesday, December 8th. News of potential vaccines offers hope about a possible return to normality in our lives. People may have concerns and questions about the vaccine and the speed with which it has been developed, this is completely understandable. CFI will continue to update you with information as it becomes available to help you to make an informed decision. Please ask all the questions you need to and we encourage you to seek out information from reputable sources.
Is a vaccine for COVID-19 currently available?
There are no vaccines approved yet for use in Europe to prevent or treat COVID-19 in humans. There are many vaccine candidates currently under development.
Before a vaccine is distributed it must be proven to be safe and effective through large-scale clinical trials with thousands of people. It must also be approved and licensed by regulators, for Ireland this is the European Medicines Agency.
Two vaccines have been submitted to the European Medicines Agency for possible approval. These include the Pfizer BioNTech vaccine and the Moderna vaccine. The EMA are due to meet to decide whether to approve the Pfizer BioNTech vaccine on the 21st of December and on the 12th of January for the Moderna vaccine. A vaccine, if approved, would be available in Ireland approximately one week after this decision.
When will people with CF be able to get a vaccine?
The vaccines will be delivered in stages so it will take time to vaccinate the population. Certain priority groups will be vaccinated first. Pending approval of a vaccine from the European Medicines Agency, people aged 18-65 with medical conditions which put them at high risk of severe disease are currently in group 7 of the Government’s vaccination allocation sequence. Adults aged 70 and over are in the third group and adults aged 65-69 are in the fifth group. The exact timing of when each priority group will be vaccinated will depend on the availability of the vaccine once manufactured. While initial supplies will be limited, as more vaccine is manufactured and more vaccines are potentially approved, supply will increase. Once this occurs, the difference in timing between the groups may only be a few weeks.
Will children and adolescents with CF be able to get the vaccine?
The initial wave of vaccination is unlikely to include children or young adolescents. It is common practise to assess the safety and efficacy of vaccines in adults before trialling or authorising the use of vaccines in children. While some of the clinical trials did start to include children from the age of 12 upwards, there is not yet sufficient data to authorise the use in these groups. Research is ongoing and it is likely that children and adolescents will have access to a vaccine at some point next year. The final age groups for which each vaccine is approved will be decided by the European Medicines Agency based on the data available to them.
A new study, published in the Journal of Cystic Fibrosis last week, revealed that children with CF who do not have pre-existing severe lung damage experienced mostly mild or asymptomatic illness when infected with COVID-19. This international study was the first of its kind to investigate the impacts of COVID-19 in children with CF and we hope this information will bring reassurance to our members as the wait for a vaccine for children with CF continues. Details of this study can be found here.
Children with CF should continue to take precautions against Coronavirus and you are advised to continue to follow all public health guidance.
Will family members/carers of PWCF be prioritised?
At the moment, family members of people at higher risk from Covid-19 are not included in a priority group. This could change though as more evidence is gathered from clinical trials and other research studies. The initial clinical trials were designed to assess the effectiveness of the vaccine in preventing a person from getting severe Covid-19 disease. They have not been assessed to see if vaccination prevents a person from asymptomatically spreading the virus. More research is being undertaken to assess this but it will take some time to see the results. Until then, there is no evidence currently that vaccinating carers or family members would protect a vulnerable person they live with. As new evidence becomes available the Government will update it’s vaccine strategy.
Where can I get further information on the vaccine?
Further information on the Government’s vaccination strategy and implementation plan can be found here: https://www.gov.ie/en/publication/bf337-covid-19-vaccination-strategy-and-implementation-plan/
Specific information on each of the vaccines will become available as they are approved. Information will be available on the HSE website and the Government website.
Information on the vaccines and the regulatory approval process from the EMA can be found here.
For specific queries about your own circumstance please consult your doctor.
What types of COVID vaccines are there?
The EU has signed six Advance Purchase Agreements with pharmaceutical companies for their vaccines. Each vaccine needs approval from the EMA before it can be marketed here. The Irish Government has signed five of these Advance Purchase Agreements and may sign up to the sixth when trial data emerges. Vaccines are all designed to teach the body’s immune system to safely recognise and block the virus that causes COVID-19. The six vaccine candidates within the EU advance purchase agreements use a variety of different methods to achieve this, these include:
Non replicating Viral Vector Vaccines
These vaccines use a virus that has been genetically engineered so that it can’t cause disease, but produces coronavirus proteins to safely generate an immune response.
Protein subunit vaccine
These vaccines use harmless fragments of proteins that mimic the COVID-19 virus to safely generate an immune response.
RNA vaccines
These are a new cutting-edge approach that uses genetically engineered RNA to generate a protein that itself safely prompts an immune response.
Regardless of the vaccine type, all candidate vaccines must go through the same rigorous evaluation by the European Medicines Agency before they are approved for use in Europe.