A COVID-19 VACCINE is set to be rolled out in Ireland from early next year and, naturally, people have a lot of questions about how the process will work.
TheJournal.ie has been breaking down the latest pandemic and vaccine developments in explainers, factchecks and other articles in recent weeks:
As well as this, we’re beginning this vaccine Q&A series to help answer questions readers may have – either about a specific Covid-19 vaccine or how the programme will work in Ireland.
If there’s something you want to know, tell us and we can put your queries to the experts.
The vaccine taskforce delivered its strategy plan – covering logistics, workforce, communication and collection of data on the efficacy of the vaccine, amongst other areas – to government yesterday.
The strategy will then be discussed by Cabinet on Tuesday next.
Earlier this week the government announced the allocation strategy for a vaccine here – outlining which groups will receive the vaccine first.
As expected, care home residents over the age of 65 and staff at these facilities will be first on the list. Next will be frontline healthcare workers in direct patient contact roles, and then those aged 70 and older.
Covid-19 vaccines will be free of charge for everyone in Ireland and will not be available privately, the HSE has confirmed.
The Irish government has said that roll-out of a vaccine could start in the Republic as early as next month, once approval is given by the European Medicines Agency (EMA).
The EMA is set to complete a review of the Pfizer/BioNtech vaccine by 29 December with a decision on the Moderna vaccine also potentially happening a couple of weeks later.
Dozens of vaccines are being developed globally and several are in Phase III of clinical trials – that is to say the vaccine has been trialled on thousands of people to help ensure it is safe and effective for broader use.
Ireland has signed up to six advance purchase agreements to date – with Pfizer, Moderna, AstraZeneca, Jansen, Sanofi and CureVac.
For the purposes of this article, we’re going to focus on the two vaccines set to be reviewed by the EMA in the coming weeks – Pfizer and Moderna, which are both in Phase III of clinical trials.
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including vaccines, drugs and other treatments.
As set out by the World Health Organization (WHO) here, there are four phases of biomedical clinical trials:
A quick note before we begin addressing reader questions: We’ve had dozens sent in since we put out our first call out for questions last weekend.
We compiled them into categories, and have begun to address some of the questions that popped up most often in this article.
As the planning process for the vaccine rollout is ongoing, there are some questions that can’t properly be answered yet – so if you’ve sent us a question this week but don’t see it appear here, it may be included in a future article in this series.
Finally, some questions sent in by readers have been edited for length.
If you have a suggestion for a question you’d like answered, the email address is answers@thejournal.ie. Rest assured we won’t be including your name or any other identifying details in articles.
Children and pregnant women
Several readers asked if the Covid-19 vaccines being developed are safe for children and people who are pregnant. The most common questions included the following:
In short, more research needs to be carried out before a Covid-19 vaccine is deemed safe and effective for children and pregnant women.
Vaccines are typically tested on adults first, then children, to ensure they are as safe as possible prior to being given to these groups. This is standard practice and done in order to protect more vulnerable groups from possible side effects.
The vaccine hasn’t been tested on pregnant women or children under 12 to date, and there isn’t enough data on children aged 12 to 15. However, trials on children are planned or ongoing by a number of manufacturers.
For this reason, people under the age of 18 and pregnant women are at the bottom of the current list of people who will get the Covid-19 vaccine in Ireland.
The government’s plan states that children and those who are pregnant will get the vaccine “if evidence demonstrates safety and efficacy”.
Essentially, the vaccine needs to be trialled on these groups in order to ensure it is safe and effective before it is rolled out to them. The vast majority of people who have taken part in trials to date are non-pregnant adults.
Therefore, the impact of the vaccine on pregnant women and children is not yet known and won’t be until more trials are carried out.
A spokesperson for the Department of Health told TheJournal.ie:
Pregnant women and children were not part of the cohorts tested during the current candidate Covid-19 vaccine trials, therefore there are no safety data for the administration of these vaccines in those cohorts at this time. We will continue to monitor this closely.
Dr Nuala O’Connor, the Irish College of General Practitioners’ (ICGP) lead on Covid-19 and Antibiotic Resistance, said she thinks the “correct groups” will receive the vaccine first, adding that the Irish approach is “in line with what’s being done worldwide”.
Speaking to TheJournal.ie, O’Connor said the reason children and pregnant people are at the bottom of the list is “because the evidence isn’t there yet, but there are some studies that have been started in children”.
Speaking about the rollout details announced on Tuesday she said it was the initial prioritisation list, adding:
2.4 million people have to get it before we get as far as children and pregnant persons. As the vaccine rolls out, and more data becomes available, then we’ll be able to advise on that, NIAC [National Immunisation Advisory Committee] will be able to advise on that.
O’Connor stressed that a vaccine isn’t licensed in Ireland yet, and, as trials continue, there are some questions we can’t answer yet.
The medical authorisation hasn’t been approved, and without any medical authorisation, there is always quite detailed advice about contraindications and cautions.
She added that when vaccines are being developed, some people who were given the vaccine later get pregnant, resulting in more data being collected on this group over time.
Plans to trial vaccines on children and pregnant women
The vaccine being developed by Pfizer and BioNTech – the one being rolled out in the UK from this week – expanded its testing to children aged 12 and older in October.
As of this week, 43,000 people have taken part in Pfizer’s trials, but just over 260 have been children aged 12 to 15, and about 600 aged 16 or 17. This vaccine has an overall efficacy rate of 95% when measured a week after participants are given its second dose.
Pfizer’s vaccine is being tested in adolescents the same way it has been tested in adults – with the two doses given three weeks apart.
The UK government’s Joint Committee on Vaccination and Immunisation (JCVI) has said the Pfizer vaccine will not yet be given to most children under 16 and pregnant women until more trials are carried out.
“The committee advises that only those children at very high risk of exposure and serious outcomes, such as older children with severe neuro-disabilities that require residential care, should be offered vaccination.
“Following infection, almost all children will have asymptomatic infection or mild disease” and therefore don’t need it, the JCVI stated this week.
Moderna, which is developing a separate vaccine, announced on 2 December plans to begin trials in 3,000 children aged 12-17.
Moderna will also give children two doses of the vaccine, but four weeks apart, the same way they administered it to adults. The second dose serves as a ‘booster shot’ – similar to how the MMR (measles, mumps and rubella) vaccine is delivered.
Moderna and Pfizer have both indicated an interest in future vaccine trials involving pregnant women, possibly early next year.
Advice for those who are pregnant or breastfeeding
The Pfizer/BioNTech vaccine is being rolled out to other groups in the UK, but is not available to pregnant women or most children under 16. As outlined above, the JCVI has advised that older children with severe neuro-disabilities that require residential care should be offered vaccination.
In relation to pregnancy, the JCVI stated this week: “There are no data as yet on the safety of Covid-19 vaccines in pregnancy, either from human or animal studies.
Given the lack of evidence, the JCVI favours a precautionary approach, and does not currently advise Covid-19 vaccination in pregnancy. Women should be advised not to come forward for vaccination if they may be pregnant or are planning a pregnancy within three months of the first dose.
The JCVI adds that it expects data to be made available from clinical trials, and will review that to update their guidance.
“If you are breastfeeding you should wait until you have finished breastfeeding and then have the vaccine. If you were breastfeeding when you had the first dose you are advised not to have the second dose until you have finished breastfeeding,” the JCVI stated.
It added that this advice is “precautionary until additional evidence is available to support the use of this vaccine in pregnancy and breastfeeding”.
A similar approach is being taken in Ireland (although we may end up using a different vaccine to the UK), hence why pregnant people are currently at the bottom of the vaccine roll-out list.
O’Connor, of the ICGP, said if people are thinking about getting pregnant but also due to get the vaccine, they should hold off on becoming pregnant if possible.
When more information is available, she said people may yet be advised to not get pregnant for a certain time period, perhaps two to three months, after they get the vaccine.
People who are breastfeeding should also avoid getting the vaccine for now, medical experts have said.
“Inevitably, what happens as time goes on, you find that people have become pregnant who have the vaccine. And that’s actually often how you get more safety data. That will become clearer as time goes on,” O’Connor explained.
In the prioritisation list announced by government this week, people aged 18-64 with certain medical conditions are seventh out of the 15 categories.
People aged 65-69 are fifth on the list “with those with medical conditions that put them at high risk of severe disease first in this cohort”.
The government said the rationale behind this is because people with particular medical conditions are “at higher risk of hospitalisation and death”.
“By protecting those at greatest risk of poor outcomes from the disease the principle of minimising harm is upheld,” the vaccine roll-out plan states.
The medical conditions mentioned on the government’s list include the following:
A spokesperson for the Department of Health told us the Covid-19 Vaccine Allocation Strategy “sets out a provisional priority list of groups for vaccination once a safe and effective vaccine(s) has received authorisation from the European Medicines Agency (EMA)”.
They said the strategy was “developed to consider how to prioritise different groups”.
It is based on (1) ethical principles and (2) epidemiological considerations, and takes account of the current and evolving understanding of distinctive characteristics of Covid-19 disease, its modes of transmission, the groups and individuals most susceptible to infection and the characteristics of the candidate vaccines.
The spokesperson said it is important to note that any Covid-19 vaccine administered in Ireland will have to be authorised by the EMA, “ensuring these vaccines comply with all of the EMA’s requirements of quality, safety and efficacy”.
Co-leader of the Social Democrats, Róisín Shortall, has asked the government to consider moving teenagers with underlying health conditions further up the priority list.
Speaking in the Dáil on Thursday, Shortall said it is “surprising and disappointing” that people under the age of 18 are last on the current list.
“There are a significant number of young people in this category with serious underlying health conditions, so it is difficult to understand why they are so far down the list.
“We know from the analysis done on cases – in terms of mortality or admissions to hospital and ICU – that having one or more underlying health conditions is a very significant factor for outcomes.”
Shortall added that the mental health impact of the pandemic is “multiplied several times over” for teenagers living with serious medical conditions.
“It was a terrible blow to young people in those circumstances to hear they are last on the list to get the vaccine,” she stated.
Tánaiste Leo Varadkar said the government will engage with the Chief Medical Officer Dr Tony Holohan and NPHET in relation to these concerns.
He added that the prioritisation list was not “set in stone”.
Weakened immune systems
If people have a weakened immune system, whether or not they can take a vaccine depends on a number of factors such as their condition and medication. If people are unsure about taking a vaccine, health officials have advised them to consult their doctor.
The ICGP’s O’Connor explained that people with compromised immune systems will be able to get the vaccine, but it’s not clear “how effective the vaccine would be, depending on what way their immune systems are being suppressed”.
She said the vaccine may not be as effective on people who are taking immunosuppressant drugs.
From a scientific point, it’s possible that the message that’s being used to suppress your immune system to treat the disease that you have might interfere with the ability of your body to get a really brisk response to the vaccine.
So it’s a caution, it’s not saying you can’t take this. There’s a word of caution in there as to how effective it would be.
O’Connor stressed that, as trials continue, “we haven’t seen all of the data” and more research is needed.
She added that while the development of Covid-19 vaccines is “very exciting”, it is “just one tool in the toolbox that we have”.
It is going to take probably nine months for us to be able to offer immunisation to enough of the population for it to have a good effect.
O’Connor said there is “a lot of speculation out there at the minute” about the vaccine, and stressed that people should get their information from reputable sources like the HSE and Department of Health.
“There will be a public information campaign with all of the information as we get it,” she added.
It was recently confirmed that the Irish government has agreed to indemnify five drug companies that are developing Covid-19 vaccines.
This means if there was some issue with the vaccination, such as a severe side effect in a recipient in Ireland, the State would be liable. Any compensation in the event of a successful legal case would come from the taxpayer and it would mean the vaccine developer could not be pursued.
The European Commission has been working to procure safe and effective vaccines in sufficient quantities and so far has six Advance Purchase Agreements (APAs) in place with developers.
In response to a query from TheJournal.ie, the Department of Health said the content of these APAs, including with regard to liability or indemnity, are negotiated on behalf of member states.
Countries can decide to opt in or out of the whole agreement but they cannot change individual provisions of any APA.
The department said these clauses address the risk to the vaccine supplier with regard to manufacturing a pandemic vaccine.
“Opting into these provisions is one of the pre-conditions for obtaining access to the vaccines.”
The department said responsibility for claims management will be assigned to the State Claims Agency. It said vaccines can only be approved if they comply with all requirements of quality, safety and efficacy and no vaccine will be used until market authorisation is obtained from the European Medicines Agency.
These contracts are not published for confidentiality reasons, which the Commission says is warranted by the highly competitive nature of this global market.
The Commission has said this is in order to “protect sensitive negotiations as well as business related information, such as financial information and development and production plans”.
In order to compensate for potential risks taken by manufacturers due to the unusually short timespan for vaccine development, the Commission has said the agreements provide for member states to indemnify the manufacturers for “possible liabilities incurred only under specific conditions set out in the APAs”.
The Commission said provisions on liability and indemnification do not change the regulatory burden of proof borne by companies to demonstrate the safety and efficacy of their products.
It said any vaccine put on the market will have to meet the necessary safety requirements and undergo the independent scientific assessment by the European Medicines Agency as part of the EU market authorisation procedure.
It said the EU and member states will continue taking all necessary measures to protect citizens, ensuring that:
There was a lot of discussion when Pfizer first announced success from its Phase 3 trials about the ultra low temperature it needed to be stored at. The vaccine is a new type, called a messenger RNA (mRNA) vaccine and needs to be kept at -75 degrees until it is to be used.
Then, it can be transported and temporarily stored at between two and eight degrees for five days, before it is deemed ineffective or unsafe for use.
HSE CEO Paul Reid said last week that a key requirement in preparation for the vaccination programme had been procurement, and on 1 December nine ultra low temperature freezers arrived in Ireland.
He said each of those nine freezers can store about 200,000 doses of vaccine and there is also a cold storage facility at Citywest in Dublin, procured a number of years ago.
We're preparing for the #COVID19 vaccine roll out in Ireland. At the HSE National Cold Chain Centre, we have received and are currently commissioning & validating a consignment of 9 x Ultra Low Temperature Freezers for storage of the vaccines at -75 degrees. @HSELive pic.twitter.com/ooGUc9OSQo
— Paul Reid (@paulreiddublin) December 4, 2020
Initially, the Pfizer vaccine would be transported from the manufacturing site – likely the Pfizer facility in Belgium – in special cooler boxes packed with dry ice (dry ice is the solid form of carbon dioxide, primarily used as a cooling agent).
Once the doses arrive in Ireland, these ultra cold freezers will be used for longer term storage until the vaccine doses are moved to the sites at which vaccinations will be administered, whether that’s a GP surgery, a pharmacy or a dedicated vaccine centre.
The Pfizer vaccine can be kept in a regular refrigerator – the kind GPs would already have – for up to five days. This will mean the delivery timings and batch sizes will have to be worked out to ensure appointments are done within this timeline, but that will all be part of the planning that is currently being done ahead of the rollout.
Speaking to TheJournal.ie, Stephen Delaney, CEO of Q1 Scientific, a Waterford-based company that specialises in stability storage for the pharmaceutical industry, said a common household fridge has temperature settings of between 2 and 8 degrees and GP offices and pharmacies that administer vaccinations already have those.
“Once it’s taken from the -70 storage you have five days from that point, after that the efficiency of the vaccine would be questionable and it wouldn’t be safe to administer.”
The system to store, transport and administer the vaccine will have to be extremely well planned if the healthcare system is to avoid waste.
“You want to give whoever is administering the vaccine, whether that’s GPs or in mass vaccination centres, as much of those five days as you can.
“You don’t want to be landing in with the GP and telling them that two of those five days have been spent in transit. That will be one of the logistical challenges if there are are lots of centres around the country, it’ll be a balancing act.
How many times can you visit each centre? How much do you leave with them? You probably can’t deliver to every GP every day so you’d want to work out how many they need for five days and give them that.
Technically, the vaccine could be transported at -70 degrees and given to GPs in its frozen state to thaw, giving them the full five day period. However this transportation method would be significantly more expensive and time consuming.
“To transport it at -70, you have to submerge it in dry ice and pack it into an insulated container. We do have capacity for it, there’s a company that provides dry ice in Ireland. But it would be a lot more work, you’d have to have guys packing it in a storage centre and they’d have to build out each container with dry ice.
“Transporting it at five degrees, they can load a pallet and then take it out of the truck as they go and onto the next GP. With dry ice, they’d have to build out each package, spending time on it at each destination.
The dry ice you use to pack it also eats space. If you imagine the vaccine batch comes in a container the size of a tub of butter, to send it on dry ice you’re talking about packing that small container into a box the size of an oven. It can become an inefficient way to use the transport.
Each of those boxes could cost around €200 each, he said, on top of the general transport costs such as petrol for the truck. It would be significantly less expensive to use refrigerated trucks that could transport larger volumes at five degrees instead.
It is expected that some of these plans will be made clear in the coming days as the government’s vaccine taskforce rollout plans are made public.
Delaney said it may make sense to have regional storage centres (in cities or larger towns) with bulk shipments stored in ultra-cold freezers and then transported within that region. Additional infrastructure would be needed to protect the vaccine stores, however.
“Facilities would have to be set up to monitor the temperature as well as electrical backup in case power is lost at some stage. There are companies around the country that can provide this, it just takes planning and I’m sure that’s part of what’s being considered.
We use -70 freezers and they can break so you have to be well set up. If there is a freezer down, we’ll be notified within 15 minutes.
If it’s something that will take time to fix, we’ll always have a spare one right beside it so you can move everything into the one next to it in a worst case scenario.
“There’s also a monitoring probe inside that checks the temperature every minute. And if our power goes there’s a generator here that will start and supply the whole building.”
In terms of the temperature the vaccine is administered at, readers do not need to worry about having a substance at -70 degrees injected into them.
“You couldn’t do anything with it at -70, it would be hard as a rock,” Delaney said. “That’s where the five degrees comes in, you can store it at that temperature for the five days.”
Cork GP and Covid lead for the Irish College of General Practitioners (ICGP) Dr Nuala O’Connor also said the vaccine will be administered at “an acceptable temperature”.
So it’s stored at the ultra low temperature fridges nationally and then it is delivered via the normal cold chain process. Let’s say initially it’s got to go to a nursing home, it goes to a nursing home, everything is set up, it gets defrosted, brought down to an acceptable temperature and then the four days start that it has to be given in. That’s all set up in advance, there are logistics there.
Do you have questions about the Covid-19 vaccine? Email answers@thejournal.ie and we’ll do our best to get through as many as we can over the coming weeks.
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