HSE chief executive Paul Reid is an avid soccer fan. He said Irish people may feel like the country is 5-1 down in the Covid-19 battle but "we can slowly pull this back".
“We have the wind behind us, and we do have a key striker to come on, which is the vaccine.”
Amid spiralling hospitalisation numbers, growing mortality, and record case numbers, there is intense focus on vaccination – and like any high-profile signing in soccer, there is no shortage of scrutiny.
New vaccination figures on Thursday saw Ireland shooting up the EU vaccination league table, now lying second to Denmark with 77,303 jabs administered. It was welcome news for an under-pressure Government.
However, that pressure is unlikely to fade. As the State moves forward with the biggest logistical effort in its history, how did Ireland get to where it is with vaccines, and where is it going?
The starting point is in Europe.
This summer the 27 European Union member states pooled money to help pharmaceutical companies cover vaccine development costs. In return manufacturers agreed to deliver vaccines early for Europeans, to be distributed proportionally.
The EU hoped to avoid a repeat of the early scramble for medical equipment such as ventilators and vaccines that pitted states against each other in the early months of the crisis caused by the pandemic.
Then, US president Donald Trump was accused of offering large sums to a promising German company to relocate there and make its vaccine exclusively for the US. Instead, an EU team involving member states and the European Commission led negotiations, picking the most scientifically promising vaccines without knowing which, if any, would be successful.
Two vaccines are now approved by the European Medicines Agency (EMA): BioNTech-Pfizer and Moderna. The EU will get 600 million doses of the BioNTech-Pfizer vaccine, 275 million of them by the end of June. Moderna is to deliver 160 million doses this year, 35 million by the end of June.
Pfizer is going to face a short-term supply interruption as it upgrades one of its factories. But more vaccines are coming from elsewhere. AstraZeneca, which will supply 400 million doses, applied for EMA authorisation on January 12th and may receive it this month.
Johnson & Johnson – which could transform the situation, as it is a one-shot vaccine – may apply for EMA authorisation in February and could begin delivering its 400 million doses in April, according to EU officials.
These alone are enough to vaccinate the entire EU population with plenty left over – an approach that has drawn criticism from the World Health Organisation for hogging too much of the global supply. Deliveries were also prebooked with vaccines that have fallen further behind: Sanofi-GSK (300 million) and CureVax (405 million).
Irish supply
Ireland makes up about 1.1 per cent of the EU’s population of 448 million. Ireland will get enough doses to vaccinate 700,000 people by March, 1.8 million people in April-June, and 1.9 million people in July-September, according to the Government.
As the first BioNTech-Pfizer and Moderna deliveries arrived, a bitter debate sprang up over whether the EU had done well enough. The UK started vaccinations three weeks before it, gaining national political kudos.
The European Commission was criticised for failing to finalise a contract with BioNTech-Pfizer as soon as it emerged as a promising candidate, though negotiations were slowed because not all member states were keen on it.
It was based on unfamiliar technology, is relatively expensive and is logistically difficult since it must be stored at -70 degrees. Some EU countries have even turned down part of their allocation, preferring to wait for other options.
In addition, Brussels bargained hard. "The EU insisted on liability. This was the delay. That is why the contract was not signed in August. If the company makes a mistake in production, then they have to be liable," says German MEP Peter Liese. "People are better protected after this."
With populations desperate to know when normal life might return, the issue of vaccination has become combustible across the EU
The EU bargained on price, too. Israel, a global star performer that has given shots to more than 22 per cent of its population, paid two to three times what the EU did and has agreed to share vaccination data with BioNTech-Pfizer, making the country something of a giant lab.
As negotiations were ongoing and with domestic pressure growing in Germany, Berlin jumped the gun and spoke directly with BioNTech – which is a German company – on delivering 30 million doses. This caused a pan-European uproar when it came to light.
Irish MEP Mick Wallace questioned the European Commission's head of the procurement scheme, Sandra Gallina, this week. "What she said was: They're not going to get them ahead of the queue." Germany's extra doses will arrive, but only after the EU's order has been filled.
Approval process
There are also questions over whether the European Medicines Agency could have approved vaccines earlier. Pfizer was given an “emergency use authorisation” in the UK, a quicker process that requires less proof of safety.
Individual member states could have done the same, but they would have been on the hook if anything went wrong. They chose not to. Instead the 27 member states followed the usual approval process for medicines, albeit at a sped-up pace.
The regulator assessed trial results as they emerged, rather than waiting for one complete submission. The EU said its approach was important for public trust given the relatively high levels of vaccine scepticism in the continent, particularly in countries such as France.
"While we have taken every step to expedite our evaluation process, I want to stress … ensuring vaccine safety has been our number one priority," the head of the EMA, Irish woman Emer Cooke, said this week.
With populations desperate to know when normal life might return, the issue of vaccination has become combustible across the EU, with opportunists trying to sow doubt about the vaccines or to lambaste authorities for not procuring enough.
Hungary's authoritarian right-wing government, led by Victor Orban, has declared it will buy a Chinese vaccine that has yet to apply for EMA authorisation, slamming the EU's process as "scandalously" slow.
"If we look beyond the European Union's borders, we can see that in the United States, in Britain and in Israel, people are vaccinated at warp speed," foreign minister Peter Szijjarto wrote in a Facebook post.
Focus is likely to shift on to national governments as more vaccines come on stream and arrive in greater quantities. The first weeks of the EU rollout revealed deep differences in national organisation.
So far Denmark is the best performer, with 2.2 per cent of people given a first jab. It bet the house on the Pfizer vaccine, showing off dedicated freezers in December. And it has superb health IT, with a central database that can search by age and location.
That makes it easier to set up appointments. The Danes also chose to give out as many first doses as they could, rather than holding back some vials for the second. It has bet that it can get enough doses in time for a second jab.
Will the vaccines work against Covid-19 mutations, now popping up with regularity? The more the virus spreads, the greater chance new, resistant mutations will occur
Denmark is followed by Ireland on 1.6 per cent and Italy on 1.5 per cent – far ahead of Belgium on 0.6 per cent, France on 0.5 per cent and the Netherlands on 0.27 per cent, according to figures as of Thursday on Our World in Data.
There are some key unanswered questions about the vaccines. Can vaccinated people still infect non-vaccinated people with the virus? This should be known in February, according to Pfizer. That will be key to how quickly normal life can begin to return.
Trials are ongoing to see if vaccines can be given to children. Another question is: how long does immunity last? Vaccine producers are hopeful that it will be at least a year, but with such a new virus, it is not yet known.
Finally: will the vaccines work against Covid-19 mutations, now popping up with regularity? Research so far suggests Pfizer is effective against at least the UK and South African strains. But the more the virus spreads, the greater chance new, resistant mutations will occur.
Irish preparations
There have been criticisms of preparations closer to home.
In the Dáil this week Fianna Fáil's Marc MacSharry rounded on Minister for Health Stephen Donnelly. "We are slapping each other on the back, saying how great the job we are doing is, and taking pictures of a handful of vaccines coming in off a plane," he said.
"The reality is we did not prepare when we had time to prepare," said MacSharry, a rebel within the Fianna Fáil ranks and a regular critic of Government policy, publicly and privately. But privately, sources with knowledge of the vaccination plan agree with some of what he said.
Senior medics involved say more could have been done, and earlier. One describes planning as “shambolic”. “We’ve known for quite a long time, but at least since September, that a vaccine was on the horizon.
“There’s no excuse that we shouldn’t have had a masterplan, down to the tiniest detail,” the source says. Meanwhile, an experienced pharmaceutical industry executive says “very little advance thought was given about the Covid vaccine until quite late in the day”.
Equally there is no deal with GPs or pharmacists, while the lack of a national immunisation database, and ageing IT in the HSE that has been known about for years. Updated training and work on informed consent, which delayed the rollout in nursing homes, could have been undertaken, they say.
There is evidence the State was working on some issues early in the pandemic. In June priority lists for immunisation were discussed by the National Public Health Emergency Team (Nphet), and a subgroup was established to look at vaccine policy.
In April minutes of a meeting of the National Immunisation Programme, first reported by the Medical Independent, show concerns were raised about the absence of a National Immunisation Information System.
The NIIS database brings together all other regional and national immunisation information. “In 10 years since [the] last pandemic there is still no system. If we get a Covid vaccine there will be issues with data recording,” the minutes warn.
However, often it was months before final, or even interim, decisions were made. The State ultimately procured a system from IBM and SalesForce, designed only for the Covid-19 pandemic. Even here there are issues, and some data has to be manually transferred from paper.
A dedicated Covid-19 immunisation group first met at the end of August. That group eventually became the High Level Taskforce, charged with co-ordinating vaccination strategy, and chaired by Prof Brian MacCraith. This met for the first time only at the end of November.
By comparison, its UK counterpart was established in April. Senior HSE sources say planning was “largely theoretical” during the summer, arguing that there was little evidence that a safe, effective, mass-produced vaccine would be available soon.
The speed of the vaccines' arrival did catch the State by surprise. In September, Tánaiste Leo Varadkar said there was "growing" confidence that vaccines could be given to vulnerable groups in the first half of 2021.
However, that sparked a significant pushback. Department of Health sources told the Irish Examiner a day later that they had "no idea" where he had got his information. "We're highly unlikely to have an approved vaccine in January," said an unnamed senior source.
Making progress
Whether the State was as prepared as it could have been, the latest figures indicate that it is moving relatively quickly, reflected in the current strength of Ireland’s performance relative to its European peers. Prof MacCraith says he is “in awe of the incredible work and commitment of the people in the HSE working on it. These are people who had no Christmas, to get us ready for this and have worked very long hours since then to deliver the vaccination numbers that were released yesterday”
Prof Karina Butler, chairwoman of the National Immunisation Advisory Committee, says the speed of vaccine development "exceeded everyone's expectation. I think there have been a lot of new considerations in this for everyone, and I don't think people can always anticipate every little step. Maybe it takes something like a pandemic to highlight the areas where we haven't been as proactive as we should be."
The Government is increasingly confident about supply. A memo brought to Cabinet last week says “the latest indications … suggest that, within a matter of weeks, substantial additional quantities of vaccine will become available”.
The new mantra is reflected in the memo. However, it notes that “it will be essential that the system is ready to scale up significantly” and that work is under way to achieve this.
In the words of one senior official, "We have f***-all in the fridge. We have emptied it"
However, the HSE has been noticeably reluctant to sign its name to the detailed rollout as laid down by the Minister for Health, who told Newstalk this week that all over-70s would be vaccinated by the end of March and all over-55s by the end of June.
The high level of vaccinations in recent days was facilitated by strategic changes. Firstly, Ireland was able to move away from a strategy where one dose was held in reserve for every dose administered, to a “buffer” strategy where a week’s supply is held back.
That buffer has been depleted to allow for greater nursing home vaccinations. In the words of one senior official, “We have f***-all in the fridge. We have emptied it.” The HSE has also extended the interval between doses of the vaccine to 28 days to speed up rollout.
This strategy was based on growing confidence that it will get 40,000 vaccines per week from Pfizer, even with 48-hour confirmations before arrival. That confidence will have been affected by yesterday's news from Norway that Pfizer supplies there will be reduced this month until its upgrades a Belgian factory.
Extra vaccinators
Some 110,000 doses of Moderna have been promised before April. Staff and residents in long-term residential facilities, front-line healthcare workers and older people should be covered shortly. In all, that means 700,000 people vaccinated by the end of March.
However, all of that depends on getting 600,000 doses of AstraZeneca. The further out the horizon goes, the greater the uncertainty. At its peak, the State must be able to give out 200,000-250,000 shots per week. That requires thousands of vaccinators.
Extra people will be needed for this, including registered healthcare professionals and other groups such as the Red Cross or the Order of Malta, though the State has been slow to reply to pre-Christmas offers of help from them.
Mass vaccination centres must be established, and a deal with GPs and pharmacists must be signed, too. Last week the Cabinet discussed the issue of indemnity cover for such groups – a reflection of the litigation hurdles common in the State.
The large increase in vaccinations this week has largely been driven by the fact that they are being given in hospitals to hospital staff. It will not be so easy in other locations, such as nursing homes, say senior HSE officials, where disease outbreaks and logistical complications are expected.
"There'll be trouble, there'll be problems, there'll be complications," says HSE chief clinical officer Dr Colm Henry. "There will be people we can't get to because they're sick or recovering. There will be bends and bumps in the road."
On top of the massive challenges with supply and distribution, the Government also has to sell its plans to the people – and its own members. Criticisms so far are not confined to the Opposition benches, or rebel Government voices, such as Mark MacSharry.
The Fine Gael parliamentary party heard widespread criticism of the communications of the campaign. On Wednesday, Minister for Health Stephen Donnelly faced a barrage of criticism in the Dáil from Government TDs.
Fianna Fáil TD John Lahart warned: "The message is not getting through. There is a hunger for information that will be replaced by anger very quickly if answers are not forthcoming."
Fine Gael’s Jennifer Carroll MacNeill said she could not answer questions from lone parents with diabetic children, or a man wanting to know when his 91-year-old mother would be vaccinated.
“This is the biggest logistical exercise this State will face and the risk is that if we do not do this and we cannot provide that clearly, we will lose the solidarity we have.”
