The first Covid-19 vaccinations could begin before the new year depending on approval from the European Medicines Agency, the Minister for Health said on Tuesday.
Stephen Donnelly said: “It is possible that if the EMA does authorise this vaccine that an initial – it would be a very low level – but that an initial round of vaccination could actually begin before the new year”.
The Minister’s comments came after the agency said it would seek to approve “if possible” the Pfizer BioNTech vaccine on December 21st, eight days earlier than planned.
The committee was originally scheduled to convene on December 29th. The new date may shift forward the vaccination schedule for the EU by more than a week.
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The EU body said its human medicines committee (CHMP) had been “working intensively” to check data sent by the pharmaceutical companies over the past few weeks, and on Monday had received additional information it had requested.
“Pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for December 21st to conclude if possible,” the agency said in a statement.
In a statement to mark the publication of the report of the Government’s high level vaccination taskforce, Mr Donnelly said the vaccination programme would be rolled out in three phases.
An initial rollout will be followed by a mass ramp-up and finally, open access. The highest priority groups – those over 65 in long-term care facilities, and frontline healthcare workers in direct contact with patients – will receive the vaccine first.
“It will be bigger and more complex than previous vaccination programmes. It will play a central role in our exit from the pandemic”.
He said over time, “it will allow us to return to reopen our society and to reconnect in the ways we once took for granted”.
However, Mr Donnelly cautioned: “A vaccine won’t have a positive impact on the direct trajectory of this disease for at least months to come.”
Dr Lorraine Nolan, the chief executive of the Health Products Regulatory Authority (HPRA), said that if the EMA made a positive decision on the Pfizer vaccine on the December 21st, it would be several days before a conditional marketing approval was granted, which would allow for the distribution of the vaccine. She said that could happen by the 23rd.
“It will then take a number of days, potentially up to a week for the initial vaccination here,” Mr Donnelly said.
Training materials would have to be developed for vaccinators which would take seven to ten days, Professor Brian MacCraith said. But this could not happen until the conditional marketing approval was granted, and that cannot be completed until the CMA is granted.
Prof MacCraith, who chaired the taskforce, said there were a “number of unknowns” at the time the report was being written, including approval dates, delivery schedules and in some cases the specific characteristics of the vaccines.
He said consequently there were some open issues on how the programme would be implemented. In addition to the two sites mentioned in the report as potential mass vaccination centres - Citywest and the National Exhibition Centre in Dublin - Prof MacCraith said he had held talks with the presidents of NUI Galway, Waterford Institute of Technology, the University of Limerick and UCC.
Disease trajectory
Dr Tony Holohan, the Chief Medical Officer, struck a more cautious tone, welcoming the report and warning against misinformation, particularly online. He said, however, that the virus “doesn’t care that the vaccine is on the horizon”.
He said that in “medical and technical terms”, the virus is just as big a danger to those who are infected as it was in March. “A vaccine won’t have a positive impact on the direct trajectory of this disease for at least months to come. And in the meantime, we need to continue to do all that we can to save lives now,” he said.
Dr Holohan said the State is “actively planning” to vaccinate people in early 2021, but speakers at the launch repeatedly emphasised that the first consignments of the vaccine will be limited in scope and scale.
Paul Reid, the chief executive of the HSE, said “it is widely expected that the delivery of volumes in the first phase will be smaller.” He said the HSE is establishing a plan for the workforce for administering the vaccine, and has selected an IT provider - a joint venture of IBM and Salesforce - to administer the “digital process” underpinning the rollout. That system will cover making appointments, the administration of the shots needed, and ongoing monitoring and reporting after vaccination, he said.
A backup IT system, Healthlink, which currently manages GP referrals, would be ready to support the first wave of vaccinations if the full system was not ready to deploy. “If it’s not ready we have a backup solution that will work. So we won’t be delaying the rollout”, he said.
Mr Reid said the HSE was working on a Data Protection Impact Assessment (DPIA) of the project, and was in dialogue with the Data Protection Commissioner.
In addition to trained vaccinators, GPs, pharmacists and other medical professionals, recent retirees may play a role in administering the vaccine, as might the national ambulance service, he said, adding that the HSE would be engaging with GP and pharmacist representative bodies. Some 26 private nursing homes will be part of the first deployment, he said.
The news conference heard that the first batch of Pfizer-BioNtech vaccines would be produced in Belgium, before being shipped from Karlsruhe to the State’s central cold storage facility in Citywest, where ultra low temperature freezers have been installed. Mr Donnelly said he did not anticipate Brexit impacting on the delivery of the vaccines “at all”. The first phases of rollout will be on a “hub and spoke” model, done by mobile units or through hospitals.
Adverse reactions
Asked about the potential for adverse incidents and associate legal actions, Dr Nolan said an “absolute guarantee” that the vaccines would be risk free is “simply not possible”.
“We know this vaccine will have the typical profile of any vaccine and we can expect there will be effects,” she said, adding they would be mild. She said that moving from clinical trials to real world use of the vaccine, however, “you have to be open to the possibility that that widespread use and that scale may show up rare effects that the clinical trials haven’t shown”.
Dr Nolan argued that any such incidence would be very rare, “less than one in a hundreds [of] thousands”, and that Covid, on the other hand, is associated with “very real risks”. “One in 40 people that have got this have actually died, and in Ireland, 8 per cent of people that have got Covid have ended up in hospital with severe disease,” she said.
Dr Holohan said he hoped that daily updates on the number of people vaccinated would be issued next year, along with the daily case numbers.
In his statement, Mr Donnelly said: “Today is a really positive day for all of us. After a very difficult year, we are hopefully that Covid-19 vaccines will be approved for use in Ireland in a matter of weeks.”
Mr Donnelly thanked Prof MacCraith for his work on the strategy, which he said was the result of close co-operation between the Department of Health, the HSE and other stakeholders.
Vaccines will be administered from long-term care facilities, mass vaccination clinics, GP surgeries and community pharmacies, and will be carried out by trained healthcare workers.
The Minister said Ireland had largely avoided a significant rise in ICU admissions and many deaths due to its pre-emptive action in recent months, but that Covid-19 is “still out there”.
“Cases of Covid-19 have crept up again in recent days, and so we must all be careful,” he said.
Taoiseach Micheál Martin said on Tuesday the rollout of Covid-19 vaccines would in part be determined by drug companies’ capacity to produce doses, as well as authorisation timelines.
Mr Martin told reporters before Cabinet on Tuesday morning that the rollout of the State’s immunisation “all depends on the manufacturing capacity within the various companies, and the timing of the various vaccines getting authorisation”. He said the timing was “very much subject” to these factors.
Mr Martin said earlier this week that the “optimal” time for administering the inoculations would not be until late spring, tempering expectations that the rollout will quickly follow the approval of the first vaccine by regulators, which is expected before the end of the year.
Up to 14 million doses may be purchased by the State, depending on whether a sixth advanced purchase agreement is signed off by the EU with drug company Sanofi.
Sources have said the cost of the drugs will be about €112 million.
