There will be no “lowering of the bar” in the approvals process for new Covid-19 vaccines, the head of Ireland’s drugs regulator has said.
No regulatory body, here or abroad, will make the new vaccines available “without having full confidence that they are safe and that they work,” Dr Lorraine Nolan, chief executive of the Health Products Regulatory Authority told a National Public Health Emergency Team (Nphet) briefing on Monday.
The deaths of a further two patients with Covid-19 were reported by Nphet. This brings to 2,126 the total number of deaths in the pandemic.
Another 264 confirmed cases of the disease was also reported, bringing the total number of cases to 76,449 in the Republic.
With the five-day moving average increasing to 312 cases a day compared to 258 last Thursday, chief medical officer Dr Tony Holohan said there had been a change in the pattern of transmission of the virus, with an uptick in numbers.
Nphet’s basic messages remained that people should plan ahead for Christmas, limit their social interactions, and choose between what activities were possible rather than trying to do them all, he emphasised. People can still influence the course of the infection by limiting their contacts.
Dr Nolan told the briefing: “All vaccine applications will be reviewed just as carefully and as rigorously as for any other medicine. We will be led by the evidence and by the science. That is the backbone of any regulatory system.”
Acknowledging there is concern about the pace at which vaccines are being developed, she stressed that many factors have come together at the same time to enable this to happen.
These included huge public and private investment, the lessons learned dealing with Zika and Ebola viruses, the early publication of the genetic sequencing of SARS-CoV-2, and the fact that some of newer-type vaccines can be produced much faster than traditional vaccines.
And while the regulatory process was being accelerated, this would not compromise the “detailed and thorough nature of scientific scrutiny”.
Asked if the UK had lowered the bar through its earlier approval of the Pfizer/BioNTech vaccine, she said it had used a different, emergency regulatory process which was “more limited” and which may have reflected the epidemiology of the disease there.
Asked about a new variant of the virus identified in the UK, assistant chief medical officer Dr Ronan Glynn said very little information was available about this at the moment and it was too early to say if this variant has any effect on the immune response.
Of the new cases, 79 are in Dublin, 24 in Donegal, 19 in Kerry, 18 in Limerick, 14 in Kildare, 14 in Wexford and the remaining 96 in 16 other counties.
On Monday afternoon, there were 215 Covid-19 patients in hospital, including 33 in ICU. There were 17 additional hospitalisations in the previous 24 hours.
The national incidence of the disease is now 83.4 cases per 100,000 over the past 14 days. Donegal, with an incidence of 225.5, has the highest county incidence, followed by Kilkenny and Louth.
Leitrim has the lowest incidence, at 25, with eight new cases over the past 14 days.
So far this month, there have been 38 deaths of Covid-19 patients, compared to 122 in October and 148 in November.
He again expressed concern about people travelling to Ireland from other countries over Christmas, as many European countries are currently experiencing their highest incidence of Covid-19 at present.
In contrast, Ireland has the lowest incidence in the EU and the second-lowest death rate.
Asked if it will be safe for Santa to visit homes this Christmas, the chief medical officer said it would.
Santa would take all the necessary safety measures so it would be safe for him to visit children “who are good and those doing their homework and helping around the house and not fighting with their sisters and brothers”.
“The important thing for kids to do now is to write their letters, keep doing their homework and Santa can come,” said Dr Holohan.
Mr Martin said the Government wanted to be in a position to begin the rollout “within days” of the vaccine’s expected approval by European Medicines Agency (EMA) on December 29th.
He said that although there would be limited quantities of the vaccine in January and February, there would be enough for priority cases.
Greater quantities of the vaccine will become available in March, April and May as further vaccines come on stream and manufacturing around the world is increased. There will be a staged timeline approach depending on availability, he said.
Speaking on RTÉ Radio’s Morning Ireland, Mr Martin said he was concerned about the recent rise in coronavirus cases and he warned “we cannot let our guard down”.
Just because there was now a vaccine available did not mean that the public should not adhere to public health measures, Mr Martin said. If numbers continued to rise then further restrictions could be introduced in January. People needed to be very careful about their contacts in the run-up to Christmas, he said.
The vaccine would be a complementary tool to enhance public health measures and would “add significantly to our armoury in putting pressure on this virus”, he said.
The Pfizer/BioNTech vaccine will have to be carefully handled and the Government will announce plans on Tuesday on how it will be administered, he said. Public health teams and doctors, along with GPs and pharmacists, will be involved in administering the vaccine.
A second vaccine, created by US company Moderna, is expected to approved by the EMA on January 12th, Mr Martin said.
The optimal period for a vaccination programme will be May and June, he said.
Meanwhile, Minister for Further and Higher Education Simon Harris said that there will be “quick movement” to roll out the vaccine in nursing homes and among healthcare workers in January.
When asked about vaccinating third level students before they returned home for the Christmas holiday, Mr Harris told RTÉ’s Today with Claire Byrne show there was no particular reason why third level students needed to be vaccinated after the college term ends.
The advice for students was the same as for everyone else and while the University of Limerick had started offering antigen tests to students, he said there would be no mass screening of students.
Mr Harris also pointed out that “the bulk” of third level students were working remotely online under Level 3 restrictions.
No impact for months
Deputy chief medical officer Dr Ronan Glynn on Monday said a vaccine would not have any positive impact on Covid-19 for months to come.
“As we face into Christmas and the New Year, there are many reasons for hope,” he said on Twitter.
“Through people’s collective efforts we have avoided to the greatest extent possible the devastating impact that Covid-19 has had across Europe over the past two months. But … we are not through this yet.
“This virus doesn’t care that we have done well recently. It doesn’t care that we are tired or that we are desperate to see our families and friends. It is no less dangerous now than it was last March.”
Dr Glynn said in a statement on Sunday, the State was “on the cusp” of deploying at least two Covid-19 vaccines but concerns remained around ensuring sufficient numbers of people take up the option of getting vaccinated.
“Our research tells us that the majority have already decided that they will definitely (45 per cent) or probably (28 per cent) take the vaccine when it is offered to them while. At the other end of the spectrum, a small – but vocal – minority (5 per cent) absolutely will not take it.”
He moved to reassure people that there were no concerns in relation to safety of the vaccine in spite of the speed at which things were happening.
Dr Glynn said the “enormous levels of investment” had cut down the timeline. The high number of Covid-19 cases had helped trials quickly measure differences in risk between those who received the vaccine and those who got the placebo. Finally, several processes that usually happen after each other had been carried out in parallel.
The State’s vaccine taskforce report on the roll out of the vaccine is expected to be published on Tuesday.
GPs seeing increase in patients with virus symptoms
Dr Mary Favier, Covid-19 lead for the Irish College of General Practitioners (ICGP), said GPs had been seeing an increase in the number of patients coming to them with coronavirus symptoms in recent days.
She told RTÉ radio’s Today with Claire Byrne show the continued high numbers in the Border counties were of particular concern. However, she was also worried about high numbers in counties Kilkenny and Limerick and there was no county about which she was not concerned.