Distribution of a vaccine for Covid-19 could start in the first weeks of the new year, Minister for Health Stephen Donnelly has indicated.
The European Medicines Agency is due to complete a final review of the Pfizer/BioNTech vaccine on December 29th at the latest. Mr Donnelly said that if the EMA approves the treatment, Irish regulatory approval would follow soon after, with distribution beginning in early January.
The EMA may approve a second vaccine, from Moderna, at a further meeting on January 12th, after which distribution would also begin in Ireland, he said.
The Department of Health said on Wednesday that supplies of the vaccines under development were being procured by the European Commission on behalf of member states. Advance purchase agreements have been negotiated by the commission with vaccine suppliers, which also cover issues relating to liability or indemnity.
On Wednesday the UK became the first country in Europe to approve a Covid-19 vaccine after its Medicines and Healthcare products Regulatory Agency approved Pfizer/BioNTech’s vaccine for use.
The development has put pressure on the EU approval process led by the EMA, which on Wednesday criticised the UK for making a decision on limited data.
A spokesman for the European Commission said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine”, as it was based on more evidence.
However, the UK health minister Matt Hancock claimed Brexit had helped it move faster. He said that “because of Brexit” its regulator had been able to move faster than the EMA while carrying out “the same safety checks”.
This was disputed by EU sources, who pointed out that the UK was still subject to EU rules and that it had used an emergency procedure available to all member states that allows it to distribute a vaccine for temporary use.
Mr Donnelly, speaking on RTÉ, described the UK development as good news, but pointed out that the EMA is also reviewing vaccines developed by AstroZeneca/Oxford and Janssen.
Taoiseach Micheál Martin told the Dáil the infrastructure to store the Pfizer/BioNTech vaccine at -70C was already being set up in Ireland. This equipment would be commissioned by the middle of next week, he said.
Referring to the “huge” responsibility on the EMA for recommending the vaccine as being safe and effective, he said “we shouldn’t create a pressure zone on the regulatory authority to do the right thing”.
The work of the taskforce on vaccine rollout, which is due to publish a plan at the end of next week, was "proceeding at pace," he told Labour leader Alan Kelly.
Mr Kelly said Finland, France, Denmark and the UK had advanced plans for the provision of the vaccine.
Ireland needs “to have equal pace and equal thought put into this”, he said, as he repeated a call for a dedicated minister for vaccines to be appointed.
Safety profile
The Tánaiste Leo Varadkar warned a private meeting of the Fine Gael party on Wednesday evening that there are a number of “unknowns” around the new Covid-19 vaccines including around possible rare side effects.
Sources at the meeting said Mr Varadkar pointed out the Government does not know how long immunity will last after vaccination and also said it will not be possible to fully understand what rare side effects exist until a million or two million people have taken the vaccine. But he insisted the safety profile of the vaccines looks very good.
It is understood he said that while the news on vaccines has been positive today “there are a number of unknowns.”
In terms of Government planning for roll out of the vaccines Mr Varadkar said that a single IT system would be needed now, something which does not currently exist.
It is understood Mr Varadkar said the vaccine will not be compulsory but that the Government will need to find a way to provide people with proof or evidence that they have had the vaccine, if they want or need it.
He also outlined that the Government was providing indemnities for the pharma companies and that had to be done before they were supplied.
There would also be a communications campaign needed for those who are vaccine hesitant, sources present said.
Cost
Earlier Mr Donnelly confirmed securing vaccines against Covid-19 will cost the State € 117.6 million.
The Minister told the Oireachtas select committee on health that the country had agreements in place to purchase 15.6 million doses of vaccines manufactured by a number of different pharmaceutical companies.
He said while there had not been a Government decision as of yet, it was his “unambiguous view” that the Covid-19 vaccine should be provided free of charge.
In the Dáil the Taoiseach defended the EU decision that national governments will indemnify companies producing the Covid-19 vaccine.
Mr Martin insisted that getting the vaccine “would simply not have happened” without pre-purchase agreements.
Ireland will now have access to vaccines from six companies through European Commission agreements but the decision to indemnify the companies is a pre-condition of accessing millions of doses of the jab.
Aontú TD Peadar Tóibín expressed concern in the Dáil that the decision “happened in secret, with no political discussion or scrutiny”.
He hoped “we have a safe, ethically produced and effective vaccine that will help the country to get back to normal”.
Mr Tóibín believed though that when the Government indemnifies private companies, “it takes away the economic imperative for those companies to make sure that their product is 100 per cent safe and leaves the country potentially exposed to millions of euro in costs in the future”.
Expressing concern at the Government’s decision to indemnify companies he also asked “what will Ireland be on the hook for, potentially, if all does not go according to plan”.
The Taoiseach said “there is no set amount. The bottom line here is that we either want a vaccine in the middle of a global pandemic or we don’t”.
He said to Mr Tóibín: “Now, get real. This is unprecedented in terms of the progress around getting this vaccine done and without pre-purchase agreements, it simply could not and would not have happened.”
He said “this was very clear from the outset to those following the European debate on this.
“The European Commission, on behalf of the member states, entered into pre-purchase agreements with companies with a view to getting vaccines to deal with a virus that is crippling economies all over the world.”
He said trillions of euro had been spent globally on trying to save economies, and keep jobs.
“The balance is correct in this context. It is the right balance,” he said.
