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Distribution of a vaccine for Covid-19 could begin in the first weeks of the new year, Health Minister Stephen Donnelly said.
The European Medicines Agency must complete a final review of the Pfizer / BioNTech vaccine by December 29 at the latest. Donnelly said that if the EMA approves the treatment, Irish regulatory approval would follow shortly thereafter, and distribution would begin in early January.
The EMA could approve a second vaccine, from Moderna, at an additional meeting on January 12, after which distribution in Ireland would also begin, he said.
The Health Department said Wednesday that the European Commission was procuring supplies of vaccines under development on behalf of member states. The commission has negotiated advance purchase agreements with vaccine suppliers, which also cover issues related to liability or compensation.
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 the Pfizer / BioNTech vaccine for use.
The development has put pressure on the EMA-led EU approval process, which on Wednesday criticized the UK for making a decision on limited data.
A spokesperson for the European Commission said that the EMA procedure was “the most effective regulatory mechanism to give all EU citizens access to a safe and effective vaccine” as it was based on more evidence.
However, UK Health Minister Matt Hancock claimed that Brexit had helped him move faster. He said that “due to Brexit” his regulator had been able to move faster than the EMA while performing “the same security checks.”
This was disputed by EU sources, who noted that the UK was still bound by EU rules and had used an emergency procedure available to all member states that allows it to distribute a vaccine for temporary use.
Donnelly, speaking on RTÉ, described the UK development as good news, but noted that the EMA is also reviewing vaccines developed by AstroZeneca / Oxford and Janssen.
Taoiseach Micheál Martin told Dáil that the infrastructure to store the Pfizer / BioNTech vaccine at -70 ° C was already being installed in Ireland. This equipment would be commissioned in the middle of next week, he said.
Referring to the “enormous” responsibility of the EMA to recommend the vaccine as safe and effective, he said that “we should not create a pressure zone on the regulatory authority to do the right thing.”
The work of the task force on the launch of the vaccine, which is due to publish a plan by the end of next week, “is progressing apace,” he told Labor leader Alan Kelly.
Kelly said Finland, France, Denmark and the United Kingdom had advanced plans for the supply of the vaccine.
Ireland needs to “have the same pace and the same consideration on this,” he said, repeating a call for a minister dedicated to vaccines to be appointed.
Safety profile
Tanaist Leo Varadkar warned at a private gathering of the Fine Gael party on Wednesday night that there are a number of “unknowns” surrounding the new Covid-19 vaccines, including rare potential side effects.
Sources at the meeting said that Varadkar pointed out that the government does not know how long immunity will last after vaccination and also said that 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 that the safety profile of the vaccines looks very good.
It is understood that he said that although the news about vaccines has been positive today, “there are a number of unknowns.”
Regarding government planning for the deployment of vaccines, Mr. Varadkar said that a single IT system would now be needed, something that does not currently exist.
It is understood that Mr. Varadkar said that the vaccine will not be mandatory, but that the Government will need to find a way to provide people with proof or proof that they have received the vaccine, whether they want or need it.
He also stressed that the government was providing compensation to pharmaceutical companies and that had to be done before they were supplied.
A communication campaign would also be needed for those who hesitate to vaccinate, the sources present said.
cost
Previously, Donnelly confirmed that obtaining vaccines against Covid-19 will cost the State 117.6 million euros.
The minister told the Oireachtas health select committee that the country had agreements to purchase 15.6 million doses of vaccines manufactured by several different pharmaceutical companies.
He said that while there had not been a government decision yet, it was their “unequivocal opinion” that the Covid-19 vaccine should be provided free of charge.
In the Dáil, the Taoiseach defended the EU decision that national governments will compensate companies producing the Covid-19 vaccine.
Mr. Martin insisted that getting the vaccine “just wouldn’t 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 precondition for access to millions of doses of the jab.
Aontú TD Peadar Tóibín expressed concern in the Dáil that the decision “occurred in secret, without political discussion or scrutiny.”
He hoped that “we will have a safe, ethically produced and effective vaccine that will help the country return to normalcy.”
However, Tóibín believed that when the government compensates private companies, “it takes away the economic imperative for these companies to ensure that their product is 100% safe and leaves the country potentially exposed to millions of euros in costs in the future.”
Expressing concern about the government’s decision to indemnify the companies, he also asked “why is Ireland in danger, potentially, if not everything goes according to plan”.
The Taoiseach said “there is no fixed amount. The conclusion here is that either we want a vaccine in the midst of a global pandemic or we don’t want it ”.
He told Mr. Tóibín: “Now, be real. This is unprecedented in terms of progress in making this vaccine and without pre-purchase agreements, it just couldn’t and wouldn’t have happened. ”
He said that “this was very clear from the beginning for those who followed the European debate on this.
“The European Commission, on behalf of the member states, entered into pre-purchase agreements with companies in order to obtain vaccines to deal with a virus that is paralyzing the economies of the entire world.”
He said billions of euros have been spent globally to try to save economies and maintain jobs.
“The balance is correct in this context. It’s the right balance, ”he said.
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