European Medicines Agency to complete review of Pfizer vaccine by December 29th
Covid-19 vaccine distribution could start early in new year, says Donnelly

Covid-19 vaccine distribution could start early in new year, says Donnelly

Covid-19 vaccine distribution could start early in new year, says Donnelly

Covid-19 vaccine distribution could start early in new year, says Donnelly

Covid-19 vaccine distribution could start early in new year, says Donnelly

Covid-19 vaccine distribution could start early in new year, says Donnelly
Covid-19 vaccine distribution could start early in new year, says Donnelly
  • 2020-12-03 02:10:12 2 months ago
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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 (EMA) 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 yesterday 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 supplier, which also cover issues relating to liability or indemnity.

“Member states may decide to opt in/opt out, but do not have the scope to recast the provisions of any advance purchase agreement.”

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 yesterday 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.

Brexit

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 the 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” as he repeated a call for a dedicated minister for vaccines to be appointed.

Free of charge

Mr Martin also defended the EU decision that national governments will indemnify companies producing the Covid-19 vaccine amid concerns that it could potentially expose the State to millions of euro in future costs. Mr Martin insisted that getting the vaccine “would simply not have happened” without pre-purchase agreements.

Mr Donnelly confirmed on Wednesday that securing Covid-19 will cost the State €117.6 million. The Minister told the Oireachtas select committee on health on that the country had agreements in place to purchase 15.6 million doses of vaccines manufactured by a number of different pharmaceutical companies.

Mr Donnelly 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.

Elsewhere Tánaiste Leo Varadkar told a meeting of the Fine Gael parliamentary party last night 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. Mr Varadkar also said that a single IT system would be needed, something which does not currently exist.

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Covid-19 vaccine distribution could start early in new year, says Donnelly