Vaccination rollout strategy taking shape

Taoiseach pressed for comprehensive outline on rollout strategy for Covid-19 vaccines

A vial of the Pfizer BioNTech
mRNA-based vaccine

The United Kingdom (UK) has become the first country to approve a vaccine for use against Covid-19 as the regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), has granted a temporary authorisation for emergency use of the Pfizer BioNTech mRNA-based vaccine, with supplies to be launched next week.

This constitutes the first Emergency Use Authorisation, while the United States Food and Drug Administration (US FDA) and European Union’s European Medicines Agency (EMA) decisions on authorisation are expected this month.

The companies stated they were ready to deliver the first doses to the UK immediately.

The MHRA’s decision is based on a rolling submission, including data from a Phase III clinical study, which demonstrated a vaccine efficacy rate of 95 per cent (p<0.0001) in participants without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose.

According to a statement issued this morning by Pfizer and BioNTech, the companies previously signed an agreement to supply a total of 40 million doses to the UK with delivery in 2020 and 2021.

Yesterday, the Labour Party in Ireland called for the appointment of a dedicated Minister with responsibility for vaccines and politically accountable to the Dáil.

Party Leader and Health Spokesperson, Deputy Alan Kelly, said the Irish Government needed to outline how the vaccine would be rolled out, how vaccine passports would be generated and who was politically accountable for the rollout.

Speaking at Leader’s Questions, he asked the Taoiseach to give a comprehensive briefing on the rollout strategy for Covid-19 vaccines and appointment of a dedicated Minister with responsibility for the vaccination programme.

He said we needed to go “broader” than the vaccine taskforce.

“I think we really need somebody who’s going to be directly politically accountable for the most important thing in this country over the next 12 months.

“The word taskforce fills me with concern. This isn’t anything to do with politics.” He accepted what the Taoiseach has said about EU procurement and in relation to the number of vaccines.

“And this is all very positive but there are simple logistical issues that need to be addressed. How will people who get vaccination, be distinguished from those who don’t? How are we going to generate passports for people who have the vaccination and will anyone who does not get the vaccination be allowed to go into certain public events?” he added.

An Taoiseach Micheál Martin said the Covid-19 vaccine taskforce had met twice so far.

Complex logistical challenges had been identified, including storage and transport requirements.

The high-level task force was to work with the Department of Health and the Health Service Executive to develop a national Covid-19 vaccination strategy and implementation plan for consideration by the Government “and the chairman has undertaken to me that it will be ready by December 11,” added the Taoiseach.

He said we still did not have a vaccine approved but it was moving quickly.

“I suspect the EMA, which is the European approval authority, will work almost in tandem with the FDA in terms of the respective timelines,” the Taoiseach told the Dáil.

In Dublin, the Pfizer Grange Castle operation is currently working on quality testing batches of the vaccine candidate that are being manufactured at the group’s plant in Belgium.

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