Q&A: Where is Ireland in vaccine rollout race?

It is thought that GPs and pharmacists will be involved in any Covid-19 vaccination programme but mass vaccination clinics could also be set up here as in other countries.

Where is the vaccine to be rolled out first?

The UK has become the first country in the world to approve a Covid-19 vaccine and expects to begin vaccinating from next week.

Today, UK regulatory authorities approved the Pfizer / BioNTech Covid-19 vaccine, which has been shown in clinical trials to be 95% effective with no safety concerns among 43,000 people tested. 

The UK, which has ordered 40m doses, expects to secure 800,000 doses next week and 10m in the coming weeks. The two-dose Pfizer / BioNtech vaccine, which is given 21 days apart, must be stored at -70C, which could bring logistical challenges.

How is the UK ahead of Ireland and the EU?

The UK Health Minister said Brexit has allowed it to forge ahead with authorising Covid-19 vaccines outside of European mechanisms that it was previously tied to.

Matt Hancock said the UK was no longer bound by the European Medicines Agency (EMA) and did not have to follow the “pace of the Europeans”.

The approval of drugs and vaccines in Ireland is governed by the Health Product Regulatory Authority and the EMA, neither of which have signed off on any Covid vaccines to date, although Health Minister Stephen Donnelly said they were a “few weeks apart” from UK authorities on deciding on the Pfizer/ BioNtech vaccine.

Why do we need a Covid-19 vaccine?

Vaccines can play a role in protecting people, in particular at-risk groups, from becoming critically ill from Covid-19. Close to a dozen Covid-19 vaccines are in the final phase of development, with a handful of frontrunners moving closer to gettting approval for use.

This week, the Pfizer / BioNtech vaccine became the first to secure approval for use in the UK.

Public health measures and treatments will continue to be as important in the fight against Covid-19 until a majority of the population is vaccinated and protected against the virus.

At this stage it is not clear how long any of the new vaccines in development can protect for.

The EU has pre-ordered around 2bn Covid-19 vaccine doses that are in development but have yet to be approved for use.

The EMA is assessing four Covid-19 vaccines at present.

This week, it signalled that it will be December 29 before it makes a decision on the Pfizer/ BioNtech vaccine that is being rolled out in the UK from next week.

It also hopes to make a decision on the Moderna mRNA vaccine by January 12, raising hopes of two vaccines becoming available across Europe in January.

The EMA is also assessing a vaccine being developed by AstraZeneca and the University of Oxford and also by Janssen.

When will Ireland see Covid-19 vaccines?

Vaccine rollout in Ireland will be dependent on regulatory approval, which could happen in late December and early January.

Meanwhile, a Covid-19 vaccine taskforce, led by Professor Brian MacCraith, is expected to deliver a plan on December 11 on how vaccines will be rolled out and who will be prioritised for vaccination.

It is thought that GPs and pharmacists will be involved in any Covid-19 vaccination programme but mass vaccination clinics could also be set up as in other countries.

Health Minister Stephen Donnelly said the taskforce was "confident" that the necessary infrastructure would be in place to roll out approved vaccines.

Will we have enough Covid-19 vaccines?

The EU  has pre-ordered around 2bn Covid-19 vaccine doses that are in development but have yet to be approved for use.

Ireland has signed agreements with six pharmaceutical companies for Covid-19 vaccines.

Once approval is granted, it is expected that vaccines could be rolled out with a week to ten days.

How quickly vaccines can be deployed will also depend on how quickly they are manufactured and distributed around the world and any particular logistical challenges, such as cold storage requirements.

Who will be prioritised for vaccination? 

It is likely that the older and vulnerable population will be prioritised for vaccination in Ireland but some other at-risk groups, such as healthcare staff and possibly teachers, may also be first in line.

In the UK, health authorities are prioritising nursing home residents, the elderly, and healthcare staff as well as individuals who may be clinically vulnerable to the virus.

Ireland’s Covid-19 vaccine supplies

According to the Department of Health, more than 8 million doses of the vaccine have been purchased in advance. 

Ireland has opted into five Advance Purchase Agreements (APA), with a process in place to opt into a sixth APA. 

The 8 million doses include: 

• AstraZeneca, which is partnering with Oxford University (3.3m doses) 
• Janssen, a Belgian Pharmaceutical company owned by Johnson & Johnson (2.2m doses) 
• BioNTech / Pfizer. (2.3m doses) 
• CureVac (final allocation not yet determined) 
• Moderna (875,000) 

Sanofi Pasteur – Government approval in place; this is not required until the current phase of clinical trials of the vaccine have been completed (final allocation not yet determined)

Covid-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation, according to the Department of Health. 

"No vaccine will be used until market authorisation from the European Medicines Agency is obtained and any authorised vaccine will be subject to ongoing monitoring by the HPRA."