The beginning of the end: 10 things to know about Covid-19 vaccines

So, here is what we know.

1) So when will it end?

The honest answer is that for now, we still don’t know.

2) But what about the new vaccines? I thought a vaccine was going to bring all this to an end?

Recent news on the new Covid-19 vaccines (Pfizer/BioNTech, Moderna, and Oxford/AstraZeneca) is hugely welcome and a much-needed shot in the arm. However, right now, there is still a lot we don't know about these vaccines and we need to see and analyse all the clinical and safety data from these trials before we get too excited. And, yesterday, Oxford and AstraZeneca said when their vaccine was given as a half dose, followed by a full one at least one month later, efficacy was 90 per cent.

The good news is that the Pfizer and Moderna vaccines were found to be more than 90 per cent effective in preventing Covid-19. This means that they were shown to reduce the risk of someone contracting Covid-19 by more than 90 per cent.

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To put this in context, flu vaccines usually reduce the risk of infection by 40 to 60 per cent, depending on a person’s age, whether or not they are in an at-risk group and the type of flu vaccine they receive. However, flu vaccines also reduce the severity of illness, complications of flu, as well as the rate of hospital and ICU admissions.

Once further safety and efficacy data is available, the developers of the new vaccines are expected to apply for emergency authorisation to the Food and Drug Administration (FDA) in the US. The FDA is responsible for protecting public health by ensuring the safety and efficacy of human and veterinary medicines in America.

3) What does emergency authorisation mean?

The Health Products Regulatory Authority (HPRA) is the body in Ireland responsible for protecting public and animal health by regulating medicines, medical devices and other health products here. The HPRA works closely with its European counterparts in the European Medicines Agency (EMA).

The term "emergency approval" does not exist in Europe; instead it is called "conditional approval". If a drug receives conditional approval it means that it has enough data to show that it provides tangible benefit to treat a serious threat to public health where no other medicine exists.

According to the HPRA: "It enables earlier access to a medicine in special circumstances and is an important tool where an approval for a medicine can happen sooner than is usually the norm. It can be used in emergency situations and in response to public health threats that are recognised by the World Health Organisation. This approval is also considered where a medicine can treat or prevent a seriously debilitating or life-threatening illness. All these circumstances apply to Covid-19. Under the conditional approval process, clinical trial and supporting data must still be provided to the regulators and this must indicate that the medicine's benefit outweighs its risks."

According to the HPRA, given that Covid-19 is a public health emergency, it is expected that initial applications for all Covid-19 vaccines will seek conditional approval. More than 30 medicines have been given conditional approval by the EMA in the last 13 years.

4) What stage must a Covid vaccine get to before it can be approved?

Before any medicine can be made available to the general public, it must first be approved for use. The vaccine developer must submit an application with comprehensive supporting clinical data to the regulatory authorities.

For Covid-19, it is expected the applications for vaccines will be made to the EMA and, if approved, they can be used in all member states. The EMA relies on scientific expertise from all the national agencies, including the HPRA in Ireland, in conducting its assessment of medicines. For a Covid vaccine to be approved, it must ultimately prove that it protects against Covid-19 and is safe.

Ireland, through the HPRA, is an active participant in all European reviews, and the HPRA contributes directly to the assessment of all new medicines and the monitoring of their safety once in use. This will also be the case for Covid-19 vaccines.

5) This all seems a little rushed. How can we be sure it’s safe?

The process of researching, testing, gaining regulatory approval and manufacturing vaccines is costly and complex,and can take an average of 12 years. To date, the fastest vaccine ever to be developed was the mumps vaccine, which was licensed in 1967 and took just four years. Given that we first heard about Covid-19 less than 12 months ago and a number of promising potential vaccine candidates have already been produced, the speed at which Covid-19 vaccines are being developed is truly record-breaking.

However, speed does not and will not be allowed to trump safety, and these vaccines will be subject to rigorous and ongoing monitoring before, during and after authorisation has been granted.

In its work with the EMA, the HPRA will take part in the review of all vaccine applications and will use its clinical and scientific experts to ensure the safety, effectiveness and quality of any vaccines approved. As with all medicines, the HPRA will closely monitor the safety profile of these vaccines by reviewing all reports of suspected adverse events (harmful side-effects) it receives. All reports submitted by healthcare professionals or the public at a national level come to the HPRA. This data is then assessed closely both nationally and at European level.

It is important to note that, while the development of numerous Covid-19 vaccines is ongoing and some initial positive results have been made public, no formal applications to the regulators have been made to date.

According to the HPRA, it is anticipated that the first application for approval will be received before the end of the year.

Along with the Pfizer/BioNTech, Moderna and Oxford/AstraZeneca Covid-19 vaccine candidates, there are also a number of others in the pipeline, so we may well have a number of different vaccines to choose from in the coming months.

6) So how does Ireland get its share of a new vaccine if one is approved?

Ireland is currently involved in an EU procurement exercise operated by the European Commission on behalf of member states to procure suitable, safe and effective vaccines, in sufficient quantities, to combat Covid-19.

As part of this exercise, the European Commission has conducted a central procurement process on behalf of all member states, including Ireland.

To date, the commission has signed agreements with five different companies who are currently working on a new Covid vaccine. These are AstraZeneca, Sanofi Pasteur, Janssen/Johnson & Johnson, Pfizer/BioNTech and CureVac. The commission is also working on a sixth agreement with Moderna.

Commenting recently on the agreement with German biotech company CureVac, the president of the commission, Ursula von der Leyen, said: “We do not know at this stage which vaccines will end up being safe and effective. The European Medicines Agency will authorise them only after a robust assessment. This is why we need to have a broad portfolio of vaccines based on very different technologies. In parallel, we are working with COVAX to provide access to vaccines for low- and middle-income countries. Thus, we want to ensure that all have access rapidly to safe and effective vaccines.”

According to the Department of Health, "the purpose of the procurement arrangements is to develop a portfolio of vaccines with various vaccine developers. This serves to spread the risks relating to the development and procurement of Covid-19 vaccines for vaccine developers and member states respectively. It also facilitates, through greater collective purchasing power, access for all member states to safe and efficacious vaccines that they would not be in a position to procure if they were operating in an individual capacity."

All member states will get access to any new approved vaccine at the same time, and doses will be allocated depending on population size.

Speaking in the Dáil recently, Taoiseach Micheál Martin said that Ireland would get approximately 1 per cent of Europe’s portfolio of Covid vaccines.

The EU has signed an agreement for 300 million doses of the Pfizer/BioNTech potential vaccine, with Ireland to receive 3.3 million doses. This would be enough to vaccinate 1.6 million people, as the Pfizer/BioNTech candidate vaccine requires two doses per person.

7) But there are almost 5 million people in Ireland, so who decides who gets the vaccine first?

It is widely accepted that there won’t be enough vaccine to inoculate everyone in the country at the same time, and therefore decisions will have to be made as to who should receive it first.

The National Immunisation Advisory Committee (NIAC) has been working on which groups should be prioritised to receive the vaccine, and decisions will be based on the need to protect individuals, break transmission of the virus and protect essential services.

Established within the Royal College of Physicians of Ireland (RCPI) in 1998, NIAC advises the chief medical officer in the Department of Health on a number of matters including specific vaccine recommendations for use in Ireland.

The expert members of NIAC have been working quietly behind the scenes for months now on recommendations for any new potential Covid-19 vaccine that may be approved.

NIAC makes recommendations about the use of authorised vaccines and has no involvement in the authorisation assessment process. Therefore, once a vaccine is approved by the EMA and authorised for use in Ireland, NIAC will make recommendations to the Department of Health on its use, and it will be up to the department to decide on vaccine policy.

NIAC has been keeping abreast of all the developments in the field of Covid vaccines worldwide and, while its advice cannot be finalised without knowing which vaccine or vaccines will be authorised for use, the committee has made a submission to the Department of Health on the different at-risk groups it recommends should be prioritised to receive a vaccine should one be approved for use in Ireland.

Prof Karina Butler, chair of NIAC and consultant paediatrician and infectious disease specialist at Children's Health Ireland, explained that those most at risk from Covid-19 would be high on the vaccination priority list, as would essential staff.

“We know the risk groups who are most likely to suffer from it and therefore, obviously, we want to protect them by having them high on those priority lists for vaccination. And we know that it is key to keep essential services up and running and that if we lose staffing from those services, everyone will be compromised, and therefore that means that they are likely to be prioritised as well,” she said.

While nothing has been set in stone, groups such as the elderly, frontline and essential workers including healthcare staff and people at higher risk of more severe disease if they contract Covid-19, such as those with underlying medical conditions, would be among those most likely to be on the priority list for vaccination.

Given that, to date, there are two strong potential Covid-19 vaccine candidates, it is likely that over time there will be a number of different vaccines to choose from, some of which may be more appropriate for use in specific groups of people.

According to Prof Butler, “If we have a good vaccine we have to make sure that it is safe, that it is effective. . . and then in the event that we have different vaccines, some of them may more suitable for different age groups or risk groups. Because some of them, there may be more data, for example in the elderly who obviously are a high-risk group, and that may determine that one vaccine is used in one group if we have the luxury of having more than one to choose from, which I certainly hope we will over time.”

Ultimately, once a vaccine or vaccines are approved, NIAC will make its recommendations to the Department of Health.

8) What plans are in place for the roll-out of a national immunisation programme?

Work is ongoing in the Department of Health, the HSE and across Government to prepare for the roll-out of a Covid-19 immunisation programme for Ireland. A new Covid-19 Immunisation Strategy Group, chaired by the Department of Health, has recently been established to advise on national vaccine policy.

According to the Department of Health, “The purpose of the group is to advise on and assist in the development of national policy relating to Covid-19 vaccines. The group’s membership includes representatives from relevant Government departments and relevant agencies/organisations, including the HSE’s National Immunisation Office. In addition, a Covid-19 immunisation programme implementation team has been established in the HSE.”

NIAC will also be responsible for drafting guidelines for healthcare professionals in the administration of Covid-19 vaccine(s) once approved for use here.

9) So how are we going to get millions of doses of Covid vaccines to Ireland and roll out an immunisation programme given the major logistical challenges involved?

The Government has recently established a high-level taskforce to oversee the rollout of Covid-19 vaccines once they are approved for use in Ireland. According to a Government spokesperson, “logistics, ICT and arrangements for administration of the vaccines have been identified as priority elements of a high-level implementation plan prepared by the HSE”.

“Complex logistical challenges have been identified, having regard to issues such as delivery from the European continent of products with very demanding storage and transport requirements, the need to plan timely delivery to the locations of immunisation provision to patients, and the need to ensure that waste is avoided. The high-level vaccine task force will be tasked with co-ordinating preparations in this area and ensuring the nationwide roll-out of a Covid-19 vaccine when one is safe and ready to be distributed.”

The taskforce will be chaired by Prof Brian MacCraith from DCU. Members of the group include the chief medical officer, Dr Tony Holohan; Paul Reid, CEO of the HSE; Liz Canavan, chair of the senior officials group on Covid-19; Barry Lowry, Government chief information officer; and Paul Quinn, Government chief procurement officer.

In addition, there will be a nominee yet to be confirmed from the Department of Business, Enterprise and Innovation, a logistics cold chain expert and a project management expert.

10) Be honest with me – when will life get back to normal?

This writer would like to refer you to the first question in this piece.

While there have been some incredibly positive reports, and researchers and scientists have been working at breakneck speed to develop vaccines for Covid-19 that we hope will ultimately allow life to get back to the normal we all knew and loved before the Covid-19 “new normal”, it is still too early to say.

It is very difficult to predict how long it will take for the public to be vaccinated against Covid-19 when we don’t know what type of vaccine or vaccines will be used and to date not one candidate vaccine has been approved for use.

While it is heartening to have two potential Covid-19 vaccines that promise to be more than 90 per cent effective against the virus in the pipeline, we also still don’t know how long that effectiveness lasts.

What we do know is that certain priority groups will be vaccinated first, and it is likely to take months before the entire population is immunised.

Crucially, we also know that vaccines work and, without them, as we have seen in the course of this global pandemic, life falls apart. According to the HPRA, “it is in a time of greatest public health need that the real value of vaccination is understood. And the past 10 months have shown that for sure.

“The introduction of new vaccines over the years has eradicated or significantly reduced the incidence of many diseases that killed millions of people across the world. These include: polio, tuberculosis, smallpox and typhoid. Conversely, the effectiveness of vaccines can be viewed through the lens of what happens to society when we don’t have one.”

Speaking at the National Public Health Emergency Team (Nphet) press briefing on Monday November 16th, deputy chief medical officer Dr Ronan Glynn said the news about potential new vaccines for Covid-19 was "promising and should give people hope, but it is that at best at the moment". Ultimately, he said, we needed to wait for the full data and ensure that these vaccines were effective, safe and durable.

He also warned that vaccine hesitancy would need to be overcome. “People are very justifiably asking questions about these vaccines and its very important that we wait for the data, we ensure that they are effective, we ensure that they are safe, and we will communicate with people when we have data and when we are confident that these are safe and effective and not before that.

“I am hopeful, I am optimistic, I do hope that these vaccines and other vaccine candidates in development will be a very significant development in relation to this pandemic, but it is too early at this point to conclude that and its certainly too early for people to start dropping their guard.”