Public can have real confidence in the excellence and thoroughness of the Covid-19 vaccine approval process

Statement from the Chief Executive of the Health Products Regulatory Authority in Ireland

Dr Lorraine Nolan, Chief Executive of the Health Products Regulatory Authority

Reporter:

Dr Lorraine Nolan, Chief Executive of the Health Products Regulatory Authority

vaccine coronavirus covid-19

Nurse Joanna Sloane was the first person on the island of Ireland to be vaccinated when she got the jab at the Royal Victoria Hospital in Belfast

The Health Products Regulatory Authority (HPRA) is the national authority responsible for the safety and effectiveness of medicines in Ireland.

Many of these medicines, including vaccines, are authorised across Europe by the European Medicines Agency - the EMA. It does this by bringing together scientific expertise from all the national agencies, including ourselves in the HPRA. This means the public can have real confidence in the excellence and thoroughness of the approval process. This approach combines the best available scientific expertise within Europe, in a very open and transparent way, so as to ensure, the safety, effectiveness and quality of new medicines.

As regulators, patient safety and protecting public health will always be our highest priority.

Earlier this month, the EMA received two separate applications for a conditional marketing authorisation of COVID-19 vaccines. One application was received from Pfizer/BioNTech and another from Moderna. In the case of the Pfizer/BioNTech vaccine, there has been ongoing assessment of data supplied by the company. This started in October under the EMA’s ‘rolling review’ process.

Much has been made about the pace at which these vaccines have been developed. Many factors have come together at the same time that have enabled this to happen. These are a combination of unprecedented and targeted public and private sector funding, recent developments in science and vaccine technology, and a consolidated product development and manufacturing cycle.

In addition, rather than regulatory oversight happening at the end of this process we, as regulators, have been engaging in parallel using rolling reviews. Also, regulators across the globe, including the WHO, have been working in solidarity and have been completely united in this objective.

All of these factors are facilitating the timely and ongoing development of safe and effective vaccines. Although we await the authorisation of a first vaccine in Europe, getting to this point is a remarkable achievement for science.

In relation to the Pfizer/BioNTech application, the EMA’s scientific committee for human medicines (CHMP) is aiming to conclude its assessment of the safety, efficacy and quality of the vaccine during an extraordinary meeting scheduled for 29 December. HPRA experts will participate in that meeting, along with representatives from all 27 Member States and EEA countries.

If a recommendation for authorisation is forthcoming, it will be provided to the European Commission who will ultimately grant an EU-wide marketing authorisation. This authorisation will then be legally binding across all EU Member States, including Ireland. MORE BELOW PICTURE.

In relation to the Moderna vaccine, a recommendation by the EMA is expected by 12 January next.

While we do understand the deep public health need and indeed the excitement around the availability of a vaccine, it is important that the EMA takes the time necessary to conduct a thorough scientific evaluation of these vaccines. The data must clearly show that COVID-19 vaccines are safe, effective and of suitable quality. The benefits of the vaccines must always outweigh the possible risks.

While we have accelerated the regulatory process, it is important to stress that this will not compromise the detailed and thorough nature of scientific scrutiny. There will be no lowering of the bar on this. All vaccine applications will be reviewed just as carefully, and as rigorously as for any other medicine. We will be led by the evidence and by the science. That is the backbone of the regulatory system.

And you can be assured that we in the HPRA, our colleagues in Europe and around the globe, working within their respective regulatory frameworks, will not make vaccines available without having full confidence that they are safe and that they work.

I must also emphasise that regulatory oversight will not end with the initial conditional marketing authorisation. The vaccine company, or indeed companies, will have significant obligations to provide on-going data on the performance and safety of their vaccines over the long term. In addition, as real-world use of the vaccines takes place, this will be supported with extensive monitoring programmes to ensure the authorised vaccines remain safe and effective. We in the HPRA have prepared and put in place plans and resources to support effective vaccine monitoring. In addition, we will work closely with our colleagues across national, European and global networks in this regard.

While any initial regulatory approval of these first vaccines will be a hugely positive development and a very significant intervention, in themselves they will not bring an end to the pandemic. Even when available, vaccines will serve as just one additional measure in our continued fight against the virus. Other public health recommendations, including handwashing, mask-wearing and social distancing, will continue to be vital to tackling this pandemic.

It will be in the totality of our response by continuing to follow public health advice, by adhering to the existing proven measures and by combining these with the benefits of vaccination, that we can provide the greatest protection for ourselves, for our families and for our communities.