Following months of rigorous clinical trials, the Pfizer/BioNTech Covid-19 vaccine has been approved for use in the UK by the Medicines and Healthcare products Regulatory Agency.

This and the other vaccines are a huge step forward in the fight against coronavirus and could save tens of thousands of lives.

So is the vaccine safe? Who’ll get it first? And will it mean a return to normal life?

Our panel of medical experts - made up of Deputy chief medical officer Professor Jonathan Van-Tam, Chief Executive of the Medicines and Healthcare products Regulatory Agency Dr June Raine CBE and Head of Immunisations at Public Health England Dr Mary Ramsay - are here to answer all your questions...

Professor Jonathan Van-Tam, Dr June Raine CBE and Dr Mary Ramsay answer your questions

Q. Vaccines usually take years to develop, so how can the Covid-19 vaccination be safe if it’s ready in months?

Professor Van-Tam: These vaccines have been through phase one, phase two and phase three, just like ordinary vaccines. With the Pfizer vaccine, I think the total clinical trial size is something like 45,000; the AstraZeneca results so far reported are based on just over 24,000 volunteers – there’s at least another 10,000 to follow, and the number size for Moderna is very similar. These are very, very big studies.

The numbers involved were essentially the same as you’d expect for a normal peacetime vaccine, and on top of that the safety assessments and the assessments of effectiveness at the end are the same.

Dr Raine: The public can be completely confident that Covid-19 vaccines will only be available once they have met robust standards of safety, quality and effectiveness.

As Covid-19 is a public health emergency, scientific evaluation and approval is being done in the shortest time possible while complying with established and robust safety, quality and effectiveness standards. Extensive knowledge on vaccine development with existing vaccines is applied. Safety is our watchword. Everyone can be absolutely clear that the standards that need to be met, will be met.

I am completely confident that there has been no pressure whatsoever on the agency and our expert staff to pass the vaccine. None at all.

Q. How have you decided who gets the vaccine first?

Dr Ramsay: We looked at a lot of data showing who was getting infection and who was dying from infection. The primary thing the Joint Committee on Vaccination and Immunisation (JCVI) looked at was death rates by age, by clinical factors, and by any other factors that GPs could measure, such as deprivation, geography or ethnicity.

It’s very clear the death rate is much higher as you get older, particularly over 75. That’s why we’re prioritising people in older age groups, then coming down in age, picking up people who are clinically vulnerable and those who have underlying conditions along the way.

Those working in health and social care will be high on the list as well – they are at risk because they’re getting exposed to infection every day and they may be spreading it to others. The same goes for care home workers – they’re a very high priority. 

Q. Will the vaccine prevent disease or just reduce symptoms?

Professor Van-Tam: If you’re going to prevent transmission you need a vaccine that is taking out the illness and also the asymptomatic infections. There are some signs from AstraZeneca that this might be the case.

That does not mean the other vaccines where results have already been announced or that are or are still in development, don’t also reduce transmission; it’s just we don’t know at this point in time. We hope they will because they’ll have a bigger effect if they can take out transmission.

Q. Are there any side effects?

Dr Ramsay: All the side effects are predictable – the kind of thing you get with other vaccines: a sore arm, bit of a temperature or feeling a bit fatigued, so we’re expecting it to have a similar safety profile to other vaccines.

Professor Van-Tam: Every single vaccine authorised for use in the UK has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).

The three components of authorisation are a safety assessment, an effectiveness assessment and a manufacturing quality assessment – all three need to be ticked before anything is authorised. But there is not a single medicine without side effects. Is it possible that rare side effects could come to light that you’d never pick up in a clinical trial of 40,000-50,000 patients? Yes, it is – but that’s no different from any other medicine. 

Q. How will the vaccine be rolled out?

Dr Ramsay: The actual act of giving the injection isn’t particularly skillful – all nurses are trained and most vaccines are given by nurses, but with the flu jab we use health care assistants. The key thing is they work under the supervision of nurses.

I think there’s going to be a lot of different models used because, for example, with elderly, frail people they’re clearly not going to drive to the nearest centre – you might have to take vaccine to them in their home. The hospitals will probably be doing their staff, then there will potentially be these vaccination sites which will probably be more important for the slightly younger population who can drive there.

Q. Is there anyone who shouldn’t have it?

Dr Ramsay: A reason to defer a vaccination is being pregnant – that’s just being precautionary. We don’t expect there to be a problem, but without having the vaccine tested on pregnant women we’ll probably recommend they wait until after they’ve had the baby. Similarly, it hasn’t been tested in children, although a teenager would probably respond similarly to a young adult so they could likely have the vaccine.

Q. Will it be available privately?

Professor Van-Tam: I don’t know, but I think it would be a bad thing for public health if the rich and privileged were able to pay their way to the front of the queue, leaving someone at very high risk and not wealthy low down the list – and they would be; there’s going to be a global shortage of these vaccines. So I’m opposed to that.

Q. How long will it take to immunise as many people as is needed for us to return to normal life?

Dr Ramsay: A normal flu programme will immunise about 15 million people in two and a half to three months – most are done in the first two months. We need enough vaccine – that’s the key issue – and the ones so far all involve two doses. For the first phase of 30 million people, we’re talking about 60 million vaccines. The NHS is going to bring in more staff so we hope we can do it quickly, but we’re talking several months before we’re really at the point of getting a large proportion of the public immunised. And until we really know how the vaccine is working and how long the protection lasts, it’s very hard to predict when we’ll be back to normal life.

Q. What would you say to young people who think they’re low risk, so would say no to the vaccine if it was offered to them?

Dr Raine: Clearly the advice on who gets the vaccine will take into account priorities and the more vulnerable, older people who have the most serious risk from Covid. We need to use every way possible to reduce the threat of the disease.

We know there are vulnerable populations; we know the elderly can be badly affected and it’s up to all of us to make sure we make the right decisions, and follow “hands, face, space”. It’s up to all of us to think about the vulnerable, the elderly, people who we treasure in our family, and do our bit to make sure we can get back to normal life and hugging.

This article is part of a paid-for partnership with the UK Government.