No doubt over safety of Covid-19 vaccine, says head of UK regulator

PA

The head of the UK’s medicines regulator has said there “should be no doubt” about the safety of the Covid-19 vaccine which will be rolled out this week in the largest scale immunisation programme in the UK’s history.

Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), which approved the Pfizer/BioNTech jab, said there should be “real confidence” in the rigour of their approval.

Vaccinations will be administered at dozens of hospital hubs from Tuesday – with people aged 80 and over, care home workers and NHS workers who are at higher risk the first to receive the jab.

The distribution of the vaccine across the UK is being undertaken by Public Health England and the NHS in England, Scotland, Wales and Northern Ireland through systems specially adapted from those used for the national immunisation programmes.

NHS England said staff were working through the weekend to prepare for the launch.

Asked on the BBC’s Andrew Marr Show about how important the public health message is to make sure that people actually take the vaccine, Dr Raine said: “It’s vitally important.

“And I would really like to emphasise that the highest standards of scrutiny, of safety and of effectiveness and quality have been met, international standards.

“And so there should be real confidence in the rigour of our approval.

Coronavirus – Fri Dec 4, 2020
Coronavirus – Fri Dec 4, 2020

“More than that, our Commission on Human Medicines has scrutinised every piece of data too, so there should be no doubt whatever that this is a very safe and highly effective vaccine.

“It will help us turn the corner. There’s really not one of us who hasn’t been affected by this pandemic, and our organisation, like every other, has been completely focused on doing our job to be able to help defeat this terrible disease.”

Dr Raine was asked how she had coped with becoming a “global figure” and about reports that the Queen, 94, will have the Pfizer injection within weeks.

She told the BBC’s Andrew Marr: “I’m proud, I’m honoured. I think that news that you’ve just given us is humbling, and it’s everything that we’re here to do at the MHRA.

HEALTH Coronavirus
HEALTH Coronavirus

“We’re a public health organisation, we work as full partners, if I can say, in the public health family, and our goal is totally to protect every member of the population, Her Majesty of course, as well.”

Environment Secretary George Eustice said it will be a “personal decision” for the Queen whether she takes the vaccine.

Asked on Times Radio if he would like to see the monarch take the vaccine and then announce publicly that she had done so, Mr Eustice said: “It will be a personal decision for the Queen, as it is for everyone.”

When asked about reports that the Queen and Duke of Edinburgh, 99, would have the jab within weeks and share the news, a Buckingham Palace spokesman said: “Medical decisions are personal and this is not something we will comment on.”

Audiences at Buckingham Palace
Audiences at Buckingham Palace

Meanwhile, there is still no guaranteed date for when care home residents will be vaccinated despite them being at the top of the priority list, with Health Secretary Matt Hancock saying there are “significant challenges” to overcome.

Logistical issues mean there are difficulties in getting the jab to residents, as the Pfizer/BioNTech vaccine needs to be stored at minus 70C before being thawed out and can only be moved four times within that cold chain before being used.

The vaccine boxes containing 975 doses will need to be split so that they can be brought to care homes.

Dr Raine told Marr: “We have approved how the vaccine can be put into the small packs, but obviously what we’re doing is giving advice and guidance on how well that, carefully, that is done.

“Our goal is to ensure that the vaccine reaches people in care homes, the residents there, as safely as possible.

“So, everyone is working hard with our colleagues in the NHS, to make sure that happens safely.”

Coronavirus – Sat Dec 5, 2020
Coronavirus – Sat Dec 5, 2020

Asked when people will get the vaccine, she replied: “As I say we’re working very hard to make sure that this is done as quickly as possible.

“It’s a special vaccine, it does need to be kept very cold, and then when the larger packs are split into smaller ones to go to where they will be given, that does need to be done very carefully, but I think we’ll be seeing the first person in a matter of days having that really important vaccine.”

There are 50 hubs in the first wave of the vaccination programme in England, with more hospitals starting to vaccinate over the coming weeks and months as the programme ramps up.

Asked about the impact of Brexit on the rollout of the vaccines, Dr Raine told Marr: “What I’d like to say is that our goal at the Medicines and Healthcare products Regulatory Agency is to make sure that whatever the outcome, whatever the deal, that medicines and medical devices and vaccines reach anyone in all parts of the country in the same way, without any interruption at all.

“And we’ve rehearsed, we’re ready, and we know that whatever the deal, we will be able to ensure that people have access,”

She said they are “fully prepared for any possible outcome”.

Environment Secretary George Eustice said there will be no disruption to the vaccine, telling Sky News’s Sophy Ridge On Sunday: “Huge amounts of work has gone on to maintain the flow of goods at the border in the event of there being a no-deal Brexit and we have also got contingency plans in place including a government procured ferry that is on standby and of course, the option, should it be needed, to use air freight too.

“We have got many contingency plans in place and there won’t be any effect on the deployment of this vaccine from a no-deal Brexit.”

A further 397 people had died within 28 days of testing positive for Covid-19 in the UK as of Saturday, while there were another 15,539 cases.