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Cumbria and Newcastle participants support NIHR SIREN study showing Pfizer-BioNTech vaccine effectiveness

On Monday 22 February, Public Health England published the first independent analysis in the UK showing the Pfizer-BioNTech vaccine provides high levels of protection against COVID-19 infection and symptomatic disease from the first dose.

The NIHR-supported SARS-CoV-2 Immunity & REinfection EvaluatioN (SIREN) study aims to find out if prior SARS-CoV-2 infection confers future immunity to reinfection by studying healthcare workers’ immune response to the virus causing COVID-19. Healthcare workers are one of the earliest groups to be offered the vaccine, therefore this study is likely to provide one of the earliest estimates of vaccine effectiveness against infection.

Early data from the study show a promising impact on infection in healthcare workers aged under 65, with one dose reducing the risk of catching infection by more than 70%. This rises to 85% after the second dose. The study has also yielded promising data for those aged over 80, suggesting that one dose of the Pfizer-BioNTech vaccine is 57% effective against symptomatic COVID-19 disease for this age group. The second dose is expected to boost effectiveness to more than 85%.

The SIREN study’s early data also suggest that vaccinated people who go on to become infected are far less likely to die or be hospitalised. Overall, hospitalisation and death from COVID-19 were reduced by over 75% in those who received a dose of the Pfizer-BioNTech vaccine.

The risk of dying in those aged over 80 is less than half in vaccinated cases compared to unvaccinated cases. People in this age group who develop COVID-19 infection after vaccination are around 40% less likely to be hospitalised than someone with infection who has not been vaccinated.

These high levels of protection are also seen against the variant of concern (B.1.1.7) first identified in South East England in December 2020.

The SIREN study is funded and sponsored by Public Health England, while NIHR supports the delivery of the study working together with NHS Trusts. In the North East and North Cumbria the Newcastle upon Tyne Hospitals and North Cumbria Integrated Care NHS Foundation Trusts have contributed to the study.

John Elliott, Principle Investigator for SIREN at the North Cumbria Integrated Care NHS Foundation Trust said: “I am pleased with the number of participants we have recruited to the SIREN study at North Cumbria Integrated Care and I am very proud of the focused way in which the whole research team went about this. In fact we are having a webinar on Thursday to explain how we managed such a great response to this trial.”

Brendan Payne, Principle Investigator for SIREN at the Newcastle upon Tyne Hospitals NHS Foundation Trust said: “We have been very grateful for the support from outpatient services in setting up dedicated clinics at both RVI and Freeman sites for the SIREN blood tests. It was exciting to see that early data from SIREN on vaccine efficacy contributed to the government’s new plans for easing lockdown. We do still have a few available spaces in SIREN and are especially keen to enrol more male and BAME staff.”

Professor Caroline Wroe, Clinical Director at NIHR Clinical Research North East and North Cumbria said: “I am delighted to see the early indications of a positive vaccine effectiveness against infection. I would like to thank the staff from both Newcastle and North Cumbria who have volunteered to take part in this important study.”

Dr Mary Ramsay, Head of Immunisation at PHE, said: “This is strong evidence that the Pfizer-BioNTech vaccine is stopping people from getting infected, while also protecting cases against hospitalisation and death. We will see much more data over the coming weeks and months but we should be very encouraged by these initial findings.

“But protection is not complete, and we don’t yet know how much these vaccines will reduce the risk of you passing COVID-19 onto others. So even if you have been vaccinated, it is really important that you continue to act like you have the virus, practice good hand hygiene and stay at home.”

Health Secretary Matt Hancock said: “This crucial report shows vaccines are working – it is extremely encouraging to see evidence that the Pfizer vaccine offers a high degree of protection against coronavirus.

“Vaccines save lives, and so it is vital we roll out the vaccine programme as fast as possible, and that as many people as possible take the jab. This new evidence shows that the jab protects you, and protects those around you.

“It is important that we see as much evidence as possible on the vaccine’s impact on protection and on transmission, and we will continue to publish evidence as we gather it. As we roll out the jab, it is vital people continue to play their role in protecting the NHS by sticking with the rules.”

SIREN has been classed as a Priority 1A Urgent Public Health Study, research which is being prioritised to inform national policy and to enable new diagnostic tests, treatments and vaccines to be developed for COVID-19. A full list of Urgent Public Health Studies can be found here: nihr.ac.uk/covid-studies/