Published: 08 February 2021
The NIHR has launched a new call to fund research to compare head-to-head the clinical effectiveness of the licensed COVID-19 vaccines being used in the UK.
The UK has approved several new vaccines to tackle COVID-19 and has begun rolling out immunisation of the population. This roll out is currently using the Pfizer/BioNTech and University of Oxford/AstraZeneca vaccines and is focusing on older people and those who are clinically vulnerable.
The approved vaccines have met essential safety requirements and been shown to produce effective immune responses. However, questions exist as to how these two vaccines compare in terms of clinical effectiveness, such as reducing infections and preventing people from becoming so ill that they need to be hospitalised.
To answer these questions, NIHR is seeking to fund a £10 million rapidly implementable randomised platform study to support ongoing head-to-head scientific evaluation of new COVID-19 vaccines.
The initial focus of the trial, due to start in April 2021, will be on the effectiveness of the Pfizer/BioNTech and University of Oxford/AstraZeneca vaccines, but the study will have the flexibility to evaluate other vaccines that may be used in the UK in the future.
The funded study will focus on clinical outcomes, especially infections and hospitalisations, rather than serological or immunological endpoints and will use existing electronic datasets where possible.
Both the Pfizer/BioNTech and University of Oxford/AstraZeneca vaccines require two doses at separate time points to provide optimal immunity against coronavirus infection. To support rapid roll out and protect as many people as possible, the government has opted for an interval of 84 days between the first and second doses of these two vaccines. This recommendation is supported by data suggesting most of the available short-term protection from these vaccines is achieved after the first dose.
The new trial funded by this call will evaluate first-to-second dose intervals of 28 and 84 days, and will also assess the long-term effectiveness of different dosing intervals over a follow up period of at least 12 months.
The funded study will dovetail with the UK’s ongoing vaccination programme and will not interfere with its execution. For example, the study will exclude people 70 years old and over and clinically vulnerable individuals, who are being targeted as a priority during the vaccine roll out, and will not alter delivery of the first dose of vaccine for other priority groups, in terms of delayed timing or diversion of limited vaccine supplies.