Clinical trials of COVID-19 vaccines 25 November 2022 All vaccines go through a robust clinical trial process and are only given to patients once they have met the strict safety, effectiveness and quality standards of the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The UK has provided funding and responded quickly to fast-track the world’s most innovative vaccines for COVID-19 through the UK’s clinical trial system. These cutting-edge developments in COVID-19 research mean that results for brand new vaccines have been seen in months rather than years. This enables the government to get even more safe and effective treatments to the NHS rapidly through a more streamlined process. Are corners being cut in the speedier rollout? There are extensive checks and balances required at every stage of the development of a vaccine, and this is no different for a COVID-19 vaccine. No stages in the vaccine development process were bypassed. In this case, to meet the global need for safe and effective protection against COVID-19, timelines were expedited wherever possible, for example through the provision of funding and the rapid recruitment of trial participants. Ket clincial trials at a glance: Many pieces of clinical research and data sets continue to be analysed to support clinical and policy decision-making. Some of the key trials have included: COVBOOST – Data from the COV-BOOST trial (published on Friday 3 December 2021) showed that Pfizer/BioNTech and Moderna vaccines being used in the UK as boosters give the best overall immune response. COMCOV – The results from this trial showed that mixing the doses slightly increases the frequency of mild-to-moderate symptoms following vaccination, but there were no serious outcomes. COMFLUCOV – The ComFluCOV trial indicated that co-administration of the influenza (flu) and COVID-19 vaccines is generally well tolerated with no reduction in immune response to either vaccine. Therefore, the two vaccines can be co-administered where operationally practical. Are clinical trials safe? Yes, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK and ensures the highest standards are met in clinical trials. There are checks in place at every stage in the development of a vaccine and that is not being compromised. In addition to this, each trial has an independent safety committee that keeps the study under active review, including any reports of side effects. They can take immediate action such as suspending the trial, if any problems are found. Are clinical trials regulated and ethical? The MHRA has to review and authorise all clinical trials before they can be undertaken. In this process they will visit sites where trials are planned to be conducted to ensure that they meet good clinical practice guidelines. Meanwhile the Health Research Authority (HRA) has responsibility for protecting and promoting the interests of patients and the public in health research, including the use of ethics committees across the UK. All medical research involving people in the UK, whether in the NHS or the private sector, first has to be approved by an independent research ethics committee. The committee protects the rights and interests of the people who will be in the trial. Why join a clinical trial? Clinical trials help healthcare professionals understand how to treat a particular illness. It may benefit you, or others like you, in the future. If you take part in a clinical trial, you may be one of the first people to benefit from a new treatment. But there’s also a chance that the new treatment demonstrates statistically significant differences compared to the standard treatment. How do I take part in a clinical trial? The easiest way to get involved is to ask your doctor or a patient organisation (such as us) if they know of any clinical trials which you would be eligible for. You can also search for information online for example via: Be Part of Research (nihr.ac.uk), where you can register your interest in taking part in research trials. You can find out more about NRAS’ involvement in research and how you can get involved here: Research | NRAS. The NHS COVID-19 Vaccine Research Registry offers people the chance to sign up to a database which allows researchers in their area to contact them about volunteering for ongoing vaccine studies. Register your interest here. Trial results so far: COVBOOST: The COV-BOOST study looked at safety, immune response (immunogenicity) and side-effects (reactogenicity) of seven vaccines when used as a third booster jab. The study found that six different COVID-19 boosters are safe and increase immunity when given after two doses of Oxford-AstraZeneca or Pfizer/BioNTech, with large variations in immune responses. Data from the CovBoost trial (published on Friday 3 December 2021) showed that Pfizer/BioNTech and Moderna vaccines being used in the UK as boosters give the best overall immune response. COMCOV The results from this trial showed that mixing the doses slightly increases the frequency of mild-to-moderate symptoms following vaccination, but there were no serious outcomes. COMFLUCOV The ComFluCOV trial indicated that co-administration of the influenza (flu) and COVID-19 vaccines is generally well tolerated with no reduction in immune response to either vaccine. Therefore, the two vaccines can be co-administered where operationally practical. Moderna Omicron bivalent COVID-19 booster vaccine The study supported the MHRA’s decision to approve the bivalent vaccine, with the study showing the vaccine provided a strong immune response to different strains of coronavirus. Half of the vaccine targets the original COVID-19 strain and the other half targeting the Omicron variant. Are participants paid for participation in NIHR funded/supported research? The National Institute for Health and Care Research (NIHR) does not pay participants to take part in trials that are funded or supported by the organisation. Payments for clinical research tend to be made for phase 1 trials that do not fall under the remit of the NIHR. In certain cases, participants may have their expenses reimbursed (i.e. for travel), however such payments are expressly paid to reimburse for a specific expense incurred and are not paid in lieu of the participant’s time to take part in the study. On occasion, incentives to encourage participation may be offered for specific types of research, with the most common example being high street vouchers to incentivise completion of a survey. However, any incentives offered are always subject to approval by a research ethics committee to ensure that the level of any incentive offered is appropriate.