COVID-19 vaccine study letter Feb 2021
For participants enrolled into the Novavax COVID-19 vaccine trial at our Trust
Dear participant
We are very pleased to inform you that a recent press release from Novavax has reported that the Novavax COVID-19 vaccine demonstrates 89.3% efficacy in the UK trial. It is important to note that these results are based on an interim analysis and your continued study participation is crucial for our end of study final analysis. Even with these results it is important to continue the study for its full duration to collect information on special groups, like those older than 65 years of age, as well as long-term safety data in all participants. We are extremely grateful for your contribution to this important trial.
We are aware that many of you are being offered appointments for the nationally deployed licensed COVID-19 vaccines and we will continue to unblind you in this situation if you wish to receive a licensed vaccine.
However, we would like to inform you that there are now plans to modify this current trial to offer participants the opportunity to take part in ‘cross-over’ vaccinations.
In the proposed cross-over visits you will be offered either two doses of the Novavax COVID-19 vaccine (if you haven’t received them already) or the placebo (if you have received the Novavax COVID-19 vaccine already). You would remain ‘blinded’—meaning that you will not know whether you received the Novavax COVID-19 vaccine in the first ‘part’ of the study or in the ‘second’ part of the study, but this ensures that you will receive 2 doses of the Novavax COVID-19 vaccine which we now know to be effective.
Your continued participation in this study in this way will not only ensure you receive a Novavax vaccine but will also assist in maintaining the integrity of this important study. Details of this process will be sent to you in the coming weeks. Please note this would require that you voluntarily decline the licensed vaccine if it is offered to you.
We thank you again for your contribution.
With kind regards,
The Study team
Chelsea and Westminster Hospital
Clinical Research Facility
caw-tr.crf@nhs.net