Norwich trial - just got this letter (no response to my unblinding request)
edited by MNHQ at OP's request
Please find response from the Principal Investigator – I hope this will reassure you
Dear Novavax Study Participant
Many thanks for your enquiry. We are receiving a lot of enquiries at present and unfortunately are unable to reply to them all individually. We are desperately aware of how concerned many of you are about several factors concerning your involvement in the study. Please forgive us but we have prepared a standard letter giving answers to the most frequently posed questions:
Firstly, certification of vaccine status via the NHS Covid App: Further to the letter from the Deputy Chief Medical Officer (Prof Jonathan Van Tamm) that we forwarded to you on 23rd of June. We would like to apologise sincerely that as of the 8th of July the Novavax vaccine is still not showing up as fully green on the Vaccine status page of the NHS Covid App. This is partly because the part of the NHS that handles this (“NHSX”) is still uploading NHS numbers and dates of Birth of all Novavax study participants but also partly because there seems to be a separate problem recording the second green tick. Thus some participant’s apps are showing them as green for “events” but not green for “travel”. We have raised this issue with Novavax and are also currently escalating this directly within the NIHR Clinical Research Network. Like many of you, we think it is not acceptable that you should not have the same access to events and foreign travel as people who have received a licensed vaccine such as Pfizer and Oxford-AZ. We are pushing as hard as we can on this issue and will update you as soon as we have any more news. We would like to reassure you that every time we have been asked to provide information in support of recording your vaccination status we are of course completing such requests in the fastest possible manner.
We do also encourage you, before planning to travel, to check any country-specific restrictions via the .gov.uk website as many destinations are using their own rules about travel, vaccination, PCR testing and quarantine. Finally, we are still hopeful that at some point in the near future the Novavax Vaccine will receive a license from the MHRA and at that point many of these difficulties should diminish rapidly.
Secondly, booster vaccines: As you may be aware some Novavax study sites across the country are running a Novavax booster study later this year. At present Norfolk and Norwich University Hospital is not a booster study site. However, there are ongoing discussions and this situation may change. We will, again, inform you immediately if there are any developments on this front. Outside of the study, despite all the discussions in the press about boosters, there is not any official NHS plan for booster doses at present. It is thought likely that from September onwards booster doses may be offered to the over 70s and those in certain vulnerable groups but we would stress that this is not official yet.
Thirdly, expenses: several of you have asked if Novavax will cover the costs of PCR tests for travel where these are incurred because of delays in getting your vaccination status recorded and displayed in the NHS Covid app. Regrettably at present, after presenting this to colleagues at Novavax, the answer has thus far been that they will not. We are continuing to work on this issue and will update you as soon as we have any news
As ever, we cannot thank you enough for the amazingly altruistic act of offering to take part in this crucial piece of research. You have done and are doing a very important thing to help the country and possibly humankind as a whole, combat this awful disease.
We will be in contact again as soon as we have further news.