Credit UK PHE/CMO
#15,973
Although the current batch of vaccines are expected to provide some - perhaps even substantial - protection against the dizzying array of SARS-CoV-2 variants that have emerged over the past 6 months, there are enough `red flag's suggesting diminished protection that it is prudent to begin to explore `booster shots' for the COVID vaccine.
The duration of protection from the current vaccines is currently unknown, and if that becomes an issue, booster shots might extend that protection significantly.
Since studies can take months, yesterday the UK announced the first clinical trials to explore the effectiveness of booster shots on 7 vaccines, with initial results expected in the fall. Full results will take at least a year.
Although we've seen talk about new vaccine formulations that may be required to address variants, these boosters are from existing vaccines. Participants may receive the same booster as the vaccine they originally received, or one from another manufacturer.
First the press release from the UK's CMO, followed by excerpts from the COV-BOOST website.
World-first COVID-19 vaccine booster study launches in UK
New government-funded clinical trial looking at different COVID-19 ‘booster’ vaccines launches in the UK.
From:Department of Health and Social Care Published 19 May 2021
- Initial results trialling seven vaccines expected in September to inform plans for booster programme
- Clinical trials on agenda for G7 Health Ministers’ Meeting in early June which Health Secretary announces will be hosted in Oxford
- Announcements come ahead of International Clinical Trials Day (Thursday 20 May 2021)
Thousands of volunteers will receive a booster COVID-19 vaccine in a new clinical trial launching today, Health Secretary Matt Hancock has announced.
The Cov-Boost study, led by University Hospital Southampton NHS Foundation Trust and backed by £19.3 million of government funding through the Vaccines Taskforce, will trial seven vaccines and will be the first in the world to provide vital data on the impact of a third dose on patients’ immune responses.
It will give scientists from around the globe and the experts behind the UK’s COVID-19 vaccination programme a better idea of the impact of a booster dose of each vaccine in protecting individuals from the virus.
The study will take place at 16 NIHR-supported sites across England, and also within Health and Care Research Wales and NHS Research Scotland sites. It will include a total of 2,886 patients and participants are to begin being vaccinated from early June.
All participants will be monitored throughout the study for any side effects and will have bloods taken to measure their immune responses at days 28, 84, 308 and 365, with a small number having additional blood tests at other times. All sites will have an electronic diary for all participants that will send alerts to the team in real time if needed and a 24-hour emergency phone to a doctor on the study, who can provide further clinical advice.
The initial findings, expected in September, will help inform decisions by the Joint Committee on Vaccination and Immunisation (JCVI) on plans for a booster programme from autumn this year, ensuring the country’s most vulnerable are given the strongest possible protection over the winter period.
The Health Secretary has also announced that the 2021 G7 Health Ministers’ Meeting will be held in-person at Oxford University on 3-4 June. As part of the UK’s G7 Presidency, we are bringing together health leaders from the world’s leading democracies to agree life-saving action in the critical areas of clinical trials, global health security, antimicrobial resistance, and digital health to help protect us all from future pandemics.
Health and Social Care Secretary, Matt Hancock, said:
The UK vaccination programme has been a phenomenal national effort, with seven in 10 UK adults now having had their first COVID-19 jab. It is vital that we continue to support the world-renowned British research sector that has contributed to its success.We will do everything we can to future-proof this country from pandemics and other threats to our health security, and the data from this world-first clinical trial will help shape the plans for our booster programme later this year.I urge everyone who has had both doses of a COVID-19 vaccine, and is eligible, to sign up for this study and play a part in protecting the most vulnerable people in this country and around the world for months and years to come.The trial will look at seven different COVID-19 vaccines as potential boosters, given at least 10 to 12 weeks after a second dose as part of the ongoing vaccination programme. One booster will be provided to each volunteer and could be a different brand to the one they were originally vaccinated with.Vaccines being trialled include Oxford/AstraZeneca, Pfizer/BioNTech, Moderna, Novavax, Valneva, Janssen and Curevac, as well as a control group. The trial has received ethics approval by the NHS Research Ethics Committee, as well as approval from the Medicines and Healthcare products Regulatory Agency.The study will open for applications from volunteers shortly via the study’s website and will be recruiting participants through the NHS COVID-19 Vaccine Research Registry.Participants will be adults aged 30 years or older as these will have been those immunised early on in the vaccination programme - for example, adults aged 75 and over or health and care workers.The trial was commissioned by the Department of Health and Social Care through the National Institute for Health Research (NIHR) and funded by the Vaccine Taskforce, with the study being undertaken by the Southampton team at sites across the UK as part of the National Immunisation Schedule Evaluation Consortium (NISEC).The team leading the trial is committed to including participants from a wide variety of backgrounds, and individuals from ethnic minorities are encouraged to apply to take part.
What is the purpose of this research trial?
There are now a number of vaccines that have been approved in the UK to prevent COVID-19 and other vaccines that are still in UK clinical trials but which may be approved later in the year. Millions of people have now received their first 2 vaccinations, which we call a “prime-boost” course. There were 2 vaccines used by the NHS to deliver an initial prime-boost during the first part of the NHS immunisation campaign: ChAdOx1-nCov19 (commonly known as the “Oxford vaccine”), and BNT1162b2 (commonly known as the “Pfizer vaccine”).
Whilst these have been shown to be highly effective at preventing severe disease due to COVID-19, we don’t know how long the immune protection from vaccination will last. In addition, variants of the virus which causes COVID-19 (SARS-CoV-2) have emerged with mutations which might make the immune response from vaccination less effective.
It is therefore likely that additional, “booster” vaccinations might be needed for high risk groups after a period of time to provide added protection. This study is trying to find out which vaccines against COVID-19 are most effective as a booster vaccination, depending on which vaccine was used to provide the initial prime-boost course. We will be enrolling men and women over the age of 30 who received their initial prime-boost course of vaccination against COVID-19 in December 2020 or January 2021.(SNIP)
Summary of the study
We are studying combinations of seven different COVID-19 vaccines compared to a control group, who will be receive a vaccine against the meningococcal bacteria which causes meningitis and sepsis (Men ACWY). There will be 2886 participants.
As new SARS-CoV-2 vaccines become available, more vaccines may be included in the trial and so the total number of participants may increase (these will be in later stages of the trial).
Participants will be allocated, at random, (rather like a flip of a coin) to receive one dose of one of the seven study vaccines, or the control vaccine (MenACWY).
Three of the vaccines are currently approved by the MHRA for NHS use to prevent COVID-19, 2 are under review for approval by the MHRA and 2 are still in clinical trials but may be available in the UK later in 2021 if approved by the MHRA.
Between 4 and 6 routine blood tests will be taken over the course of a year to look at the immune responses to the vaccine depending on the group you are in. You may also be asked for a nasal fluid sample and an (optional) saliva sample at each visit. You might also be asked to attend for a repeat blood test if there were any safety concerns. If you were to test positive for the virus causing COVID-19 we may ask you to attend for an extra visit.
Participants will need to complete an online diary for up to 28 days following vaccination.
The trial will take one year to complete per participant (from the time the first dose of vaccine is given).
We would not be offering diagnostic COVID-19 testing as part of this trial, but it is important that participants in this trial access COVID-19 testing outside of the trial following normal government guidance.
You would not know which vaccine you had received until the end of the trial. Unless specifically advised by us, you would not be eligible to receive any further vaccine doses via the government vaccination scheme.
If you become eligible for a booster vaccination via the NHS during the course of the trial, we can find out whether you received a COVID-19 vaccine or the control vaccine (MenACWY). If you had not received a COVID-19 vaccine and you are eligible for one during any future NHS deployment, we will offer you one as part of the study.
If the vaccine you have been given in the trial is not found to be effective enough at providing a boost overall, and if your age group become eligible for NHS boost immunisation during 2021/2, then you will receive the approved NHS booster vaccine as part of the trial.
If you have received a vaccine that is considered effective you will remain in the trial for the remainder of the year with no further booster.
(Continue . . . )
While there are some encouraging signs that the pandemic - at least in highly vaccinated countries - may be losing some of its grip, it is far too soon to declare victory. Work, such as this, needs to continue since we can't know what this virus may throw at us next fall or winter.
