Maeght
Distinguished Member
Novavax approved by MHRA
There’s a working theory for the origins of Covid-19. It goes like this: Somewhere in an open-air market in Wuhan, China, a new coronavirus, growing inside an animal, first made the jump to a human. But what happens when diseases spread in the other direction?
Sonia Shah, a science journalist, explores the dangers of “spillback,” or “reverse zoonosis”: when humans infect non-humans with disease. Using the history of diseases spreading through mink farms in the United States and Europe as a focus, Shah considers the implications of spillback, and how we might minimize its future impact.
Shah considers how spillback can ignite epidemics in wild species, including endangered ones, and can ravage whole ecosystems. More worryingly, she describes how it can establish new wildlife reservoirs that shift the pathogens’ evolutionary trajectory, unleashing novel variants that can fuel new, dangerous waves of disease in humans.
A clinical trial of a COVID-19 booster vaccine for volunteers ages 16 and older
A clinical trial conducted by Moderna is evaluating an investigational booster vaccine that may protect against the COVID-19 Omicron variant.
Trial ID: mRNA-1273-P305 [EudraCT ID: 2022-000063-51]
Trial Details
The mRNA-1273-P305 clinical trial is evaluating the safety and immune response of the investigational mRNA-1273.529 booster vaccine that may protect against the COVID-19 Omicron variant. The investigational mRNA-1273.529 booster is being compared to a booster dose of Moderna’s COVID-19 vaccine, Spikevax, which is the vaccine that received conditional marketing authorization in the EU. All participants will receive either mRNA-1273.529 or Spikevax.
With different strains of COVID-19, there is an urgent need to develop vaccination plans that will provide greater protection. A booster vaccine that protects against COVID-19 variants, including the Omicron variant, would be a crucial public health tool to help curb the pandemic.
Estimated Enrollment
3000 Participants
Phase
2/3
Eligibility Criteria
Participants must:
- Be 16 years of age or older
- Be in good health
- Have previously received two or three doses of the COVID-19 vaccine
- Participants who have previously received a third dose must have received an mRNA vaccine (Moderna, Pfizer/BioNTech) as a third dose
- Participants who have previously received two doses may have received mRNA (Moderna, Pfizer/BioNTech) or non-mRNA (Oxford/AstraZeneca, Janssen) vaccines
Participants must not:
- Have received a COVID-19 vaccine within the past 3 months
- Have tested positive for COVID-19 since November 8, 2021 or have had significant exposure to someone who has tested positive within the past 14 days
- Have participated in another trial in the past 28 days
What to Expect
Participation in this clinical trial lasts up to 13 months and includes phone calls and visits to the trial site.
Insurance is not needed to join this clinical trial, and compensation for participant’s time/travel will be available.
- Participants will be given one injection in the upper arm. Participants will either receive the investigational booster vaccine, mRNA-1273.529, or the already authorized vaccine, Spikevax.
- Participants will be asked to attend trial site visits including a Screening Visit, a Vaccination Visit, and approximately five subsequent trial site visits (Day 8, Month 1, Month 3, Month 6, and Month 12).
- Participants will be asked to have up to four phone calls with the clinical trial doctor to monitor for any symptoms. During these phone calls, the doctor and medical staff will check how you are feeling and ask for updates on your health.
- Participants will be asked to use an eDiary app on your smartphone or a provided smartphone to report any COVID-19 symptoms you experience.
- Participants will be closely monitored by the clinical trial team if any symptoms of COVID-19 are reported at any time throughout their participation.
13 months? By which point we will be another 2 variants down! Why so long compared to the original?New Moderna trial, just read about it in the NHS COVID-19 Vaccine Research Registry Newsletter. Taking place at up to 29 research sites across England, Scotland and Wales, some sites will begin recruiting in March, and the study will last up to 13 months.
UK volunteers to receive Moderna Omicron COVID-19 booster vaccine in clinical study
One of the world’s first Omicron-specific COVID-19 variant vaccines is to be trialled at multiple sites across the UK, as the biotechnology company Moderna, Inc works alongside the NIHR.www.nihr.ac.uk
Citeline Connect
connect.trialscope.com
I'm still on a two year trial with Janssen, regarding a two-dose regime. Doesn't stop approval, this is looking at long term immunity.13 months? By which point we will be another 2 variants down! Why so long compared to the original?
Shankar Balasubramanian’s diary records 26 August 1997 as the day of “The Solexa Idea!” Sitting in the beer garden of the Panton Arms in Cambridge, he and David Klenerman sketched out their plans to watch DNA polymerase as it assembled the building blocks of life. Their ideas were progressing fast – and with them, something even more exciting. They realised that if they could watch the enzyme copying a genome then they were inadvertently also reading the genome. They had discovered a radically new way to sequence DNA that would be fast, accurate, low-cost and scalable. To make the technology more broadly available to the world, in 1998 they co-founded the company Solexa, which was acquired by Illumina in 2007. Today, rapid genome sequencing brings huge benefits to society. Coronavirus is tracked worldwide, diseases are diagnosed, crops are improved, and new therapies and vaccines are developed. We talk to the inventors about their journey of discovery.
In this video Professor Shankar Balasubramanian of University of Cambridge talks about his research and shares his feelings about winning the Tetrahedron Prize 2013.
In this video, Professor Shankar Balasubramanian of University of Cambridge talks about his career journey, his mentors and the challenges he has faced. He also offers advice to young researchers who are starting out.
I had AstraZeneca for my 1st and 2rd dose from the doctor but like you I had Moderna for my booster, this was at the end of November 2021 and then on Boxing Day everyone in the family apart from my son got Covid again.At the end of April I had the 3rd. dose but it was Moderna. No e-diary, follow-up or anything. The 1st. and 2nd. were Pfizer.
I think that the reason was due to the 3rd. one being at a hole-in-the-wall pharmacy and the others were at a health centre, so storage could have been the issue.
No noticeable effects apart from the immediate area being a bit uncomfortable and tender for 3 - 4 days.
I had AstraZeneca for my 1st and 2rd dose from the doctor but like you I had Moderna for my booster, this was at the end of November 2021 and then on Boxing Day everyone in the family apart from my son got Covid again.
Oddly when I got in back in May 2020 I only had a really bad headache for a few days but this time and with the supposedly mild version of the virus it hit me way harder, it completely floored me for 24 hours and after 2 more days I developed an intestine issue that required a heavy double dose of antibiotics for 9 days to cure.
Covid has been dismissed by so many people but after all of us getting it the first time a few weeks later each of us suffered different medical issues, the son’s iron levels in his blood hit the dirt, the wife developed a thyroid issue and my cholesterol levels jumped to the point the doctors were concerned and totally out of character for me, my age, weight and fitness level. I do think they will be studying covid for years to get to the bottom of why it has affected some many people long term and in such varying ways.
Oh and btw the way we are all back to normal now.