Back in August, the UK and American vaccine maker Novavax announced an agreement to proceed to a Phase 3 clinical trial testing that company’s COVID-19 experimental vaccine called NVX-CoV2373. This randomized, double-blind, placebo-controlled efficacy study targets 9,000 adults, aged 18-85 in the UK. Scotland’s NHS Grampian has issued a call for vaccine participation in this northeastern section of Scotland where Aberdeen Royal Infirmary (ARI), the largest hospital within the UK regional health board, serves as trial site organization for the Novavax vaccine trial. A total of 450 residents from Aberdeen and Aberdeenshire between the ages of 18 and 84 are needed for this important study. A total of 9,000 are sought after by the NHS from 18 regions across the UK as the clinical trial commences, targeting COVID-19. In the meantime, a resurgence of COVID-19 represents growing danger in Scotland, which has registered a higher death rate than the whole of the UK.
COVID-19 in Scotland
The United Kingdom (UK) has registered a total of 480,017 COID-19 cases with 43,317 deaths. After a reduction in cases, Scotland has seen cases steadily go back up. Presently, 764,178 tests have come out negative and 31,451 or about 4 percent of the total are positive. Currently, 4,257 deaths in Scotland have been associated with COVID-19. 46 percent of these deaths were associated with long term care homes (e.g. nursing homes for the elderly) and another 46 percent in hospitals with the other 7 percent in home or non-institutional settings, as reported in the Scottish government website.
With approximately 5.5 million, Scotland represents about 8 percent of the UK’s 66.6 million population. Scotland has registered about 9.8 percent of the total deaths, a higher ratio when factoring in its population. As of this writing, the BBC reports that the resurgence continues with 2,519 people passing in the past 28 days—a frightening number.
UK Jumps Directly to Phase 3 Trial Testing NVX-CoV2373
Novavax announced in an Aug 14 company press release that it signed a Term Sheet with the Government of the UK for the purchase of 60 million doses of the investigational product NVX-CoV2373 targeting COVID-19. In this announcement, the parties included the introduction of a Phase 3 clinical trial to assess the efficacy of the vaccine in the UK population. Interestingly, the company announced this Phase 3 trial before the completion of the firm’s Phase 1/2 clinical trial (NCT04368988) in the United States and Australia (targeted completion Dec. 2020) or their Phase 2 trial (NCT040533399) in South Africa, which just commenced the same month.
The UK undoubtedly made the decision to progress directly to a Phase 3 trial (the last stage) due to what Kate Bingham, Chair of the UK Government’s Vaccine Taskforce, commented: “it is encouraging that Novavax’ recent clinical data shows that their the vaccine triggers an immune response greater than that in patients who have recovered from the disease.” Emphasizing the greenlight, Ms. Bingham continued, “We believe that Novavax has a highly innovative vaccine that could be first in its class of protein-based vaccine options. We are happy to partner with them and global organizations such as CEPI to further our mutual commitments to ensure global access to the vaccine.”
NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials commenced in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Contract Manufacturing Deal
Often biotech and pharma outsource vaccine manufacturing to contract manufacturing organizations or “CMOs.” Novavax needs manufacturing capability and capacity and inked a deal with FUJIFILM Diosynth Biotechnologies, one of the world’s leading CMOs for vaccines, plans to make the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in the UK in addition to CMO sites in North Carolina and Texas in the United States. The UK site is expected to produce up to 180 million doses per year, which adds to production capacity for dose production worldwide.
This Phase 3, randomized, double-blind, placebo-controlled efficacy study targets approximately 9,000 adults UK-wide and 450 adults in this part of Scotland. The trial has commenced (announced in August) and the UK government offers support and infrastructure to the American sponsor in the trial’s execution. The trial assesses the ability of the investigational vaccine product, NVX-CoV2373 and its ability to protect against symptomatic COVID-19 disease as well as evaluate antibody and T-cell responses.
As was announced in the local press, Aberdeen City Council co-leader Douglas Lumsden, who also happens to sit on the NHS Grampian board, signed up to become a volunteer in the study, commenting, “It’s vital to get people to come forward to take part in the trial.” The Councilman continued, “I’m a suitable volunteer, I hope I can take part. I think it’s important everyone does their bit to get through this.”
The Principal Investigator Point of View
This study site in Scotland is led by a consultant physician at Aberdeen Royal Infirmary, Dr. Roy Soiza, who recently told the local press that “he is quietly confident about the success of Novavax.”
The Evening Express reported Dr. Soiza commented, “We’ve been trying for some weeks to persuade the COVID vaccine manufacturers to come to Aberdeen and test their vaccine because I think we have very good facilities and I’m sure there’s a great appetite amongst the people in the north-east to participate, so I’m delighted that we can offer people the opportunity to participate in a COVID vaccine trial.” The Scotland-based physician went on to emphasize that this was actually the very first Phase 3 study for this vaccine, hence the stakes are big and the UK becomes potentially one of the first nations to access a ready vaccine should the trial go well.
Aberdeen Royal Infirmary (the Trial Site)
The Aberdeen Royal Infirmary serves as the trial site for this part of Scotland. It is the largest hospital in the Grampian area, and includes a teaching hospital with approximately 900 inpatient beds, offering tertiary care for a population of over 600,000 across the North of Scotland. The hospital offers all medical specialties with the exception of heart and liver transplants, according to Wikipedia. The hospital is part of the NHS and is managed by NHS Grampian.
The hospital actually goes way back in time until 1739 at Woolmanhill. The current hospital was opened in 1936 officially by the Duke and Duchess of York; it joined the National Health Services after World War 2 in 1948.
Dr. Soiza graduated from Edinburgh University in 2000 and became a member o the Royal College of Physicians in 2003. He thereafter joined the North of Scotland training program as a Specialist Registrar in Geriatric Medicine and General Internal medicine. By 2006, he became a clinical lecturer in Elderly Medicine at University of Aberdeen.
Call to Action: If you are based in the north-east region of Scotland, consider reviewing the information and discussing with your physician. You can reach out directly to NHS at [email protected].