Coronavirus Notebook: UK Sets Up ‘Pioneering’ Vaccines Lab, MSF Piles Pressure On TRIPS Waiver Holdouts
Executive Summary
The UK has OKd trials of a new AI-derived combination treatment from Canadian firm Skymount Medical. Health Canada has approved Novavax’s COVID-19 vaccine, and Australia has given the go-ahead to use Moderna’s Spikevax in children aged six years and up.
The UK Health Security Agency has opened what it calls a “world-class” facility for developing and testing new COVID-19 vaccines and conducting research into virus variants of concern (VoCs) at its Porton Down site in Salisbury.
The £27m ($36.5m) building is one of two facilities making up a new £65m Vaccine Evaluation Centre that will help in the development and licensing of a new generation of vaccines, the UKHSA said. The project is fully funded by the Vaccine Taskforce, a unit run jointly by the Department for Business, Energy and Industry Strategy and the Department of Health and Social Care.
Research undertaken at the facility will include clinical trials to support the approval of new vaccines, research and data-gathering to inform government decisions on future vaccination policies, and the conduct of risk assessments of VoCs, “including those with potential vaccine escape,” according to the agency.
“Vaccines are one of the most important weapons we have against COVID-19 and they have prevented countless deaths and hospitalizations through this pandemic,” said Dame Jenny Harries, CEO of the UKHSA. “Our teams will use these new facilities to ensure we stay on the front foot in protecting against future threats.”
New UK Research On Vaccine Efficacy
A study backed by the UKHSA has thrown more light on the effectiveness of vaccines in preventing infection with SARS-CoV-2 in those who have had two vaccine doses, those who have previously been infected with the virus, and unvaccinated individuals.
The latest findings from the SIREN study, which involves regular testing of a large cohort of health care workers, show that two doses of vaccine provide “significant short-term protection against infection among those who had not had a previous infection” but that this protection wanes significantly after six months.
Unvaccinated participants who had been previously infected with COVID-19 were found to have an 86% reduced risk of reinfection compared with the risk of primary infection in those who had no previous infection and were also unvaccinated, the UKHSA said, adding that “this protection waned to 69% after a year.”
Dual protection in people who had been previously infected and subsequently double vaccinated “was even greater and more durable, standing at over 90% after two doses,” according to the agency. “This protection remained strong over a year after infection and over six months following vaccination.”
Susan Hopkins, SIREN study lead and chief medical advisor at the UKHSA, said the research showed why it was crucial to get vaccinated as it “provides a significantly greater level of protection against infection from COVID-19, whether or not you have been previously infected.”
But she cautioned that the study showed protection conferred by just two doses “wanes significantly within months, which is why the rollout of booster jabs has been an instrumental part of our efforts to contain COVID-19.”
The agency noted that vaccine effectiveness for Pfizer Inc./BioNTech SE’s Comirnaty, where the second dose was administered six weeks or more after the first dose, stood at 85% from 14 to 73 days after the second dose, falling to 51% after six months.
Vaccine effectiveness where the two doses of Comirnaty were administered within six weeks of each other was 89% 14 to 73 days after dose two, decreasing to 53% after 6 months.
Skymount’s Drug Combo OKd for UK Trials
Also in the UK, Canadian firm Skymount Medical said the Medicines and Healthcare products Regulatory Agency had given the go-ahead for a clinical trial of a novel two-drug combination product for treating patients with mild-to-moderate COVID-19.
The product is designed to address both the viral load and inflammatory aspects of COVID-19, and has shown up to 97% efficacy in reducing the amount of SARS-CoV-2 in cell and animal studies, without negative side effects, Skymount said. It now needs to obtain ethics committee approval and to identify suitable UK trial sites, and said it expected about 150 patients to take part in the study.
The two compounds in the combination are a cancer medicine and an antiparasitic agent that are both approved by the US Food and Drug Administration. The company did not identify the compounds and had not responded to a request for comment at the time of publication.
The combination drug emerged from the DeepDrug artificial intelligence platform, which uses a set of components to deliver “a state-of-the-art compound and formula generation capability that greatly reduces the time and cost associated with traditional drug discovery,” the company said. DeepDrug was developed by researchers at Louisiana State University, with which Skymount has a licensing agreement.
"We asked the AI to predict which FDA-approved drugs could act in a similar way, and found several good candidates" – Supratik Mukhopadhyay, Louisiana State University
The platform was trained to recognize similarities between existing drugs and antiviral peptides targeting coronaviruses and was then tested on unseen pairs where it achieved an accuracy of 97.28%, unrelated to the efficacy of the drugs themselves, according to Skymount.
“Next, we asked the AI to predict which FDA-approved drugs could act in a similar way, and found several good candidates, with one of the most promising combinations now entering human trials in the UK,” said said Supratik Mukhopadhyay, DeepDrug team leader and professor in the LSU Department of Environmental Sciences.
Skymount reported in November last year that a US clinical study of the combination was about to begin to demonstrate safety and efficacy against placebo and determine the impact on the length and severity of symptoms without negative side-effects. It added that similar studies were already under way in Europe.
Canada Approves Nuvaxovid
On 17 February Health Canada announced that it had approved Novavax’s Nuvaxovid for preventing COVID-19 in adults aged 18 and over, making it the fifth coronavirus vaccine to be authorized for use in Canada.
The government department said that while additional confirmatory data were still needed, “preliminary and exploratory data shows that Nuvaxovid does produce neutralizing antibodies against the Omicron variant.”
As a condition associated with the authorization, Novavax is required to provide information on the vaccine’s ability to protect against current and emerging VoCs as soon as it becomes available, Health Canada noted. The company will also be required to furnish data on the vaccine’s safety, efficacy and quality “to ensure its benefits continue to be demonstrated through market use.”
Health Canada is publishing a number of documents related to its decision, including a high-level summary of the evidence it reviewed to support the vaccine’s approval. “More detailed information will be available in the coming weeks, including a detailed scientific summary and the full clinical trial results that support the use of this vaccine,” it added.
Australia OKs Spikevax In Younger People
In Australia, the Therapeutic Goods Administration has provisionally approved the use of Moderna, Inc.’s Spikevax in individuals aged six years and above. This follows provisional approvals for the vaccine in people aged 12 years and over and for a booster dose in adults aged 18 and up.
“As for other age groups, the use of this vaccine in children aged 6-11 years should be administered as two doses at least 28 days apart,” the TGA said. The same vaccine preparation employed for older age groups will be used, although a lower dose of 0.25ml (50 micrograms) will be given to children aged six to 11 years, compared with to the 0.5ml (100 microgram) dose used for those aged 12 years and older.
In making its decision, the TGA took account of data from the KidCOVE clinical trial, which was conducted at multiple sites throughout Canada and the US and included up to 4,000 participants aged 6 to 11 years. “The study demonstrated that the immune response to the vaccine in children was similar to that seen in older age groups,” the agency noted.
Moderna has been asked to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-marketing assessment.
As an extra check, the agency said its laboratories would perform an assessment of each batch of the vaccine before it could be supplied to people in Australia.
Further advice on the rollout of Spikevax to this age group will be provided to the government by the Australian Technical Advisory Group on Immunisation.
MSF Pressures European Countries Over IP Waiver
This week, negotiations are resuming at the World Trade Organization on the proposed IP waiver for vaccines and other medical tools for COVID-19 that is supported by more than 100 low- and middle-income countries. The waiver would involve a temporary suspension of certain rules contained in the WTO's TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.
The medical NGO, Médecins Sans Frontières, has called on the EU, the UK and Switzerland to change tack and support the waiver, saying it would promote access, local production and self-reliance. It has also urged the US to “show concrete leadership to accelerate the negotiations and to broaden the scope of its support beyond only vaccines to include medicines and diagnostics.”
Yuanqiong Hu, senior legal and policy advisor for MSF's Access Campaign, said it was “heartbreaking for us to continue to witness outrageous inequity in access to COVID-19 medical tools in many of the low- and middle-income countries where we work while wealthy countries which have hoarded vaccines are now buying up much of the supply of new treatments.”
Baricitinib "is widely patented in more than 50 countries and priced out of reach in most low- and middle-income countries” – MSF
As well as vaccine inequity, MSF also said that access to COVID-19 treatments “remains a challenge,” noting that Eli Lilly and Company's baricitinib, whose use was recently endorsed by the World Health Organization, “is widely patented in more than 50 countries and priced out of reach in most low- and middle-income countries.” These patents “would only start expiring in 2029, and are likely to continue blocking generic production and supply in countries where granted,” the NGO declared.
“Generic versions of baricitinib are available for under US$7 per 14-day treatment course in India and Bangladesh, which is significantly less than patent holder Eli Lilly’s prohibitive price of $1,109 per 14-day treatment course in the US.”
MSF also highlighted what it sees as “another case of inequity” in Latin America where it said “a majority of countries are facing limited access to new treatments,” partly because of “patent barriers and restrictive licensing deals controlled by pharmaceutical corporations.”
For example, it said, most Latin American countries have been excluded from the deal signed by Pfizer and the Medicines Patent Pool for the company’s Paxlovid (nirmatrelvir/ritonavir) in November last year. (Also see "Pfizer & MPP Sign Deal For Generics Of COVID-19 Candidate Paxlovid" - Pink Sheet, 16 Nov, 2021.)
“This means those countries will not be allowed to buy generic versions of this oral drug that are produced under the deal,” MSF claimed, noting that the product “also has patents pending in most Latin American countries, which, if granted, would not expire in many countries until 2041.”
This, it said, would leave countries “solely dependent on Pfizer’s supply and pricing decisions.” Local production and supply of generic Paxlovid to Latin American countries “would need to be supported by removing the main IP barriers, which could be accomplished by adopting the TRIPS waiver,” it declared.