Pharmaceutical Market Europe • September 2023 • 8-9
NEWS
NHS England to bring forward flu and COVID-19 vaccine programmes
NHS England has announced that its flu and COVID-19 vaccination programme, which was due to start in October, will now offer vaccinations from September onwards.
In line with the latest guidance announced by the Department of Health and Social Care and the UK Health Security Agency, millions of eligible people will now be offered vaccines from 11 September.
The acceleration of the programme will ensure those most at risk are vaccinated by the end of October, due to the increased risks presented by the COVID-19 variant BA.2.86.
Steve Russell, NHS England chief delivery officer and national director for vaccinations, said: “While we know that flu and COVID-19 usually hit hardest in December and January, the new COVID-19 variant presents a greater risk now.”
Residents of older adult care homes, people who are immunosuppressed, carers, pregnant women, and health and social care staff will receive their COVID-19 vaccine first.
Additionally, the Joint Committee on Vaccination and Immunisation previously recommended that adults over the age of 65 would be eligible for flu and COVID-19 vaccinations this year.
As of 18 September, the NHS will begin inviting eligible, high-risk individuals to book an appointment on the National Booking Service.
Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine approved by EC
Pfizer and BioNTech’s Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, known as Comirnaty Omicron XBB.1.5, has been approved by the European Commission (EC) for adults, children and infants aged over six months.
The authorisation follows a positive opinion from the European Medicines Agency’s human medicines committee, which recommended marketing authorisation for a single dose of the vaccine in eligible individuals aged five years and older, regardless of their COVID-19 vaccination history.
The committee also recommended that children aged from six months to four years may have one to three doses of the updated vaccine, depending on their previous primary vaccination and whether they have had COVID-19.
The approval is supported by preclinical data showing the vaccine generated a substantially improved response against multiple XBB sublineages of the SARS-CoV-2 virus variants, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
Efficacy against variants included the globally dominant variant EG.5.1, known as Eris, which was designated as a ‘variant of interest’ by the World Health Organization in August.
Pfizer and BioNTech have previously said that doses of the updated vaccine will be ready to ship immediately upon authorisation by the EC.
The companies have also filed an application with the US Food and Drug Administration for the approval of the vaccine.
US government awards $1.4bn for development of COVID-19 vaccines and therapeutics
The US Department of Health and Human Services (HHS) has awarded over $1.4bn for the development of new vaccines and therapies against COVID-19.
The funding, which is part of a $5bn initiative called ‘Project NextGen’, will support clinical trials to enable the rapid development of more effective and longer-lasting vaccines, a new monoclonal antibody and technologies to streamline manufacturing processes.
“As the virus continues to evolve, we need new tools that keep pace with those changes,” said assistant secretary for preparedness and response, Dawn O’Connell.
Project NextGen is led by HHS’s Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority in partnership with the National Institute of Allergy and Infectious Diseases.
Coordinating across the federal government and the private sector, the project aims to better understand COVID-19, with HHS developing, using and re-evaluating the strengths and weaknesses of current vaccines and therapeutics.
The funding includes $1bn for four mid-stage clinical trials of new COVID-19 vaccines, and $100m to a non-profit organisation that invests in new technologies to accelerate responses to diseases, the Global Health Investment Corp.
Also included in the funding is a $326m contract with Regeneron Pharmaceuticals for the development of its next-generation antibody therapy for the prevention of COVID-19 infections.
US survey reveals ‘critical’ drug shortages are affecting cancer care
A survey by the American Society of Hospital Pharmacists (ASHP) has revealed that 57% of hospital pharmacists in the US have reported ‘critical shortages’ of chemotherapy drugs, which is affecting the care of cancer patients.
The survey, conducted between 23 June and 14 July, found that 99% of 1,123 hospital and health system pharmacists in the US reported that they were experiencing issues getting hold of some medicines.
Around 63% reported that the shortages were ‘moderately impactful’, allowing them to navigate around the problem, but still affected patient care.
ASHP’s chief executive, Paul Abramowitz said that pharmacists are “working diligently with other clinicians to provide safe and effective care, despite ongoing drug shortages”.
Despite this, he added: “There are no alternatives to the affected drugs, which puts patients at risk.”
After chemotherapy, the drug categories most affected were corticosteroid and hormonal drugs (28%), oral liquids, antibiotic amoxicillin and anaesthetic lidocaine (22%), and ‘crash cart’ drugs like epinephrine or atropine (18%).
By the end of the second quarter of 2023, over 309 active, ongoing drug shortages had occurred – the highest number reported in nearly a decade, close to the record high of 320, according to ASHP.
UK government invests £210m to fight antimicrobial resistance
The UK government has announced a £210m investment to support the global fight against antimicrobial resistance (AMR).
For the next three years, the funding from the government’s UK aid budget will support the Fleming Fund’s activities to tackle AMR across Asia and Africa to help reduce the threat it poses to the UK and globally.
The investment is the largest ever to be seen in global AMR surveillance by a country and builds on the government’s plan to incentivise drug companies for the development of new antibiotics.
The funding will support 25 countries where the threat and burden of AMR are highest, including Indonesia, Ghana and Kenya, enhancing surveillance capacities and upgrading over 250 laboratories, which will gain state-of-the-art equipment, including new genome sequencing technology.
Over 20,000 training sessions will be provided to strengthen the international health workforce, including laboratory staff, pharmacists and hospital staff.
Around 200 Fleming Fund scholarships will be also be offered to enhance expertise in microbiology, AMR policy and One Health.
The investment will drive the second phase of the UK-India Fleming Fund partnership and accelerate collaboration on AMR surveillance across One Health sectors, helping both countries deliver on their 2030 road map.
US government announces first ten drugs subject to Medicare pricing negotiations
The US government has announced the ten drugs selected for the first round of pricing negotiations under President Biden’s Inflation Reduction Act (IRA).
The IRA allows Medicare, the government health plan for older adults, to negotiate lower prices for a selected group of prescription medicines.
The list includes Bristol Myers Squibb and Pfizer’s Eliquis (apixaban), Novartis’ Entresto (valsartan/sacubitril), Amgen’s Enbrel (etanercept), AstraZeneca’s Farxiga (dapagliflozin), Merck & Co’s Januvia (sitagliptin), Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and Novo Nordisk’s Novolog/Fiasp (insulin aspart).
Johnson & Johnson’s Stelara (ustekinumab) and Xarelto (rivaroxaban) are also listed, as well as its AbbVie-partnered Imbruvica (ibrutinib).
Once implemented, the prices of negotiated drugs will decrease for up to 9 million seniors, who currently pay up to $6,497 in out-of-pocket costs per year for these prescriptions, the Biden administration outlined in a statement.
After the negotiation period, the new prices will be announced in September 2024 and will be effective at the beginning of 2026.
However, the IRA’s price negotiation element is currently facing court challenges from leading drugmakers and industry groups, including Merck & Co, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca and the Pharmaceutical Research and Manufacturers of America.
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