Pharmaceutical Market Europe • November 2023 • 10-11
CORONAVIRUS NEWS
This year’s Nobel Prize in Physiology or Medicine has been awarded to Katalin Karikó and Drew Weissman for their discoveries that enabled the development of effective messenger ribonucleic acid (mRNA) vaccines against COVID-19.
The prize was selected by the Nobel Assembly of Sweden’s Karolinska Institute medical university and comes with approximately $1m of prize money for the pair to share between them.
The Nobel Prize committee said: “Through their groundbreaking findings, which have fundamentally changed our understanding of how mRNA interacts with our immune system, the laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times.”
Vaccines train the immune system to create antibodies to help it fight off a particular pathogen, but the method they use to achieve this depends on the underlying vaccine technology.
Despite the mechanism of action for mRNA technology being relatively straightforward, researchers have had to work for years to develop technologies to allow mRNA to work in the real world.
In 2005, Karikó and Weissman jointly developed ‘nucleoside base modifications’, which stop the immune system from launching an inflammatory attack against lab-made mRNA, previously seen as a major obstacle against the use of the technology.
Moderna has announced positive results from a phase 1/2 trial of its investigational mRNA combination vaccine against COVID-19 and influenza.
The combined vaccine approach has the potential to alleviate the impact of both COVID-19 and flu while offering a combined administration, potentially simplifying immunisation practices and leading to higher vaccine uptake.
The ongoing phase 1/2 clinical trial is evaluating the safety and immunogenicity of the vaccine, called mRNA-1083, compared to GSK’s standard dose Fluarix flu vaccine in adults aged 50 to 64 years and Sanofi’s high-dose Fluzone flu vaccine in those aged 65 to 79 years.
For both age groups, mRNA-1083 was compared against Moderna’s stand-alone COVID-19 booster, Spikevax.
Results showed that the combination vaccine appeared effective against all four flu vaccine strains when compared with both Fluarix and Fluzone and achieved SARS-CoV-2 neutralising antibody levels similar to Spikevax.
Moderna also said the combination was found to be safe and tolerable and that the rates of adverse effects were similar to those experienced by the stand-alone COVID-19 vaccine group.
The company said it is now planning to begin a phase 3 trial of mRNA-1083 this year and is targeting potential regulatory approval for the combination vaccine in 2025.
Novavax has announced that an updated version of its COVID-19 vaccine has received Emergency Use Authorisation (EMA) from the US Food and Drug Administration (FDA) for use in individuals aged 12 years and older.
The Novavax COVID-19 vaccine, adjuvanted has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5.
The authorisation was based on non-clinical data showing that the monovalent vaccine induced functional immune responses against the XBB.1.5, XBB.1.16 and XBB.2.3 variants.
Additionally, the vaccine was shown to induce neutralising antibody responses to the emerging subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, along with robust CD4-positive polyfunctional cellular responses against EG.5.1 and XBB.1.16.6.
Individuals aged 12 years and older who were previously vaccinated with COVID-19 vaccines, as well as those who have not recently received an updated mRNA COVID-19 vaccine, will be eligible to receive a single dose. Unvaccinated individuals will be eligible to receive two doses of the vaccine.
In July this year, Novavax’s COVID-19 vaccine was granted full marketing authorisation in the EU for use as a primary series in individuals aged 12 and older for COVID-19 prevention, as well as a booster dose in adults aged 18 and older.
A team of researchers has found that an individual’s immune response to SARS-CoV-2 variants depends on their previous exposure to infections and vaccination, which could help optimise future vaccines.
The new study, published in the journal Science, involved collaboration across ten research institutes, including the University of Cambridge, and unveiled a snapshot of early global population immunity to COVID-19.
After collecting 207 serum samples from blood samples of people who had been infected by the SARS-CoV-2 variants or had previously been vaccinated against SARS-CoV-2 with a number of doses of the Moderna vaccine, the researchers analysed the immunity that they had developed.
Funded by the National Institute of Allergy and Infectious Diseases and National Institutes of health, the study discovered significant differences between immune responses, depending on which variant an individual had been infected with first.
Omicron variants were noticeably different from others, which explained why individuals still succumbed to infection with Omicron despite previous vaccination or infection with a different variant.
“These results give us a deep understanding of how we might optimise the design of COVID-19 booster vaccines in the future,” said Derek Smith, director, Centre for Pathogen Evolution, Department of Zoology, University of Cambridge.
Two AstraZeneca studies have highlighted the continued significant and disproportionate burdens of COVID-19 on immunocompromised (IC) individuals.
Covering almost 30 million people, the INFORM and EPOCH real-world studies showed that IC individuals have a higher rate of severe outcomes from COVID-19 compared to the general population.
Including around 12 million participants aged 12 years and older in England, the INFORM study aimed to assess clinical outcomes and utilisation of healthcare resources in relation to COVID-19.
The EPOCH study conducted an extensive insurance claims database of around 17 million people, providing real-world data on COVID-19 risks and outcomes in IC and non-IC populations within the US.
The data revealed that 22% of all COVID-19 hospitalisations consisted of IC individuals, along with 28% of ICU admissions and 25% of deaths in England.
The results from the studies revealed that, despite receiving repeated doses of COVID-19 vaccines, IC individuals’ risk of COVID-19 hospitalisations was 14 times greater than that of the general population.
Data from EPOCH showed that the mean total costs for hospitalisations associated with the first COVID-19 diagnosis for IC patients was estimated at nearly $1bn, with a mean cost of $64,029 per patient and mean length of hospitalisation stay of 15 days.
The Centers for Disease Control and Prevention (CDC) and the National Foundation for Infectious Diseases (NFID) have urged people to get vaccinated against influenza and COVID-19 for the upcoming autumn and winter virus seasons.
US health experts encourage everyone aged six months and older to get vaccinated against flu and COVID-19 and urge those most at risk for severe disease to discuss new RSV prevention tools (vaccines and monoclonal antibodies), as well as pneumococcal vaccination with a healthcare professional.
NFID released new survey data from 1,000 individuals, conducted by the National Opinion Research Center at the University of Chicago, which revealed that 43% of adults in the US do not plan to or are unsure whether they will get vaccinated against the flu. Additionally, only 40% plan to get vaccinated against COVID-19.
When asked about why they would not get vaccinated, respondents expressed concerns about side effects, distrust of vaccines and a belief that vaccines were ineffective.
At the NFID Annual News Conference on 2 October 2023, Mandy Cohen, director at the CDC, encouraged people to get vaccinated, saying: “[This is] the first time we have immunisations available to help protect against the three major respiratory viruses – COVID-19, flu and RSV.”