Pharmaceutical Market Europe • May 2023 • 10
CORONAVIRUS NEWS
WHO declares end to COVID-19
global public health emergency
The World Health Organization (WHO) has declared that COVID-19 no longer constitutes a public health emergency of international concern (PHEIC).
The decision follows recommendations given by the agency’s emergency committee at a meeting in early May.
During the deliberative session, the committee members highlighted the decreasing trend in COVID-19 deaths, the decline in hospitalisations and intensive care unit admissions, as well as the high levels of population immunity to SARS-CoV-2.
WHO director-general, Dr Tedros Adhanom Ghebreyesus, said: “This means…it is time for countries to transition from emergency mode to managing COVID-19 alongside other infectious diseases.”
Globally, 13.3 billion doses of COVID-19 vaccines have been administered and 89% of health workers and 82% of adults aged over 60 years have completed their primary vaccination series, according to updated figures provided by WHO.
Ghebreyesus also announced the publication of the 2023-2025 COVID-19 Strategic Preparedness and Response Plan, which is designed to guide countries in transitioning to long-term management of COVID-19.
An International Health Regulations (IHR) review committee will also be established, Ghebreyesus said, to advise on recommendations on how to manage COVID-19 on an ongoing basis.
During this transition, countries are advised to continue following the temporary recommendations issued by WHO, including preparing for future outbreaks and integrating COVID-19 vaccination into life course vaccination programmes.
FDA simplifies use of Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines
The US Food and Drug Administration (FDA) has amended the emergency use authorisations of both the Moderna and Pfizer/BioNTech bivalent mRNA COVID-19 vaccines to simplify the vaccination schedule for most individuals.
The current bivalent vaccines, targeting the original and omicron BA.4/BA.5 strains, can now be used for all doses administered to individuals aged six months and older, including for an additional dose or doses for certain populations.
Each vaccine now has one fact sheet for healthcare providers and one for recipients and caregivers, rather than different fact sheets for the various authorised age groups.
The safety and effectiveness of both vaccines are based on the FDA’s previous analyses of clinical trial data on the companies’ respective monovalent and investigational BA.1 bivalent vaccines.
The authorisations follow discussions that took place during the meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in January. During that meeting, the committee unanimously recommended “harmonising the strain composition of COVID-19 vaccines” in the US and supported simplifying the vaccine dosing schedule.
The VRBPAC is set to meet in June to discuss the strain composition of the COVID-19 vaccines for autumn 2023, much like the FDA does yearly with influenza vaccines.
Gilead presents results for COVID-19 treatment for vulnerable patients
Gilead Sciences has presented positive results from several clinical and real-world evidence studies of its COVID-19 treatment, Veklury (remdesivir), at the European Congress of Clinical Microbiology & Infectious Diseases.
Results from the phase 3 REDPINE study demonstrated the safety profile of Veklury in patients with moderately and severely reduced kidney function who were hospitalised for COVID-19.
Two real-world studies also examined the treatment’s efficacy in reducing COVID-19-associated mortality for those living with cancer, as well in reducing hospital readmission for immunocompromised patients infected with dominant variants of concern.
Results from the first analysis, which evaluated nearly 7,500 cancer patients who were hospitalised for severe COVID-19, showed that those who were treated with Veklury within the first two days of admission had a significantly lower risk for mortality compared to those who were not.
In the second analysis of over 4,500 immunocompromised patients, those who received treatment with Veklury had lower risk for hospital readmission at both 30- and 60-day time periods.
Veklury is already approved in more than 50 countries worldwide to treat hospitalised patients with COVID-19, and in September the World Health Organization updated its guidelines to also recommend the drug for patients with severe COVID-19.
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