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Can a supranational medicines agency restore trust after vaccine suspensions? The case of Vaxzevria.

ABSTRACT: Over the first half of March 2021, the majority of European governments suspended Astrazeneca's Vaxzevria vaccine as a precaution following media reports of rare blood clots. We analyse the impact of the European Medicines Agency's (EMA) March 18th statement assuring the public of the safety of Vaxzevria and the immediate reinstatement of the vaccine by most countries on respondents' intention to get vaccinated. By relying on survey data collected in Luxembourg and neighbouring areas between early March and mid-April, we observe that the willingness to be vaccinated was severely declining in the days preceding the EMA statement. We implement a regression discontinuity design exploiting the time at which respondents completed the survey and find that the vaccine reinstatement substantially restored vaccination intentions.

SUBMITTER: Albanese A

PROVIDER: S-EPMC9710792 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Can a supranational medicines agency restore trust after vaccine suspensions? The case of Vaxzevria.

Albanese Andrea A Fallucchi Francesco F Verheyden Bertrand B

PloS one 20221130 11

Over the first half of March 2021, the majority of European governments suspended Astrazeneca's Vaxzevria vaccine as a precaution following media reports of rare blood clots. We analyse the impact of the European Medicines Agency's (EMA) March 18th statement assuring the public of the safety of Vaxzevria and the immediate reinstatement of the vaccine by most countries on respondents' intention to get vaccinated. By relying on survey data collected in Luxembourg and neighbouring areas between ear ...[more]

PMID: 36449501

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Project description:BackgroundDrug regulators assess and describe uncertainties regarding treatment outcomes and the benefit-risk balance of newly authorised medicines. We aimed to evaluate the type and number of uncertainties described in the benefit-risk assessment for initial marketing authorisations of oncology medicines assessed by the European Medicines Agency (EMA). We also aimed to develop a systematic classification of uncertainties to contribute to improved communication about uncertainties.Materials and methodsWe included all medicines containing a new active substance assessed by the EMA and granted an initial marketing authorisation by the European Commission in 2011-2022 for an oncology indication. We extracted characteristics of these oncology medicines and uncertainties described under the benefit-risk balance section of European public assessment reports. Uncertainties were categorised and their frequencies stratified according to time of marketing authorisation, and medicine and regulatory characteristics.ResultsIn total, 121 oncology medicines were included for which 800 (median 6, range 0-23) uncertainties were identified. Uncertainties were classified into five categories: safety (n = 404, 51%), efficacy (n = 322, 40%), pharmacology (n = 58, 7%), use in clinical practice (n = 10, 1%), and quality (n = 6, 1%). Among 27 subcategories, most uncertainties were related to specific adverse events (n = 156, 20%), effect size (n = 155, 20%), safety in subpopulations (n = 124, 16%), or efficacy in subpopulations (n = 88, 11%). The type of medicine (P = 0.012), type of marketing authorisation (P = 0.001), and year of marketing authorisation (P = 0.007) were associated with the number of uncertainties per medicine, with the highest number observed for cell and gene therapies [8 (3-23)], medicines granted conditional marketing authorisation [7 (3-23)], and medicines authorised in 2019-2022 [7 (2-23)].ConclusionAt the time of initial marketing authorisation of oncology medicines, uncertainties about their benefit-risk balance most often concerned safety aspects, followed by efficacy. The number of uncertainties was highest for cell and gene therapies, conditionally authorised medicines, and medicines authorised in recent years.

Project description:ObjectivesStratified medicine is often heralded as the future of clinical practice. Key part of stratified medicine is the use of predictive biomarkers, which identify patient subgroups most likely to benefit (or least likely to experience harm) from an intervention. We investigated how many and what predictive biomarkers are currently included in European Medicines Agency (EMA) licensing.SettingEMA licensing.ParticipantsIndications and contraindications of all drugs considered by the EMA and published in 883 European Public Assessment Reports and Pending Decisions.Primary and secondary outcome measuresData were collected on: the type of the biomarker, whether it selected a subgroup of patients based on efficacy or toxicity, therapeutic area, marketing status, date of licensing decision, date of inclusion of the biomarker in the indication or contraindication and on orphan designation.Results49 biomarker-indication-drug (B-I-D) combinations were identified over 16 years, which included 37 biomarkers and 41 different drugs. All identified biomarkers were molecular. Six drugs (relating to 10 B-I-D combinations) had an orphan designation at the time of licensing. The identified B-I-D combinations were mainly used in cancer and HIV treatment, and also in hepatitis C and three other indications (cystic fibrosis, hyperlipoproteinaemia type I and methemoglobinaemia). In 45 B-I-D combinations, biomarkers were used as predictive of drug efficacy and in four of drug toxicity. It appeared that there was an increase in the number of B-I-D combinations introduced each year; however, the numbers were too small to identify any trends.ConclusionsGiven the large body of literature documenting research into potential predictive biomarkers and extensive investment into stratified medicine, we identified relatively few predictive biomarkers included in licensing. These were also limited to a small number of clinical areas. This might suggest a need for improvement in methods of translation from laboratory findings to clinical practice.

Project description:Medicines reconciliation is integral to patient safety, symptom control and reducing patient anxiety. During a 3-month period on the respiratory ward at St. Peter's Hospital, 54% of drug charts were not reconciled with pre-admission medicines at the point of discharge for admissions up to 17 days. Only 18% were reconciled within 24 hours of admission. 50% of drug charts were missing 0-2 pre-admission medicines and 50% were missing 3-5 pre-admission medicines. The most common medicines that were not reconciled included topical applications which included eye, ear, nasal and skin applications (14%); vitamins i.e. vitamin B12 and thiamine, analgesia, PRN inhalers (11% individually); antidepressants and lipid regulators (6% individually); amongst a range of other medications including antiplatelets, calcium channel blockers, ACE inhibitors and diuretics. Two interventions were carried out to improve the rate of medicines reconciliation onto hospital drug charts with pre-admission medicines. These were: 1) a green sticker placed in the medical notes by the pharmacist when drug charts were incomplete, which required a date and signature from the doctor when the drug chart had been reconciled 2) the placing of the loose medicines reconciliation record (a list of pre-admission medicines retrieved from a reliable source usually by the pharmacist) to the front of the drug chart. These measures were designed to alert the doctors that the drug chart was incomplete. After 2 PDSA cycles, the results showed positive outcomes. In 75% of the cases where the interventions were used, medicines reconciliation was complete at the point of discharge with 34% of drug charts reconciled within 24 hours of admission. Of the 25% of drug charts that were not reconciled despite the use of the interventions, 100% of them were missing 0-2 medicines however 0% were missing 3-5 medicines. This highlights that the interventions were effective in improving the rates of medicines reconciliation.

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Can a supranational medicines agency restore trust after vaccine suspensions? The case of Vaxzevria.

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Can a supranational medicines agency restore trust after vaccine suspensions? The case of Vaxzevria.

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