Year: 2020
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Safety signal alerts from Pharmacovigilance Programme of India
The National Coordination Centre – Pharmacovigilance Programme of India (NCC-PvPI) has made a recommendation to the Central Drugs Standard Control Organisation (CDSCO) to request that the patient information leaflet (PIL) for cardiac drug pentoxifylline, hypertension drug benidipine, respiratory infection drug piperacillin/tazobactum, enlarged-prostate drug alfuzosin and tinidazole should be revised to incorporate clinically significant adverse drug…
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Bharat Biotech Covaxin safety updates
COVAXINTM, India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility. Covaxin is an inactivated vaccine. That is, it introduces a part…
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Adverse event information from Oxford – AstraZeneca COVID 19 vacccine phase 2/3 trial
A safe and effective vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will be an important tool in controlling the global COVID-19 pandemic. Although there are no licensed vaccines against COVID-19, 48 potential vaccine candidates based on a variety of platforms including lipid nanoparticle mRNA, DNA, adjuvanted protein, inactivated virus particles, and non-replicating viral…
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Vaccine Safety Signal detection
As per CIOMS, signal is “Information that arises from one or multiple sources (including observations and experiments) which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood…
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Why pharmacy students and experts in medicine should know about spontaneous reporting system
In the late 1950s, a drug called thalidomide, given to pregnant women for morning sickness led to thousands of babies being born a serious birth defect called phocomelia (rare congenital deformity in which the hands or feet are attached close to the trunk, the limbs being grossly underdeveloped or absent). After this incidence the regulatory…
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EMA’s Pharmacovigilance plan for Covid-19 vacccine
EMA and the national competent authorities (NCAs) in EU Member States have prepared a safety monitoring plan for COVID-19 vaccines. The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed. Once COVID-19 vaccines are authorised is anticipated to be very high which may…
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Adverse event of special interest (AESI)
As per CIOMS VI, An adverse event of special interest (AESI) (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate. Such an event might require further investigation in order to characterise…
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AEFI – Coincidental event
Coincidental events (AEFIs) can result from underlying or emerging conditions of the vaccine as well as external exposures that can cause harm independent of immunization. Coincidental events occur after a vaccination has been given but are not caused by the vaccine or its administration. Vaccinations are normally scheduled in infancy and early childhood, when illnesses…
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Immunization stress-related reaction and case study
Immunization stress-related reactions (ISRR) are AEFI arising from stress about the immunization. Individuals can react in anticipation to and as a result of an injection of any kind. These reactions are not related to the vaccine, but to fear of the injection. Formerly, this spectrum was described as an Adverse Event Following Immunization arising from anxiety…
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Every report counts – Medicine safety
No medicine, not even vaccine are 100% safe. There is a certain risk associated with them. Drug safety cannot be considered as an absolute, it can only be assessed relative to drugs benefits. Safety and risk are always individual depending on with whom, when and conditions the drug interacts. At the time of marketing (the…