All COVID-19 vaccines in use at the moment have been granted a special licence by the EMA, a conditional marketing authorisation, because as yet the clinical data available, especially for long-term effects, is not comprehensive. Is there a body to which GPs and other medical professionals are encouraged to report symptoms which they encounter in patients that might be related to the vaccines? – Noel Tanti
Before COVID-19 vaccines were granted an EU marketing authorisation, the efficacy and safety of the vaccine were assessed through pre-clinical studies and large clinical trials. Like all medicines, these vaccines can cause side effects, although not everybody will experience them. The most common side effects known are usually mild or moderate and get better within a few days after vaccination.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
The scope is to prevent any possible harm from adverse reactions in humans arising from the use of authorised medicinal products and to promote the safe and effective use of medicinal products. A reporting system was introduced in Malta for all medicines in May 2004 which is the primary means of data collection for post-authorisation safety surveillance of medicinal products in Malta.
Healthcare professionals are encouraged to report all ADRs to the Medicines Authority using a specific reporting form. EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the EU system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the detection of potential safety issues.
I would like to have a small wedding celebration in the garden of a private residence. We are hoping to have around 40 people on tables of six, each two metres apart. We will ensure all rules concerning social distancing and face coverings are followed. Would this be permissible? – Maria Vella
In accordance with the legislation titled, ‘Groups of Persons in Residential Properties Regulations, 2021’, groups of persons who respectively between them live in more than four different residences shall not gather in a residential property. Therefore, any gathering for whatever occasion cannot have more than four households in a private residence.
Am I responsible for verifying that a person I walk with in public without a mask from July 1 is vaccinated? Do I risk a fine if someone tells me they have a vaccine certificate, when in reality they do not? – Danny Kruse
As from tomorrow, July 1, a person or a group of up to two persons who are in possession of a vaccination certificate which is issued in that official form, and with regards a vaccine, recognised and approved by the Superintendent of Public Health, can stay without a mask in public spaces. This will also apply for children aged less than 12 years when in the company of a person who is in possession of a vaccination certificate. It is the person who does not have the vaccination certificate who is responsible for any breaches.
I am trying to generate the vaccine certificate. When can I apply for my vaccine certificate? Can I use the card they provided me from the vaccination centre? I don’t have an E-ID, what can I do? – Fiona Mizzi
The vaccine certificate can be issued 14 days after taking the second dose of the Pfizer, Moderna or AstraZeneca vaccine or the single dose in the case of the Johnson & Johnson vaccine. You will not be allowed to apply for the vaccine certificate before the lapse of this time. The vaccination card is the paper card given to you at the vaccine centre containing details of your vaccine and appointment dates. This is not recognised as an official certificate. If you do not have an E-ID account, you can select the alternative login function and proceed with your application.
If one loses the vaccine certificate, the vaccine certificates can be generated more than once, however, each new certificate will revoke the previous certificate. Therefore, only the most recent vaccine certificate generated will be valid.
Why is the Delta variant spreading so fast? Will vaccines still work? – Julia Sammut
ECDC have published an assessment on the implications for the EU/EEA on the spread of the SARS-CoV-2 Delta (B.1.617.2) variant of concern. This report outlined the findings which were based on global data submitted to GISAID (global science initiative and primary source that provides open-access to genomic data of influenza viruses and the coronavirus responsible for the COVID-19 pandemic).
It has been estimated that the effective reproductive number for the Delta variant is 55 per cent higher than the Alpha VOC and 97 per cent higher relative to non-variant of concern or interest. This increased transmission has been seen in the UK where the Delta variant spread rapidly and, as of June 14 accounted for 91 per cent of sequenced cases.
Available evidence indicates that those who have only received the first dose of a two-dose vaccination course are less protected against infection with the Delta variant than against other variants, regardless of the vaccine type. However, full vaccination provides nearly equivalent protection against the Delta variant as for the Alpha variant.
Have any questions to ask the superintendent? To submit your questions for consideration, e-mail askcharmaine@timesofmalta.com