Deleted User wrote: » I think a big part of the vaccine scepticism has to come down to the fact that the vast majority of people with experience of the virus haven't had a massive impact from it. Vast majority of younger (funny to say that about 50 year olds) people who had it were sick for a couple of days. And that was it. Even for me I'm 3 degrees of separation from anyone who's died from it. And that was an old man who smoked. When most of the deaths are people who have lived beyond average life expectancy it's hard to get so worried about a disease. One wonders also about people who are seriously ill going into hospital with it. If it's mostly people in their 80s with a few other things wrong with them would they have been allowed take up an ICU bed for whatever amount of time if it was heart failure a few months later that landed them in there?
Deleted User wrote: » Batch release takes time and done on a batch by batch basis, with testing to be completed to ensure it meets predefined criteria. They dont just stick it in a vial and ship. The qualified person is an individual within a pharma plant who is responsible with ensuring all batches released meet the requirements fully. There are criminal consequences to that individual with not fulfilling those requirements
Red Silurian wrote: » Just so we have this straight USA won't export vaccines and 100m get vaccinated. UK won't export vaccines and 55% of the population get vaccinated. But if the EU won't export vaccines we will have supply chain issues.... Looks to me like the UK and USA haven't suffered supply chain issues.
Irish Stones wrote: » In Italy? LOL!
Legal Basis for Qualified Persons in Europe. The Legal Basis for the Qualified Person is defined in the DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 6 NOVEMBER 2001 ON THE COMMUNITY CODE RELATING TO MEDICINAL PRODUCTS FOR HUMAN USE. For Veterinary Products, the requirements are defined in DIRECTIVE 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. In Article 48, the Directive 2001/83 (for veterinary medicinal products, please read Article 52 of Directive 2001/82) requests that EU Member States have to assure that each holder of a manufacturing authorization has to have at least one QP. 1. Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at his disposal the services of at least one qualified person, in accordance with the conditions laid down in Article 49, responsible in particular for carrying out the duties specified in Article 51. 2. If he personally fulfils the conditions laid down in Article 49, the holder of the authorization may himself assume the responsibility referred to in paragraph 1. In Article 49 of Directive 2001/83 (for veterinary medicinal products, please read Article 53 of Directive 2001/82), the qualification level as well as the necessary experience of a QP is defined 1. Member States shall ensure that the qualified person referred to in Article 48 fulfils the minimum conditions of qualification set out in paragraphs 2 and 3. 2. A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level. Where two university courses or two courses recognized by the State as equivalent co-exist in a Member State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the second subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question. The course shall include theoretical and practical study bearing upon at least the following basic subjects: Applied physics General and inorganic chemistry Organic chemistry Analytical chemistry Pharmaceutical chemistry including analysis of medicinal products General and applied biochemistry (medical) Physiology Microbiology Pharmacology Pharmaceutical technology Toxicology Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin). Studies in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 51. In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in the first subparagraph do not fulfil the criteria laid down in this paragraph, the competent authority of the Member State shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved. 3. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products. The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years. The responsibilities of a Qualified Person are defined in Article 51 of Directive 2001/83 (for veterinary medicinal products, please read Article 55 of Directive 2001/82) 1. Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 48, without prejudice to his relationship with the holder of the manufacturing authorization, is responsible, in the context of the procedures referred to in Article 52, for securing: (a) in the case of medicinal products manufactured within the Member States concerned, that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization; (b) in the case of medicinal products coming from third countries, that each production batch has undergone in the importing Member State a full qualitative analysis, a quantitative analysis of at least all the active constituents and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization. The batches of medicinal products which have undergone such controls in a Member State shall be exempt from the controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person. 2. In the case of medicinal products imported from a third country, where appropriate arrangements have been made by the Community with the exporting country to ensure that the manufacturer of the medicinal product applies standards of good manufacturing practice at least equivalent to those laid down by the Community, and to ensure that the controls referred to under point (b) of the first subparagraph of paragraph 1 have been carried out in the exporting country, the qualified person may be relieved of responsibility for carrying out those controls. 3. In all cases and particularly where the medicinal products are released for sale, the qualified person must certify in a register or equivalent document provided for that purpose, that each production batch satisfies the provisions of this Article; the said register or equivalent document must be kept up to date as operations are carried out and must remain at the disposal of the agents of the competent authority for the period specified in the provisions of the Member State concerned and in any event for at least five years.
Icantthinkof1 wrote: » Does anyone know if dentists/ dental hygienist’s have been vaccinated? I need to take my son for a check up and would feel much safer bringing him if his dentist was vaccinated
Deleted User wrote: » If the below is not complied with, medicinal products cannot be marketed within the EU, irrespective of where they come from
josip wrote: » Everyone at our dentist was vaccinated a few weeks ago. Why not give them a call to check?
Deleted User wrote: » The US blocked all exports of vaccines from plants in the us until the past week when they sent a few that they weren’t using anyway to Canada and Mexico. The EU have allowed exports to 33 countries of 40million doses from plants within the EU. If the eu had banned exports they would have administered nearly as many as the US overall and more than the uk per capita as they have been the biggest importer from the eu. Its a bit c*ntish to vaccinate young people in your own country while hcw or the very old can’t get it in countries with continuing large outbreaks. Due to the uproar the eu is now considering going down the c*ntish route, but looks like maybe only towards those countries that have already vaccinated the vulnerable, until the eu get their own vulnerable vaccinated.
eeepaulo wrote: » Regardless of what is decided at the summit, I'd love to hear ursula von der leyen start the press conference with either Due to the c*ntish behaviour of britian...... Or Inspite of the c*ntish behaviour of britian......
Apogee wrote: » Just passed 500,000 people mark having received first dose on Monday.
Mitch Connor wrote: » https://twitter.com/FergalBowers/status/1375037640169361412 Considering we had previously been over 90% doses to Jabs, why is there a gap of 175k doses unadministered now? Last I checked we were not doing 100k a week, so that gap amounts to two weeks of doses just sitting around. There should be no excuse for not hitting 150k to 170k jabs this week as the vaccines are there.
Melanchthon wrote: » The way people go nuts over the UK and don't give a damn about the Israeli exports when they were having to give free shots in pubs to people as encouragement sort of highlights how tied up this is with Brexit. And yes I know Pfizer /BioNTech have delivered
Deleted User wrote: » Something doesnt look right there. 1 million is almost 30% of the population of Berlin. 362,000 is 10%. We have given first jab to 10%. So it appears they are right in line with our rollout
Skygord wrote: » Anyone notice that the number of vaccinations reported for cohort 1 went DOWN? Monday 15 March: cohort 1 180,594 Monday 22 March: cohort 1 176,676 Link to 15th:https://www.hse.ie/eng/services/news/newsfeatures/covid19-updates/vaccination-programme-dashboard-as-of-15-march-2021.pdf Link to 22nd:https://www.hse.ie/eng/services/news/newsfeatures/covid19-updates/vaccination-programme-dashboard-as-of-22-march-2021.pdf
NeuralNetwork wrote: » Well, you'd sort of expect cohort 1 to be completed or nearly completed at this stage on second shots. So it will feature less on the stats. I am aware of plenty of people in the over 85 cohort who have now 100% completed their vaccinations this week. Cohort 1 was even earlier than that so I would fully expect the number of doses needed to be reducing by now.
Skygord wrote: » The point is the reported TOTAL number of vaccinations is less than the total reported last week. Either this week is wrong, or last week was wrong.
MerlinSouthDub wrote: » It is interesting the way people think differently about the same fact i.e. we have 170,000 unused vaccine doses Some people: "This is terrible - why are we leaving these in storage and not doing anything with them". My head: "This is great - we have 170,000 doses ready to use to protect more people"
Sweet.Science wrote: » They only protect people when they are used
![Photo of [Deleted User]](https://w2.vanillicon.com/v2/282101dc2976956f9dfc87f7a2ef2413.svg)
![Photo of [Deleted User]](https://w5.vanillicon.com/v2/5117ec177439400b1e5944f4d30acdda.svg)
![Photo of [Deleted User]](https://w8.vanillicon.com/v2/8a022abb175d445f2b5b8a1c545f3d3f.svg)
