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UK formally approves Pfizer/BioNTech vaccine against Covid-19

The UK has become the first western country to licence a vaccine against he virus.

THE UK HAS formally approved a vaccine against Covid-19 developed by Germany’s BioNTech and US giant Pfizer, becoming the first country to do so.

The vaccine has been authorised by the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) for emergency use.

The Guardian reports that the UK has bought 40 million doses of the vaccine, with a statement form the company saying that the first doses will arrive in the UK in coming days.

“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency to approve Pfizer-BioNTech’s Covid-19 vaccine for use,” the UK’s department of health said in a statement.

“The vaccine will be made available across the UK from next week,” the statement said, with priority groups including care home residents, health and care staff.

After months of “rigorous” clinical trials and thorough analysis of the data, the MHRA “concluded that the vaccine has met its strict standards of safety, quality and effectiveness”.

Pfizer chairman Albert Bourla said it was a “historic moment in the fight against Covid-19″. 

“This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” he said.

Pfizer and BioNTech added that they expected further regulatory decisions from other countries “in the coming days and weeks”.

The announcement came as England exited a month-longlockdown, but most of the country remained under restrictions as a new regional system for cutting infection rates kicked in.

The four-week lockdown, which began in November, was imposed to stop surging rates of infection, ease pressure on health services, and to allow families to gather for Christmas.

Yesterday, the European Medicines Agency (EMA) said it would hold an extraordinary meeting on 29 December “at the latest” to consider emergency approval for the vaccine.

However, UK regulators do not have to wait for the EMA’s approval because of Brexit. 

Large-scale trial data released last month showed that the vaccine was safe and around 95 percent effective against Covid-19, the disease caused by the coronavirus.

European Commission spokesman Stefan de Keersmaecker said that once the EMA gave regulatory permission, formal authorisation from Brussels would follow “very quickly” – probably “in a matter of days”.

The companies previously said that the vaccine could potentially be rolled out “in Europe before the end of 2020″ if it is approved.

“We have known since the beginning of this journey that patients are waiting, and we stand ready to ship Covid-19 vaccine doses as soon as potential authorisations will allow us,” Pfizer CEO Albert Bourla said.

The vaccine is based on new technology, using mRNA (messenger ribonucleic acid) to deliver genetic material to the body and make human cells create a protein from the virus.

This trains the immune system to be ready to attack if it encounters SARS-CoV-2.

BioNTech/Pfizer have also applied for emergency use authorisation in the United States, where Americans are expected to start getting vaccinated around mid-December.

The companies said they had asked the EMA for “conditional market approval” of their vaccine on Monday, after filing a request for emergency authorisation in the US on 20 November.

Contains reporting from © AFP 2020.

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    Mute Kevin Conway
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    Dec 2nd 2020, 7:29 AM

    This will be interesting to watch. Hopefully it’s a success all round. Best of luck.

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    Mute Paolo
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    Dec 2nd 2020, 9:06 AM

    @Kevin Conway: Genuine question. Does someone only need 1 dose or do they receive a course of doses? If it’s the latter, then 40m doses does not reach 40m people.

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    Mute K C
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    Dec 2nd 2020, 9:47 AM

    @Paolo: two doses and it has to be kept at -70 as far as I know. The idea is to give the vaccine to health care workers and the people with underlying health issues first then everyone else (if they will take it).

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    Mute Paolo
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    Dec 2nd 2020, 1:38 PM

    @K C: Thanks for this. Do you know how far apart the two dosages are given? The 40m is already halved based on this information.

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    Mute Mark Hughes
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    Dec 2nd 2020, 8:41 AM

    I can’t stand this narrative being pushed that it’s “rushed so I’ll let the sheep take it”. In normal circumstances, if the scientific community threw it’s whole weight into one specific treatment, we could potentially have new solutions for diseases quicker. We work so bloody hard to ensure safety, because this is for us, our family, friends, parents, grandparents. A vaccine cannot mutate you. The only reason it causes a bit of pain/tiredness etc is because it’s being injected, and normally contains a compound to let your immune system sense the injection and use the extremely localised vaccine to spread it through the body and train the immune system to fight the virus. A vaccine cannot control you, and honestly, if that technology did exist, you think they’d use an optional vaccine?

    123
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    Mute Eric Vdc
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    Dec 2nd 2020, 7:34 AM

    ‘Conditional marketing authorisation’ : https://www.ema.europa.eu/en/glossary/conditional-marketing-authorisation
    => ‘The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future. ‘

    In order words, the applicant will be served as a guinea pig to provide complete data for a vaccine the outcome and risks are unknown on a longer term. Great mass experimentation for a new mRNA-based type vaccine

    57
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    Mute Eric Vdc
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    Dec 2nd 2020, 8:13 AM

    @Eric Vdc: no doubt the GSK one will follow. : Patrick Vallance UKs Chief scientific adviser has £600k of shares in vaccine maker GSK and has made million worth of dividend in recent years.

    conflict of interest ? nah all grand

    https://www.telegraph.co.uk/news/2020/09/23/revealed-sir-patrick-vallance-has-600000-shareholding-firm-contracted/

    31
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    Mute Teegan Maguire
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    Dec 2nd 2020, 8:22 AM

    @Eric Vdc: No matter what the medicine is or how long it takes to become available, there are always a cohort of people that are the “guinea pigs” as you so cruelly put it. People that are involved in clinical trials so that YOU can have your antibiotic or painkiller when you need it. Or the many people that go through clinical trials for cancer medicines in the hopes that that research will save other people’s lives. Progress takes some level of risk – that’s the way the real world works.

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    Mute Opinionated
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    Dec 2nd 2020, 8:43 AM

    Why are so many comments being deleted from this tread? Surly it cant be that toxic to say your not going to rush out to take an untested rushed vacation

    56
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    Mute The Descolada
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    Dec 2nd 2020, 9:12 AM

    @Opinionated: maybe not toxic, but it is stoo pid

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    Mute Critical Thinker
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    Dec 2nd 2020, 7:46 AM

    Have all the data been published and peer reviewed yet?

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    Mute Frank Carty
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    Dec 2nd 2020, 8:08 AM

    @Critical Thinker: of course

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    Mute Tom Kelly
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    Dec 2nd 2020, 8:14 AM

    @Critical Thinker: wrong place to ask that question!

    28
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    Mute Hundredth Idiot
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    Dec 2nd 2020, 8:18 AM

    Whilst there appear to be more data to come in terms of efficacy, it seems to me that the safety is proven to the point where there is much, much less risk in taking the vaccine than to not do so (and to risk contracting COVID), across all age groups.

    Speculation about autoimmune responses ought to take into account that those same risks apply to the virus itself, only more so.

    All that said, I think I’ll rely on the advice of my GP.

    32
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    Mute The Firestarter
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    Dec 2nd 2020, 8:41 AM

    Guarantee you we’ll be the last to get it as King Tony will keep us in a cycle of open up/lockdown until well into next year, while the rest of the world is rolling out the vaccine to its citizens.

    30
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    Mute Michael Mc Carthy
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    Dec 2nd 2020, 9:38 AM

    I don’t understand the logic. We are in lockdown based on the number of cases and the vaccine is supposed to save us from this. Yet the vaccine, so far has been confirmed to reduce symptoms not prevent infection or therefore being infectious and transmitting the disease. There are studies going on to see if the vaccine will prevent infectiousness but there will be no major reduction of cases or lockdowns until a vaccine can be confirmed to do this. p.s journal, stop censoring peoples comments, believe it or not there is a difference between the narrative you wish to push upon people and the actual facts.

    26
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    Mute Damo
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    Dec 2nd 2020, 10:20 AM

    @Michael Mc Carthy: jesus, the journal would never do that. The journal is the bastion of free speech and open comment

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    Mute John Sheahan
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    Dec 2nd 2020, 8:50 AM

    Anti vaxers and their “plandemic research” are the reason we are going to be under restrictions, lockdowns and all the other measures for at least a few more years. They fail to understand vaccines can never be 100% safe. We know that. But the benefits far outweigh the alternatives – letting viruses and disease run rampant and killing millions.

    35
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    Mute Gere
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    Dec 2nd 2020, 9:18 AM

    @John Sheahan: I honestly cannot understand why anyone would put their health at risk taking a vaccine that has no history & no one knows what future damage it can do. We know what Covid can do, but to put your kids/parents health in the trust of the politicians & vaccine makers is pure madness.

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    Mute Hundredth Idiot
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    Dec 2nd 2020, 9:24 AM

    @Gere: when you say “vaccine makers” you mean scientists, right? Using the same scientific process that’s used for all modern medicine. Would you also turn down chemo if you had cancer? Or skip the anaesthetic when having an operation? Sure, what would those scientists know? They’re only in it for themselves. FFS.

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    Mute John Sheahan
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    Dec 2nd 2020, 9:41 AM

    @Gere: “I honestly cannot understand why anyone would put their health at risk taking a vaccine”

    That’s my point. You have to look at the small risk vs the enormous benefits of vaccines. Literally millions of lives have been saved by vaccines in the last 25+ years.

    Ironically the less people that take the vaccines or are anti-vax, the less effective they are to the general population.

    27
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    Mute Gere
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    Dec 2nd 2020, 9:41 AM

    @Gere: Seems as I am been blocked from giving you an answer by the journal. Yep, free speech

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    Mute MaxDemons
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    Dec 2nd 2020, 9:53 AM

    @Gere: And just like that, you become the new problem.

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    Mute Isabella Hickey
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    Dec 2nd 2020, 9:57 AM

    @Gere: you and me both…mind boggling, I’ll take my chances on clean hands and a mask where approptiate for the timebeing

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    Mute Isabella Hickey
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    Dec 2nd 2020, 9:59 AM

    @Gere: no such thing it seems…of course they blocking you and anyone with an open mind

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    Mute John Sheahan
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    Dec 2nd 2020, 10:03 AM
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    Mute MaxDemons
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    Dec 2nd 2020, 10:25 AM

    @Isabella Hickey: Now there’s 2 problems, please don’t breed.

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    Mute The Mrs O’B
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    Dec 2nd 2020, 9:42 AM

    How many of these anti vax brigade are plenty happy to get a jab when they want to go on holiday to some tropical paradise?? Never mind them not even being here without vaccinations for smallpox and TB

    28
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    Mute Rory Mac Daibhéid
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    Dec 2nd 2020, 9:38 AM

    Professor Sam McConkey said what I’ve said before there’s zero evidence this vaccine will stop the deaths.
    The deaths in Ireland are in the majority 81 plus (median age is 83, highest 105) age range with an underlying condition.
    The vaccine Trials shows efficacy for mild illness prevention in the average age of a healthy 40 year old.
    Let’s me honest as Professor McConkey was, no evidence this will prevent deaths.
    For an 81 year with underlying conditions to successfully mount an immune response to a vaccine would be quite an achievement.
    Indirectly less virus could work.
    But a healthy 40 year should only be getting a mild symptoms of covid In the first place.
    Let’s see what happens with the difficult logistics of a sub zero vaccine.

    16
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    Mute NotMyIreland
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    Dec 2nd 2020, 8:50 AM

    @Opinionated: excess deaths are up in many countries. The amount varies with how the countries handled the pandemic. Ireland as an example is looking at 900-1200 excess deaths or 3-4% rise. But in the US, a country that badly handled the pandemic, deaths are up 329000 or 17%. Or Peru where their health system collapsed has excess deaths of 94000 or 133% So left unchecked it can seriously increase the death rate.

    9
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    Mute SmallbutMighty
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    Dec 2nd 2020, 8:42 AM

    @Eva may: wow strong guarantees there, care to back em up with any eh scientific data lol

    5
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    Mute Pat ALTHEA
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    Dec 2nd 2020, 8:37 AM

    @Eva may: who is the sheep when your the one who won’t trust the medical experts?

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    Mute tomas o beag
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    Dec 2nd 2020, 9:18 AM

    Great diversion for Boris Johnson

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    Mute Jonathan McCoy
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    Dec 2nd 2020, 8:39 AM

    @Stephen: Doctor of Codology

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    Mute Philip Mckenna
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    Dec 2nd 2020, 2:29 PM

    Let’s line up all the politicians for the first doses then?? And isn’t this the 2 dose one so 40m would be 20m doses?

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    Mute Damo
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    Dec 2nd 2020, 10:13 AM

    Good let the brits b the guinea-pigs

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    Mute Eddie Michael
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    Dec 2nd 2020, 2:15 PM

    Bad idea to rush a vaccine….

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    Mute Keth Warsaw
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    Dec 2nd 2020, 11:49 AM

    The Irish government will of course take its own sweet time with the excuse that it’s superior health advisers will want to test the vaccines out themselves to ensure they’re not dangerous. This of course a smokescreen because we don’t have the necessary logistics to implement the jab successfully, as yet. I can just see the mess that awaits us. Still, the government have the 50 billion it borrowed on the backs of future generations to quell the anger of impending job losses and mental health atrocities looming. 99/100 questions.. . The answer is €50 Billion.

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