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THE US DRUG regulator has limited use of the Johnson and Johnson vaccine over fears of clotting.
The Food and Drug Administration (FDA) said that only adults who “have personal concerns” about mRNA vaccines, access issues or medical reasons for refusing them may now receive the Johnson & Johnson Covid shot, which has been linked to a rare but serious clotting condition.
The vaccine, which was authorized as a single shot, is less protective than those developed by Pfizer and Moderna, and in December the Centers for Disease Control and Prevention advised the public to steer clear.
Thursday’s decision by the FDA builds on that recommendation by limiting the J&J vaccine’s emergency use authorization.
“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” said FDA scientist Peter Marks in a statement.
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Sixty US cases of thrombosis with thrombocytopenia syndrome (TTS), which produces rare and potentially life-threatening blood clots with low levels of blood platelets, had been reported by March 18, with nine deaths.
Symptoms begin approximately one to two weeks following administration, and the condition — which can cause life-long impacts even when not fatal — occurs more frequently in premenopausal women.
Concerns over the vaccine have already limited uptake: Only 18.7 million doses have been administered in the United States, or about 3.2 percent of the total 577 million.
But the FDA stopped short of an outright de-authorization, with Marks acknowledging the impact a ban might have on global use of the vaccine, as well as concerns some may have specifically against mRNA vaccines, rather than the adenovirus vector platform J&J uses.
There are certain health-based justifications for not taking an mRNA vaccine — such as rare instances of heart inflammation in adolescent males and young men — although these are usually transient in nature and the vast majority affected recover completely.
However, anti-vaccine groups have also raised more general objections against mRNA vaccines, which are tied to conspiracy theories.
Although those types of concerns are not rooted in evidence, the exemption to use J&J’s shot nonetheless extends to “individuals who have personal concerns with receiving mRNA vaccines and would otherwise not receive a Covid-19 vaccine,” the FDA’s statement said.
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Well that’s what happens when you run a public health system on the brink of collapse for 9 years. Soon as there’s unforeseen extra load placed on it, you’re in trouble.
@Unconvertible Rebel: Bit of a difference between an extra load and a global pandemic. Health services all over the world are struggling to deal with this issue
@Unconvertible Rebel: Ah stop, I agree our public health service was under performing but nobody could have imagine a health emergency of these proportions.
@Unconvertible Rebel: a ridiculous comment. You can’t run a health service for a pandemic that might happen every hundred years. It’s not feasible and definitely not necessary.
@Unconvertible Rebel: oh ,just go away please -I am sick and tired of the same old BS being trotted out here every day – If you have nothing positive to say just keep quiet .
@Unconvertible Rebel: There’s no hospital system in the world that would have the capicity we’ll need in the coming weeks. By the way, our health system has been unslder resourced for much longer than 9 years, not sure where you’re getting that time frame from!
@Unconvertible Rebel: my sentiments exactly, as much as they appear to be doing all they can, there has been fundamental problems that have gone unsolved in the HSE for years which has then caused this enormous pressure on the service. I wonder statistically speaking if you contract serious complications with covid-19 in which areas of the country are you most likely to die, such as it is with heart attacks etc due to lack of services and resources? Morbid but true.
@Unconvertible Rebel: Look if you’re going to use this epidemic to score political points the *least* you could do is actually expand on the topic in some kind of meaningful or useful way.
For example, as a country we are in the Top 10 worldwide in terms of spending per capita on health. As such we don’t have a spending (ie political) issue, we have a management (ie civil-service) issue. So the reality is it doesn’t really matter who gets elected in terms of our health service since our civil service is entrenched in their position like it’s the Somme and the year is 1916.
And if you ask a politician what they think they can do about this they will just stare at you as if you just asked them to fly. So not only does the actual problem get almost no recognition, it’s further compounded by the fact that our health service is treated like a political football come election time. Unless we solve these structural blockers actual reform is borderline impossible. You might as well be trying to learn how to fly.
@Breda Kelly: I’m don’t seem to be buying into this government doing a great job.. the government are simple taking orders from the health professionals. And why is Leo Varadkar posing for photos. Seems every opportunity is a photo shoot for them..
@Unconvertible Rebel: Sinn Fein troll. You are doing more damage to the party with your rubbish on herd than their elected members singing IRA songs drunk in bars.
@Breda Kelly: per percentage of population, the UK are faring both better and worse than us in Ireland, so it’s a fairly uninformed argument that they are faring much worse than us. Better In UK: 0.0449% as of population who are infected as to Ireland’s 0.0714%. However, deaths in UK 0.00354% compared to Ireland’s 0.00176%. Median age in Ireland is 36.5years while in the UK it is 40years, so you should statistically see more deaths there than here as a % of population. What I’d love to compare are the number of beds and ICU beds, ventilators and testing kits
@Irene Mc Hugh: Irene it would be very boring here if people cannot say what they want. Be more open minded to a variety of comments & opinions. Adds variety.
If u can’t take it deactivate your account.
@johnny onion eye: didn’t take it into account! We’re pretty much on the same playing field so. I did expect UKs numbers to be much worse considering that 83% live in urban areas compared to Ireland’s 63%.
@Declan Edward: I’m sorry Declan but you can’t draw meaningful comparisons with the U.K. in terms of the numbers of infected. They aren’t testing serious numbers of people. Proportionately, Ireland is testing far more people. The U.K. stats are internationally accepted as unreliable. Moreover, where deaths occur outside of the hospital environment due to Covid they are not included in the U.K. figures at the moment as I understand it.
@John O Brien: Another person who thinks, conveniently, that the Govt are taking orders from civil servants. The legal of ignorance amongst a cohort of certain Journal commentators about how democratic Government works is illuminating. The Govt takes advice from civil and public servants. Advice. All key decisions are taken by Government and nobody else. They are them accountable for those decisions. The Govt don’t follow “orders” from the unelected. They are not SF for goodness sake.
@Colette Kearns: I remember visiting hospitals be in the 1970s when religious orders were in charge. Everything was spotless. You could smell the antiseptic in the air. There wasn’t any huge waiting lists. A first world health service at time when we were economically poor. It seems like our liberal “progression” has regressed our health system to that of a 3rd world nation. Bring back the nuns!
@Colette Kearns: thanks Colette for your intelligent input to the unforeseen problem Ireland and the whole world are experiencing at this moment in time. When this is all over run for the elections and you can show us all the expert you are while running the health service in this country.
@Colette Kearns: maybe you should run the health service so?. We can all complain. Unfortunately the HSE isn’t a quick fix. Increase in funding has been allocated in the last few budgets, but it is once of those areas that every country find it hard to run effectively.
@John Devaney: no. Nostalgia isn’t what it used to be. My grandmothers used to say that you only go into hospital to die. Nuns or no nuns, we didn’t have a wonderful health system. There was a very recent modern push to reform it, by which I mean shake off the abusive practices that other countries had successfully reformed from 1964 onwards. You were far too young to realise how many women were literally crippled by an outdated system; nor how many men died before their time. Oh, and the clean smell of antiseptic was applied by enslaved pregnant women, conned into believing they deserved to work for a pittance, while their children were being starved in orphanages. Stop sniffing the air and support the health service staff working in this century.
@John Devaney: Was that when you were out pulling women? Looking back is great, the good times ehhh…. except medicine has moved on quite a bit, costs a fortune and we can treat way more illnesses…..
@John Devaney: that’s a common misconception. Hospitals nowadays are just as clean. Its the superbugs you can’t see due to decades of over prescribing which are the problem in controlling infections.
@Colette Kearns: Very true. Its what happens when you initiative something to Death. The money can spread over far far too much and not enough Butter. Scale back protect the core services.
@brian reid: I see that. It might be the camera angle, it’s hard to judge with foreshortening. They certainly don’t look as if they’re 2 metres apart. We can’t tell but let’s assume for the sake of thinking it through that they have both been tested recently and aren’t carriers, because they have essential roles.
@Fiona Fitzgerald: Silly statement..( they have been tested )does not stop them from catching it in the future…this virus does not distinguish what job you do..
This has publicity stunt wrote all over it. How in the midst of the worse pandemic we have seen in our lifetime is he going round smiling in these pictures like its something to be proud of. I really dont understand this man at the best of times in the riddles and smoke screens but these pics are like a bloody advert!
@Christine Hanway: reminds me a bit of when he saw what way the wind was blowing & jumped on the Repeal bandwagon. Everything is calculated PR opportunity with him
@Christine Hanway: did he not advise us to NOT make any non essential journeys? Did he not advise us to stay at home where possible? Was this really an essential journey, did both himself and Harris really have to be there? Another photo opportunity and a chance for them to tell us how wonderful they are.
His ego is out of control!!!
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