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US set to approve Johnson & Johnson Covid vaccine

The European Medicines Agency is expected to approve the Johnson & Johnson vaccine for use in the European Union in early March.

A US PANEL of independent experts has voted unanimously in favour of recommending Johnson & Johnson’s one-dose Covid-19 shot for emergency approval.

The decision clears the way for a third vaccine to soon begin being distributed in the country hardest hit by the global pandemic.

The committee’s 22 members were convened by the Food and Drug Administration and included leading scientists as well as consumer and industry representatives.

Although their recommendations are not binding, they are usually followed.

An emergency use authorisation (EUA) will now likely follow in the coming days making the J&J vaccine the third to be licensed in the United States after the Pfizer-BioNTech and Moderna inoculations.

Reacting to the vote from Texas, where he is visiting in the wake of a deadly winter storm, President Joe Biden said: “We’ve all seen the news about the Johnson and Johnson vaccine today, the third, safe effective vaccine.

“We’re going to use every conceivable way to expand manufacturing of the vaccine and make even more rapid progress in getting shots to people’s arms.”

Administration officials said this week they hoped to deliver three to four million doses next week.

The recommendation followed a day-long, live-streamed virtual meeting to decide if the known benefits of the drug outweigh its known risks for use in people aged 18 and over - which gave the public an inside look at the details of the scientific debate.

Johan Van Hoof, global head of vaccines research and development at J&J’s Janssen subsidiary, had told the meeting: “Janssen’s vaccine candidate will play a critical role in the global efforts to fight Covid-19,” emphasising the shot’s high efficacy against severe Coronavirus, including against new variants.

He also stressed the fact that it was proven to work with a single shot, and could be stored long term at fridge temperatures, which “offers logistical and practical advantages.”

In a global trial of almost 40,000 people, the vaccine’s efficacy against severe disease was 85.4%, but it fell to 66.1% when including moderate forms of the disease.

This makes it slightly less protective than Pfizer and Moderna’s two-shot regimens, which both have an efficacy of around 95% against symptomatic Covid-19.

Nevertheless, experts say J&J’s shot will bring to bear a powerful new weapon against the outbreak in the United States, where more than 500,000 people have died.

The company is also planning to soon begin testing its vaccine on children.

It is separately studying whether two doses might be more protective than one, which raised concerns among some panelists who felt people who got one dose might feel short-changed if two doses ends up proving more effective.

In almost 44,000 people studied for safety issues, the vaccine was well tolerated, with typical side-effects like injection-site pain, headache, fatigue and muscle pains.

There were a handful of cases of people who developed hives, which could have been linked to the shot.

The FDA also said long-term monitoring was needed to determine whether the vaccine was linked to a small number of cases of potentially dangerous clotting, and to tinnitus (ear ringing).

There was a hint, based on preliminary data, that the vaccine might be partly effective against asymptomatic infection.

The company has announced it aims to deliver a total of 20 million doses to the United States by the end of March, with 100 million by June,  though the US is pushing to speed up that timeline.

The J&J vaccine uses a common-cold causing adenovirus, which has been genetically modified so that it can’t replicate, to carry the gene for a key protein of the Coronavirus into human cells.

Those cells then produce that protein, which in turn trains the human immune system should it encounter the real virus.

After J&J submitted an application for approval in the US, South Korea began a review of the vaccine.

The South Korean food and drug safety ministry said it would study the vaccine with private advisory panels before it authorises it.

The European Medicines Agency is expected to approve the Johnson & Johnson vaccine for use in the European Union in early March. 

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    Mute JillyBean
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    Feb 27th 2021, 7:19 AM

    We should expect the ema to authorize it just in time for Christmas

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    Mute Joe Johnson
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    Feb 27th 2021, 9:56 AM

    @JillyBean: Agree they need to see the urgency of approving this new vaccine and do so asap over here.

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    Mute padraig mcgill
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    Feb 27th 2021, 10:15 AM

    @Joe Johnson: did either of you actually read the article, it’s due for approval in the EU early March. J&J only recently applied for approval in the EU in mid February so early March is a quick turn around by the EMA.

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    Mute Sean Oige
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    Feb 27th 2021, 11:40 AM

    @JillyBean: if they used the who to authorize it, which I think all companies, it can be used pretty much worldwide. There is no need for a region by region validation. Not sure why big pharma aren’t going that route….

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    Mute Joe Johnson
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    Feb 27th 2021, 3:04 PM

    @padraig mcgill: EMA are slow off the mark the UK and US are way ahead to vaccinate their people.

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    Mute Mel Fitzpatrick
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    Feb 27th 2021, 7:51 AM

    Excellent, soon enough there’ll be no more tears… great news.

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    Mute Gert McNulty
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    Feb 27th 2021, 8:36 AM

    Another one of d’ildo Donnelly’s gamechangers. What impact will this have on us this year?? Not much. They are promising 100 million doses for the americans by june. Doesn’t mention the EU. Look what happenend with Astrozenica and the uk. The EU has not only dropped the ball on vaccine procurement its burst the ball. Countries prolonging or indeed strengthening lockdowns. The people are paying for these mistakes.

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    Mute AL
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    Feb 27th 2021, 9:38 AM

    @Gert McNulty: they have promised at least 100 million to the EU before June also, meaning 1.1 million for Ireland before June. This could mean everyone will be vaccinated by the end of June

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    Mute Gert McNulty
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    Feb 27th 2021, 9:55 AM

    @AL: that is great news. Havent seen that before. It would be great if the supply timeframes were made public to bolster public support and satiate lockdown weariness a bit

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    Mute padraig mcgill
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    Feb 27th 2021, 10:47 AM

    @Gert McNulty: according to your first comment it won’t have any impact on us this year… Maybe before you dust off the keyboard to lambast everyone and everything… do a small bit of research and get your facts correct. Then lambast away!!

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    Mute Gert McNulty
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    Feb 27th 2021, 12:30 PM

    @padraig mcgill: actually not using a keyboard as it happens McGill. It is very difficult to find concrete statistics on deliveries of vaccines from various countries. News articles here and there point to quarters of the year. Bit like our health minister. So far though this quarter has been a joke. I’m only basing my opinion on performance this far. Would you happen to know where I could do further research? Thanks McGill.

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    Mute padraig mcgill
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    Feb 27th 2021, 2:03 PM

    @Gert McNulty: it’s a evolving situation with alot of moving parts so I agree information can be fragmented and obviously the mixed communication from govement definitely doesn’t help…and people are right to be critical of that, myself included. The J&J vaccine is a positive and will be rolled out here soon. Keep the faith there Gert!

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    Mute Gert McNulty
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    Feb 27th 2021, 2:37 PM

    @padraig mcgill: will do lad. As must we all

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    Mute Shaun Gallagher
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    Feb 27th 2021, 8:09 AM

    If its good enough for the states its good enough for us

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    Mute Euro McPúnty
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    Feb 27th 2021, 10:19 AM

    @Shaun Gallagher: you reckon?

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    Mute Maalouf
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    Feb 27th 2021, 10:42 AM

    @Shaun Gallagher: tell that to the chlorinated chickens am I right

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    Mute Eugene James Cunningham
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    Feb 27th 2021, 10:52 PM

    @Maalouf: as opposed to the “chlorinated” vegetables and salad we already have……

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    Mute Spbeak
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    Feb 27th 2021, 7:37 AM

    Presume they mean EMA set to approve it in title. The US already approved it yesterday…

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    Mute Thomas O' Donnell
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    Feb 27th 2021, 9:22 AM

    @Spbeak: It was recommended for approval in US yesterday

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