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THE EXECUTIVE DIRECTOR of the European Medicines Agency (EMA) has said that work is ongoing to assess the Astrazeneca Covid-19 vaccine, and it’s hoped that a decision will be made on whether to grant approval “by the end of this week”.
Addressing the European Parliament committee on public health this afternoon, Emer Cooke referenced the shortage in supply of the Astrazeneca vaccine and said the EMA was “working” with the company and it’s hoped the problems with supply will be “short-lived”.
If the EMA agrees to grant a conditional marketing authoritisation to the Astrazeneca vaccine this Friday, it paves the way for its rollout in Ireland.
However, that rollout here is set to be lower than initially expected due to the company’s unexpected delay in delivering millions of doses of its Covid-19 vaccine to EU member states.
Last Friday, the pharma giant said it would not meet its contractual delivery commitments to the European Union because of unexplained “reduced yields” in its European supply chain.
Health Minister Stephen Donnelly said last night that delivery of the vaccine in March is set to be “considerably lower than what was originally stated by the company”.
However, if approved on Friday, Ireland will receive a supply of the Astrazeneca vaccine “within the expected range” for February.
Commenting on the already approved Pfizer/BioNTech and Moderna vaccines today, the EMA’s Cooke said that it is requiring rigorous safety and effectiveness studies of these products.
She said that monthly safety updates are required from the companies with approved vaccines, and this is in addition to regular updates already required by legislation.
“With respect to the transparency of this work, we’re planning to publish the first Covid-19 vaccine safety update later this week, and this is based on the monthly safety report that has been reviewed and assessed for the Pfizer vaccine,” she said.
Cooke also said today, in response to questions from MEPs, that EMA staff are working around the clock on the process to approve vaccines. She said it wouldn’t be unusual to see staff exchanging emails in the middle of the night.
She said that it wasn’t specifically in the remit of the EMA to boost production of a vaccine, but the agency would “do everything we can to facilitate production from a scientific and regulatory perspective”.
She said: “The other issue that we’re working on with the companies of the national authorities is how to ensure that production capacity can be increased.
“And we’re looking at different manufacturing options which require formal manufacturing changes in order to increase the production capacity. I think you’re all aware of the problems with supply identified at a European level, due to some of the manufacturing issues. We’re working with the companies on these and we very much hope that these will be short lived.”
Cooke said the EMA is continuously monitoring the impact of new variants of Covid-19, and was requesting companies with approved vaccines to submit information on the immunse response induced by the vaccine against these new strains.
She said the next vaccine potentially in line for approval – made by Janssen (the pharmaceutical wing of Johnson and Johnson) – is being examined on a rolling basis, but there is no indicative date for when it could reach approval stage as of yet.
Cooke also addressed the media reports regarding the efficacy of the Astrazeneca vaccine in people aged over 65.
This morning, Germany’s health ministry joined the pharma company rubbishing reports quoting unnamed government sources that claimed the vaccine showed little efficacy for people above 65.
Cooke said that the EMA is examining the “totality of the data” provided by Astrazeneca across different age groups. She said she wouldn’t prejudge any decision on the vaccine’s approval, but said it was possible for an approval to contain a provision that the vaccine only be given to certain age groups.
MEP Mick Wallace questioned Cooke on the speed with which the EMA is approving its vaccines, compared to the UK which has already approved the Astrazeneca vaccine as well as the Pfizer/BioNTech and Moderna vaccines.
“Does the EMA demand more complete or higher quality data than the UK regulator?” Wallace asked.
Cooke said that the mechanism used by the UK to approve vaccines was through a temporary use authorisation, which is not something within the remit of the EMA. The EMA instead provides conditional marketing authorisation to vaccines it deems safe and efficacious.
Astrazeneca’s vaccine was already approved for use in the UK before it applied for European approval earlier this month, and Cooke said this was a reflection of the further data needed, and that this data had been provided by Astrazeneca in recent weeks.
“We are confident that the process behind a conditional marketing authorisation provides a robust scientific review that can be relied upon in all 27 member states,” she said.
“The conditions and criteria that we use for the evaluation of the conditional marketing authorisation are the same conditions we would expect for any vaccine.”
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Contrary to the most popular misleading post on an earlier vaccine story that now has locked comments, that falsely stated that 1. “fully vaccinated could still spread the disease ” and 2. this is unlike “all other known vaccines”.
1. The Pfizer/BioNTech vaccine will likely prevent further infections and mass vaccination will likely provide Herd Immunity, ending the Pandemic.
This is because vaccinated people generate 6 to 20 times as many neutralising antibodies as a natural infection. This high degree of immunity, more robust than people who recover from an infection, means people vaccinated will likely not pass on the infection. This is known as Sterilising Immunity. Few vaccines provide Sterilising Immunity.
“A new serological study has found that participants who have received the second dose of the Pfizer/BioNTech coronavirus vaccine have developed 6-20 times more antibodies for the pathogen, Sheba Medical Center said in a statement on Monday.”
“Regev-Yohai also added that people who received both doses of the vaccine will most likely not become carriers of the virus and will not spread it further due to the high level of antibodies.”
https://www.ynetnews.com/health_science/article/H1jaK7mkd
2. Most vaccines for other diseases do not provide Sterilising Immunity, most only prevent symptoms.
“In an ideal world, all vaccines would induce sterilising immunity. In reality, it is actually extremely difficult to produce vaccines that stop virus infection altogether. Most vaccines that are in routine use today do not achieve this. For example, vaccines targeting rotavirus, a common cause of diarrhoea in infants, are only capable of preventing severe disease.”
That said, the likelyhood that the Pfizer/BioNTech and Moderna vaccines (which is also an nRNA vaccine) provide Sterilising Immunity is a welcome bonus.
@David Jordan: thx phizer vaccine simply isn’t suitable as a mass community vaccine , it’s handling difficulties prevent widespread usage. U.K. is now almost totally using Astra. Which Ireland now can’t get due to EU incompetence.
The irony is the EMA is about to approve a vaccine that won’t be available to most EU countries in any volume now.
@Dave McCabe: That is not true. Israel vaccinated more than 25% of it’s population so far using just the Pfizer/BioNTech vaccine (41 doses per 100). They are well ahead of the UK:
https://ourworldindata.org/covid-vaccinations
They are also seeing excellent results:
“The preliminary results shared by Israeli HMO Maccabi showed that only 20 people out of some 128,600 who received both shots have since been infected with the COVID-19 virus.”
The Pfizer/BioNTech and Moderna vaccines require very cold storage and so are unsuitable for 3rd world countries, but I don’t think that’s true for developed countries, which Israeli shows.
That said, Johnson & Johnson are a week to two away from revealing the result so their Phase III vaccine trial, for a single dose vaccine that does not need low temperature storage.
“…the vaccine, if successful, is estimated at launch to remain stable for two years at -20 °C and at least three months at 2-8° C.”
@David Jordan: The problem here is of course timing. We will have billions of doses on June, but all want them now. The problem of not being able to exactly predict yields from cultures is real, and is the sort of messy detail that gets overlooked.
I do think the EMA have been very lacking in urgency, and why the richest block in history couldn’t have ensured extra capacity across the 27, even if we never used it is a mystery. We’re they focused on saving money? Striking a good deal?
We appear to have capacity for 400 million doses by June, under the projections. However the Serum Institute in India have been gearing up since last June to produce 1 billion doses by May.
Throwing a billion or two at this project last year would have been smart considering the eye watering g numbers already lost to lockdowns, especially since Oxford was pretty much a sure thing after their MERS and SARS work.
There are a lot of people with a lot of questions about a lot of covid related issues. This is leading to confusion and frustration. Is there no one capable of organising an online forum where these questions can be gathered, answered by experts and indexed so that they can be found whenever needed?
It’s been a year, honestly I feel like at times people want to be confused by the guidelines so they can have a good moan. Then if you post evidence and reputable sources that usuall gets ignored because it doesn’t fit in with the persons narrative.
I find this with alot of articles for example, you have end the lockdown article, people all for ending the lock down whilst beneath it could be an article about how we are using ICU surge capacity to deal with the pandemic, that artical gets ignored by people cause it doesn’t suit their narrative.
You have experts answering questions but then the anti science people will come along and spew their nonsense and provide a link to a very questionable expert.
@Michael Flynn:
What’s Covid questions ? There is loads of data and resources to read if you want answers
@Ally Mc Culladgh:
Actually Ally which “science people “ are you referring , the CMO for example is a “ generalist “. There is very evidence of data based scientific analysis going into Ireland’s actions at present.
Why so long approving this vaccine?
@Hugh Fogerty: There is a competing German one perhaps?
@Hugh Fogerty:
Because the EMA was based in the U.K. and relied heavily on U.K. local resources it had to move to Amsterdam in a hurry , lost expertise and resources and is slowly trying to get up to speed
It’s dysfunctional as a result. The Germans have lost faith and are doing side deals. Expect to see German emergency authorisations next bypassing ema
@Hugh Fogerty: They must be getting early data from the US study for safety.
https://www.ema.europa.eu/en/news/update-rolling-review-astrazenecas-covid-19-vaccine
This isn’t a Astra production issue. Astra have contracted to provide other countries with product from the Belgian plant. The EU was predicated on timely approval the EMAhas given Astra a contractual get out
Rumour has it Germany has a separate deal with Astra.
Eu has completely screwed up. Ireland will now have to shelve the community vaccine process as it can’t get enough vaccine.
Moderna is tied to the us. Phizer handling prevents it being used in mass vaccinations , Johnson won’t be approved for months
Lockdown in paddy land to continue all through 2021 imho. U.K. at nearly 10% vaccine with full output from Astra U.K. plant. It will begin to permanently reduce restrictions from end of feb. We will look on in envy all summer at our neighbours vaccinating away gaily while we stew in lockdown Not looking could here at all we’re been screwed by eu commissions purchasing incompetence
@Dave McCabe: Cue Paul Furey’s bewilderment as his bedroom view implodes
@Dave McCabe: That’s a bit of a stretch. The EMA have screwed up, no doubt, and are now looking for someone to blame, which will fizzle out as the week progresses. As for the delay, it will cause a delay, not a cessation.
In June Oxford insisted on multiple manufacturers worldwide, with price conditions attached. Worse case scenario we end up throwing money at someone.
In really dire straits we could probably get a supply from the U.K., since it would make sense for them as well, what with a porous border.
Maybe Because the EU took so long to approve the AtraZ vaccine…and still hasn’t done so. So quite possibly, the contract was predicated on approval and fulfilment by a certain date, which the EU has screwed up big time, and now the vaccines are going to countries that have agreed to distribute it.
Why is the news story, carried in the Irish Times, the Examiner, the Guardian etc being glossed over here? Astrazeneca has reneged on its commitment to supply the EU and is exporting over 50% of the EU quota to an unnamed country.
EU backtracking majorly today after it’s attempts to talk tough yesterday. Let’s face it the EMA gambled with its strategy and it at this point has shown it to be well behind the curve.
Would be interested to see if supply distribution was tied to an approval date. All the conspiracy heads need to understand this isn’t a tin pot garage run Amazon shop, it’s a multi billion dollar international behemoth. Suspect AstraZeneca have put them back in their box
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