To further refine this. AZ was approved in the UK before the EU primarily because AZ worked along side the UK regulatory body in development and so were able to complete their submission to MHRA sooner than they did to the EMA. Another example of how important the company’s regulatory strategy is for getting approval in a territory, AZ is not yet approved in the US and now possibly never will be (the justification for granting an emergency use authorization gets small every day).
7 Likes
I still believe the EU were slow to react (as were the individual nations within the EU).
Whilst EMA represents all EU nations. All those nations had the same ability to do exactly what the UK did. They all had the ability to for emergency authorisation. None of them exercised that.
On the Phizer vaccine the EMA had a month head start upon the UK. Holding weekly meetings in October. Yet it was not approved till 3 weeks after the UK. The EMA said they were taking a more “robust” approach.
The Slovak prime minister said
Dear Christa, we would all be very happy for you to change your working hours at the EMA for the following months to 24 hours a day and 7 days a week - and to approve vaccines not in three months but in three weeks. It’s a matter of life and death’."
The UK did react fast, what I am saying is the EU nations equally needed to to the emergency.
I know we hold very different perspective on the vaccine roll out. But I think it’s fair to say there has been wide spread critism of the authorisation (both within and outside the EU).
I agree largely with what you said about the over 65s. My perspective is that it would have been better not approving it at all till fully satisfied. Or they state they are happy with the proxy measurement (immune response measures). Going halfway sowed doubts.
On the Halix factory there is something badly wrong there. The fact that this is not subject to vitriol of EU tells me there is more to this. Something that looks like a failure on both sides.
On vaccine suspension I meant national bodies (not the EMA).
1 Like
Halix is listed in the AZ(EU)/EU agreement as a “drug substance manufacturing” facility, as distinct from a “drug production manufacturing” facility. The substance manufacturing facilities are Novasep (France/Belgium), Halix (Netherlands), Oxford Biomedica (UK), and Cobra Biologics (UK).
The production manufacturing facilities are Catalent (Italy), IDT Biologika (Germany), Wockhardt (UK) and “potentially other suppliers”.
The EU are obliged to help AZ obtain the raw materials, which is presumably what is required for the drug substance manufacture. It may be that there is a difficulty here?
As mentioned previously, don’t get too excited by the referral to UK sites, incidentally. AZ are contractually obliged (paragraph 5.1) to “use its Best Reasonable Efforts to manufacture the Initial Europe Doses within the EU”. The contract acts to specifically exclude the sites in the UK as falling within AZ (EU)'s obligations to manufacture the Initial Europe Doses.
Wow.
But there’s more…
Also threatening to suspend intellectual property rights…
There actually isn’t a process for member states to grant CMA (emergency use) of vaccines in the EU. What independence the individual member states have to regulate medicinal products is not applied to emergency use of vaccines. More importantly, the applications are a mammoth undertaking, which is why for something considered a public health emergency, only the centralized path through the EMA exists preventing the companies themselves from having to split their resources going through the process multiple times.
To that point then it is important to recognize that AZ did not submit their application to the EMA for near a month after it finalized its application to the MHRP. When comparing the time between final submission and approval, it’s a pretty comparable timeframe.
The conversation about EMA “delay” was largely based around why they want to do their own review rather than just accepting the judgement of the first body to approve it, which is not a particularly fair argument or one that reflects how the process works. There is actually a pretty good argument that had Brexit not happened, the process to go through the MHRP would not have been created (or been politically feasible to create on the fly) leaving AZ less administrative work to get their submissions in for a whole of EU approval rather than having to split their efforts between 2 distinct tracs.
3 Likes
(“deceived” an unfortunate typo!!)
At the same time though AZ (EU) was able to share with the EMA all of AZ (UK)'s UK clinical trial data prepared for MHRA approval.
And AZ (EU) vaccine production for the EU benefited from the scaling up process that AZ (UK) had already started to put in place for the UK, prior to AZ (EU) signing the APA with the EC.
Not sure that’s right.
Menu
Donate
Vaccine approval isn’t quicker because of Brexit
4 DECEMBER 2020
WHAT WAS CLAIMED
The UK was able to approve the Pfizer/BioNTech vaccine more quickly because of Brexit.
OUR VERDICT
This is not correct. Under European law, the UK was permitted to act independently to approve the vaccine in an emergency.
“Because of Brexit we’ve been able to make a decision [to approve the Pfizer vaccine] based on the UK regulator, a world class regulator, and not go at the pace of the Europeans who are moving a little bit more slowly. We do all the same safety checks and the same processes, but we’ve been able to speed up how they’re done because of Brexit.”
MATT HANCOCK, TIMES RADIO, 2 DECEMBER 2020.
In an interview on Times Radio, the health secretary Matt Hancock incorrectly claimed that the UK was able to approve the use of the Pfizer/BioNTech coronavirus vaccine more quickly because of Brexit. Similar claims have also been made by other MPs including the leader of the House of Commons Jacob Rees-Mogg, health minister Nadine Dorries and the MP Michael Fabricant. This is not correct.
Regulation 174 of the Human Medicine Regulations 2012
The facts behind this story lie with regulation 174 of the Human Medicine Regulations 2012.
Until the Brexit transition period ends on 31 December, vaccines in the UK are supposed to be authorised via the European Medicines Agency (EMA). However, since 2012, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been free, under regulation 174, to give temporary approval to an unlicensed medicinal product in the case of certain types of public health threat, such as a pandemic.
When the MHRA approved the Pfizer/BioNTech coronavirus vaccine for use in the UK on 2 December, the government press release accompanying this announcement made clear that approval was given under regulation 174.
The government has previously said that “if a suitable Covid-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation which we have implemented via regulation 174 of the Human Medicines Regulations allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.”
This is clear that using regulation 174 is implementing EU legislation.
Were the rules going to change?
It is true that the government has consulted on and made changes to the Human Medicines Regulations 2012. We have written about this before.
However, the consultation document did not propose any changes to the regulations which would have accelerated the approval of the Pfizer vaccine.
It said: “If the need arises, regulation 174, in its present form, could be used to authorise nationwide distribution and supply of an unlicensed Covid-19 vaccine (or treatment) in the UK, as well as other potential products. In practice, this means that, if a suitable Covid-19 vaccine candidate – with strong supporting evidence of safety, quality and efficacy – became available before the end of the transition period but it had not yet been licensed by the European Medicines Agency, regulation 174 could be used to enable temporary UK-only deployment.”
The head of the MHRA, Dr June Raine, has been clear that the vaccine was approved under EU law. Asked directly whether Brexit made the process quicker, she said: “We have been able to authorise the supply of the vaccine using provisions under European law which exist until 1 January.”
1 Like
I see Cummings has been giving evidence in some committee / hearing thingy. He’s stated that No.10 (it was him really) stripped the Department of health of responsibilities and using a seperate body which opened the door to the UK procuring PPE and securing vaccines.
I simply don’t believe a word he’s saying there other than it obviously did work on the vaccines but my immediate question other than the cronyism is what did they strip out which allowed the quick vaccine approval.
They created a dedicated procurement department (previously each departments were responsible for their own procurement) and seconded in a huge number of human resources from all over the place (including the army) who had experience in dealing with procurement.
I think that was probably a reasonable response in the circumstances. What we need to know more about is not what steps they took to respond, necessarily, but how were contracts pitched, evaluated and awarded. What influence did ministers, SpAds or other MPs have on that process?
We’re still waiting on Justice O’Farrell’s judgment on the awarding of the Public First contract by the Cabinet Office. This is the first of these sorts of alleged chumocracy deals that has been subject to Court scrutiny. The hearing was over a month ago now so her judgment really ought to be any day now.
1 Like
The law you cited is one that applies to the UK though. So it’s right to say the UK would have had the powers to do what it did without the Brexit vote (as technically the law was enacted before the referendum). Regardless though, the exemption does not apply to the the rest of the EU member states
1 Like
The Human Medicines Regulations 2012 were implementing EU law, including the Medicinal Products Directive (Directive
2001/83/EC relating to medicinal products for
human use). Regulation 174 is permitted pursuant to Article 126a of the Medicinal Products Directive and is available to all competent authorities of individual Member States.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
Article 126a
- In the absence of a marketing authorisation or of a pending application for a medicinal product authorised in another Member State in
accordance with this Directive, a Member State may for justified public
health reasons authorise the placing on the market of the said medicinal
product.
See, this is why I refuse to do work with our EU clients
2 Likes
You were part of one of the biggest vaccination days so far (think it might have been the 3rd highest to date).
No aches, no pains, vaccinated within 5 mins, easy peasy…Every day we stay in, keep away from crowds, disinfect door handles, gate locks etc…is a day nearer some kind of normality…
6 Likes
European Commission President Ursula von der Leyen on Wednesday upped the ante in an escalating global fight over coronavirus vaccine shipments.
Speaking at a midday press conference, von der Leyen threatened to cut off vaccine exports to countries that refuse to share their own vaccines — a thinly veiled shot at the U.K. The EU may also restrict vaccine exports to countries with higher vaccination rates than Europe, she added, a threat that could affect countries like Israel and Chile.
“We want to see reciprocity and proportionality in exports, and we are ready to use whatever tool we need to deliver on that,” von der Leyen said, adding that she would discuss the proposal with EU heads of state and government. “This is about making sure that Europe gets its fair share.”
The move comes as the EU faces criticism over its vaccine rollout, which has repeatedly failed to meet supply targets. The effort faced further setbacks in recent days after scores of European countries halted their use of the Oxford/AstraZeneca shot amid reports of blood clots, despite assurances from medical officials including at the European Medicines Agency that the benefits of the vaccine clearly outweigh the risks.
On Wednesday, von der Leyen put other countries in the crosshairs, vowing that unless they reciprocate on the EU’s openness and start exporting vaccines to the EU, Europe will stop exporting to those countries.
“These six last weeks, 41 million doses have been exported [from the EU] to 33 countries. And this shows that Europe is trying to make international cooperation work,” she said. “But open roads run in both directions. And this is why we need to ensure that there is reciprocity and proportionality.”
If the EU doesn’t see such reciprocity, she added, “we will have to reflect on how to make exports to vaccine-producing countries dependent on their level of openness.”
Besides reciprocity, the EU should consider the principle of “proportionality” when deciding whether to allow exports, von der Leyen said: “We will reflect on whether exports to countries who have higher vaccination rates than us are still proportionate.”
Von der Leyen got some initial backing on Wednesday afternoon from European leaders.
“I support the announcements made by the president of the Commission … in particular to require reciprocity,” said French President Emmanuel Macron.
Asked which countries this principle might cover, von der Leyen cited the U.K., which she said was the “No. 1” destination for EU vaccine exports, while not sending any shots back in the other direction.
“We have observed that in the last six weeks, actually 10 million doses by now have been exported to the U.K.,” she said. “We’re still waiting for doses to come from the U.K.”
That is different than the current setup with the U.S., von der Leyen noted. The U.S., she said, was neither exporting nor importing finished vaccines.
With the U.S., “there is a seamless flow back and forth of pre-products, raw materials and drug substance,” she explained. “So there reciprocity is given.”
Shortly after von der Leyen’s proclamation, the U.K. shot back, chiding her for making threats after previously claiming the EU’s export mechanism was just meant to encourage transparency.
“It remains the case that we expect the EU to stand by its commitment,” said a spokesperson for British Prime Minister Boris Johnson.
“We’ve said before that the global recovery from COVID relies on international collaboration,” the spokesperson added. "Putting in place restrictions endangers global efforts to fight the virus.”
A Commission spokesperson said the reciprocity principle would apply for all types of vaccines, meaning the EU could cut off BioNTech/Pfizer vaccines to the U.K. unless Britain agrees to export AstraZeneca vaccines to the EU.
Asked whether the proportionality principle could also apply to other countries, the spokesperson said it “could also apply to countries that are not producing their own vaccines” but have higher vaccination rates than the EU.
In addition to Israel and Chile, the U.S., the United Arab Emirates, Bahrain, Serbia, Qatar, Turkey and Morocco all have higher vaccination rates than the EU.
1 Like
Hmmm…is this timing coincidental? It could also be that there’s a shortfall in the expected doses of the Moderna vaccine, which were due to arrive around this time (I think).
Ah, the FT had expected a drop in April although it remains unclear as to the extent of it. Also references that it is to do with AZ and Moderna production challenges, so I was half right. [Possibly a drop in expected AZ doses from India as AZ has confirmed domestic production remains unaffected.] States Pfizer remains on track but I guess we’ll have to wait and see whether the EC follows through with its thread today.
I agree. I would like to see / hear about all the background to these decisions. But not from Cummings. He can head back to Barnard Castle as far as I’m concerned. I heard a snippet of his “testimony” and it wreaked of that same “you cant touch me” type trope.
He used the terms “we stripped the Dept. of Health of its duties”. He was then questioned. “who” and he responded “No. 10”
I would certainly like to know what changes were made to ease the vaccine approval process. I think that is most certainly in the public interest, especially as I go for my AZ vaccine tomorrow. I want to know if I will be able to tune into TAN while I spend the next 2 days on the toilet.
1 Like
You ought to be happy to know that if you’re getting the AZ vaccine you’re much less likely to spend the next few days shitting yourself than if you had Pfizer. 
I know this one is relevant to a few of us in here…
https://twitter.com/Smyth_Chris/status/1372233272831397888