Australian AstraZeneca manufacturer CSL still committed to make 50 million vaccine doses


The Australian manufacturer of the AstraZeneca COVID-19 vaccine says it still plans to fill a federal government order of 50 million doses, despite health authorities recommending a different vaccine be preferred for those under 50 years of age.

On Thursday night, the panel of experts that advises the federal government on immunisation issues recommended that Pfizer be the preferred COVID-19 vaccine for adults under 50 due to the risk of a rare blood clotting disorder in that age group.

The panel, ATAGI, said if the risks outweighed the benefits, AstraZeneca could still be used, and that people who had received the first dose without experiencing the rare side clotting disorder could still get a second one.

“Immunisation providers should only give a first dose of AstraZeneca COVID-19 vaccine to adults under 50 years of age where benefit clearly outweighs the risk for that individual’s circumstances,” National Chief Medical Officer Paul Kelly said.

The recommendation has dashed hopes that all Australians will have had their first COVID-19 vaccine by October, as the federal government may have to try and source other vaccines to cover that age group.

But on Friday afternoon, Prime Minister Scott Morrison announced Australia had secured an extra 20 million doses of the Pfizer vaccine, in addition to 20 million that had already been ordered.

Originally the AstraZeneca vaccine was going to make up the majority of Australia’s COVID-19 vaccination program.

Australia had ordered nearly 54 million doses of the AstraZeneca vaccine, with the vast majority to be produced by biotechnology company CSL at its factory in Melbourne suburb Broadmeadows.

The remaining 3.8 million doses were to be shipped from Europe.

CSL said it remained “committed to meeting its contracted arrangements with the Australian Government and AstraZeneca for locally produced AstraZeneca COVID-19 vaccines”.

“We will continue our focused and important efforts to manufacture this vaccine which remains critical for the protection of our most vulnerable populations,” a spokesperson said in a statement.

“We are proud of our unique role in Australia as the only onshore manufacturer that can produce this vaccine and remain dedicated to our ongoing contribution towards this effort.”

The first batch of 830,000 locally produced AstraZeneca vaccines was released on March 24, with a goal for CSL to ramp up to producing one million per week.

The federal government earlier this week said 1.3 million locally produced doses had been received so far, with more to come in following weeks.

“We’re expecting later this week over 470,000 [doses], early next week, approximately 480,000 and then late next week or early the following week 670,000,” Health Minister Greg Hunt said.

If any doses are left over from the 50 million produced in Melbourne, it is understood it will be up to CSL’s clients — the federal government and AstraZeneca — to decide what to do with them.

About 8.75 million of Australia’s roughly 25.7 million residents are over the age of 50, according to ABS data from last September.

Infectious diseases expert Allen Cheng, who co-chairs ATAGI, said the recommendation was made based on an assessment of the benefits and risks.

“If there was a lot of COVID about, then the benefit in preventing COVID would outweigh the risk for almost all adults, except for very young adults. This is pretty much the situation in the UK at the moment,” he said on Twitter.

Professor Cheng also said the word “prefer” was used in the recommendation because people had a choice about the vaccines and treatments they get.

“If a younger person said that they were happy to take a 1 in 200,000 risk of clotting for the benefit of getting protected from COVID earlier, then as long as this was an informed decision, we should respect that choice,” he said.

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AstraZeneca COVID-19 vaccine doses have better efficacy when given 12 weeks apart, study finds


Waiting three months between the first and second dose of the AstraZeneca COVID-19 vaccine results in high efficacy, backing current recommendations from Australian authorities, new research shows.

The study, which involved more than 17,000 participants and was published recently in The Lancet, found the vaccine — which most people in Australia will receive — had an 81 per cent efficacy rate when a second dose was given three months after the first.

This dropped to a 55 per cent efficacy rate if the second dose was given less than six weeks after the first.

Jodie McVernon, a director of epidemiology at the Peter Doherty Institute for Infection and Immunity, said the result was not surprising.

“That finding, of a delayed interval between a primary dose and a booster dose giving a better antibody response, is consistent with some other vaccines that we have seen before,” she said.

Vaccines for the flu, Ebola and malaria also give greater protection and stronger immune responses after a longer interval between doses.

But Professor McVernon said a longer wait time between doses was not ideal for every vaccine.

“This is where every vaccine needs to be trialled and needs to be studied to work out those doses and what the best interval will be,” she said.

Depending on the country, the two-dose AstraZeneca vaccine has been offered to people between four and 12 weeks apart.

In Australia, the Therapeutic Goods Administration recommends waiting 12 weeks between doses.

Burnet Institute program director for disease elimination Heidi Drummer welcomed the study’s findings.

“It’s great news for Australians because what it’s saying is that if you wait three months between your first dose and your second dose, there seems to be a really good increase in efficacy,” she said.

But why waiting longer leads to better results is still not clear.

Theories on why waiting boosts immune response

Professor Drummer said she knew of two theories why the 12-week wait between doses led to a higher efficacy rate.

The first theory, she explained, built on the fact that after someone was vaccinated, their body had a reaction to the jab itself.

This reaction is the body’s immune system kicking in.

“Some of those molecules that are produced could be quite inflammatory and when you receive the vaccine [shots] in a short window, those inflammatory responses could limit the ability of the immune system to generate a boosting immune response,” Professor Drummer said.

The second theory has to do with the make-up of the AstraZeneca viral vector vaccine, which uses a harmless chimpanzee adenovirus to deliver DNA into our cells.

The vaccine contains a viral particle which has the gene for the spike protein, and adenovirus particles are present on the surface of the particle.

Professor Drummer said it was possible our bodies were making antibodies to those surface proteins.

“That means when we get the booster shot, if we get it too soon after that vaccination, the antibodies that we made for the adenovirus protein actually get rid of the booster dose,” she said.

“So it doesn’t get the opportunity to deliver the spike protein into the cells and for you to then deliver the second round boosting immunity.”

High level of protection between doses

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What to expect from the COVID-19 vaccine rollout

Researchers also found the first dose offered 76 per cent protection in the three months between jabs, meaning people have high coverage while waiting for their second dose.

“Often we have, when two doses are required for full protection, there might be a lower level of partial protection in the middle,” Professor McVernon said.

“But over that time window, we know that that first dose of the vaccine will work well.”

The findings in The Lancet are also backed up by a real-world study out of Scotland.

That research, which is yet to be peer reviewed, examined the effectiveness of the first dose of the Pfizer and AstraZeneca vaccines in a national study of about 5.4 million people.

It found a single dose of either vaccine “resulted in substantial reductions in the risk of COVID-19 related hospitalisation”, but AstraZeneca outperformed Pfizer.

One shot of the Pfizer option was 85 per cent effective at preventing hospitalisation at 28-34 days post-vaccination, whereas one shot of the AstraZeneca vaccine was 94 per cent effective at preventing hospitalisation in the same interval.

“They’re both almost equally as good as each other at preventing hospitalisation and even symptomatic mild to moderate COVID.”

Professor McVernon said the study in Scotland showed both vaccines were achieving similarly high levels of effectiveness and that early concerns about AstraZeneca’s efficacy rate “don’t seem to be playing out in reality”.

‘Still learning’ about adenoviral vaccines

Professor Drummer said the research showed Australia was on the right track with its vaccination rollout.

Both AstraZeneca and Pfizer’s vaccine candidates use new technology: the former uses a viral vector, and the later uses messenger RNA (mRNA) encased in a lipid layer, which, until recently, had not been approved for use in a human vaccine.

Professor Drummer said there would be more research about both options in the months and years to come, and that could inform future vaccination programs.

“Adenovirus vaccines are very new and we’re still learning,” she said.



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Coronavirus vaccine rollout continues, doctors working to increase doses given per day


Australia needs to vaccinate 200,000 people every day to reach the goal of all adult Australians being able to get their first vaccine dose by the end of October.

As of Monday, 541,761 Australians have received the vaccine, according to Federal Health Minister, Greg Hunt who gave an update on the state of the rollout.

“The latest guidance I have is we remain on track for all the first doses before the end of October,” said Mr Hunt.

Australia has just finished the first week of Phase 1B rollout, the first stage of broad vaccination in the community, which is available to 6 million Australians.

It includes those aged over 70, critical workers like police and people with some underlying medical conditions.

But so far the daily target of 200,000 vaccinations has proved to be a challenge.

In the first week of Phase 1B, a total of 259,000 people were vaccinated.

In an e-mail to Australian GPs last week, reported by the Guardian, the Health Department also acknowledged “teething problems”.

Teething problems have included confusion between some GPs and the Federal Health Department over who was supposed to provide needles to use with the vaccines and frustration around the National Booking Scheme.

Royal College of General Practitioners (RACGP) president Karen Price said early hurdles were inevitable and said the public should have faith that authorities are working tirelessly to ramp up vaccinations.

“Most of us are on the phone all weekend, talking 24/7 about making sure we get this right for the public,” she said.

“It really is a national effort and for that, I am very, very grateful because like everybody else in Australia and pretty much around the world, I want my life back, and I want my kids to have their life back, and I want my community to have their life back.”

Leading health economist Stephen Duckett said now was the time for health officials to reflect on some of the early challenges seen in the vaccine rollout, and to make changes before more Australians became eligible for the jab.

“We set a target of four million, we’ve got 600,000 or so. That is a long way short of the target,” said Dr Duckett of the Grattan Institute.

“What are we going to do differently into the future? My hope is also that we are going to do things very differently in April and May from what we did in March.”

He said the early rollout had encountered logistical challenges.

“GP’s don’t know how many vaccines they’re going to get, they’ve booked patients, then they have to unbook patients.

“There have been problems in the distribution where the number of vaccines that have been allocated to GPs have been too many for small practices and too few for large practices.”

A spokesperson for the Health Minister said everyone who wants a vaccine will have the opportunity by the end of October.

“We have every confidence in our GPs, who in In the last week administered almost 120,000 vaccines, bringing our total number of vaccinated Australians to 541,761,” the spokesperson said.

“Mr Duckett predicted in March 2020 that Australia would run out of ventilators three weeks later. In reality, we had capacity of 7,500 ventilators and approximately 50 people on COVID ventilation at the time of the peak.

“He is entitled to different views but comments such as these utterly and profoundly incorrect predictions […] on ventilation should be taken into account.”

Dr Duckett has previously claimed this criticism takes his comments out of context.

Elizabeth Jackson, an expert in supply chains from Curtin University, said she believed Australia would reach the daily vaccination target soon and learning lessons from this early period would help develop the supply chain.

“I can completely understand the frustration [but] in Australia, we enjoy highly efficient supply chains and we’re just not used to having to go without or wait,” Dr Jackson said.

Health Minister Greg Hunt has said that GPs were the “cornerstone” of the national rollout strategy.

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Covid: More than 700,000 vaccine first doses given in NI


“As an airport we would never challenge decisions made by the health minister in relation to the running of the health service,” he said.  “However, we would expect decisions on international air travel to emanate from the NI Executive, rather than the health minister or an advisor.”

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Regulator approves first Australian-made AstraZeneca COVID-19 vaccine doses for use


Australians can soon start being inoculated against COVID-19 using an Australian-made vaccine.

The nation’s medicine regulator overnight approved more than 830,000 doses of Melbourne-made AstraZeneca vaccine, confirming they are of the same quality as those made overseas.

“Testing of the vaccine batches in our Canberra laboratories plus a review of extensive manufacturing documentation, has ensured that the locally-manufactured vaccine has exactly the same composition and performance as the overseas-manufactured vaccine,” the Therapeutic Goods Administrations said in a statement.

“We will now be able to provide secure access to large numbers of doses of a domestically-produced vaccine, with the Australian government having procured 50 million doses for delivery in the coming months.”

The approval is a shot in the arm of the federal government’s vaccination rollout, which has copped criticism for slow progress.

The locally-produced AstraZeneca doses will be used as part of the ‘phase 1b’ vaccination program which started on Monday and will be available at more than 4000 providers including GP clinics and official health services.

Prime Minister Scott Morrison walks past vials of the AstraZeneca vaccine as he visits the CSL serum lab in Melbourne in February.

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“(Regulatory) approval is required for each and every batch of any vaccine supplied in Australia,” the administration said.

“All subsequent batches of the Melbourne-manufactured vaccine completed in the coming weeks and months will go through the same individual batch testing and release process.”

CSL’s Melbourne facilities are producing 50 million doses of the AstraZeneca vaccine.

So far 62,000 people within the aged care sector have received the vaccine.

Phase 1b will see six million Australians get their jabs, mostly via GP clinics.

The program takes in everyone over the age of 70, along with Indigenous Australians over 55 and younger adults with a medical condition or disability.

Workers deemed critical or high risk can also apply.



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COVID-19 vaccination rollout reaches Indigenous communities as first AstraZeneca doses administered


COVID vaccinations have begun in some of Australia’s most vulnerable populations, with today’s rollout of the AstraZeneca vaccine in Indigenous communities.

Under phase 1b of the country’s rollout plan, all Aboriginal and Torres Strait Islander adults over 55 will start to receive the jab from today, while in some remote communities all Indigenous adults are eligible.

At the Mallee District Aboriginal Service (MDAS) in Mildura, Iris Johnson was one of the first Indigenous community members to get the COVID-19 vaccine.

The vaccine provided some much-needed hope for Ms Johnson, who spent most of the year in “complete lockdown,” due to her existing kidney disease, which leaves her immune system compromised.

“I was scared to come and get the vaccine, but my daughter said, ‘You’ve got to come and get it,'” she said.

While she said she felt lucky, she was also very nervous.

“Oh my, that’s a big needle,” she said before shutting her eyes and getting her first dose of the vaccine.

“This is just a weight off your shoulders when you’ve got someone in the family with a chronic disease,” her daughter Tiny Kelly said.

“Due to the high burden of chronic disease, the Indigenous community is especially vulnerable, so it’s important that we could start vaccinating as soon as possible,” said Jacki Turfrey, the CEO of MDAS.

Ten vials of the AstraZeneca vaccine were delivered to MDAS on Monday morning, and health workers wasted no time administering the jabs.

“We have the opportunity for our elders to get their injections today, and they can promote this to the rest of the community,” Ms Turfrey said.

“There is a level of hesitancy in the community just because it’s so new … but I think this will set the scene for a successful rollout.”

She said the organisation had worked tirelessly to train and prepare staff so they could begin administering doses as soon as possible.

“It’s a pretty good mood in here today, everyone is feeling pretty happy about this,” she added.

Peter Peterson, a 56-year-old Barkindji man from the Mildura community, said he was grateful he could receive his vaccine from an Aboriginal health provider.

“Knowing it’s here, and seeing the doctor and everyone else getting it makes me feel good,” he said.

Sixty-eight-year-old Gubbi Gubbi man Garry Swallow said he hoped today might mark the beginning of the end of a very tough year.

“I haven’t seen any of my family, my kids, my grandkids, my brothers for a whole year, because they’re in Queensland,” he said.

“With these borders being shut for most of the year, I’ve just been here on my own, it’s hard when you’re single, keeping safe and healthy at home.”

It’s expected that more than 100 Aboriginal community-controlled health organisations will begin to administer the vaccine in the coming months.

Indigenous Australians over 55 can also be vaccinated at GP providers like the rest of the population.

Emergency doses of the vaccine have already been rolled out to island communities in the Torres Strait, as neighbouring Papua New Guinea battles a surging coronavirus pandemic.

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Philippines inks deal for 20 million Moderna vaccine doses


A pharmacist holds a vial of the Moderna vaccine inside a Walmart store in West Haven, Connecticut, U.S., Feb. 17. — Reuters/Mike Segar

The Philippine government and the private sector have sealed an agreement with Moderna, Inc. for 20 million doses of its coronavirus vaccine, according to the presidential palace, making it the country’s largest vaccine supply deal to date.

The government secured 13 million doses of the Moderna vaccine, while private firms led by International Container Terminal Services Inc. (ICTSI) Chairman Enrique K. Razon Jr. will get 7 million doses for their workers, vaccine czar Carlito G. Galvez, Jr. said in a statement.

“We would also like to thank Mr Patrick Bergstedt and the whole Moderna Team for keeping up with their commitment in providing 20 million ‘doses of hope’ for 10 million Filipinos,” Mr. Galvez, chief implementer of the country’s pandemic plan, said.

Mr. Galvez said the signing of the tripartite agreement boosts Manila’s goal of having a steady supply of vaccines this year.

“This is part of our goal to vaccinate 70 million of our adult population and recover the economy from the pandemic,” he said.

The government started negotiating with the US-based drugmaker after its two-dose vaccine, which has a 94.5% efficacy rate, was authorized for emergency use in the United States.

Moderna, however, has yet to secure an emergency use authorization from Manila’s drug regulator.

“We are honored to be part of this enormous and noble endeavor to help our people recover from the impact of pandemic and to catalyze a return to growth for our nation,” ICTSI Foundation said on behalf of the so-called Moderna Vaccine Buyer’s Group.

There were no details on which companies are getting the Moderna vaccines.

In a televised press briefing on Friday, Mr. Galvez said the country would take delivery of Moderna vaccines in the second quarter, along with about two million vaccine vials from China’s Sinovac Biotech Ltd.

Massive vaccinations will be held from May to June, he added.

Mr. Galvez earlier said Manila would receive at least 1.4 million more doses of Sinovac vaccines this month. Of the total, about 400,000 vials were donated from Beijing, and the rest were paid for by the government.

About 900,000 more doses of the shots developed by British drugmaker AstraZeneca, Plc. and secured under a global initiative for equal vaccine access will also arrive in late March or early April, he said.

The shots developed by America’s Novavax, Inc., Janssen Pharmaceuticals, Inc, Pfizer Inc, and Russia’s Gamaleya Institute are also included in the government’s coronavirus vaccine portfolio.

The Health department reported a record 7,103 new cases of COVID-19 on Friday. This brought the total number of cases in the Philippines to 648,066.


FIRMS NOT ALLOWED TO IMPORT VACCINES DIRECTLY

Meanwhile, Finance Secretary Carlos G. Dominguez III said in a Viber message on Friday that private firms are not allowed to import COVID-19 vaccines directly due to existing laws and the request of pharmaceutical companies that make the vaccines.

“[There are] two reasons [why]: first, the pharmas insist on the government providing the indemnity, second, [there is] the COVID 19 Vaccination Program Law,” he said when asked if he supports the proposal of Philippine Chamber of Commerce and Industry (PCCI) to allow private companies to import vaccines themselves,” he said.

“Moreover the requirement by pharma companies of government indemnity necessitates government involvement in purchases by the private sector.”

Republic Act 11525 signed on Feb. 26 allows DOH and the National Task Force (NTF) against COVID-19 to directly procure vaccines from manufacturers.

For local government units and other entities who want to buy the vaccines, the DOH and NTF have been tasked to negotiate on their behalf. – with Beatrice M. Laforga








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All Katherine residents in phase 1A receive first doses of coronavirus vaccine


The Northern Territory has achieved the highest rate of coronavirus vaccinations of any state or territory on a per capita basis.

There have been nearly 4,000 jabs in total across the NT so far.

Katherine has also achieved a milestone with all residents in phase 1A receiving their first doses of the vaccine.

For nurse Rachel Jones, getting the coronavirus vaccine was a bittersweet moment.

She lost her father to coronavirus in the United Kingdom last year as she spent the pandemic working in the isolated NT town of Katherine, separated from family overseas.

“I’m a bit emotional about the whole thing, but I think we’re very lucky in Australia that we haven’t had to go through what they went through in the UK,” Ms Jones said.

Rachel Jones and other frontline health workers who have received their first doses of the vaccine are looking forward to helping other Territorians during the rollout.(

ABC News: Nicholas Hynes

)

Ms Jones is one of about 160 frontline workers in Katherine who have been vaccinated this week, as the town rapidly approaches the end of the first phase of the rollout.

Two deliveries of the ultra-cold Pfizer vaccine were brought to the town on charter flights from Darwin.

“The response has been great and we’ve managed to give 160 vaccines during the two days with no wastage,” Top End Health Service’s Angela Brannelly said.

Support officer Adam Kadadykasim Barma said he would be relieved when the vaccine rollout was complete.

A man shows his vaccination certificate and bandaid on his arm after receiving his coronavirus jab.
Support officer Adam Kadadykasim Barma said getting his first dose of the vaccine was an important step.(

ABC News: Nicholas Hynes

)

The Northern Territory’s small population and centralised hospitals have seen it lead the country in the rollout, with the highest vaccination rate on a per capita basis.

The next phase

But attention is now turning to the next phase, which will see the vaccine taken to the Territory’s remote Indigenous communities.

The first batch of the AstraZeneca vaccine — which does not need to be stored between -60 and -90 degrees Celsius — is due to arrive in the Territory within days.

“With the AstraZeneca vaccine, we won’t have the challenges around charter flights so we can make sure we can give the maximum amount of vaccine,” Ms Brannelly said.

On Friday, the Federal Government expanded the next phase to ease logistical challenges of the rollout into remote communities.

For Ms Jones and other frontline workers in Katherine, the focus is now on supporting the ongoing success of the rollout.

“I just want it (the vaccine) to be out in the communities and remote communities to vaccinate those people, because we have so many vulnerable people.”

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Von der Leyen says EU’s vaccine doses to ‘double’ to 100M per month in April – POLITICO



The number of vaccine doses available in the EU is expected to double to 100 million per month from April, European Commission President Ursula von der Leyen told Germany’s Stuttgarter Nachrichten newspaper in an interview published today.

“From April onwards, the quantities could double again according to the manufacturers’ plans, also because further vaccines are about to be approved,” von der Leyen said. She added that she expects “an average of around 100 million doses per month in the second quarter, a total of 300 million by the end of June.”

In a separate TV interview this morning with France 2, Internal Market Commissioner Thierry Breton had a similarly upbeat message: “The good news is that we have a wide-enough portfolio of companies and factories that makes me confident that we will be able to catch up on delays,” Breton said.

The European Commission and von der Leyen have faced criticism over the slow rollout of vaccinations around the bloc, with some countries turning abroad for jabs that aren’t approved for use in the EU.

The European Medicines Agency (EMA) has approved three vaccines — from Pfizer/BioNTech, Moderna and Oxford/AstraZeneca — for use in the EU. It is expected to make a decision on a fourth, from U.S. firm Johnson & Johnson, as early as this Thursday.

Breton last week said the EU would be able to produce between 2 billion and 3 billion doses of vaccine a year by the end of 2021, and that he was confident the bloc will have enough doses to vaccinate 70 percent of adults by the end of the summer.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.



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Europe blocks 250,000 AstraZeneca doses bound for Australia


The AstraZeneca COVID-19 vaccine was bound for Australia.Credit:Getty Images

The first 300,000 doses of the Europe-manufactured Oxford University-AstraZeneca COVID-19 vaccine landed on Australian soil last Sunday morning. Some 50 million AstraZeneca doses will be manufactured at a factory in Melbourne but 3.8 million will have to arrive from overseas, primarily Europe.

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Australia is thought to be collateral damage in an ongoing war of words between European officials and AstraZeneca, a British-Swedish company. The European Union is unhappy that the company has not delivered the number of doses it expected.

Newly installed Italian Prime Minister Mario Draghi criticised the export of vaccines during a recent meeting of EU leaders in late January.

However millions of AstraZeneca doses have been put into storage across Europe because some citizens are refusing to take it.

French President Emmanuel Macron falsely called it “quasi ineffective” for the elderly, a comment which is widely seen as having caused huge damage to crucial public confidence in the jabs.

A string of nations in Europe earlier this year said the vaccine should not be given to over 65s, citing a lack of trial data. However most are now reversing that decision given the vaccine is proving hugely successful in Britain.

The EU has previously described the export controls as a “transparency and authorisation mechanism”. The regulation underpinning the measure states it is not the intention of the EU to “restrict exports any more than absolutely necessary”.

Under the system, Pfizer and AstraZeneca have to ask the EU for approval before vaccines can be flown abroad. Officials would be lawfully permitted to curb exports if they conclude the shipments would deprive the EU’s 27 member countries of its pre-agreed doses.

But the approach has prompted an outcry from a host of experts and officials who believe it represents a dangerous precedent in so-called ‘vaccine nationalism’.

It was also viewed as an attempt by the bloc to find a culprit for its trouble-plagued rollout, which is lagging well behind Britain’s.

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