Italian PM: Giuseppe Conte vows to take legal action against Pfizer and AstraZeneca

Italian Prime Minister Giuseppe Conte says a delay in the supply of coronavirus vaccines from Pfizer and AstraZeneca is “unacceptable”.

Both companies have warned they will not be able to deliver vaccines to the EU as agreed due to production issues.

Mr Conte has accused them of serious contract violations.

A senior Italian health official has warned that the country will have to rethink its vaccination programme if supply issues continue.

The AstraZeneca vaccine, developed by Oxford University, has not yet been given EU approval; however the bloc’s drug regulator is expected to give it the green light at the end of this month.

A spokesman for AstraZeneca said on Friday that “initial volumes will be lower than originally anticipated” without giving further details.

Officials have not confirmed publicly how big the shortfall will be, but an unnamed EU official told Reuters news agency that deliveries would be reduced to 31m – a cut of 60% – in the first quarter of this year.

The drug firm had been set to deliver about 80m doses to the 27 nations by March, according to the official who spoke to Reuters. 

Last week Pfizer announced it was slowing supplies to Europe to make manufacturing changes that will boost capacity. The EU has ordered 600 million doses from Pfizer. 

On Saturday, Mr Conte wrote on Facebook: “Our vaccination plan … has been drawn up on the basis of contractual pledges freely undertaken by pharmaceutical companies with the European Commission.”

“Such delays in deliveries represent serious contractual violations, which cause enormous damage to Italy and other countries,” he added.

Italy’s Health Minister Franco Locatelli said Pfizer deliveries were 29% lower than planned this week but the levels were expected to return to those agreed by 1 February.

Mr Conte vowed to use “all available legal tools”.

Poland has also vowed to take action over the delay.

What is happening elsewhere in Europe?

Austrian media have reported that only 600,000 of 2m AstraZeneca doses promised by the end of March will arrive in the country on time, with the remaining 1.4m now being delivered in April.

A delay would be “completely unacceptable”, Austrian Health Minister Rudolf Anschober said on Friday.

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Hungary’s government, which has complained over the time it is taking EU regulators to approve the Oxford-AstraZeneca vaccine, has reached a deal with Russia to buy up large quantities of its Sputnik V vaccine, even though it has not received EU approval.

European Council President Charles Michel, who led a call with EU leaders this week, said on Thursday that officials were considering all ideas to try and stop future vaccine delays.

“All possible means will be examined to ensure rapid supply, including early distribution to avoid delays,” he said.

European Commission President Ursula von der Leyen and Mr Michel both say they are still aiming for the target of 70% of the EU population being vaccinated by summer.

There has been criticism and frustration across the region about the speed of vaccination roll-outs.

Israel, the United Arab Emirates, the UK, and the US are all well ahead of EU nations in terms of doses given per capita so far.

Vaccination does by population graphic

The European Commission has co-ordinated orders for all member states, with vaccines then distributed based on their population size.

Vaccines are seen by public health experts as an important part of a route out of the Covid-19 crisis, with many European nations struggling to cope with a deadly surge of the virus over the winter period.

Borders to remain open

The total number of German Covid-19 deaths climbed above 50,000 on Friday – a day after the country warned that it could close its borders if other EU countries were less strict in controlling the virus. Berlin sounded the alarm amid rising concern about new variants.

EU leaders agreed late on Thursday to keep their internal borders open but warned non-essential travel might need to be restricted to curb the spread of the virus.

Ms von der Leyen said Thursday that more testing and “targeted measures” were needed throughout the EU in order to keep internal and external borders open. 

For its part, France said it would impose tighter travel restrictions for European arrivals from Sunday, requiring a negative PCR Covid test within three days of travel.

In the Netherlands, a ban on all flights from the UK, South Africa and South American countries came into effect on Saturday to try and prevent new coronavirus variants gaining a foothold.

Looking ahead to the future, officials from EU nations reliant on tourism – including Spain and Greece – have floated the possibility of using vaccination certificates to allow for cross-border travel but there has been scepticism within the bloc.

Covid-19 vaccine: First person receives Pfizer jab in UK

A UK grandmother has become the first person in the world to be given the Pfizer Covid-19 jab as part of a mass vaccination programme.

Margaret Keenan, who turns 91 next week, said the injection she received at 06:31 GMT was the “best early birthday present”.

It was the first of 800,000 doses of the Pfizer/BioNTech vaccine that will be dispensed in the coming weeks.

Up to four million more are expected by the end of the month. 

Hubs in the UK are starting the rollout by vaccinating the over-80s and some health and care staff.

Senior NHS sources told the BBC “thousands of vaccinations” had taken place across the UK on Tuesday.

Dubbing the day “V-day”, Health Secretary Matt Hancock said it was “a tribute to scientific endeavour and human ingenuity and to the hard work of so many people. 

“Today marks the start of the fightback against our common enemy, the coronavirus,” he said.

Prime Minister Boris Johnson, on a visit to a London hospital to see some of the first people getting the jab, said getting vaccinated was “good for you and good for the whole country”.

Scotland’s First Minister Nicola Sturgeon said: “Today we should all allow ourselves a smile – but we must not drop our guard.”

On Tuesday, the UK government reported a further 616 people had died within 28 days of a positive test, taking the total, by that measure, to 62,033. A further 12,282 people tested positive for the virus.

At University Hospital, Coventry, matron May Parsons administered the very first injection to Ms Keenan.

“I feel so privileged to be the first person vaccinated against Covid-19,” said Ms Keenan, who is originally from Enniskillen, Co Fermanagh.

“It’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the new year, after being on my own for most of the year.

“My advice to anyone offered the vaccine is to take it. If I can have it at 90, then you can have it too,” she added.

Prof Stephen Powis, national medical director of NHS England, who witnessed the “historic moment”, said: “We couldn’t hug her but we could clap, and everybody did so in the room.”

Sister Joanna Sloan
image captionAn emotional Sister Joanna Sloan said she had been looking forward to the vaccine for so long

Throughout the day, patients and health workers at some 50 hospitals around the UK have been getting the jab: 

  • Sister Joanna Sloan, who will head up the vaccine rollout in Belfast, received the first vaccine administered in Northern Ireland, just after 08:00 GMT at the Royal Victoria Hospital
  • In Wales, a nervous Craig Atkins, 48, from Ebbw Vale, became the first person to get the jab. It was “scary” but he could smile now, the care home worker said
  • Consultant anaesthetist Dr Katie Stewart was among the first people in Scotland to get the jab, saying there was something to celebrate after “a very long hard year” looking after Covid patients and staying apart to protect each other

The UK is the first country in the world to start using the Pfizer vaccine after regulators approved its use last week.

On Tuesday, US regulators confirmed the vaccine is 95% effective, paving the way for it to be approved for emergency use.

The Oxford/AstraZeneca vaccine has also been found to be “safe and effective”, according to a paper published on Tuesday and assessed by independent scientists.

Speaking in the Commons, the health secretary stressed people did not need to apply for the vaccine. He said the NHS would be in touch with those eligible and urged them to “please step forward for your country”.

Mr Hancock went on to warn that there was “still a long march ahead”, saying there were “worrying signs” of the virus growing in Essex, London and Kent.

New data released by national statisticians for the week ending 27 November showed that of the 14,106 deaths registered in the UK, nearly 3,400 involved Covid. This is 20% higher than the five-year average but similar to the percentages seen in the past two weeks.

NHS England chief executive Sir Simon Stevens called the first vaccinations “remarkable achievement”, but cautioned it was a “first step” and “incredibly important” people continued to act sensibly.

On a visit to London’s Guy’s Hospital, the prime minister spoke to 81-year-old Lyn Wheeler, who was the first to receive the vaccine there.

“It is really very moving to hear her say she is doing it for Britain, which is exactly right – she is protecting herself, but also helping to protect the entire country,” Mr Johnson said.

Earlier, he thanked the NHS, volunteers and “all of the scientists who worked so hard to develop this vaccine”.

Labour’s shadow health secretary Jon Ashworth said it was “absolutely fabulous” to see people getting the vaccine and thanked everyone involved in making it happen.

How the Pfizer vaccine requires two doses

Some 800,000 doses of the Pfizer/BioNTech vaccine have been secured by the governmentto be administered in the coming weeks – although vaccination is not compulsory.

Orders have been placed for 40 million in total – enough for 20 million people, as two courses are needed. However, most supplies are not expected to become available until next year.

Mr Hancock said he expected it to take “several weeks” to get the first group of health workers, care staff and over-80s vaccinated.

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‘A momentous day but huge task ahead’

Analysis box by Nick Triggle, health correspondent

This is a momentous day, but make no mistake the NHS faces a huge task in rolling out this vaccine.

First, there needs to be a smooth supply – and already there are reports of manufacturing problems, which means the UK is expecting less than half of the 10 million doses of the Pfizer jab it was planning for by the end of the year.

The fact it needs to be kept in ultra-cold storage and in batches of 975 units is an added complication that has meant it cannot yet be taken into care homes to vaccinate residents – the very highest priority group – or sent out to GPs to run vaccination clinics in the community.

NHS bosses hope to receive guidance from the regulator next week on how to get around this.

But these factors illustrate why the UK is still pinning its hopes on a second vaccine developed by Oxford University. 

That one can be kept in fridges and so is easier to distribute, is British-made and – what is more – there is an ever-growing stockpile ready to use.

If that vaccine gets the green light from regulators, there will be a genuine hope the first few months of 2021 will see rapid progress in offering jabs to the most vulnerable people, so the UK can return to something closer to normality.

Covid Pfizer vaccine approved for use next week in UK

Breaking News image

The UK has become the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine for widespread use. 

British regulator, the MHRA, says the jab, which offers up to 95% protection against Covid-19 illness, is safe for roll out next week.

Immunisations could start within days for people in high priority groups. 

The UK has already ordered 40m doses – enough to vaccinate 20m people, with two shots each.

Around 10m doses should be available soon, with the first doses arriving in the UK in the coming days.

It is the fastest ever vaccine to go from concept to reality, taking only 10 months to follow the same developmental steps that normally span a decade.

Health Secretary Matt Hancock tweeted saying: ”Help is on its way. The NHS stands ready to start vaccinating early next week.”

Although vaccination can start, people still need to remain vigilant and follow coronavirus rules to stop the spread, say experts. 

That means sticking with the social distancing and face masks, and testing people who may have the virus and asking them to isolate. 

What is the vaccine?

It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.

An mRNA vaccine has never been approved for use in humans before, although people have received them in clinical trials. 

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The vaccine must be stored at around -70C and will be transported in special boxes, packed in dry ice. Once delivered, it can be kept for up to five days in a fridge.

Who will get it and when?

Experts have drawn up a provisional priority list, targeting people at highest risk. Top are care home residents and staff, followed by people over 80 and other health and social care workers.

They will receive the first stocks of the vaccine – some as soon as next week. Mass immunisation of everyone over 50, as well as younger people with pre-existing health conditions, can happen as more stocks become available in 2021. It is given as two injections, 21 days apart, with the second dose being a booster.

What about other Covid vaccines?

There are some other promising vaccines that could also be approved soon. 

One from Moderna uses the same mRNA approach as the Pfizer vaccine and offers similar protection. The UK has pre-ordered 7m doses that could be ready by the spring. 

The UK has ordered 100m doses of a different type of Covid vaccine from Oxford University and AstraZeneca. That vaccine uses a harmless virus, altered to look a lot more like the virus that causes Covid-19. 

Vaccine comparison

Russia has been using another vaccine, called Sputnik, and the Chinese military has approved another one made by CanSino Biologics. Both work in a similar way to the Oxford vaccine.

By Michelle Roberts
Health editor, BBC News online

Covid vaccine: Pfizer to apply for authorisation in US

Pfizer and its partner BioNTech have said they will apply for emergency authorisation in the US for their Covid-19 vaccine on Friday.

It will be the job of the US Food and Drug Administration (FDA) to decide if the vaccine is safe to roll out.

It is not clear how long the FDA will take to study the data. However, the US government expects to approve the vaccine in the first half of December.

Data from an advanced trial showed the vaccine protects 94% of adults over 65.

The trial involved 41,000 people worldwide. Half were given the vaccine, and half a placebo.

The UK has pre-ordered 40 million doses and should get 10 million by the end of the year.

Last week, Pfizer and BioNTech published preliminary data suggesting the vaccine offered 90% protection against Covid-19 and said there were no safety concerns. Subsequent data released on Wednesday suggested 95% effectiveness.

This was followed by data on a vaccine made by US company Moderna suggesting nearly 95% protection and similarly promising results from trials of another developed in Russia, called Sputnik.

Prof Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine (LSHTM), said both the FDA and the European Medicines Agency (EMA) would need to approve the Pfizer data.

“We can expect both agencies to conduct a very careful evaluation and we can rely on their conclusions,” he said.

But BBC health correspondent Naomi Grimley says this vaccine is still a long way off widespread use as regulators need to be absolutely sure that it’s safe – not least because Moderna and Pfizer both use an experimental technology that has never been approved before.

Pfizer says early analysis shows its Covid-19 vaccine is 90% effective

(CNN) Drugmaker Pfizer said Monday an early look at data from its coronavirus vaccine shows it is more than 90% effective — a much better than expected efficacy if the trend continues.

The so-called interim analysis looked at the first 94 confirmed cases of Covid-19 among the more than 43,000 volunteers who got either two doses of the vaccine or a placebo. It found that fewer than 10% of infections were in participants who had been given the vaccine. More than 90% of the cases were in people who had been given a placebo.

This 12-year-old is happy to be testing a Covid-19 vaccine

Pfizer said that the vaccine provided protection seven days after the second dose and 28 days after the initial dose of the vaccine. The final goal of the trial is to reach 164 confirmed cases of coronavirus infection.

In a news release, the pharmaceutical giant said it plans to seek emergency use authorization from the US Food and Drug Administration soon after volunteers have been monitored for two months after getting their second dose of vaccine, as requested by the FDA.

Pfizer said it anticipated reaching that marker by the third week of November.

The Phase 3 trial of the Pfizer vaccine, made with German partner BioNTech, has enrolled 43,538 particpants since July 27. As of Sunday, 38,955 of the volunteers have received a second dose of the vaccine. The company says 42% of international trial sites and 30% of US trial sites involve volunteers of racially and ethnically diverse backgrounds.

“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis,” Pfizer CEO Albert Bourla said in a statement. “We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

Pfizer says it has added a secondary endpoint to its study. It will evaluate whether the vaccines protects people against severe Covid-19 disease and whether the vaccine can provide long-term protection against Covid-19 disease, even in patients who have been infected before.

The FDA has said it would expect at least 50% efficacy from any coronavirus vaccine.


By Nadia Kounang, CNN