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Pfizer now says its Covid-19 jab is safe, 95% effective and will be ready for approval by the end of the week... days after Moderna's breakthrough

Pfizer now says its Covid-19 jab is safe, 95% effective and will be ready for approval by the end of the week... days after Moderna's breakthrough
  • Pfizer and BioNTech say they have now completed a final stage clinical trial of their Covid-19 vaccine
  • Final results show it has 95% efficacy, with over 94% even in at-risk elderly people – up from 90% early result 
  • A second vaccine by Moderna bettered Pfizer's 90% trial result last week, claiming 94.5% in release this week
  • Pfizer says it now has enough safety data to apply for a licence in the US and other countries 'within days' 
  • UK has bought 40million doses of Pfizer's vaccine and could get 10m this year, distributing from December 1

Pfizer and BioNTech today revealed they can prove their coronavirus vaccine is safe and up to 95 per cent effective at preventing Covid-19.

Their announcement comes just days after rival firm Moderna claimed its own jab was 94.5 per cent effective, and is an improvement on Pfizer's early estimate that the vaccine was 90 per cent effective.

Pfizer made the newest claim about its vaccine in a statement confirming the third stage of the trial has now been running for long enough that it can submit the required two months' worth of safety data to regulators, and that it would do so in the US and UK 'within days'.

Britain has already pre-ordered 40million doses of the vaccine and could be set to get 10m of those next month, with the NHS gearing up to start a major Army-backed operation to deliver it from as soon as December 1.

UK drug regulator the MHRA has been doing a 'rolling review' of the vaccine and could, as a result, complete the approval process within days of receiving the company's application.

Final trial results showed that only eight people out more than 20,000 who got the vaccine caught coronavirus in the study, compared to 162 who were given a fake jab. A total of 10 people got severe Covid-19, one of whom had been given the real vaccine.

An independent safety committee 'has not reported any serious safety concerns related to the vaccine' since the final stage trial began in July, Pfizer said. Side effects were limited – the most common was fatigue, which 3.8 per cent of people got, and headaches (2 per cent). The company said side effects were less common in older people and insisted that the vaccine works just as well for over-65s, who are known to be most vulnerable to the disease.

Questions were raised when Moderna announced its results on Monday about whether the UK had hitched its wagon to the wrong project, ordering 40m doses of Pfizer's jab – then thought to be 90 per cent effective – but none of Moderna's.

The updated data from Pfizer and BioNTech should reassure critics but the Government still faces the mammoth task of transporting and storing the jab, which may need expensive specialist freezers and huge supplies of dry ice to keep it at the required -70°C (-94°F). Moderna's, meanwhile could be kept in normal fridges and freezers at between -20°C (-4°F) and 8°C (46°F).

Pfizer and BioNTech today upgraded the estimate of how effective their vaccine is, taking it from 90 per cent in interim clinical trial results to 95 per cent today (stock image)

Pfizer and BioNTech today upgraded the estimate of how effective their vaccine is, taking it from 90 per cent in interim clinical trial results to 95 per cent today (stock image)

Pfizer and BioNTech's vaccine works by using genetic material called RNA from the coronavirus to trick the body into making the 'spike' proteins that the virus uses to latch onto cells inside the body, and then training the immune systems to attack the spikes

Pfizer and BioNTech's vaccine works by using genetic material called RNA from the coronavirus to trick the body into making the 'spike' proteins that the virus uses to latch onto cells inside the body, and then training the immune systems to attack the spikes

More than 40,000 volunteers from countries around the world are taking part in trials of Pfizer and BioNTech's vaccine. Pictured: A woman in Cincinnati receives the jab

More than 40,000 volunteers from countries around the world are taking part in trials of Pfizer and BioNTech's vaccine. Pictured: A woman in Cincinnati receives the jab

US-based Pfizer developed the vaccine alongside German pharmaceutical company BioNTech using genetic material from the virus which can be injected to force the body's own cells to create 'spike' proteins that the immune system can practise on (Pictured: A technician in a Pfizer lab in St Louis, Missouri)

US-based Pfizer developed the vaccine alongside German pharmaceutical company BioNTech using genetic material from the virus which can be injected to force the body's own cells to create 'spike' proteins that the immune system can practise on (Pictured: A technician in a Pfizer lab in St Louis, Missouri)

In other coronavirus developments: 

  • Christmas get-togethers look set to be given the green light but it will mean living with bolstered lockdown measures before and after the festive period that could jeopardise New Year, officials warned;
  • Boris Johnson refused to apologise after a devastating report laid bare the Government's £18billion rush to source PPE during the coronavirus crisis and claims Conservative cronies were given VIP access to lucrative contracts;
  • Testing tsar Baroness Dido Harding revealed that she has been ordered to self-isolate by her own coronavirus contact tracing app;
  • One in eight coronavirus cases were placed in the wrong areas between September and November because students' test results were pinned to their home addresses, it was revealed; 
  • Immunity to coronavirus lasts at least eight months, according to data that suggests survivors could be protected for years; 
  • Britons could be required to show QR codes on their phones to prove they have been vaccinated against Covid-19 in order to attend football matches, the theatre and other events, it was suggested.

Professor Trudie Lang, a global health expert at the University of Oxford, said: 'Today’s update from Pfizer provides further encouraging news and more detail on the protection against disease that their vaccine is showing from this definitive phase three trial. 

'The detail on achieving 94 per cent protection in the elderly participants in the trial is particularly excellent news...

HOW DO THE PFIZER/BIONTECH AND MODERNA VACCINES COMPARE? 

Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.

Here's how they compare: 

CREATOR:

MODERNA (US)

PFIZER (US) & BIONTECH (DE)

How it works: 

mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making 'spike' proteins and learning how to attack them.

mRNA vaccine – both Moderna's and Pfizer and BioNTech's vaccines work in the same way.

How well does it work?

94.5% effective (90 positive in placebo group, 5 positive in vaccine group) 

90% effective (estimated 86 positive in placebo group, 9 positive in vaccine group)

How much does it cost?

US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose; $30.50 (£23.14) per person.

US will pay $1.95bn (£1.48bn) for the first 100m doses, suggesting a cost of $19.50 (£14.80) per dose; $39 (£29.61) per person.

Can we get hold of it?

Vaccine is not expected to be available to Europe until spring 2021, the UK Government says. Moderna will produce 20m doses this year, expected to stay in the US. 

UK has already ordered 40million doses, of which 10million could be available in 2020. First vaccinations expected in December.

What side effects does it cause? 

Moderna said the vaccine is 'generally safe and well tolerated'. Most side effects were mild or moderate but included pain, fatigue and headache, which were 'generally' short-lived. 

Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee 'has not reported any serious safety concerns'

'We will need to wait and learn over time how long the protection lasts, and to see whether this vaccine can also prevent transmission – meanwhile, this vaccine does look likely to have a strong role immediately once it is approved in protecting health workers and the vulnerable from disease.'

Professor Lang added: 'This is a remarkable and very reassuring situation that we find ourselves in. To go from identifying a new virus to having several vaccines at the point of applying for regulatory approval is an incredible milestone for science.'

If there is a stumbling block for the vaccine between now and the time it can be given to members of the public in Britain, it will likely be linked to how the vaccine is stored. 

Pfizer and BioNTech's product has to be stored at temperatures below -70°C (-90°F) because if it becomes warmer than this before the time it needs to be used it could become chemically unstable and fail to work properly. 

To combat the issue, the American drug maker has designed a special suitcase-sized box to help deliver the vaccines.

But according to leaked Pfizer documents, the suitcases containing the doses can only be opened for a minute at time and not more than twice a day, making it difficult to supply the doses to patients. 

It means transporting and storing the vaccine at most pharmacists, GP surgeries and hospitals will be a logistical headache.  

Oxford University testing expert and adviser to the Government, Sir John Bell, said this month said the development was a huge breakthrough as long as officials don't 'screw up' the cold chain. 

Moderna's jab, on the other hand, can be stored in a normal fridge for up to a month before it is given out, meaning it will be cheaper to store and distribute. Although it must be shipped at -20°C (-4°F), this is not too cold for normal freezers to handle.

That vaccine will not be ready until spring 2021, though, and top medics say it is more important to have a vaccine as soon as possible than to wait for one that is more effective or easier to transport. 

Pfizer today revealed it had now got the two months of safety data it needed to apply for a vaccine licence from the US's Food and Drug Administration (FDA) and would submit the same information to international regulators.

The drugmaker said the vaccine seemed to work 'consistently' well on people across all age groups and ethnicities, which is crucial for protecting elderly and non-white communities, who are most at risk from severe Covid-19. This also means that the vaccine will be useful for countries all over the world and not just Western Europe and the US.

Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94 per cent.

The vaccine, named BNT162, is split into two doses given three weeks apart, with the study measuring results starting 28 days after the first dose of the jab, when immunity is thought to be established.

It is not yet clear how long protection against coronavirus will last for in people who get the vaccine – only the coming months, years and potentially decades of follow-up will confirm this. The study will continue for at least another two years.

BioNTech CEO Ugur Sahin said: 'We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against Covid-19 can be achieved very fast after the first dose, underscoring the power of BNT162 in providing early protection.'

The final analysis comes just one week after initial results from the trial showed the vaccine was more than 90 per cent effective.

Moderna on Monday released preliminary data for its vaccine, showing similar effectiveness at 94.5 per cent.

Reacting to today's news, Professor Stephen Evans, an epidemiologist at the London School of Hygiene & Tropical Medicine, said: 'This announcement in a press release is very good news indeed. There are now rather more data accrued with, it is said, no serious side effects.

'It seems there is some evidence that in older adults (but we do not have data in detail and there are probably no data for 80 years and older) there is also very good efficacy with minimal side effects. This is again very good news, not just for this vaccine, but as it also makes it more likely that other vaccines will also be reasonably effective in older adults.

'There is also good news that severe COVID-19 is reduced as well as mild disease. Again, there is considerable uncertainty because results are based on only 10 cases, but this is nevertheless good evidence that the vaccine protects against severe disease. Differences between vaccines cannot be concluded on the basis of these results.' 

PFIZER CEO SAYS FIRM DIDN'T CONSPIRE WITH ANYONE AFTER TRUMP ACCUSED OFFICIALS OF DELAYING RESULTS OF TRIAL UNTIL AFTER THE ELECTION

'We didn't conspire with anyone, of course. The election was an artificial line. It may have been important to the president, but it wasn't for us,' Pfizer CEO Albert Bourla said at a conference on Tuesday

'We didn't conspire with anyone, of course. The election was an artificial line. It may have been important to the president, but it wasn't for us,' Pfizer CEO Albert Bourla said at a conference on Tuesday

The CEO of drugmaker Pfizer has claimed the company 'didn't conspire with anyone' to delay releasing efficacy results for its COVID-19 vaccine until after the U.S. presidential election.

'We didn't conspire with anyone, of course. The election was an artificial line. It may have been important to the president, but it wasn't for us,' CEO Albert Bourla said at a conference on Tuesday.

Pfizer drew scrutiny after announcing trial results showing its vaccine is 90 percent effective on November 9, two days after Joe Biden was declared winner of the election, despite previously insisting the results would be known by the end of October.

President Donald Trump raged at the discrepancy, accusing the Food and Drug Administration of imposing restrictions to delay the results of the trial.

'As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn't have the courage to do it before,' he tweeted after the results were published.

The better-than-expected data from the two vaccines have raised hopes for an end to the pandemic, which has killed more than 1.3million people globally and at least 52,000 in the UK.

However, while some groups such as healthcare workers will be prioritized in the United States for vaccinations this year, it will be months before large-scale rollouts begin.

Pfizer said on Wednesday there had been 170 cases of the disease in its trial of more 43,661 volunteers, of which 162 were observed in the placebo arm and 8 were in the vaccine group.

Ten people developed severe COVID-19, one of whom received the vaccine.

It also said the vaccine was well-tolerated and that side effects were mostly mild to moderate and cleared up quickly.

The only severe adverse event that affected more than 2 per cent of those vaccinated was fatigue, which affected 3.7 per cent of recipients after the second dose. Older adults tended to report fewer and milder solicited adverse events following vaccination.

Pfizer's phase three trial was carried out at 150 clinical sites in six different countries, including 39 US states.

Four out of 10 trial participants were aged between 56 to 85, as researchers were particularly focused on assessing if the jab could protect the most vulnerable - the elderly.

Almost half (42 per cent) of the trialist were from black, Asian or ethnic minority (BAME) backgrounds - who have been disproportionately affected by the pandemic. 

Broken down, 26.1 per cent of participants were Hispanic or Latino, 10 per cent were black, 4.5 per cent were Asian and 0.8 per cent were Native American.

The results come as the virus is running rampant in the United States, Europe and elsewhere, placing an enormous strain on healthcare systems with record numbers of new cases and hospitalizations.

The approach of winter in the northern hemisphere in tandem with the holiday season is expected to worsen case numbers as people spend more time indoors and get together for family gatherings.

'With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,' Pfizer CEO Albert Bourla said in a statement.

Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world as well as the United States. They also plan to submit data from the study to a peer-reviewed scientific journal.

Pfizer reiterated it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year. 

It comes after Pfizer's chief executive officer yesterday claimed the company 'didn't conspire with anyone' to delay releasing efficacy results for its Covid-19 vaccine until after the US presidential election.

'We didn't conspire with anyone, of course. The election was an artificial line. It may have been important to the president, but it wasn't for us,' Albert Bourla said.

Pfizer drew scrutiny after announcing early trial results on November 9, two days after Joe Biden was declared winner of the election — despite previously insisting the results would be known by the end of October.

President Donald Trump raged at the discrepancy, accusing the Food and Drug Administration (FDA) of imposing restrictions to delay the results of the trial.

'As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn't have the courage to do it before,' he tweeted after the results were published. 

'Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!

'The @US_FDA and the Democrats didn't want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later - As I've said all along!'

Bourla also came under scrutiny after it was revealed that he sold 60 percent of his Pfizer shares on the same day that the trial results were announced.

It was part of a pre-arranged trade that he set up in August, but the timing of the vaccine trial announcement allowed him to cash in on the surge in Pfizer's share price.

THE SIX CORONAVIRUS VACCINES BRITAIN HAS PRE-ORDERED

BIONTECH/PFIZER - 40MILLION

This is the first coronavirus vaccine so far that has been shown to work, having been found to be 90 per cent effective in a trial of more than 43,000 people.

There are some concerns about the two-dose jab, because it needs to be largely kept in ultra-cold storage at around minus 70C.

But the interim results suggest it is one of the most successful vaccines ever developed. It uses genetic code in a fat droplet to instruct the body to make the coronavirus spike protein, which causes the body's immune system to produce antibodies.

Ugur Sahin and his wife Oezlem are the brains behind the vaccine and the German couple's company BioNTech is developing it with US pharmaceutical giant Pfizer. The UK is promised ten million doses by the end of the year, and 30million next year. So far only hundreds of thousands have been produced.

OXFORD UNIVERSITY/ ASTRAZENECA - 100MILLION

Results on this vaccine are hoped for this week. Up to 100million doses have been promised to the UK, and 13,000 British volunteers have taken part in global trials.

The vaccine uses a deactivated chimpanzee cold virus, containing genetic code which triggers cells to produce the spike protein on the outside of the coronavirus, so the body can recognise it and fight it off.

JANSSEN - 30MILLION

An international trial of 30,000 people, including 6,000 in the UK, starts today, measuring the effectiveness of two vaccine doses. It works like the Oxford vaccine, but uses a common cold virus to deliver the genetic code which triggers cells to produce the spike protein of the coronavirus.

NOVAVAX VACCINE - 60MILLION

The vaccine from US biotech firm Novavax began being tested in a UK study in September and has so far recruited 10,000 people.

The vaccine contains a synthesised copy of the coronavirus spike protein and a 'booster' to enhance the immune response. There are 60million doses promised to the UK, which it is hoped will be available by mid-2021.

VALNEVA - 60MILLION

This is a traditional vaccine unlike the more innovative design from BioNtech. The immune system is safely exposed to an inactivated version of the coronavirus.

Up to 190million doses are promised to the UK, although it has not yet been tested on people. Up to 100million of those are set to be manufactured at the company's facilities in Livingston, near Edinburgh. It is not expected to be available until late next year.

GSK/SANOFI - 60MILLION

British drugs giant GlaxoSmithKline has reportedly already manufactured millions of doses of a 'booster' for three vaccines.

The firm is providing its adjuvant technology and has partnered with Sanofi, Medicago and Clover Pharmaceuticals. The first results on whether one of the three traditional protein-based vaccines work are expected in the first half of next year. 

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