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[Breaking] Covid19 vaccine developed by Pfizer more than 90% effective

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Pfizer ends COVID-19 trial with 95per cent efficacy, to seek emergency-use authorization
FILE PHOTO: Pfizer's logo is reflected in a drop on a syringe needle in this illustration taken Nov 9, 2020. (Photo: REUTERS/Dado Ruvic/Illustration)
18 Nov 2020 07:56PM (Updated: 18 Nov 2020 08:20PM)
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REUTERS: Pfizer Inc said on Wednesday that final results from the late-stage trial of its COVID-19 vaccine show it was 95per cent effective, adding it had the required two-months of safety data and would apply for emergency U.S. authorization within days.
The drugmaker said efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnicity demographics, and that there were no major side effects, a sign that the immunization could be employed broadly around the world.

Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94per cent.
The final analysis comes just one week after initial results from the trial showed the vaccine was more than 90per cent effective.
Moderna Inc on Monday released preliminary data for its vaccine, showing similar effectiveness.
The better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), have raised hopes for an end to a resurgent pandemic that has killed more than 1.3 million people globally and wreaked havoc upon economies and daily life.

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 43,000 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 2per cent of those vaccinated was fatigue, which affected 3.7per cent of recipients after the second dose. Older adults tended to report fewer and milder solicited adverse events following vaccination.
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.
(Reporting by Michael Erman in Maplewood, N.J., Additional reporting by Ankur Banerjee in Bengaluru; Editing by Bill Berkrot, Peter Henderson and Edwina Gibbs)
Source: Reuters/kv
 

Hypocrite-The

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Commentary: Can we be sure to be impressed with Moderna's vaccine trials?
The high efficacy rates of Moderna’s and Pfizer’s vaccines are promising, but it’s necessary to dig deeper to find out what exactly any new results may mean, says an observer.
A nurse prepares a shot as the world's biggest study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna, gets underway on Jul 27, 2020, in Binghamton, New York. (Photo: AP/Hans Pennink)
By Simon Kolstoe
18 Nov 2020 06:19AM (Updated: 18 Nov 2020 06:20AM)
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PORTSMOUTH, England: It is very exciting to hear another positive story about vaccine trial results – a good vaccine is the most likely way of ending the pandemic.
Last week, interim results from Pfizer suggested its vaccine reduces cases of COVID-19 with 90 per cent efficacy. Now Moderna has gone one better, with interim results showing nearly 95 per cent efficacy for its vaccine – with hints that it may protect against severe disease.

Neither have reported any serious safety concerns and have tested their vaccines in tens of thousands of participants.
With so many COVID-19 vaccines in development, more results are likely to follow in the coming months. Their headline figures may, like these, be very impressive, but it’s necessary to dig deeper to find out exactly what any new results mean.
READ: Commentary: Pfizer reaches COVID-19 vaccine breakthrough – a step closer to pandemic's end
LISTEN: The COVID-19 vaccine will be the biggest product launch in history. Can we pull it off?


VACCINE SAFETY
First, does this mean the vaccine is safe?
Almost certainly yes if it has successfully passed through a phase 3 trial with thousands of participants. Vaccines do not get this far if there are any major doubts about safety.
Historically, pharmaceutical companies have been able to suppress negative results, but it’s now legally required for all trials to post their results so that other scientists can review them.

As a consequence the sector is generally far more trusted than it used to be, although we should still be cautious if only interim results are being reported.
Some people are concerned that COVID-19 vaccines have been produced with unprecedented speed; however, the vast majority are based on platform technologies with excellent safety profiles.

FILE PHOTO: A scientist filters out samples during the research and development of a vaccine against the coronavirus disease (COVID-19) at a laboratory of BIOCAD biotechnology company in St Petersburg, Russia June 11, 2020. REUTERS/Anton Vaganov/File Photo

There are a few newer technologies being used, but the clinical trial and regulatory process is extremely rigorous and will pick up the majority of potential complications fairly early on in development.
Of course, it is still difficult to know yet about long-term side-effects, but these are rare for vaccines, and any risk is normally significantly lower than the risks from getting the disease being vaccinated against.
SUCCESS OF TRIALS
There’s the question if headline figures reflect what the trial was designed to measure.
Trials often measure many things, but there is always a single primary research question or objective that a trial has been designed to answer.
Trials will also have several secondary research questions, but answering these is not considered a mark of success. If you test enough different objectives, a few will always be met due to blind chance.
READ: Commentary: Why rushing a COVID-19 vaccine could spell disaster
Misrepresenting trial data in this way is a form of research misconduct called p-hacking. You can find out the primary and secondary objectives of any trial by checking a clinical trial registry.
Again, it is important to consider whether these are interim results. Although such results can be promising – as Pfizer and Moderna have shown – they are not guaranteed to be the final result.
READ: Commentary: COVID-19 may become the new seasonal flu
Determining what counts as a medicine or drug “working” can be quite complicated for many diseases. But for vaccines, the question to ask is quite simple: Did people who had the active vaccine get the disease?
Any measure that’s more complicated than this (often referred to as a surrogate outcome) should be treated with caution.
WHO THE VACCINE WAS TESTED ON
Are the results of a trial transferable to the real world? Here it’s important to understand the difference between a population (in this case everyone who can catch COVID-19) and the sample of that population who took part in the trial.

Tens of thousands of volunteers are participating in Phase 3 clinical trials for the Moderna and Pfizer vaccines. (Photo: AFP)

In many cases, trials use two carefully matched (and so comparable) samples in carefully controlled conditions.
One is given the vaccine and the other a placebo (such as saline injection or an already developed vaccine for another disease) to control for the effect of participants thinking they have been vaccinated – which does have an effect.
In phase 1 trials, safety concerns mean that samples are generally made up of young and fit people with few health concerns, who are probably not representative of the overall population.
However, as trials progress into later phases and get bigger, researchers try to ensure a more representative sample of the population. This is why the final-stage (phase 3) trials are so important, as the sample is chosen to represent the population that the vaccine is targeted at.
READ: Commentary: Who will get the COVID-19 vaccine Chinese companies are developing?
READ: Commentary: Could Indonesia be Southeast Asian hub for Chinese COVID-19 vaccine?

Formal publications of trial results normally provide a table describing who was in the sample, and often efficacy rates for the different groups (broken down by sex, age and so on).
Unfortunately, the headline efficacy figure (95 per cent for instance) may not apply evenly across the population.
This is very important for COVID-19, as we know older people are much more vulnerable. We therefore shouldn’t read too much into any results until we can see an age breakdown for efficacy.
PRACTICAL QUESTIONS
Before we get too excited, some practical questions must be asked. How much will the vaccine cost? Can it be made in bulk? Is it easy to transport and store? And how many boosters will be needed?
These logistic problems (for instance, the requirement to be stored and transported at very low temperatures) can easily prevent a new vaccine getting into the clinic.
READ: Commentary: The challenge of keeping COVID-19 vaccines at sub-zero temperatures during distribution

A worker moves boxes at Snowman Logistics, India's largest cold storage company in Taloja, on the outskirts of Mumbai, India, Oct 17, 2020. (Photo: AP/Rajanish Kakade)

It’s also an increasingly important skill to identify between reliable and unreliable sources. Social media is often superficial and prone to spreading misinformation.
On the other hand, journal articles and clinical trial registries can be hard to interpret for anyone except specialists.
Trusted journalism is the answer. Seek out publications with editorial oversight and a track record of reliable scientific and medical reporting. Reading more than one interpretation can help you get a balanced view.
READ: Commentary: Science goes viral, thanks to COVID-19. But there are roadblocks along the way
It’s also important to ask where a journalist found the information they are reporting on. Referencing results published in peer-reviewed journals is a good sign – it shows some rigorous fact checking has occurred.
Be careful if an article’s main sources seem to be preprints (papers not yet peer reviewed) or other so-called grey literature, such as press releases or company reports.
Likewise, be careful if the main source seems to be interviews or quotes from people with PhDs or impressive sounding job titles. A quote from a scientist in an interview is not equivalent to a quote from the same scientist in a peer-reviewed academic paper.
BOOKMARK THIS: Our comprehensive coverage of the coronavirus outbreak and its developments
Download our app or subscribe to our Telegram channel for the latest updates on the coronavirus outbreak: https://cna.asia/telegram
Simon Kolstoe is Senior Lecturer in Evidence-Based Healthcare and University Ethics Advisor, University of Portsmouth. This commentary first appeared on The Conversation.
 

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Oxford-AstraZeneca vaccine shows promise in elderly, trial results by Christmas
Posted 1dday ago, updated Yesterday at 5:03am
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Oxford-AstraZeneca COVID vaccine trial's early results show good response in elderly
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Oxford University and AstraZeneca's potential COVID-19 vaccine produced a strong immune response in older adults, newly published data has showed, with researchers expecting to release late-stage trial results by Christmas.
Key points:
  • Late stage Oxford-AstraZeneca trials have shown it develops antibody and T-cell responses in elderly patients
  • Rival drugmakers Pfizer-BioNTech and Moderna have recently pushed ahead in the race for a COVID vaccine
  • Researchers report no serious side effects from the Oxford-AstraZeneca vaccine
The data, reported in part last month but published in full in The Lancet medical journal on Thursday, suggest that those aged over 70, who are at higher risk of serious illness and death from COVID-19, could build robust immunity.
"The robust antibody and T-cell responses seen in older people in our study are encouraging," said Maheshi Ramasamy, a consultant and co-lead investigator at the Oxford Vaccine Group.
"We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure."
Catch up on the main COVID-19 news from November 21 with our coronavirus blog.
Australia's four COVID-19 vaccine 'deals'
A woman out of focus looking at a syringe.
Experts say the Government's move to lock in four different COVID-19 vaccines is "clever", but warn of significant hurdles to overcome before they can be distributed across the country.
Read more

Late-stage, or phase-three, trials are ongoing to confirm the findings, researchers said, and to test whether the vaccine protects against infection with SARS-CoV-2 in a broad range of people, including people with underlying health conditions.
Results of those trials should definitely be known by Christmas, the Oxford Vaccine Group's director Andrew Pollard said, adding it was too early to know whether and how well the vaccine works in preventing the COVID-19 disease.
"We're still waiting to get to the point where we can do the analysis to just work out how well the vaccine can protect people, and we're getting ever closer to that," he told journalists.
"We are optimistic that we'll be able to do that before Christmas, and obviously we'll share that with you as soon as we can at that point."
Earlier this month, Australian manufacturer CSL kicked off production of 30 million doses of the Oxford-AstraZeneca vaccine, despite it still undergoing clinical trials.
"We're making this ahead of time so should the clinical trial be positive with the outcome that we're looking for … the vaccine will be available in the short term to distribute to the population," said CSL's chief scientific officer Andrew Nash.
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Manufacturing of Oxford University's COVID-19 vaccine beginsRead more about coronavirus:
'It's not a competition'
The Oxford-AstraZeneca COVID-19 vaccine candidate had been among the front-runners in global efforts to develop shots to protect against coronavirus infection.
How are COVID-19 vaccines almost ready so quickly?
A scientist putting medication into a vial in a laboratory.
Previous vaccines have taken years to develop, so why are some COVID-19 candidates ready so quickly, and will they be safe?
Read more

But rival drugmakers Pfizer-BioNTech and Moderna have in the past 10 days edged ahead, releasing data from late-stage COVID-19 vaccine trials that shows more than 90 per cent efficacy.
"We're not in a rush. We and it's not a competition with the other developers," Oxford's Professor Pollard said, adding that AstraZeneca would release headline efficacy data before it was published in an academic journal.
Oxford University has set a target of 53 infections to start the interim analysis of its late-stage trial results, though "lots of cases" in its trial arms in Britain, South Africa and Brazil mean the exact number of infections reported could differ.
An employee wears a mask, goggles and hairnet at the Brazilian trials for the potential coronavirus vaccine developed by Oxford.

AstraZeneca has reached agreements with governments around the world including in Australia.(Reuters: Amanda Perobelli)
Unlike the Pfizer-BioNTech and Moderna shots, both of which use new technology known as messenger RNA, AstraZeneca's is a viral vector vaccine made from a weakened version of a common cold virus found in chimpanzees.
The Oxford-AstraZeneca Phase II trial reported in The Lancet involved a total of 560 healthy volunteers, with 160 aged 18-55, 160 aged 56-69, and 240 aged 70 or over.
Volunteers got two doses of the vaccine or a placebo, and no serious side effects related to the vaccine were reported, the researchers said.
AstraZeneca has signed several supply and manufacturing deals with companies and governments around the world.
The Federal Government signed a deal with AstraZeneca in August to lock in supply of the vaccine if trials prove successful.
Prime Minister Scott Morrison has promised to make the vaccine free for all Australians.
Reuters/ABC
 

gingerlyn

Alfrescian (Inf)
Asset
I still prefer China vaccine because it is made with Huawei 5G ingredient. UK and US vaccine are dubious. How can UK and US invent vaccine when they don’t even have 5G technology ?
 

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AstraZeneca and Oxford's COVID-19 vaccine shows 'an average efficacy of 70%' in trials
FILE PHOTO: Vials and medical syringe are seen in front of AstraZeneca logo in this illustration
FILE PHOTO: A photo illustration showing vials labelled "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe, in front of a displayed AstraZeneca logo. (Photo: REUTERS/Dado Ruvic)
23 Nov 2020 03:35PM
(Updated: 23 Nov 2020 04:22PM)
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LONDON: British drugs group AstraZeneca and the University of Oxford on Monday (Nov 23) said their jointly-developed vaccine against COVID-19 has shown "an average efficacy of 70 per cent" in trials.

"This vaccine's efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency," Pascal Soriot, AstraZeneca chief executive, said in a statement.

The results ranged between 62 and 90 per cent efficacy depending on the vaccine dosage.

The vaccine was 90 per cent effective in preventing COVID-19 when it was administered as a half dose followed by a full dose at least one month apart, according to data from the late-stage trials in Britain and Brazil.

Another dosing regimen showed 62 per cent efficacy when given as two full doses at least one month apart and the combined analysis from both dosing regimens resulted in an average efficacy of 70 per cent. All results were statistically significant.

No serious safety events related to the vaccine have been confirmed and it was well tolerated across both dosing regimens, it said.

The 70 per cent average is lower compared with the efficacy of coronavirus vaccines trialed by rivals Pfizer/BioNTech and Moderna which have come in above 90 per cent.

British Prime Minister Boris Johnson hailed the "fantastic" news that the vaccine could be up to 90 per cent effective, but said it still would require safety checks.

"Incredibly exciting news the Oxford vaccine has proved so effective in trials," Johnson said on Twitter. "There are still further safety checks ahead, but these are fantastic results."

The British drugmaker's preliminary trial results mark a fresh breakthrough in the fight against a pandemic that has killed nearly 1.4 million people and roiled the global economy.

The interim analysis was based on 131 infections among participants who received the vaccine and those in a control group who were given an established menengitis shot.

The data comes after US rivals published interim data in recent weeks showing efficacy of more than 90 per cent.

READ: Pfizer COVID-19 vaccine could get UK approval this week: Report
British Health Secretary Matt Hancock said it was "fantastic news" that data showed that the COVID-19 vaccine could be up to 90 per cent effective and reduce its transmission.

"These figures ... show that the vaccine in the right dosage can be up to 90 per cent effective," he told Sky News, after an announcement from AstraZeneca.

"We've got 100 million doses on order and should all that go well, the bulk of the rollout will be in the new year."

Hancock said AstraZeneca, Oxford and the medicine regulator would have to study the results to see how best to administer the vaccine once it was found to be safe.

"One of the things that regulator will need to look at is whether the programme for how the doses are done which can lead to the 90 per cent effectiveness figure, whether that is the appropriate way to take the Oxford vaccine forward," he told BBC TV.

He also said there was evidence in the report that the vaccine could reduce transmission of the disease.

"Now of course that would be very good news if confirmed, because obviously what we want to do is not only stop people from getting the disease but also stop its transmission," he said.

READ: Moderna to charge US$25 to US$37 for COVID-19 vaccine
On Nov 16, US-based Moderna Inc said its experimental vaccine proved to be 94.5 per cent effective based on an early data analysis.

A week earlier, Pfizer and Germany's BioNTech SE said their vaccine candidate had demonstrated greater than 90 per cent efficacy that rose to 95 per cent with analysis of full trial data.

Russia's Sputnik-V vaccine on Nov 11 was also shown to be more than 90 per cent effective, though only based on 20 infections.
 

tobelightlight

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There showing us a container full of Vaccine saying C-19 & dated 15th March 2020.

The Chicken or the Egg? The Vaccine or the Virus? What came first.

FB_IMG_1606193440923.jpg
 

3_M

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They just hastily make the grand announcement when the trial was anything but conclusive. It a marketing move aim at capturing the mass market shares.
 

Hypocrite-The

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Commentary: Why the Oxford AstraZeneca COVID-19 vaccine is a global game-changer
The Oxford AstraZeneca vaccine may only have an overall effectiveness of 70.4 per cent, but there are other success factors to consider, says an observer.

UK pharmaceutical giant AstraZeneca and its partner the University of Oxford are seeking regulatory
UK pharmaceutical giant AstraZeneca and its partner the University of Oxford are seeking regulatory approval for their vaccine after it showed an average 70-percent effectiveness, and up to 90 percent depending on the dosage AFP/JOEL SAGET
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SOUTHAMPTON, England: In the long dark tunnel that has been 2020, November stands out as the month that light appeared. Some might see it as a bright light, others as a faint light – but it is unmistakably a light.

On Nov 9, Pfizer announced the interim results of its candidate vaccine, showing it to be “more than 90 per cent effective” in preventing symptomatic COVID-19 in late-stage human trials. The news was greeted with joy.

A couple of days later, the Russian Direct Investment Fund announced that the candidate vaccine they are funding – dubbed Sputnik V – showed 92 per cent efficacy in late-stage trials.

Not to be outdone, Moderna then announced that its candidate vaccine showed 94.5 per cent efficacy.

READ: Pfizer-BioNTech COVID-19 vaccine deliveries could start 'before Christmas'
The latest COVID-19 vaccine announcement comes from Oxford University. And, as with all of the above announcements, it came via press release.

Its vaccine candidate, developed in partnership with AstraZeneca, showed an overall effectiveness of 70.4 per cent. In case that sounds disappointing, bear in mind that these are interim results and the figures might change.

Also, the Oxford vaccine was given to one group of volunteers as two standard doses, which showed 62 per cent effectiveness, and another group of volunteers as a smaller dose followed by a standard second dose. This raised effectiveness to 90 per cent.

It’s not immediately clear why this is the case. Professor Andrew Pollard, one of the lead researchers on the project, described the results as “intriguing”.

He also highlighted that the use of lower doses means that there would be more vaccine doses available.

Hopes for a virus vaccine have been dealt a blow by news that a trial by AstraZeneca and the
(Photo: AFP/JOE RAEDLE)
There were no cases of severe COVID-19 in those who received the vaccine. And it seems to generate a protective immune response in older people.

Although we’ll have to wait for the final breakdown of results to get clarification on that.

EFFECTIVENESS NOT THE ONLY MEASURE

Despite the Oxford vaccine having lower overall effectiveness than the Pfizer or Moderna vaccines – at least at this interim stage – there are other success factors to consider.

Safety is one, and the Oxford vaccine is so far reported to have a good safety record with no serious side-effects.

READ: Commentary: Can we be sure to be impressed with Moderna's vaccine trials?
Another crucial factor is storage. The Oxford vaccine can be stored in a domestic fridge.

The need for sustained freezing across the whole vaccine journey from factory to clinic at ultra-low temperatures – as seen with the Pfizer vaccine – may be a problem for many countries, but especially poorer countries.

READ: Commentary: The challenge of keeping COVID-19 vaccines at sub-zero temperatures during distribution
The Oxford vaccine, based on a viral vector, is also cheaper (around US$4) than Pfizer and Moderna’s mRNA vaccines – around US$20 and US$33, respectively. AstraZeneca has made a “no profit pledge”.

EQUITABLE DISTRIBUTION

As I have previously discussed, equitable distribution of new vaccines is vital, especially for low- and middle-income countries who don’t have the profile or purchasing power of wealthier countries.

FILE PHOTO: Coronavirus disease (COVID-19) vaccination study Research Centers of America
FILE PHOTO: Trial kits for Pfizer coronavirus disease (COVID-19) vaccination study are seen at the Research Centers of America, in Hollywood, Florida, U.S., September 24, 2020. REUTERS/Marco Bello
GAVI – a global health partnership that aims to increase access to immunisation in poor countries – has worked for years to address this very point. It set up the COVAX initiative in 2020, which has access to 700 million doses of COVID vaccine if clinical trials are successful.

Oxford and AstraZeneca have previously made their own commitments to provide a billion doses of their vaccine for low- and middle-income countries, with a commitment to provide 400 million doses before the end of 2020.

Certainly, AstraZeneca has committed to provide more doses to countries outside of Europe and the US than any of its nearest competitors.

READ: Commentary: The turning point in global fight against COVID-19 is approaching
AN EXCELLENT START

These commitments will clearly not be enough for immediate global coverage, but it is an excellent start. Around 9 per cent of the world’s population live in extreme poverty, and the health systems around them are fragile.

With promises for equitable vaccine distribution, there is hope that the poorer populations around the world will not be forgotten. The global health community must keep its focus on this area.

What does this announcement mean for the world? Potentially a huge amount.

READ: Commentary: Pfizer reaches COVID-19 vaccine breakthrough – a step closer to pandemic's end
But remember that the trials are not yet complete and, at the time of writing, the regulators have yet to approve any of the new vaccine candidates.

Even when those hurdles are cleared, we still need to vaccinate the world, which requires successfully navigating the complex obstacles of distance, terrain, politics, cold-chain logistics and human behaviour.

The global pandemic is not over and won’t be for a long time yet – but the light is getting brighter.
 

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AstraZeneca says its COVID-19 vaccine needs 'additional study'
AstraZeneca said the additional trial was not likely to delay regulatory approval in Britain and the European Union. (Photo: AFP/Joel Saget)
27 Nov 2020 03:31AM
(Updated: 27 Nov 2020 08:40AM)
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LONDON: The head of British drug manufacturer AstraZeneca said on Thursday (Nov 26) further research was needed on its COVID-19 vaccine after questions emerged over the protection it offers, but the additional testing is unlikely to affect regulatory approval in Europe.
Instead of adding the trial to an ongoing US process, AstraZeneca might launch a fresh study to evaluate a lower dosage of its vaccine that performed better than a full dosage, AstraZeneca chief executive Pascal Soriot was quoted as saying in a Bloomberg News report.
READ: UK asks regulator to assess AstraZeneca-Oxford vaccine amid questions
AstraZeneca and its partner, the University of Oxford, announced on Monday that it was seeking regulatory approval for the vaccine after it showed an average 70 per cent effectiveness.
That rate jumped to 90 per cent - similar to that in rival vaccines in development by Pfizer/BioNTech and Moderna - when an initial half-dose then a full dose was given to a sub-group of trial participants in error.
US scientists have said the higher rate of effectiveness came during tests in people aged 55 and under and was discovered by accident during the clinical trials.
The head of the Oxford Vaccine Group, Andrew Pollard, said this week that further evidence will be available next month, but the result was still "highly significant".
"Now that we've found what looks like a better efficacy, we have to validate this, so we need to do an additional study," said Soriot.
He said he expected that to be another "international study but this one could be faster because we know the efficacy is high, so we need a smaller number of patients".
The additional trial was not likely to delay regulatory approval in Britain and the European Union, Soriot said.
Asked about the Bloomberg report, an AstraZeneca spokesman said there was "strong merit in continuing to further investigate the half-dose/full dose regimen."
"We are further evaluating the data and will work with regulators on the best approach for further evaluation," he said.
"This would add to data from existing trials which are currently being prepared for regulatory submission."
There are high hopes for the AstraZeneca/Oxford vaccine, which Pollard has hailed as a "vaccine for the world" given that it could be cheaper to make, and easier to store and distribute.
It can be stored, transported and handled at normal refrigerated conditions of between two and eight degrees Celsius for at least six months.
Pfizer/BioNTech's offering requires temperatures of -70 degrees Celsius, driving up costs and potentially making it out of reach for lower and middle-income countries.
AstraZeneca/Oxford has also promised to provide its vaccine to the developing world on a non-profit basis.
WAIT AND SEE
The World Health Organization said it looked forward to the full publication of the data from the trial.
"On a review of the detailed data, we will be better positioned to understand the vaccine performance," it said.
READ: 'Infodemic' risks jeopardising COVID-19 vaccines: WHO
The chief medical officer for England, Chris Whitty, also cautioned against drawing premature conclusions, and urged patience until the data were published in peer-reviewed journals.
"It's always a mistake to make too many judgments early and in particular before the independent regulator has had a chance to look at the results," he told a news conference.
Helen Fletcher, professor of immunology at the London School of Hygiene and Tropical Medicine, said the safety data available on the vaccine had been "very robust".
"It's possible that a lower initial vaccine dose could result in higher vaccine efficacy ... More is not necessarily better when it comes to vaccines and immunotherapies," she said.
"It's also possible that a strong immune response to the first vaccine could effectively block an immune response to the second shot of the same virus."
READ: After year-long sprint, COVID-19 vaccines finally at hand
Fletcher's colleague, professor of pharmacoepidemiology Stephen Evans, said speculation about the age distribution in the trials was "not useful to anyone".
"We have good grounds for trusting that the regulation in this high-profile area will be done as carefully or more carefully for these vaccines than for any others in the past," he said.
Gillies O'Bryan-Tear, from the UK Faculty of Pharmaceutical Medicine, said "the eventual efficacy rate may change", but "the validity of the low dose/high dose group results are unlikely to be questioned".
"Even if they (the regulators) decided to ignore the results of the low dose/high dose group, the study of the high dose/high dose patients will still be strongly significant, but I think that it unlikely," he said.
 

Leongsam

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Former Pfizer VP: ‘No need for vaccines,’ ‘the pandemic is effectively over’
Patrick Delaney

19-24 minutes


November 23, 2020 (LifeSiteNews) – While Pfizer pharmaceutical made headlines announcing the imminent release of their COVID-19 vaccine, to much fanfare, a former Vice President and Chief Scientist for the company has flatly rejected the need for any vaccines to bring the COVID-19 pandemic to an end.
In a recent article, Dr. Michael Yeadon, who “spent over 30 years leading new [allergy and respiratory] medicines research in some of the world’s largest pharmaceutical companies,” and retired from Pfizer with “the most senior research position in this field,” wrote:
There is absolutely no need for vaccines to extinguish the pandemic. I’ve never heard such nonsense talked about vaccines. You do not vaccinate people who aren’t at risk from a disease. You also don’t set about planning to vaccinate millions of fit and healthy people with a vaccine that hasn’t been extensively tested on human subjects.
The British national’s comments come at the end of a comprehensive criticism of the Scientific Advisor Group for Emergencies (SAGE), a government agency of the U.K. tasked with advising the central government in emergencies. SAGE has played a predominant role in determining public lockdown policies in the U.K., including those recently implemented, as a response to the COVID-19 virus.
After pointing out that SAGE lacked essential expertise in the field they are addressing, with “no clinical immunologists” as members, Yeadon highlights two fundamental errors they have made in their presuppositions which cause their overall conclusions to go radically awry leading to the “torturing [of] the population for the last seven months or so.”
First Fundamental Error: “Ridiculous” presumption of 100% susceptibility
The first erroneous assumption SAGE makes is that “100% of the population was susceptible to the virus and that no pre-existing immunity existed.”
Yeadon states this notion is “ridiculous because while SARS-CoV-2 is indeed novel, coronaviruses are not. There’s no such thing as an ‘ancestor-less virus’.” Indeed, he points out, there are at least “four, endemic, common-cold inducing coronaviruses … [which] circulate freely in UK and elsewhere.” Those who have been infected by “one or more of these endemic, common-cold producing coronaviruses in the past, have a long-lived and robust [T-cell] immunity, not only to those viruses, but to closely related viruses. SARS-CoV-2 is one such closely-related virus.”
Striking once again at the competence of SAGE, Dr. Yeadon states, “To not expect such cross-over is … to demonstrate the lack of the requisite understanding to build a model reliable enough to use.”
Further, he states, that the common PCR test which is used for detecting COVID-19 “cases,” may come out positive when someone is infected with one of these common cold coronaviruses rendering this test that much less reliable. Of course, based on the final results of these tests, many thousands of individuals have been ordered to disrupt their lives and “self-quarantine” for up to 14 days.
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People of goodwill can disagree about the safety, efficacy and religious implications of a new vaccine for the coronavirus.
But, everyone should agree on this point:
No government can force anyone who has reached legal adulthood to be vaccinated for the coronavirus. Equally, no government can vaccinate minors for the coronavirus against the will of their parents or guardians.
Please SIGN this urgent petition which urges policymakers at every level of government to reject calls for mandatory coronavirus vaccination.
Fear of a disease - which we know very little about, relative to other similar diseases - must not lead to knee-jerk reactions regarding public health, nor can it justify supporting the hidden agenda of governmental as well as non-governmental bodies that have apparent conflicts of interest in plans to restrict personal freedoms.
The so-called "public health experts" have gotten it wrong many times during the current crisis. We should not, therefore, allow their opinions to rush decision-makers into policies regarding vaccination.
And, while some people, like Bill Gates, may have a lot of money, his opinion and that of his NGO (the Bill & Melinda Gates Foundation) - namely, that life will not return to normal till people are widely vaccinated - should not be permitted to influence policy decisions on a coronavirus vaccination program.
Finally, we must also not allow the rush by pharmaceutical companies to produce a new coronavirus vaccine to, itself, become an imperative for vaccination.
Unwitting citizens must not be used as guinea pigs for New World Order ideologues, or Big Pharma, in pursuit of a vaccine (and, profits) which may not even protect against future mutated strains of the coronavirus.
And it goes without saying that the production of vaccines using aborted babies for cell replication is a total non-starter, as the technique is gravely immoral.
However, if after sufficient study of the issue, a person who has reached the age of majority wishes to be vaccinated with a morally produced vaccine, along with his children, that is his business.
But we cannot and will not permit the government to make that decision for us.
Thank you for SIGNING and SHARING this petition, urging policymakers at all levels of government to reject mandatory coronavirus vaccination.
FOR MORE INFORMATION:
Bill Gates: Life won’t go back to ‘normal’ until population 'widely vaccinated' - https://www.lifesitenews.com/news/b...-to-normal-until-population-widely-vaccinated
COVID-19 scare leads to more digital surveillance, talk of mandatory vaccine 'tattoos' for kids' - https://www.lifesitenews.com/news/c...ce-talk-of-mandatory-vaccine-tattoos-for-kids
Trudeau says no return to ‘normal’ without vaccine: 'Could take 12 to 18 months' - https://www.lifesitenews.com/news/t...al-without-vaccine-could-take-12-to-18-months
Trudeau mulls making coronavirus vaccine mandatory for Canadians - https://www.lifesitenews.com/news/trudeau-mulls-making-coronavirus-vaccine-mandatory-for-canadians
US bishop vows to ‘refuse’ COVID-19 vaccine if made from ‘aborted fetal tissue' - https://www.lifesitenews.com/news/u...-19-vaccine-if-made-from-aborted-fetal-tissue
** While LifeSite opposes immorally-produced vaccines using aborted fetal cell lines, we do not have a position on any particular coronavirus vaccines produced without such moral problems. We realize many have general concerns about vaccines, but also recognize that millions of lives have been saved due to vaccines.

Finally, drawing from the scientific data, Dr. Yeadon concludes that due to previous exposure to common-cold coronaviruses, “a significant proportion (30%) of the population went into 2020 armed with T-cells capable of defending them against SARS-CoV-2, even though they had never seen the virus… SAGE was naively wrong to assume ‘everyone was susceptible’.”
Second Fundamental Error: An “amateur underestimate” of the infection rate
SAGE’s second erroneous assumption is “The belief that the percentage of the population that has been infected can be determined by surveying what fraction of the population has antibodies” developed due to infection with COVID-19.
Because of this assumption, “SAGE believes that less than 10% of the population have so far been infected by SARS-CoV-2.”
However, Yeadon clarifies that it’s “well understood that not every person, infected by a respiratory virus, goes on to produce antibodies. And many people, having prior immunity, never get properly infected anyway.”
While almost all of those with significant symptoms, who were admitted to a hospital, produce antibodies, those with “milder responses to the virus” do not “all produce antibodies.” Nevertheless, all of those infected have been shown to have “T-cells in their blood, capable of responding to SARS-CoV-2,” and thus they still develop immunity.
Drawing from two independent methods, which arrive at the same general conclusion, Yeadon demonstrates that the real infection rate is “in the mid-20s to low-30’s per cent,” and thus SAGE’s estimate of 7% “is a gross and amateur underestimate.”
Why it matters…“the pandemic is effectively over”
With a false presumption that 100% of the population is susceptible to the virus, along with only 7% having been infected, it is the view of SAGE, that “the pandemic has only just begun.” Yeadon clarifies, however, that this is “palpable nonsense.”
Since it is demonstrable that “around 30% of the population had prior immunity,” and if one includes some young children who are “resistant,” 40%, and while considering that the infection rate is “somewhere [in] the mid-20s to low-30s per cent,” this means that around 65 to 72% of the population currently has immunity to COVID-19.
And considering the reality of herd immunity, when susceptibility to a virus falls this low, at around 28 to 35%, “that population can no longer support an expanding outbreak of disease,” and thus the virus “wanes and disappears.”
Therefore, Yeadon concludes, “the pandemic is effectively over and can easily be handled by a properly functioning NHS (National Health Service). Accordingly, the country should immediately be permitted to get back to normal life.”
He further stipulates that he is “incandescent with rage at the damage” SAGE has “inflicted” on the U.K., charging that they have “either been irredeemably incompetent” or “dishonest,” and thus “they should be disbanded immediately and reconstituted,” as “they haven’t a grasp of even the basics required to build a model and because their models are often frighteningly useless.”
Concerns with Pfizer COVID-19 Vaccine: Severe complications
Despite an estimated 65 to 72% of the population now having immunity to COVID-19, a percentage which indicates a critical level of herd immunity, Operation Warp Speed in the United States appears intent to follow the globalist campaign advanced by Bill Gates and vaccinate all 328 million people in the nation with the Pfizerproduct or others emerging for approved distribution in the coming months.
Notwithstanding the fact that no vaccine has ever been successfully developed for any coronavirus, and such an endeavor would normally take years to safely and adequately complete, the Food and Drug Administration (FDA) has permitted the fast-tracking of this process skipping the standard stage of testing on animals to directly test these vaccines on humans.
Immediate results from some of these trials have included “severe” complications, involving headaches, fever, body aches and symptoms similar to a “severe hangover.” Further, as the New York Times emphasized, Pfizer’s initial claim that their vaccine was “more than 90 percent effective,” was “delivered in a news release, not a peer-reviewed medical journal. It is not conclusive evidence that the vaccine is safe and effective.”
Expected ‘high volume’ of adverse reactions
And given the enormous scale of the stated goal, of administering these chemicals to hundreds of millions of people, when there is normally some rate of severe complications to the use of vaccines, the negative results may be significant. For example, one study of influenza vaccines administered to adults over 65 years of age, found a rate of approximately 1% which experienced severe side effects. If a COVID-19 vaccine is merely similar for individuals in the same age bracket (54M in population), that would equate to 540,000 individuals in this age bracket alone who may need medical care in a hospital system which provides less than 925,000 total beds.
Curiously, there is evidence that at least the United Kingdom is preparing for a high number of adverse effects due to the COVID-19 vaccinations. That government’s Medicines & Healthcare products Regulatory Agency (MHRA), posted a bid request stating that “For reasons of extreme urgency,” they seek “an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs).” It goes on to explain that “it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine,” and that this “represents a direct threat to patient life and public health.”
New ‘unproven’ mRNA technology: 20% ‘serious injury rate’
Other concerns about the Pfizer vaccine is that it would be the first to use “an as-yet-unproven technology platform that relies on something called messenger RNA, usually shortened to mRNA.” Moderna, another corporation striving to develop a COVID-19 vaccine, is also venturing to utilize this mRNA platform. In May, Children’s Health Defense reported that clinical trials for Moderna’s vaccine had a 20% “serious injury rate” in its high-dose group.
Debi Vinnedge, executive director at Children of God for Life, a pro-life organization which specializes in the moral evaluation of vaccines, told LifeSiteNews, “f Moderna and Pfizer are the ones supplying the first rounds of vaccines and they mandate it, that could be a disaster. They are both using brand new technology with the mRNA that has never been used in a vaccine before and they are pushing this through in a matter of months of testing, rather than the typical 4-6 years of testing.”
Mandates and Public Distrust
With a push for vaccine mandates on the rise, and resistance for such invasive measures emerging in response, a recent study indicates a growing discomfort among Americans with vaccines overall.
A report from Civic Science (CS) indicates “a steady decline in the percentage of U.S. adults who say they’re ‘very’ comfortable with vaccines overall.” In fact, CS states, “the monthly percentage of those highly comfortable with vaccinations at large fell more than twenty percentage points since the start of 2020 (69% in January compared to October’s 47%).”
In addition, “only 22% percent of those surveyed say they would get the vaccine right away,” and CS concludes, “it’s clear that hesitancy to receive a future vaccine … is running rampant across the country” and this “sheds light on just how difficult it is for many to trust a future vaccine right now.”
Manipulation of the Public
Serving to counteract this trend, Yale University, in collaboration with the U.S. government, sponsored a study to determine the most effective means of persuading Americans to take the COVID-19 vaccine.
The study tests a variety of approaches, such as appeals to “Personal freedom,” “Economic benefit,” “Self-interest,” fears of “Guilt,” “Embarrassment,” and actually being a coward.
While several of the appeals are straightforward arguments, others hint at a willingness to use public shaming to elicit compliance.
One, for instance, “asks the participant to imagine the guilt they will feel if they don't get vaccinated and spread the disease,” with variants exchanging guilt with anger or embarrassment. Another suggests someone who refuses vaccination “doesn't understand how infections are spread or who ignores science.” Another declares that “those who choose not to get vaccinated against COVID-19 are not brave.”
The findings of this study will likely influence the messaging of state officials and academic institutions who have discussed mandating vaccination, as well as advertising campaigns surrounding a vaccine once it is completed.
Coercion of Black Communities and Children
Other strategies of coercion being developed include the “bundling” of vaccine mandates “with other safety net services,” for the poor, including “food security, rent assistance, and free clinic services” for “vulnerable populations,” with “Black and minority communities” receiving special mention.
And the District of Columbia (DC) is advancing a bill which circumvents parental consent when it comes to their minor children being given a vaccine. The “Minor Consent for Vaccinations Amendment Act of 2019,” states, “this bill permits a minor of any age to consent to receive a vaccine where the vaccination is recommended by the United States Advisory Committee on Immunization Practices. It also establishes that if a minor is able to comprehend the need for, the nature of, and any significant risks inherent in the medical care then informed consent is established.”
According to The Vaccine Reaction, “The bill would not only permit children aged 11 years and older to give consent for doctors and other vaccine administrators to give them vaccines without their parents’ knowledge or consent, but would also require insurance companies, vaccine administrators and schools to conceal from parents that the child has been vaccinated.”
The report clarifies, “If this bill passes, it is clear that minor children will be at risk of being pressured and coerced into getting a COVID-19 vaccine behind their parents’ back.”
 

tobelightlight

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Loyal
How can you own a patent on a naturally occuring entity - YOU CANNOT - so how can anyone own a patent on a vaccine that "they" claim is made of naturally occuring virus entities? YOU CANNOT - they have to be genetically modified, so to speak, into a new organism in order for anyone to own a patent on it. If you don't understand vaccine immunity or natural immunity for that matter, please look it up to help you understand. If you want to be injected with "foreign" entities, that the body does not recognize as self, you run the risk of launching a cytokine storm which is a natural reaction to an outside invader, which could lead to a very severe autoimmune condition or worse, if you already have a weakened immune system. If you value your body, your sovereignty and your well being - you will question what is being proposed - stand firm and don't hold your arm out except to help your brothers and sisters get through this mess!
 

Hypocrite-The

Alfrescian
Loyal
Why Oxford's COVID-19 vaccine could do more for the world than other shots
Australia's biggest vaccine bet Oxford University has announced trials have shown its jab is up to 90 per cent effective.
The stated 70 per cent average efficacy was significantly lower than the 94.5 per cent to 95 per cent reported by the other two leading candidates, Moderna and Pfizer.
Yet this vaccine could still prove to be more valuable for the world than the other two in the coming months. If the questions over its results are answered and it receives approval, it may lead the way in providing vaccine coverage in poorer countries where it is urgently needed.
Oxford vaccine trial
In this Thursday, April 23, 2020 file screen grab taken from video issued by Britain's Oxford University, showing a person being injected as part of the first human trials in the UK to test a potential coronavirus vaccine, untaken by Oxford University in England. (AP)
The UK government took the first step in that approval process on Friday, announcing that it had formally referred the candidate to the UK's medicines regulator for assessment.
"[T]he Pfizer vaccine is committed to its initial doses going to the EU and the US. And Moderna's supply will be tied up with the US for at least probably the first half of 2021, so in light of that, the Oxford/AstraZeneca vaccine is really good news for the rest of the world," Andrea Taylor, assistant director of programs at Duke Global Health Innovation Center, told CNN.
AstraZeneca has promised to supply hundreds of millions of doses to low and middle income countries and to deliver the vaccine on a not-for-profit basis to those nations in perpetuity. The vaccine developed at England's Oxford University is significantly cheaper than the others and, crucially, it would be far easier to transport and distribute in developing countries than its rivals since it does not need to be stored at freezing temperatures.
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A researcher in a laboratory at the Jenner Institute in Oxford, England, works on the coronavirus vaccine developed by AstraZeneca and Oxford University. (AP)
"I think it's the only vaccine that can be used in those settings at the current time," Azra Ghani, chair in infectious disease epidemiology at Imperial College London, told CNN.
The technology
The Oxford/AstraZeneca vaccine can be kept at refrigerator temperatures of 2 to 8 degrees Celsius for at least six months. Moderna's vaccine has to be stored at -20C — or at refrigerator temperatures for up to 30 days — and the Pfizer/BioNTech vaccine has to be stored at -75C, and used within five days once refrigerated at higher temperatures.
"Pfizer and Moderna require freezer storage, and that just isn't in place in many settings," Ghani said.
"Cold chain" refrigeration is the standard storage used globally to deliver vaccines from central locations to local health clinics. AstraZeneca's vaccine is so far "the only one that can definitely be delivered to those systems," added Ghani.
The vaccines are based on different technology. AstraZeneca's offering — like Johnson & Johnson's vaccine and Russia's Sputnik V — uses an adenovirus to carry genetic fragments of coronavirus into the body.
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A file photo of a University of Oxford researcher working on the vaccine. (AP)
The Moderna and Pfizer vaccines use pieces of genetic material called messenger RNA (mRNA) to prompt the body to make synthetic pieces of the coronavirus and stimulate an immune response. "This is a relatively new technology and little is known about the stability of mRNA over time," Penny Ward, chair of the Education and Standards Committee of the UK's Faculty of Pharmaceutical Medicine, told CNN.
She said that as Moderna and Pfizer build up information and manufacturing capacity, they may be able to find storage methods at higher temperatures, but the Oxford vaccine "has the potential to be able to be shipped more readily around the globe" using existing supply chains.
It will only be of value, however, if the vaccine's levels of efficacy are maintained while it's distributed in developing countries.
AstraZeneca this week said trials showed that one dosing regimen produced 62 per cent efficacy while the other achieved 90 per cent, giving an average of 70 per cent. This is a good result, comparable to the flu vaccine, but not as high as Pfizer's 95 per cent and Moderna's 94.5 per cent. The 90 per cent figure is based on a sampling of 2,741 participants, which is a relatively small number.
A general view of AstraZeneca offices and the corporate logo in Cambridge, England (Photo: July 2020)
A general view of AstraZeneca offices and the corporate logo in Cambridge, England (Photo: July 2020) (AP)
Moncef Slaoui, chief adviser to the US government's Operation Warp Speed, said this week that there were "a number of variables that we need to understand" around the dosage and age differences in the Oxford/AstraZeneca results, after which the ongoing US trial might need to be modified.
On Thursday, a spokesperson for AstraZeneca told CNN that they were currently in discussions with the FDA about including the half-strength dose regimen into their US trials, which currently has around 10,000 participants.
Ayfer Ali, associate professor of international business at Warwick Business School, said the "distribution simplicity" of the AstraZeneca vaccine could "possibly make up for the lower potential efficacy."
"The actual efficacy of the mRNA vaccines that are more fragile to transport and store may be lower in real world conditions where correct storage of each dose may be hard to verify," she added.
BioNTech said last week it was working with Pfizer to come up with a formulation that would allow storage of its vaccine at standard temperatures by the second half of 2021. Moderna this month extended its estimate for how long its vaccine could remain stable at refrigerator temperature from an estimated seven to 30 days. This, according to Moderna's Chief Technical Operations and Quality Officer Juan Andres, "would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world."
Pledging to help
AstraZeneca has pledged 300 million doses of its vaccine to COVAX, a partnership between GAVI, the vaccine alliance; the World Health Organization; and the Coalition for Epidemic Preparedness Innovations (CEPI) for ensuring equitable distribution to 92 developing countries. The only other known vaccine developer that has made a pledge of a similar scale is Sanofi, at 200 million doses.
A GAVI representative told CNN that the Serum Institute of India (SII) and Bill and Melinda Gates Foundation would also provide up to 200 million doses of the AstraZeneca and/or Novavax candidate vaccines to lower-income countries. Moderna and Pfizer have not pledged any doses to COVAX.
This could mean AstraZeneca has more manufacturing capacity than other pharmaceuticals thanks to its links to industry giants such as the SII through CEPI.
A vial of the coronavirus vaccine developed by AstraZeneca and Oxford University, in Oxford, England. (AP)
"[AstraZeneca has] been working with manufacturing experts in that coalition to help source a variety of different manufacturing sites, and of course it's not just the vaccine itself, it's also the glass vials that it goes into, the stoppers that go on top of the bottles, and syringes and needles," said Ward.
AstraZeneca says it expects to be able to have capacity to produce up to 3 billion doses of the vaccine in 2021 on a rolling basis. Pfizer/BioNTech says it can manufacture up to 50 million doses in 2020 and 1.3 billion in 2021, while Moderna says it expects to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year beginning in 2021.
After calls for transparency from groups such as Medicins Sans Frontieres and Global Justice Now, AstraZeneca and Oxford confirmed that the partnership would deliver the vaccine on a not-for-profit basis until at least July 2021 worldwide, and in perpetuity to low and middle income countries.
The Oxford vaccine is cheaper than the others, at approximately US$3 to US$4 ($4 to $6) per dose in contrast to about US$20 ($27) for the Pfizer vaccine and US$32-37 ($43-50) for the Moderna vaccine.
In this November 9 file photo walk past Pfizer world headquarters in New York. Pfizer announced November18, 2020, more results in its ongoing coronavirus vaccine study that suggest the shots are 95 per cent effective a month after the first dose (AP)
"Our vaccine can be deployed quickly in existing health settings, which will help to stop the further spread of this disease while we learn more and more about how to prevent and treat it," a spokesman for Oxford University told CNN. He added that a range of vaccines would be needed and some could be more effective for different ages and populations.
"The key with any vaccine is the potential for impact on public health, including how quickly it can be distributed. Ours can be quickly and easily distributed around the world, using existing logistics, and easily stored in a fridge," he said.
Global implications
COVAX will be critical in getting the vaccine to low and middle income countries, modeling by Duke University shows. The initiative aims to provide 2 billion doses by the end of 2021 to protect high-risk groups around the world and eventually enough doses to cover 20 per cent of those countries' populations.
However, Ghani warned that 20 per cent was "nowhere near the ideal — around 70 per cent — that we would like to see to be able to achieve herd immunity, so some countries will still fall short."
She said that it was vital for everyone that the global population is vaccinated, to enable travel and movement across borders. Rolling out the vaccine to the world could take until 2023, according to current models -- not to mention the potential need for booster shots.
"Access to safe and efficacious COVID-19 vaccines for the most vulnerable groups everywhere in the world is the only way to bring the acute stage of this pandemic under control," said Dr Seth Berkley, CEO of Gavi, as he welcomed the news on the Oxford vaccine in a statement this week.
Pfizer vaccine vials (Pfizer)
Duke's modelling shows that while wealthier countries have purchased billions of doses in advance to increase their chances of covering their population, the developing world will be entirely reliant on COVAX.
Bill Gates said the solution was "not shaming the rich countries that are doing the natural thing of wanting to protect their people," but was to vastly increase manufacturing capacity.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, warned that monitoring efficacy and safety issues would be an ongoing challenge in the developing world.
"There may be some adverse effects that would only be apparent in those low and middle income countries; they have different diets, they have different levels of nutrition in general, and different characteristics," he told CNN.
While Oxford's vaccine may have particular promise at this stage for helping lower income countries, there are still many caveats over the data that must be resolved before it can be rolled out.
Ultimately, it will be vital to have as many vaccines as possible, to ensure a faster recovery and limit further damage to the world.
 

Hypocrite-The

Alfrescian
Loyal
Moderna continuing 'rolling review' process for use of COVID-19 vaccine in Singapore
Screengrab of a video showing a researcher in a lab run by Moderna. (Photo: Moderna/Handout via REUTERS)
01 Dec 2020 10:31PM
(Updated: 01 Dec 2020 10:40PM)
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SINGAPORE: Moderna is "forging ahead" with the "rolling review" process for its COVID-19 vaccine candidate with Singapore's Health Sciences Authority (HSA), the American biotechnology company said in a press statement on Monday (Nov 30) night.
The announcement followed the results of a late-stage Phase 3 study involving about 30,000 participants in the United States, which showed that the vaccine was 94.1 per cent effective against COVID-19 and 100 per cent effective in preventing severe cases.
A rolling review expedites the review process by allowing the developer of a drug or vaccine to submit sections of their application as they are completed, according to the US Food and Drug Administration (FDA) website.
Apart from Singapore, Moderna said it has also started the rolling review process with authorities in the European Union, Canada, Switzerland, the United Kingdom and Israel.
It is also seeking emergency use authorisation for its vaccine in the US and EU, and prequalification or emergency use listing with the World Health Organization.
"This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 per cent efficacy and importantly, the ability to prevent severe COVID-19 disease," said Moderna CEO Stephane Bancel in the statement.
"We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death."
He added: "We will file today for an emergency use authorisation from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe."
CNA has contacted HSA for more information on the review.
Moderna said it expects to have about 20 million doses of its vaccine, which uses the concept of messenger RNA or mRNA, available in the US by the end of 2020.
It remains "on track" to manufacture 500 million to 1 billion vaccine doses globally in 2021, the company added.
READ: Expert committee to 'leverage scientific and clinical expertise' to assess COVID-19 vaccines – MOH
Moderna is among several drugmakers racing to develop a safe and effective vaccine for the coronavirus, which has killed more than 1.4 million people globally.
American pharmaceutical company Arcturus Therapeutics Holdings and Duke-NUS Medical School are also jointly developing a COVID-19 vaccine that started human trials in August.
Singapore's vaccine strategy is advised by an expert committee that comprises experts in infectious diseases, immunology and other relevant fields.
"The expert committee will leverage scientific and clinical expertise to assess vaccine candidates, and recommend the appropriate vaccines for use against COVID-19 in Singapore when they become available," the Ministry of Health said in announcing it to the public last month.
 
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