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AstraZeneca will likely conduct a NEW global coronavirus vaccine study, says the CEO


England's chief medical officer dodged to give his full support to the AstraZeneca rush when the company announced it would conduct a new vaccine study at Oxford University after an accidentally lower dose blocked 90 percent of infections in participants .

Chris Whitty refused to endorse it at a press conference on Downing Street Thursday night amid controversial data from the late trials.

Professor Whitty said the vaccine’s effectiveness and safety judgment should be in the hands of the UK drug watchdog.

AstraZeneca will conduct an additional global study to evaluate the effectiveness of its vaccine, according to Pascal Soriot, chief executive.

A close review of the vaccine was conducted after it was found to be 70 percent effective on average, but 90 percent effective with a low-dose burst followed by a standard booster injection.

This much higher result, based on a subgroup of around 2,700 people, met with concern when it was found that no one in the group was older than 55 years.

It is important to determine if the vaccine is also effective in people 55 and older who are at greater risk from Covid and who have higher mortality rates.

Rather than adding the test arm to an ongoing U.S. trial, a new study evaluates a lower dosage that performed better than a full amount during the company's studies.

It is believed to have increased the potential effectiveness of the shot to 90 percent while blocking an average of just 70 percent of infections across all branches of the study.

The chief medical officer refused to endorse it at a press conference on Downing Street (pictured) tonight as the data from the late trials were controversial

AstraZeneca will likely run an entirely new study to test whether using half a dose for the first injection of its coronavirus vaccine is most effective after the accidental regimen appeared to increase the effectiveness of the shot in its original study

Professor Whitty, Chief Medical Officer of the UK Government, said: “The simple answer to that is that there is always a scientific debate about practically anything.

“From our point of view, it is important to leave this in the hands of the regulator, the excellent MHRA regulator.

DETECTED: Covid vaccine studies did NOT monitor whether participants took other measures to prevent infections such as wearing masks and social distancing

Coronavirus vaccine makers strictly controlled who entered their studies, their vaccine doses, when those doses were timed, and more – but they did not monitor participants' other behaviors, such as wearing masks that affect the risk of infection.

Study participants had to decide for themselves where and how often to wear masks and how to practice social distancing, one told Business Insider.

And these differences in behavior among coronavirus vaccine trial participants could have a drastic impact on how likely it is for people who received the vaccine to become infected compared to those who received a placebo.

Neither Moderna nor Pfizer provided study participants with behavioral instructions to try to reduce their risk of infection (or not) and did not log this behavior unless they suspected someone might have contracted coronavirus.

This doesn't necessarily mean the top two vaccines won't reach the 90 percent effectiveness noted in their studies, but there remains a void in what we know about how much protection a shot offers versus masking and social distancing.

The results of the AstraZeneca trial for the Oxford University-designed shot come under fire after Oxford acknowledged that it was a manufacturing defect that resulted in an attempt to give participants half a dose for their first shot to give – a random part of the attempt that turned out to be most effective.

& # 39; You are going to make an assessment on a lot of data that is not currently publicly available on both efficacy and safety. We will see the articles published in the trade journals that will allow us to make a decision about what needs to be done.

“We have to allow this process to proceed. I think it is always a mistake to make early judgments before we have enough information. & # 39;

The UK government's chief scientist, Sir Patrick Vallance, was less shy when he was asked, "The main finding is that the vaccine is working and that is very exciting."

AstraZeneca faces tricky questions about its success rate, which some experts believe could affect its chances of rapid US and EU approval.

Several scientists have expressed doubts about the robustness of the results after the bug led to greater effectiveness.

Running an entirely new study could delay the approval of Oxford University's vaccine, which some, including the WHO, saw as the most promising sting.

The company's chief scientist, Mene Pangalos, initially defended the results, saying the shot worked "however you cut the data."

The CEO later contradicted him, saying the company will likely run an entirely new study to test whether the half strength first dose regimen is really the most effective.

Soriot told Bloomberg, "Now that we've found better effectiveness, we need to validate this and do an additional study."

The 90 percent figure is being questioned by experts because of the small number of people it was tested on.

Only 2,300 volunteers under 55 received the lower dose, and none of them were over 55, the age group at highest risk.

In Moderna and Pfizer's vaccine trials, which are about 95 percent effective, dosage regimens were tested on 10,000 volunteers, and four out of ten were over 55 years old.

Dr. Pangalos, executive vice president of research at AstraZeneca, dismissed criticism, claiming the bug was in fact irrelevant.

He added, "However you cut the data – even if you just believe in the full-dose, full-dose data …

& # 39; We still have an efficacy that meets the approval thresholds with a vaccine that is over 60 percent effective.

"I'm not going to pretend it's not an interesting result because it is – but I definitely don't get it and I don't think either of us do."

John LaMattina, past president of global research at Pfizer, has also raised the prospect that the vaccine may not be approved for emergency use in the US.

Mene Pangalos, AstraZeneca's vice president of research, defended Oxford's Covid-19 vaccine amid mounting criticism

Mene Pangalos, AstraZeneca's vice president of research, defended Oxford's Covid-19 vaccine amid mounting criticism

He tweeted that it was "hard to believe" that regulators would give the green light to a vaccine "whose optimal dose was only given to 2,300 people."

The World Health Organization has set a target of 50 percent effectiveness for a Covid-19 shock, a threshold that Oxford exceeded after its shock was 60 percent effective in people given two full doses.

Nevertheless, it is increasingly criticized by scientists.

Hilda Bastian, an accomplished scientist who became a writer and blogged for the British Medical Journal, claimed the data from the Oxford studies were "patched together" yesterday, excluding results from the groups most susceptible to Covid.

Others warn that they "still do not have all the information they need" and that the sting may be rejected based on the current emergency approval data by US regulators.

Oxford's candidate is seen as a potential silver bullet because it costs a fraction of the price of Pfizer and Moderna and doesn't need to be stored in expensive refrigerators.

Dr. Pangalos said yesterday there was a theoretical rationale as to why a lower dose followed by a higher dose might work, the Wall Street Journal reports.

The Oxford vaccine is a genetically engineered cold virus that infected chimpanzees. It was modified to make it weak so it wouldn't cause disease in humans and loaded with the gene for the coronavirus spike protein that Covid-19 uses to enter human cells

The Oxford vaccine is a genetically engineered cold virus that infected chimpanzees. It was modified to make it weak so it wouldn't cause disease in humans and loaded with the gene for the coronavirus spike protein that Covid-19 uses to enter human cells

"I'm not going to wave my hand at the immunologist," he said.

"(But) until I see some data that gives me some science behind it I'll say" I don't know "."

Professor Sarah Gilbert, part of the team behind Oxford's vaccine, said Monday that the smaller earlier dose could "stimulate" the immune system to produce a stronger response when hit with a larger dose of the vaccine.

"It may be that this mimics what happens with a real infection," she said. "It may be that giving a small vaccine and then giving it a large amount is a better way to get the immune system going."

In an article for Wired, Ms. Bastian said the critical mistake was that a dosage mistake resulted in a tremendous increase in success rate – experts inadvertently gave some volunteers one and a half doses of the push instead of two full doses that people are supposed to get.

The studies were also never designed to test this hypothesis, which leaves the door open to unconscious biases that creep into the research methods or data, making the study less rigorous.

'I'm a little proud': Volunteers in Oxford's coronavirus vaccine study welcome 'promising' results

A volunteer in the Oxford University's coronavirus vaccine study has shown she has a "tiny sense of pride" in participating in research that could finally defeat the virus.

Sarah Hurst, 47, of South Oxfordshire said it was "a great feeling" after hearing Monday that the vaccine could trigger an immune response in up to 90 percent of those who receive the sting.

Jack Somers, 35, from London, who also attended, said he was "very happy" and felt that his vaccine team had "just won".

Göring-on-Thames, 47-year-old Sarah Hurst, who participated in the vaccine trials, said she was “very proud” to prove that the push worked

Göring-on-Thames, 47-year-old Sarah Hurst, who participated in the vaccine trials, said she was “very proud” to prove that the push worked

The couple, who both work as journalists, received two shots of the experimental or the placebo vaccine. Mr Somers said he had side effects of shoulder pain and a slightly elevated temperature, but Ms. Somers said she did not experience any.

Ms. Hurst, who works as a journalist, said, “It's really the developers and everyone who did all the work, all of the medical students, who are constantly meeting vaccine participants all day, testing them and being on the front lines.

"But it's good, it's a great feeling to help make a vaccine."

Jack Somers, 35, from London, who also attended, said he was "very happy" and felt that his vaccine team had "just won".

Jack Somers, 35, from London, who also attended, said he was "very happy" and felt that his vaccine team had "just won".

Explaining why she signed up, she said, “I live near where it's done and they were looking for people in the Thames Valley. As soon as I saw that I wanted to get involved in researching a vaccine. & # 39;

She underwent health and blood tests before receiving her two recordings, and filled out a journal to keep researchers informed of her movements as the study progressed, as well as any symptoms.

"You have to treat it like you were in the placebo group anyway. You wouldn't go out and randomly expose yourself because you didn't know," she said.

Although she doesn't have any side effects, it doesn't mean she received the placebo. The study used the meningitis vaccine as a control, which scientists argued would produce a similar response to the Covid-19 shock.

She said Monday's results were "promising" and "the fact that it doesn't require refrigeration at very low temperatures and is cheaper than the other vaccines will help make it easier to distribute".

"You have to treat it like you were in the placebo group anyway. You wouldn't go out and randomly expose yourself because you didn't know," she said.

“People have only been vaccinated for a few months, so I still want to know: what will the results be after a year? Will it take effect after a year?

"You really just have to wait for that."

Mr Somers said it was hard to believe how quickly scientists came up with the vaccine.

"I can't help but take my hat off of the scientists," said the freelance journalist from southwest London.

“I remember Professor Matthew Snape of Oxford University sitting in a hospital six months ago watching a security video. He spoke very carefully, deliberately, and cautiously about how this vaccine might or might not work.

“Now it seems amazing that we are here six months later and that Jab can stop the coronavirus very effectively.

"It's not where I thought we were six months ago, it's not even the place I thought we were a month ago, but it's testament to the work of so many people, so many extraordinary people. "

Volunteers are not given any information about the progress of the process. You have therefore followed the progress in the media with everyone else.

And Mr Sommers said that while he was very excited to see positive results from other vaccines like the one developed by Pfizer, he had a special feeling about this vaccine.

She wrote: & # 39; The & # 39; This week's promising 'results are none other than the others we heard about in November (the studies the results are based on were less rigorous) – and the claims drawn from them are based on very shaky ones Science.

& # 39; The problems start with the fact that Monday's announcement did not include results from a single large-scale Phase 3 clinical trial, as had been the case with previous bulletins on the BNT-Pfizer and Moderna vaccines …

& # 39; The fact that they may have had to combine data from two studies to get a strong enough result raises the first red flag … As far as we know, some of that analysis might depend on data from just a few sick people People. & # 39;

She said this means that the results could be a fluke or "may be biased by other factors".

Former president of global research at Covid-19 vaccine competitor Pfizere, John LaMattina, has warned, based on current data, that Oxford's sting is unlikely to be approved for use in the US emergency.

He tweeted that it was "hard to believe" that regulators would give the green light to a vaccine "whose optimal dose was only given to 2,300 people."

Professor Natalie Bean, a biostatistician at the University of Florida, told the Financial Times that she still "does not have all the information we need to determine whether these results are reliable".

"We certainly don't have enough information in the public domain to decide if this half dose is really working," she added.

An investment analyst at SVB Leerink, Geoffrey Porges, told the FT that the sting was likely to be rejected because the company "tried to beautify its results" by highlighting its effectiveness in a "relatively small subset of subjects in the study." .

Florian Krammer, a virologist at the Icahn School of Medicine in New York, told the New York Times, "The only thing you can really tell right now is that the vaccine seems to be working."

And added, "It's just hard to tell how well it works compared to others."

Professor Ian Jones, a virologist at the University of Reading, told MailOnline: “We need to consider the positive aspects that the vaccine is safe and can provide protection.

"It is also a fact that a phase 3 study must be conducted in an area with current infection to ensure protection. If the infection level changes, additional sites may need to be added."

However, he admitted that "the question of dose is confusing".

He added, "This 90 percent protection seen in the subgroup who received the supposedly lower dose is really good, but I think that would only make up about 15 of the 3,000 people who received it, which may be due is low to convince regulators of its efficiency especially when it is not entirely clear what the main difference is between it and the higher dose. All of this should be much clearer when the full data is released. & # 39;

Oxford University admitted yesterday that it mistakenly administered half and full doses to some of the study participants.

They added, "The methods for measuring concentration are now in place and we can ensure that all vaccine lots are now equivalent."

Oxford's studies found that the sting had a nine in ten chance of working when given as a half dose first and a full dose a month later.

However, its effectiveness drops to just 62 percent when given two full doses a month apart.

Oxford has also claimed that its vaccine has an average effectiveness of 70 percent based on the 62 and 90 percent numbers, which would equate the Covid surge with good flu vaccines.

However, there were doubts about the reliability of the 70 percent figure as it was roughly calculated based on the two regimens and not everyone in the studies of all ages.

And because Oxford and AstraZeneca – the British pharmaceutical company that owns the rights to the sting – have so far only disclosed the percentages in a press release, it is not clear how they came up with these numbers.

This means that the analysis that could seal whether or not the shock will be delivered to millions of people worldwide could be based on data from a handful of people – which in turn leaves the door open for other factors in the study to be biased.

Since then, it has been known that the people who received the reduced dose did not include anyone over the age of 55 – who, according to Ms. Bastian, are most susceptible to getting seriously ill or dying of Covid.

This was not the case in the normal-dose group and raised questions about whether the demographic difference – and not the dose difference – is the real driver of the increased efficacy.

The Oxford-AstraZeneca study appears to have few participants over 55 years of age, even though the vaccine is directed against the elderly.

Wired reports that people in this population were originally not eligible to participate in the Brazilian study at all – compared to Pfizer's study, where 41 percent were over 55 years old.

Another mistake, according to Ms. Bastian, was the simple fact that the results from two separate studies in the UK and Brazil were combined, as opposed to a single large-scale study like the Pfizer and Moderna vaccines.

Oxford had originally planned to conduct a single study in the UK when it started its Phase 3 study in May. However, in the summer the coronavirus started bubbling, which meant not enough volunteers were naturally infected.

A month later, a second phase three attempt was launched in Brazil and the transmission began to accelerate.

However, the upshot of breaking the study in half was that the researchers couldn't control the variables as precisely as they would in a single study conducted by the same team.

There was no standardized dosing regimen for both studies, and the control groups in the studies did not receive the same fake vaccine to compare with the Covid burst.

Participants in Brazil received a saline solution as a placebo, while the UK part of the study received a vaccine against meningitis – leading to an unfair comparison.

According to UK medical regulator MHRA and FDA guidelines for emergency vaccines, jabs can be approved if they demonstrate safety and efficacy through a single Phase 3 clinical trial.

Although initial results from Oxford's clinical trials were published on Monday, the study is still ongoing.

Hilda Bastian, an accomplished scientist-turned-writer who blogs for the British Medical Journal (BMJ), claims data from the Oxford studies have been "patched up".

Hilda Bastian, an accomplished scientist-turned-writer who blogs for the British Medical Journal (BMJ), claims data from the Oxford studies have been "patched up".

Oxford has started a Phase 3 study with 30,000 people in the United States to get more accurate and precise data on its vaccine. However, the sting could be approved and introduced within weeks of these results.

Oxford researchers said they intend to publish the full results of the study in a medical journal in the coming weeks and will then apply to the MHRA for a license to use the vaccine among members of the public.

This process can then take days or weeks for the MHRA to decide whether the sting is suitable for use before it can be issued. This is currently expected to be completed in December.

The vaccine uses a harmless adenovirus to provide genetic material that causes the human body to produce proteins known as antigens, which are usually found on the surface of the coronavirus, and helps the immune system create an arsenal against developing infections.

The UK has ordered 100 million cans, with nearly 20 million due by Christmas.

The vaccine is expected to cost just £ 2 per dose and can be stored inexpensively in a regular refrigerator, unlike other puffs from Pfizer and Moderna, which showed similar promising results last week but must be kept in extremely cold temperatures using expensive equipment.

It's a fraction of the price, too: Pfizer costs around £ 15 per dose and Moderna costs around £ 26 per shot.

HOW DO THE OXFORD, MODERNA AND PFIZER / BIONTECH Vaccines compare?

Moderna and Pfizer / BioNTech have both released interim clinical trial results for their end-stage vaccines, both of which indicate that they are extremely effective.

Oxford University has published the results of its second phase, showing that the sting induces an immune response and is safe to use. It's not yet clear how well it protects against coronavirus in the real world.

How to Compare:

PFIZER (US) & BIONTECH (DE)

mRNA vaccine – Genetic material from the coronavirus is injected to stimulate the immune system to make "spike" proteins and learn how to attack them.

mRNA vaccine – both Moderna, Pfizer and BioNTech vaccines work the same way.

Recombinant Viral Vector Vaccine – a harmless chimpanzee cold virus was engineered to produce the "spike" proteins and look like the coronavirus.

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

95% effective (160 positive in the placebo group, 8 positive in the vaccine group).

62% – 90% effective, depending on the dosage.

Moderna confirmed that countries placing smaller orders, such as the UK's five million cans, will pay between £ 24 and £ 28 per dose. The US has secured 100 million doses for $ 1.525 billion (£ 1.16 billion), suggesting it will cost $ 15.25 (11.57 pounds) per dose.

The US pays $ 1.95 billion (£ 1.48 billion) for the first 100 million doses, which is the equivalent of $ 19.50 (£ 14.80) per dose.

Estimated to cost £ 2.23 per dose. The UK's full 100 million dose supply could add up to just £ 223 million.

The UK has ordered five million cans that will be available from March 2021. Moderna will produce 20 million cans this year, which is expected to remain in the US.

The UK has already ordered 40 million cans, 10 million of which could be available in 2020. The first vaccinations are expected in December.

The UK has already ordered 100 million cans and is expected to come first to get the cans once approved.

What side effects does it cause?

Moderna said the vaccine was "generally safe and well tolerated". Most of the side effects were mild or moderate, but included pain, fatigue, and headache, which “generally” were short-lived.

Pfizer and BioNTech did not provide a breakdown of the side effects, but said the Data Monitoring Committee "did not report any serious safety concerns."

Oxford said there were no serious safety concerns. Mild side effects were relatively common in small studies. Many participants reported that their arm hurt after the shock and that they later suffered from headache, fatigue, or muscle pain. Further data is collected.

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