Oxford/AstraZeneca Publish Coronavirus Vaccine Outcomes

Preliminary peer-reviewed results describing clinical trials of the COVID-19 vaccine developed by Oxford University and pharmaceutical company AstraZeneca were published Tuesday, the first announcement made in late November sparked controversy and controversy among scientists.

The paper, published in the medical journal Lancet, described the Oxford vaccine trial in the UK, Brazil, and South Africa. Overall, data from the UK and Brazil show that the vaccine was 70% effective in preventing COVID-19. No major security threats were reported in the three countries.

The results announced by the media in November showed that the vaccine could be 90% effective if given half the first dose shot. But the group did not state that the procedure was the result of a dosing problem, and scientists later criticized the leaders for not being transparent and strong.

Andrew Pollard, Oxford’s chief executive, told BuzzFeed News that he hoped the paper would address legal issues. “Many have assumed that we have been trying to select data to get the best results,” he said. “But that is not the case. We agreed in advance with the directors of the procedures to be followed. ”

However, scientists who were distracted by the old pressures did not guarantee that their concerns would be fully realized.

“In terms of data making, 70% numbers are still difficult to interpret,” Natalie Dean, a biostatistician at the University of Florida who specializes in developing vaccine vaccines against emerging diseases, told BuzzFeed News.

“It’s difficult,” said John Moore, a virologist at Weill Cornell Medical College in New York who works on HIV vaccines, told BuzzFeed News. “The vaccine ‘works,’ but we don’t know how healthy it is.”

The vaccine, produced by Oxford University and Vaccitech oil company, is coming to market in partnership with British-Swedish company AstraZeneca. They contain the chimpanzee adenovirus – a group of viruses that can cause the flu in humans – created to produce a “protein” protein from SARS-CoV-2, a virus that causes COVID-19.

Scientists and health officials have been eagerly anticipating the results because the Oxford-AstraZeneca vaccine is the official approval of the COVID-19 vaccine that governments hope to eradicate.

This attraction is due to the low cost of the vaccine and its easy delivery. The latest sales show that the Oxford-AstraZeneca vaccine will sell for less than $ 4 per dose, compared to about $ 20 to $ 25 for another large-scale clinical trial vaccine, made by giant Pfizer and Moderna, a technology company based in Cambridge. , Massachusetts.

In addition, the Oxford-AstraZeneca vaccine can be stored in refrigerators, unlike Pfizer and Moderna, which should be kept cold until shortly before use – in the case of the Pfizer vaccine at around -70 degrees Celcius.

But claims that the vaccine has been effective have been underway since November 23, when AstraZeneca released a controversial article outlining the combined results from trials conducted by Oxford University in the UK and Brazil involving about 23,000 volunteers. Based on how 131 cases of COVID-19 were distributed during vaccination and placebo testing, AstraZeneca reported “about 70%.”

This means that the vaccine was less effective than its competitors, as Pfizer and Moderna announced in early November that tests on their vaccine showed a staggering 90%.

But in hindsight, AstraZeneca and Oxford claim that their vaccine was also 90% effective, if students were given half and followed completely. The total total dose, meanwhile, only increased the strength by 62%. The most successful results were highlighted in their insistence on advertising.

“Interestingly, we have found that one of the dosages we can use is about 90% effective and if the dosing regime is used, more people can receive the vaccine and treatment they are planning,” Pollard said.

Scientists were initially confused by this. “I found the results, as mentioned, difficult to interpret,” Dean told BuzzFeed News last week.

And when more came out of the incident, experts began to question 90% of the claims. First Mene Pangalos, head of AstraZeneca’s oncology research firm, admitted to Reuters that half of the dose was due to an error – made by Italian manufacturer Advent and first revealed by the Mirror newspaper in June.

Then on November 24, Moncef Slaoui, a leading scientist at Operation Warp Speed, a U.S. government coalition to accelerate the development of the COVID-19 vaccine, told reporters that the volunteers who filed the first half were all under the age of 55 – so not a representative of the volunteer generations. all.

The fact that the dosing problem has affected the non-representative group indicates another disturbing aspect of the UK case: Since it was first reported to ClinicalTrials.gov in late May, the number of trial groups increased significantly, disrupting 12 experimental groups and 25 different treatment groups. .

“What does this test mean? We don’t know, “Moore told BuzzFeed News last week.

In a recent issue of the Lancet, Oxford’s team monitors the differences between the groups that received the most varied groups, noting that the performance of half of the drug, remained. But some scientists remain concerned that there is currently no information about how it works in older people – who are at high risk of COVID-19.

“It needs to be re-evaluated,” Dean said.

Unlike Pfizer and Moderna, Oxford University and AstraZeneca have not released a complete breakdown of their tests for other researchers to evaluate at the beginning of their major tests, making it difficult to understand the results previously published. Other problems related to exposure became apparent in September when vaccination tests were suspended after considering a problem in the UK. The resignation was only announced publicly after a private interview with the depositors was released on the Stat page.

In a statement sent to BuzzFeed News last week, the Oxford team played out the meaning of the error and said plans to continue the review had been approved by UK officials: “[W]chickens it was clear that we were using a lower dose, we discussed this with the facilitator, and agreed on a plan to test the lower / larger and larger / larger dose, allowing us to combine both methods. ”

The new report states that the ordinance was changed on June 5, about a week after the trial began. And Pollard told reporters today at a press conference that the Science Media Center in London had changed that the change took place before the “database lock” of lawsuits, which means it was part of a legal process.

However, the interference appears to be unacceptable to the FDA. A U.S. regulator is expected to wait for results from another AstraZeneca trial taking place in the US, conducted by AstraZeneca and not Oxford, before deciding whether to approve the vaccine for emergency use.

“All I can say is that there is a lot of explanation,” Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, told BuzzFeed News last week.

“It is unlikely that we are considering why it appears that the results were very good, 90% versus 62%,” Slaoui, senior scientist at Operation Warp Speed, told reporters at a press conference on December 2. “Only a clear explanation based on statistics and information in the case of the two numbers, it appears that the package could not be valid. ”

Speaking at a Science Media Center conference, AstraZeneca CEO Pascal Soriot said he hoped the FDA would request results from the US case.

Another concern is that the results have been compiled from trials in the UK and Brazil that were originally designed as a separate test for the effectiveness of the vaccine, involving slightly different treatment with placebo arms. Combining knowledge on the two trials became necessary when Oxford’s team realized that Britain’s success in reducing the spread of COVID-19 by the end of the spring meant that its testing in the UK did not see enough cases to provide meaningful results.

The Oxford team began to strengthen their chances of being the first to demonstrate the effective COVID-19 vaccine. “Maybe we’re in a place where there is a COVID virus everywhere, in Europe at the moment, then we have a chance to get good results in the next three months,” Adrian Hill, director of the Jenner Institute of Oxford, told CNN at the end of April.

But less than a month later, Hill told the Telegraph newspaper: “It’s a race to end the virus, and against time. At the moment, there’s a 50% chance we won’t get anything.”

These prices are high because of the high expectations placed on the Oxford-AstraZeneca vaccine. This is especially true in the UK, where Prime Minister Boris Johnson praised the work of “our talented scientists,” and where his office said he was pushing for the vaccine plates to be labeled with jack Union, according to the Huffington Post.

Acceptable emergency vaccination restrictions in the UK are expected to be less than in the US. In fact, Medicines and Healthcare Products Regulatory Agency has already approved the Pfizer vaccine, which is still under review by the FDA. US medical advice advisers are meeting Thursday to review the effects of the Pfizer vaccine, which is expected to be the first vaccine to receive emergency approval in the US.

The UK’s approval of the Oxford-AstraZeneca vaccine could lead to legal repercussions, as its vaccine price is relatively easy to ship. According to data analysis from the life science company Airfinity and the scientific journal Nature, it is already needed, and approximately 2.7 billion doses have already been set, more than any other vaccine user.

Scientists are concerned about the questions circulating around the effectiveness of the vaccine, because any side effects that may occur later could damage confidence in the COVID-19 vaccine in particular.

“Our biggest fear is that things will go awry that will undermine trust in people,” Moore said. “We wanted a way that was as clean as we could.”

Stephanie M. Lee provided reports on the matter.

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