Preliminary peer-reviewed results describing clinical trials of the COVID-19 vaccine developed by Oxford University and pharmaceutical company AstraZeneca were published Tuesday, after initial announcement which was made in late November caused a stir and criticized the scientists.
The program of 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 indicate 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 of the first dose shot. But the group did not comment on the dosing factor, and scientists later criticized the leaders for not being transparent and aggressive.
Andrew Pollard, Oxford team leader, told BuzzFeed News that he hopes the paper will address the concerns of the case. “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 guidelines for the course of action. ”
“When it comes to decision 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, developed by Oxford University and Vaccitech oil company, is bringing it to market in partnership with British-Swedish pharmaceutical 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.
The request is based on 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 a vaccine in the aftermath of a major clinical trial, developed by the giant Pfizer and Moderna, a technology company 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 Pfizer vaccine about -70 degrees Celcius.
But claims that the vaccine has been effective have been underway since November 23, when AstraZeneca released it. distractions journalists reporting on the combined results from a trial conducted by the University of Oxford in the UK and Brazil involving approximately 23,000 volunteers. Based on how 131 cases of COVID-19 were vaccinated with placebo trials, AstraZeneca said “About 70%.”
But by twist, AstraZeneca and Oxford say their vaccine was also 90% effective, if students were given half-hearted compliance with full dose. The full total dose, meanwhile, only triggered a power of only 62%. The most successful results were highlighted in their insistence on advertising.
“Interestingly, we have found that one of our units should be used at least 90% and if a dosing regimen is used, more people will be able to receive the vaccine they are preparing,” 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 institute, admitted to Reuters that half of it was really for the wrong reason, first revealed by the Mirror newspaper back in June.
Then on November 24, Moncef Slaoui, senior scientist with Operation Warp Speed, a US government coalition to accelerate the development of the COVID-19 vaccine, he told reporters that the wrong volunteers were given the first half were all under the age of 55 – so do not represent the age of the volunteers on all tests.
The fact that the dosing problem affected the non-representative group indicates another disturbing aspect in the UK trial: Since it was the first registered at ClinicalTrials.gov by the end of May, the number of patient groups in the scale had increased, resulting in a number of 12 experimental groups and 25 subgroups being treated differently.
“What does this test mean? We don’t know, “Moore told BuzzFeed News last week.
In a recent issue of The Lancet, the Oxford team reviewed the age difference between the receiving groups of different types, noting that the performance of half of the drug, remained. But some scientists remain concerned that there is currently no information on how it works in the elderly – which is at risk of COVID-19.
“It needs to be re-evaluated,” Dean said.
In contrast Pfizer and Moderna, Oxford University and AstraZeneca have not released a complete overhaul of their tests for other researchers to re-evaluate at the beginning of their major tests, making it difficult to understand the results previously published. Other problems with exposure became apparent in September when vaccination tests were suspended after it was suspected of having a problem in the UK. The break was only announced in public after biomedical issues were discussed Stat status.
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 were completed by UK officials: “[W]chickens it was clear that we used a low dose, we discussed this with the supervisor, and agreed on a method to test the low / high level and the high / high dose, which allows 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 held that the change took place prior to the “database lock” of litigation, 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 speculation to do,” 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 will be able to determine why the results appear to have been so positive, 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 on the causes of the two numbers, it appears that this package may not be valid.
Speaking at a Science Media Center conference, AstraZeneca CEO Pascal Soriot said he hoped the FDA would request results from US cases.
Another concern is that the results have been compiled from the UK and From Brazil trials that were originally designed as separate tests for the effectiveness of the vaccine, involving different treatments with placebo hands. Combining data from the two trials became necessary when the Oxford 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 produce real results.
The Oxford team was initially bullish about its potential to be the first to demonstrate the effective vaccine of COVID-19. “We may be in an area with COVID infection everywhere, in Europe at the moment, so we have a chance to get good results in the next three months,” said 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 against the virus, and against time. Currently, there is a 50% chance that we will not get anything. ”
These prices are high due to the high expectations offered on the Oxford-AstraZeneca vaccine. This is especially true in the UK, where Prime Minister Boris Johnson is praised the work of “our intellectual scientists,” and when his office allegedly pressured the vaccine plates to be co-authored, 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 has already been approved Pfizer vaccine, which is still still sitting down by the FDA. US medical advice advisers are meeting Thursday to review the effects of the Pfizer vaccine, 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 repression, as its vaccine price is relatively easy to ship. According to a data analysis from the biological biological company Airfinity and the scientific journal Nature, is already in demand, and nearly 2.7 billion levels have already been planned, more than any other vaccine supplier.
Scientists are concerned about the questions circulating around the effectiveness of the vaccine, because any side effects that may occur later could undermine 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.