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Post by Admin on Sept 12, 2020 19:20:13 GMT
Drugmaker AstraZeneca announced Saturday that its COVID-19 vaccine studies have resumed in the United Kingdom, though not yet in the United States. The vaccine trials had been placed on hold around the world earlier in the week after a U.K. participant in one of the studies developed a neurological illness. The candidate vaccine was developed by the University of Oxford along with AstraZeneca. The goal of the large studies is to see whether the vaccine is capable of preventing COVID-19 and whether it is safe. Although initial studies didn't reveal serious side effects from the vaccine, rare complications of any vaccine, if there are any, may not turn up until it has been administered to thousands, or tens or thousands of people. On Sunday, AstraZeneca says, all studies around the world of this particular candidate vaccine were paused after one volunteer in the U.K. developed symptoms consistent with transverse myelitis, an inflammation of the spinal cord that can cause paralysis. According to a statement Saturday from the drug company, the studies were paused "to allow review of safety data by independent committees, and international regulators." The statement goes on to say that the committee has concluded its investigations and advised the Medicines Healthcare Products Regulatory Authority, the U.K. equivalent of the Food and Drug Administration, that trials in the U.K. are safe to resume. In an email to NPR Saturday, an AstraZeneca spokesperson said, "The company will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume." AstraZeneca said it cannot disclose further medical information because it is the study sponsor, but added in its statement, "All trial investigators and participants will be updated with the relevant information, and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards." The AstraZeneca/Oxford partnership is one of the vaccine development efforts against the coronavirus that is furthest along. The company recently began a phase 3 trial in the United States that aims to enroll 30,000 volunteers. In late July, results of a preliminary safety and effectiveness study found that more than two-thirds of the people who received the experimental vaccine reported fatigue and headache after inoculation. Muscle aches and fever were also common. But the researchers said then that there were no "serious adverse reactions" among the more than 500 people vaccinated and that most of the effects were "mild or moderate in severity."
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Post by Admin on Sept 18, 2020 19:28:04 GMT
Moderna, the first pharmaceutical firm to conduct human trials of a coronavirus vaccine in the U.S., said it should know sometime in November whether its vaccine works. Moderna CEO Stephane Bancel told CNBC on Thursday that it could have enough data by October from its late-stage trial to evaluate its efficacy, although he said he viewed that timeline as unlikely, according to the report.
President Donald Trump has asserted that a vaccine could be ready "during the month of October." Experts say that is unlikely given the time required to test and evaluate the vaccines for efficacy and safety. U.S. Centers for Disease Control Director Robert Redfield told Congress Wednesday that a vaccine wouldn't be widely available until the second or third quarter of next year — a projection that Mr. Trump took issue with, saying that Redfield "made a mistake."
Redfield also said a mask could be even more effective in fighting the virus than a vaccine for someone who fails to build an immunity response from the vaccine.
"This face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine," Redfield said while showing his mask. "... If I don't get an immune response, the vaccine's not going to protect me. This face mask will."
So far, there are seven vaccines, including Moderna's product, in final Phase 3 testing, which involves large-scale tests on people.
"If the infection rate in the country were to slow down in the next weeks, it could potentially be pushed out in a worst-case scenario in December," Bancel told CNBC.
The company also said it was scaling manufacturing to produce between 500 million to 1 billion doses of the vaccine.
Moderna's vaccine, which uses messenger RNA, or mRNA, to trick the body into producing viral proteins to fight disease, could require two shots to provide protection from the coronavirus. About 10,000 volunteers have received a second shot in the Phase 3 trial, Moderna said on Thursday.
However, no mRNA vaccine has so far been approved for an infectious disease, and Moderna has yet to bring a product to market, according to Deutsche Bank analysts.
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Post by Admin on Oct 6, 2020 2:32:17 GMT
Three patients taking part in clinical trials for Moderna's (NASDAQ:MRNA) coronavirus vaccine candidate and two taking part in Pfizer's (NYSE:PFE) study have experienced intense side effects, according to a report published by CNBC. Those effects included high fever, pounding headaches, intense chills, and exhaustion. The CNBC article identified one of the participants in the Moderna study, a man named Luke Hutchison. After being given the second of two COVID-19 vaccine shots during the trial, he said he awoke late at night with chills and a fever. CNBC did not reveal the identities of the four other patients, who asked to remain anonymous, but the news network did say it had verified their participation in the studies through trial documentation. One, a participant in the Pfizer study, experienced similar side effects to Hutchison after being administered the second dose of the pharmaceutical giant's two-dose candidate. On a more positive note, all three Moderna trial participants and one in the Pfizer trial reported that their side effects, while intense, melted away after at most one day. All five, meanwhile, expressed the belief that the discomfort they experienced will be worth it for the value of the research being undertaken. Both of the trials in question are phase 3 studies that have tens of thousands of participants. And because they are double-blind, neither the patients nor the medical workers inoculating them know whether any given individual is getting the vaccine or a placebo. Pfizer -- along with BioNTech (NASDAQ:BNTX), the Germany-based biotech it is partnering with -- and Moderna are considered by many to be among the front-runners in the race to bring a coronavirus vaccine to market. Both Pfizer/BioNTech's BNT162b2 and Moderna's MRNA-1273 are messenger RNA-based candidates that have been developed relatively quickly, and are now in late-stage testing. For now, however, no COVID-19 vaccine has completed a full series of clinical trials and reported data sufficient to warrant calling it a success, nor have any candidates been approved by a major regulator.
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Post by Admin on Oct 27, 2020 19:44:35 GMT
British pharmaceutical giant AstraZeneca on Monday said its potential Covid-19 vaccine has produced a similar immune response in older and younger adults. AstraZeneca, which is developing its potential Covid-19 vaccine in collaboration with the University of Oxford, said adverse responses to the vaccine among the elderly were also found to be lower. The World Health Organization has said that older people, in addition to people of all ages with preexisting medical conditions, appear to develop serious illness on contracting the coronavirus more often than others. The announcement is likely to boost hopes of a Covid vaccine being developed before the end of the year. “It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman told CNBC via email. “The results further build the body of evidence for the safety and immunogenicity of AZD1222,” the spokesman said, referring to the technical name of the Oxford-AstraZeneca vaccine. Shares of the company rose more than 2% on the news. Drugmakers and research centers are scrambling to deliver a safe and effective vaccine in an attempt to bring an end to the coronavirus pandemic that has claimed over 1.15 million lives. Dozens of candidate vaccines are in clinical evaluation, according to the WHO, with some already conducting late-stage tests before seeking formal approval. The vaccine being developed by the University of Oxford and AstraZeneca is thought to be one of the frontrunners to secure regulatory approval. AstraZeneca CEO Pascal Soirot has previously said the drugmaker’s vaccine would likely provide protection against contracting the coronavirus for about a year.
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Post by Admin on Nov 24, 2020 5:40:48 GMT
The coronavirus vaccine developed by the University of Oxford is highly effective at stopping people developing Covid-19 symptoms, a large trial shows.
Interim data suggests 70% protection, but the researchers say the figure may be as high as 90% by tweaking the dose.
The results will be seen as a triumph, but come after Pfizer and Moderna vaccines showed 95% protection.
However, the Oxford jab is far cheaper, and is easier to store and get to every corner of the world than the other two.
So the vaccine will play a significant role in tackling the pandemic, if it is approved for use by regulators.
"The announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by [the virus]," said the vaccine's architect, Prof Sarah Gilbert.
The UK government has pre-ordered 100 million doses of the Oxford vaccine, and AstraZeneca says it will make three billion doses for the world next year.
Prime Minister Boris Johnson said it was "incredibly exciting news" and that while there were still safety checks to come, "these are fantastic results".
Speaking at a Downing Street briefing on Monday evening, Mr Johnson added that the majority of people most in need of a vaccination in the UK might be able to get one by Easter.
And Prof Andrew Pollard - director of the Oxford vaccine group - said it had been "a very exciting day" and paid tribute to the 20,000 volunteers in the trials around the world, including more than 10,000 in the UK.
There are two results from the trial of more than 20,000 volunteers in the UK and Brazil.
Overall, there were 30 cases of Covid in people who had two doses of the vaccine and 101 cases in people who received a dummy injection. The researchers said it worked out at 70% protection, which is better than the seasonal flu jab.
Nobody getting the actual vaccine developed severe-Covid or needed hospital treatment.
Prof Andrew Pollard, the trial's lead investigator, said he was "really pleased" with the results as "it means we have a vaccine for the world".
However, protection was 90% in an analysis of around 3,000 people on the trial who were given a half-sized first dose and a full-sized second dose.
Prof Pollard said the finding was "intriguing" and would mean "we would have a lot more doses to distribute."
The analysis also suggested there was a reduction in the number of people being infected without developing symptoms, who are still thought to be able to spread the virus.
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