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AstraZeneca's Covid-19 Vaccine Is Reported to Be 79% Effective in U.S. Study
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NIH Press Release: Investigational AstraZeneca vaccine prevents COVID-19
Results from a large clinical trial in the United States and South America indicate that AstraZeneca's COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The independent Data and Safety Monitoring Board (DSMB) overseeing the trial identified no safety concerns related to the vaccine. The United Kingdom-based global biopharmaceutical company AstraZeneca developed the vaccine and led the trial as regulatory sponsor. AZD1222 demonstrated statistically significant vaccine efficacy of 78.9% in preventing symptomatic COVID-19 and 100% efficacy in preventing severe or critical disease and hospitalization. In participants 65 years and older, who comprised 20% of the trial population, vaccine efficacy against symptomatic COVID-19 was 79.9%.
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Astra Zeneca press release:
AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis....
https://www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html
79% vaccine efficacy at preventing symptomatic COVID-19
100% efficacy against severe or critical disease and hospitalisation
Comparable efficacy result across ethnicity and age,
with 80% efficacy in participants aged 65 years and over
Favourable reactogenicity and overall safety profile
AstraZeneca will continue to analyse the data and prepare for the primary analysis to be submitted to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks. In parallel, the primary analysis will be submitted for publication in a peer-reviewed journal.
Amongst participants in the interim analysis, approximately 79% were white/Caucasian, 8% black/African American, 4% native American and 4% Asian, and 22% of participants were Hispanic.
Approximately 20% of participants were 65 years and over, and approximately 60% had co-morbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity or cardiac disease.
This AstraZeneca-led US Phase III trial included two doses administered at a four week interval. Previous trials have shown that an extended interval of up to 12 weeks demonstrated greater efficacy, which was also supported by immunogenicity data. This evidence suggests administration of the second dose with an interval longer than four weeks could further increase efficacy and accelerates the number of people who can receive their first dose.
The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius or 36-46 degrees Fahrenheit) for at least six months and administered without the need for preparation within existing healthcare settings.
AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.
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NY Times: AstraZeneca's Covid-19 Vaccine Is Found to Be 79% Effective in U.S. Study
The company is preparing to apply for emergency authorization from the Food and Drug Administration. But the shot may not be needed in the United States.
None of the volunteers who got the vaccine developed severe symptoms or had to be hospitalized, a major selling point for the shot. Five participants who were given the placebo developed severe Covid-19, Ruud Dobber, an executive vice president at AstraZeneca, told CNBC on Monday.
The vaccine worked well across ethnicity and age groups, AstraZeneca said. The vaccine was 80 percent efficacious in approximately 6,000 trial enrollees over age 65 - findings likely to quell concerns about insufficient clinical trial data on how well the vaccine works in older people.
https://www.nytimes.com/2021/03/22/business/astrazeneca-covid-vaccine.html
March 22, 2021Updated 11:33 a.m. ET
The coronavirus vaccine developed by AstraZeneca and the University of Oxford provided strong protection against Covid-19 in a large clinical trial in the United States, completely preventing the worst outcomes from the disease, according to results announced on Monday.
Although no clinical trial is large enough to rule out extremely rare side effects, AstraZeneca reported that its study turned up no serious side effects or safety issues. Officials and public health experts expressed hope that the results would shore up global confidence in the vaccine, which was shaken this month when more than a dozen countries, mostly in Europe, temporarily suspended the shot's use over concerns about possible rare blood disorders.
The trial, involving more than 32,000 participants, was the largest test of its kind for the shot. The vaccine was 79 percent effective overall in preventing symptomatic infections, higher than observed in previous clinical trials, the company announced in a news release. The trial also showed that the vaccine offered strong protection for older people, who had not been as well represented in earlier studies.
But the fresh data may have arrived too late to make much difference in the United States, where the vaccine is not yet authorized.
If AstraZeneca's vaccine is cleared for use in the United States, it is unlikely to become available before May. By then, federal officials predict there will be enough vaccine doses for all the nation's adults from the three authorized shots.
The results could also help a campaign by European lawmakers to buttress public confidence in the shot, one that has featured many political leaders themselves being injected in recent days.
"The results from the U.S. trial of the Oxford-AstraZeneca vaccine give strong evidence that the vaccine is both safe and highly effective," Matt Hancock, the British health secretary, said on Monday. "Vaccines are our way out of this, so when you get the call, get the jab."
AstraZeneca said on Monday that it would continue to analyze the new data and prepare to apply "in the coming weeks" for emergency authorization from the Food and Drug Administration. The vaccine has already been approved in more than 70 countries, but clearance from American regulators would bolster the vaccine's reputation globally.
The new data have been highly anticipated because of the expectation that the trial, designed to meet F.D.A. standards, would be the best measure of how well the vaccine works. The shot is the backbone of vaccine rollouts in many poor and middle-income countries.
"This is the vaccine that will likely vaccinate the world," Ashish Jha, the dean of the Brown University School of Public Health, wrote on Twitter on Monday, adding: "If you were rooting for global vaccination, this is a good morning."
The interim results announced on Monday were based on 141 Covid-19 cases that had turned up in volunteers. Two-thirds of participants were given the vaccine, with doses spaced four weeks apart, and the rest received a saline placebo. Volunteers were recruited from Chile and Peru in addition to the United States.
None of the volunteers who got the vaccine developed severe symptoms or had to be hospitalized, a major selling point for the shot. Five participants who were given the placebo developed severe Covid-19, Ruud Dobber, an executive vice president at AstraZeneca, told CNBC on Monday.
The new results could help the vaccine recover from the safety scare it has faced in Europe. Regulators there initiated a safety review after a small number of people who had recently been inoculated developed blood clots and abnormal bleeding.
Most countries are now restarting use of the shot, with some restrictions and a new warning label, after the European Union's drug regulator said on Thursday that a review determined that the vaccine was safe. The agency added that it would continue to watch for any connections to blood disorders, noting that any threat would be very small, and that the shots will prevent vastly more deaths than they might cause.
Nonetheless, the speed at which several nations suspended use of the vaccine reflected a skittishness about its safety and effectiveness that contrasts sharply with the confidence that has been shown in other vaccines. Trust in the vaccine has tumbled in Germany, France, Italy, Spain and, to a lesser degree, Britain, according to polls.
Participants who received the vaccine in the trial had no increased risk of blood clots or related illnesses. And a specific search turned up no cases of cerebral venous sinus thrombosis - blood clots in the brain that can result in dangerous bleeding - that raised some of the most serious concerns in Europe.
Michael Head, a senior research fellow in global health at the University of Southampton in Britain, said that the results could allay concerns not only in Europe but also globally. He said that he had received messages in recent days from colleagues in Ghana, fretting about how to explain the safety scare to people who had been celebrating the vaccine's arrival only weeks earlier.
"Because of the slight battering the AstraZeneca vaccine has taken over the last few weeks - and particularly in the last week or two in Europe - new data showing it is safe and effective is, if you'll excuse the phrase, a good shot in the arm," he said. "The publication of these results is actually quite well-timed, given possible hesitancy around the vaccine."
The U.S. trial also turned up no cases of serious neurological problems. That arose as a concern last summer after two volunteers in AstraZeneca's trial in Britain fell ill with neurological problems. Although those cases forced a seven-week halt to the U.S. clinical study, researchers ultimately concluded that the illnesses could not be linked to the vaccine. Still, the delay was a key factor in why AstraZeneca fell so far behind three other vaccine manufacturers that have won emergency authorization in the United States.
The vaccine worked well across ethnicity and age groups, AstraZeneca said. The vaccine was 80 percent efficacious in approximately 6,000 trial enrollees over age 65 - findings likely to quell concerns about insufficient clinical trial data on how well the vaccine works in older people. Some countries briefly limited inoculations with the shot to younger people before reversing course to allow it to be used in all age groups, after data from the vaccine's rollout in Britain showed the vaccine provided strong protection in older people.
Even if the vaccine is not used in the United States, receiving emergency authorization from the F.D.A. - whose rigorous review process is considered the global gold standard - would be an important milestone for AstraZeneca. Some countries that have not yet authorized the vaccine may look to follow the F.D.A.'s lead.
A green light from the agency could also bolster trust in countries where the shot is already authorized - a considerable challenge for the vaccine, which has been perceived by some as less desirable than other shots because of its lower overall efficacy rate in previous clinical trials.
While it is difficult to compare vaccines tested in differently designed clinical trials in different populations at different points in the pandemic, the new results put AstraZeneca's vaccine in the company of other leading vaccines.
The vaccines from Pfizer and Moderna, which rely on messenger RNA technology and must be stored at very cold temperatures, were both found in large clinical trials to be about 95 percent efficacious overall in preventing symptomatic infections. Johnson & Johnson's one-shot vaccine had a 72 percent overall efficacy rate in trial participants in the United States.
AstraZeneca's vaccine can be stored for up to six months when refrigerated. It uses an older approach similar to that of the shot from Johnson & Johnson. A delivery vehicle - a weakened version of a chimpanzee adenovirus - is used to transport coronavirus genes into human cells. That is meant to train the immune system to fight off attacks from the real coronavirus.
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