AstraZeneca to seek FDA authorization for vaccine based on foreign trial data

The company also said it would work with the agency to adjust the design of its late-stage U.S. trial to test the half-dose regimen, rather than the higher dose that proved less effective in the U.S and Brazil studies. That U.S. trial has enrolled about 10,000 of a planned 40,000 participants, but the company has not released any data from that study.

The U.K. and Brazil studies have enrolled about 24,000 participants — fewer than the 30,000 participants that the FDA is requiring for late-stage coronavirus vaccine trials.

The initial findings were based on 131 infections among trial participants. The company did not break down how many cases were reported among those who got a placebo versus those who got the vaccine, and within that vaccine group, how cases split among the two doses tested.

AstraZeneca also said that none of the infected people had severe Covid-19 or were hospitalized, but offered no further safety information.

Promising logistics: The AstraZeneca vaccine is cheaper and easier to distribute than the other two shots that have proven effective. It can be transported and stored under refrigerated conditions for at least six months, and the company says it can make up to 3 billion doses next year.

Vaccines from Pfizer and Moderna, which have each proven about 95 percent effective, must be frozen during distribution and kept at very cold temperatures.

“AstraZeneca and Oxford have developed an affordable, scalable vaccine that crucially can be stored and shipped in a regular refrigerator,” said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, said in a statement. “This makes it appropriate for use and easy to deliver almost anywhere in the world, including in low-resource settings.”

But questions remain: Others doubt whether the FDA will authorize the vaccine.

“We believe that this product will never be licensed in the US,” investment bank SVB Leerink analyst Geoffrey Porges said in a note on Monday. “This belief is based on the design of the company’s pivotal trials (which does not appear to match the FDA’s requirements for representation of minorities, severe cases, previously infected individuals and elderly and other increase risk populations), and based on the occurrence of severe safety events (why take the risk) that resulted in the extended clinical hold on enrollment into the trials in the US.”

The company halted its U.S. trial in early September over safety concerns, after a trial participant reported neurological problems. The study resumed earlier this month after FDA concluded that no evidence linked the volunteer’s symptoms to the shot.

Background: The AstraZeneca vaccine was developed by scientists at Oxford University, and uses a different technology than the Moderna and Pfizer vaccines. It uses a weakened version of the common cold that contains some genetic material from the coronavirus.

U.S. vaccine and therapeutics accelerator Operation Warp Speed paid for some of the clinical development of the AstraZeneca vaccine and purchased 300 million doses for $1.2 billion.

Other clinical trials are ongoing in Japan, Russia, South Africa, Kenya

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AstraZeneca says its vaccine produces immune response in older adults

AstraZeneca said Monday that its potential coronavirus vaccine provokes an immune response in older adults, which it touted as a positive development as clinical trials proceed.

The immune response in older adults was similar to that in younger people, the company said, and adverse responses to the vaccine, known as reactogenicity, was lower in older people.

“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 spokesperson said. “The results further build the body of evidence for the safety and immunogenicity of [the vaccine].”

AstraZeneca, partnered with Oxford University, is developing one of the leading potential coronavirus vaccines, which is now in the third phase of clinical trials, along with other potential vaccines from Pfizer and Moderna.

AstraZeneca faced a setback in early September when its vaccine trial was halted to review potential safety concerns from a participant developing neurological symptoms. The Food and Drug Administration allowed the trial to resume on Friday.

“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” AstraZeneca CEO Pascal Soriot said in a statement Friday. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

The complete picture of the potential vaccine’s safety and efficacy will not be known until the full data from the phase three trial is published.

Reacting to Monday’s announcement about the immune response, Florian Krammer, a professor of vaccinology at Icahn School of Medicine at Mount Sinai in New York, tweeted: “AZ says the vaccine is immunogenic in older individuals. This has been shown for other COVID-19 vaccines too. Good, but no breakthrough.”

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Oxford COVID-19 vaccine prompts immune response among adults old and young, AstraZeneca says

LONDON (Reuters) – The COVID-19 vaccine being developed by the University of Oxford produces a similar immune response in both older and younger adults, and adverse responses were lower among the elderly, British drug maker AstraZeneca Plc AZN.L said on Monday.

FILE PHOTO: A test tube labeled with the vaccine is seen in front of AstraZeneca logo in this illustration taken, September 9, 2020. REUTERS/Dado Ruvic/File Photo/File Photo

A vaccine that works is seen as a game-changer in the battle against the novel coronavirus, which has killed more than 1.15 million people, hammered the global economy and shuttered normal life across the world.

“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 Reuters.

“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 vaccine.

The news that older people get an immune response from the vaccine is positive because the immune system weakens with age and older people are those most at risk of dying from the virus.

The Financial Times reported earlier that the vaccine, being developed by Oxford and AstraZeneca, triggers protective antibodies and T-cells in older age groups – among those most at risk from the virus.

The Oxford/AstraZeneca vaccine is expected to be one of the first from big pharma to secure regulatory approval, along with Pfizer PFE.N and BioNTech’s 22UAy.F candidate.

If it works, a vaccine would allow the world to return to some measure of normality after the tumult of the pandemic.

Immunogenicity blood tests carried out on a subset of older participants echo data released in July which showed the vaccine generated “robust immune responses” in a group of healthy adults aged between 18 and 55, the Financial Times reported.

Details of the finding are expected to be published shortly in a clinical journal, the FT said. It did not name the publication.

OXFORD VACCINE

British Health Secretary Matt Hancock said a vaccine was not yet ready though he was preparing logistics for a possible roll out.

“I would expect the bulk of the roll out to be in the first half of next year,” Hancock told the BBC.

Asked if some people could receive a vaccine this year he told the BBC: “I don’t rule that out but that is not my central expectation.”

“We want to be ready in case everything goes perfectly but it’s not my central expectation that we’ll be doing that this year, but the programme is progressing well, we’re not there yet,” Hancock said.

Called AZD1222 or ChAdOx1 nCoV-19, the vaccine was developed by Oxford University scientists and licensed to AstraZeneca in April, which took on the task of scaling trials and production.

The vaccine is likely to provide protection for about a year, CEO Pascal Soriot said in June.

The British drugmaker has signed several supply and

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After pausing for safety concerns, AstraZeneca and Johnson & Johnson have resumed their U.S. vaccine trials.

Late-stage coronavirus vaccine trials run by AstraZeneca and Johnson & Johnson have resumed in the United States after the companies said Friday that serious illnesses in a few volunteers appeared not to be related to the vaccines.

Federal health regulators gave AstraZeneca the green light after a six-week pause, concluding there was no evidence the experimental vaccine had directly caused neurological side effects reported in two participants. The AstraZeneca news was first reported by The Wall Street Journal.

Johnson & Johnson said that its trial, which had been on pause for 11 days, would restart after a company investigation determined that a “serious medical event” in one study volunteer had “no clear cause.” To maintain the integrity of the trial, the company said, it did not check whether the volunteer received the vaccine or the placebo.

Dr. Luciana Borio, a former acting chief scientist at the Food and Drug Administration, welcomed the announcements, citing the urgent need for multiple vaccines to remain in the race for a product that could protect the global population from the coronavirus, which has already killed more than a million people worldwide.

“The demand for safe and effective Covid vaccines exceeds any single manufacturer’s production capacity,” Dr. Borio said. “We really need several in the field.”

An F.D.A. spokesperson declined to comment on Friday afternoon.

AstraZeneca and Johnson & Johnson are two of the four companies now in late-stage clinical trials in the U.S. for experimental coronavirus vaccines. Both companies are using adenoviruses, which typically cause harmless colds. The adenovirus is engineered so that it can chauffeur a coronavirus gene into human cells.

Their two high-profile competitors, Moderna and Pfizer, also in advanced trials, are instead using a technology based on genetic material known as mRNA. Delivered into human cells, the mRNA prompts the production of coronavirus proteins, triggering an immune response.

AstraZeneca moved swiftly into clinical trials, enrolling thousands of volunteers for its vaccine trials around the world in countries including Brazil, India, South Africa and Britain. A large, late-stage trial kicked off in the United States at the end of August. But all the trials were halted days later, on Sept. 6. A volunteer who had received the vaccine in the United Kingdom reportedly experienced symptoms of transverse myelitis, or inflammation of the spinal cord, triggering a global pause to the company’s efforts.

The incident sparked some concern among experts, who noted that a similar adverse neurological event, reported months ago, had occurred in another vaccinated volunteer. While this earlier event prompted its own pause in AstraZeneca’s trials, an independent safety board ultimately determined it was unrelated to the vaccine, allowing studies to resume.

Following the second AstraZeneca halt in September, trials abroad rapidly resumed in most countries. But the American hiatus persisted, with few details released as to why.

According to two vaccine experts familiar with the situation who were not authorized to discuss it publicly, the F.D.A. did not directly tie the vaccine to the two neurological illnesses, although it could

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J&J, AstraZeneca resuming trials of vaccines [Video]

Two trials involving coronavirus vaccine candidates are resuming. AstraZeneca has restarted the U.S. trial of its experimental COVID-19 vaccine, and Johnson & Johnson is set to resume its trial on Monday or Tuesday.

AstraZeneca said Friday the U.S. Food and Drug Administration has deemed it safe to continue testing the vaccine. The company had to pause its U.S. trial last month after a report of a serious neurological illness in a participant in its trial in the UK.It is developing its vaccine with researchers at Oxford University.

Johnson & Johnson said Friday that the independent safety panel, the Data and Safety Monitoring Board, has recommended that it resume trial recruitment after finding no evidence that the vaccine caused a volunteer to fall ill. The company says it’s on track to produce trial data of the vaccines’ effectiveness by the end of this year or early 2021.

Both companies have contracts to supply vaccines to the U.S. and other governments if they are cleared by regulators.

Video Transcript

Two trials involving coronavirus vaccine candidates are resuming. AstraZeneca has restarted the US trial of its experimental COVID-19 vaccine, and Johnson & Johnson is set to resume its trial on Monday or Tuesday.

AstraZeneca said Friday, “The US Food and Drug Administration has deemed it safe to continue testing the vaccine.” The company had to pause its US trial last month after a report of a serious neurological illness in a participant in its trial in the UK. It is developing its vaccine with researchers at Oxford University.

Johnson & Johnson said Friday [? that, ?] “The independent safety panel, the Data and Safety Monitoring Board, has recommended that it resume trial recruitment after finding no evidence that the vaccine caused a volunteer to fall ill.” The company says it’s on track to produce trial data of the vaccine’s effectiveness by the end of this year or early 2021.

Both companies have contracts to supply vaccines to the US and other governments if they are cleared by regulators.

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AstraZeneca, J&J resuming US tests of COVID-19 vaccines

Two drugmakers announced Friday the resumption of U.S. testing of their COVID-19 vaccine candidates.

Testing of AstraZeneca’s vaccine candidate had been halted since early September, while Johnson & Johnson’s vaccine study was paused at the beginning of last week. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.

The two coronavirus vaccines are among several candidates in final-stage testing, the last step before seeking regulatory approval.

The drugmakers said they got the go-ahead Friday from the Food and Drug Administration to restart tests in the U.S.

Such temporary halts of drug and vaccine testing are relatively common: In research involving thousands of participants, some are likely to fall ill. Pausing a study allows researchers to investigate whether an illness is a side effect or a coincidence.

Testing of the AstraZeneca vaccine, developed with Oxford University, has already resumed in the United Kingdom, Brazil, South Africa and Japan.

“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” Pascal Soriot, AstraZeneca’s CEO, said in a statement.

AstraZeneca’s study involves 30,000 people in the U.S., with some getting the vaccine and others a dummy shot.

Testing was stopped after one British participant developed severe neurological symptoms consistent with a rare inflammation of the spinal cord called transverse myelitis. AstraZeneca testing had also been paused earlier in the summer.

Johnson & Johnson said it’s preparing to resume recruitment soon for its U.S. vaccine study. In a statement, the company didn’t disclose the nature of the volunteer’s illness but said a thorough evaluation “found no evidence that the vaccine candidate caused the event.”

The company added that it’s in talks with other regulators around the world to resume testing in their countries.

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The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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AstraZeneca and Johnson & Johnson to resume COVID-19 vaccine trials as U.S. daily cases top 71,000

On Friday, both AstraZeneca and Johnson & Johnson announced that their coronavirus vaccine trials are set to resume in the U.S. after hitting pause when volunteers became sick. The Food and Drug Administration gave the green light after investigations found no link between those cases and the vaccine.

The announcement comes as the U.S. recorded more than 71,000 coronavirus cases on Thursday, which is the highest single-day increase since July, according to figures from Johns Hopkins University. A total of 41 states are reporting an increase in average new cases, and 15 states have reported record hospitalizations in the last week.

“This really does become a moment where all Americans have to recognize that each of us individually has a responsibility if we want to turn this around,” said Dr. Francis Collins, director of the National Institutes of Health.

In hot spot Wisconsin, new cases are up nearly 40% compared to two weeks ago. Wisconsin resident Ava Pennicuik, 15, is still suffering from hot flashes and extreme fatigue three months after recovering from COVID-19.

“I still feel sick sometimes. Some days are good and then some days aren’t,” said Pennicuik. “Like one day I’ll have a really bad day and also super dizzy and tired, and I’ll have to take a nap, and the other day, like, I can just do stuff, like, normally.”

The latest data from researchers at the University of Washington says wearing face masks in public could save nearly 130,000 lives in the U.S. this fall and winter.

Katelyn Evans, 16, became the first teen to get an injection as part Pfizer’s COVID-19 vaccine study at Cincinnati Children’s Hospital, the Associated Press reported. It’s part of a push to safely inoculate school-age children.  

“I figured, you know, the more people they test, the more information they get and the sooner they can put out a vaccine to keep everyone safe,” said Evans.

Since the pandemic began, more than half a million American children have been infected with COVID-19. While vaccine trials continue to move forward, the first shots are unlikely to be recommended for kids. Vaccines can’t be given to children unless they’ve been tested in their age group, the AP reported.

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Johnson & Johnson, AstraZeneca coronavirus vaccine trials set to resume

The AstraZeneca vaccine trial, on hold in the United States since early September, also got the greenlight Friday to restart from the Food and Drug Administration, according to a company statement.

When a potential adverse event occurs during a clinical trial, the testing is typically stopped so that an independent data and safety monitoring board can thoroughly investigate and determine whether the problem was likely related to the vaccine. Rules around clinical trials and patient privacy usually restrict details from being released, but the tremendous scrutiny of the coronavirus vaccine trials has led many experts to call for greater transparency in disclosing and explaining the reasons for such halts.

In the Johnson & Johnson trial, which was paused on Oct. 12, a man who received a vaccination suffered a stroke that may have been triggered by an infection. To conclude it was not likely to be related to the shot, investigators probed not only the medical details of the event, but also examined a safety database of 100,000 people who have received vaccines that use the same underlying technology.

The investigation found “no clear cause” of the incident, according to a company statement. It also found no evidence the vaccine triggered the event, the details of which were not disclosed by the company. The independent board that monitors the trial recommended lifting the pause.

“With the information which we gathered to date and the information from external experts, the company found no evidence the vaccine candidate caused it,” Paul Stoffels, chief scientific officer of Johnson & Johnson said in an interview. He did not offer any details of the illness, citing patient privacy.

The company is testing the only vaccine that aims to protect people with a single shot; other prospective vaccines require a return visit and second shot three to four weeks after the first to trigger a protective immune response.

It was the second late-stage vaccine trial put on hold in recent weeks; the vaccine being developed by AstraZeneca and the University of Oxford was halted on Sept. 6 after a British participant developed a neurological problem. While the AstraZeneca study had resumed in the rest of the world, it did not get clearance to restart in the U.S. until Friday.

AstraZeneca spokeswoman Michele Meixell did not provide further information on the illness, but said the FDA reviewed data from the trials running around the world before concluding it was safe to restart. She said the company was adding a new expert panel “to provide advice on diagnosis and causality assessment of neurological events,”in addition to continuing standard company oversight and the independent data and safety committee.

Pausing and unpausing clinical trials happens routinely, and experts have said that the public should be confident the process worked as intended to protect the health and safety of participants.

“We see this all the time during clinical research,” said Carlos del Rio, an infectious diseases physician at Emory University School of Medicine. “As long as the data and safety monitoring

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AstraZeneca, J&J vaccine trials back on track in US

Two major clinical trials for experimental Covid-19 vaccines got back on track in the United States Friday — providing a glimmer of hope as the number of cases skyrocket across the country.

Covid-19 has now killed more than 223,000 Americans, and the health crisis is a top issue in the presidential election pitting incumbent Donald Trump against Joe Biden.

AstraZeneca announced that the trial of its vaccine candidate, developed with Britain’s University of Oxford, has resumed in the US, the only country where it remained suspended following a participant’s illness six weeks ago.

“The Food and Drug Administration (FDA) today authorized the restart in the US, following the resumption of trials in other countries in recent weeks,” the drugmaker said.

The trial was suspended worldwide on September 6, but resumed shortly thereafter in Britain, and in the following weeks in South Africa, Brazil and Japan, with authorities determining the illness was not apparently linked to the vaccine.

“The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial,” AstraZeneca said.

The company added it was hoping to have results later this year, “depending on the rate of infection within the communities where the clinical trials are being conducted.”

The AstraZeneca/Oxford vaccine project is one of the most promising and advanced in the world to combat the global pandemic, which has now claimed the lives of 1.1 million people.

It is one of 10 vaccine candidates being tested on tens of thousands of people in so-called phase 3 trials.

In the United States, the two top candidates vying to get a green light from the FDA are those made by Pfizer and Moderna. Both expect to request approval next month.

Many countries are counting on using the AstraZeneca/Oxford vaccine to inoculate their populations. 

The drugmaker pre-sold hundreds of millions of doses on several continents, and signed partnership deals with other producers to ensure the doses could be made locally.

– ‘No evidence’ vaccine to blame –

Shortly after AstraZeneca’s announcement, Johnson & Johnson said it was preparing to resume recruitment for its parallel trial, which was suspended last week after a volunteer fell ill.

“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” the group said in a statement.

“The company has found no evidence that the vaccine candidate caused the event.”

Just before Friday’s announcements, a top US official involved with Operation Warp Speed, the government’s vaccine initiative, said he expected the J&J trial to resume quickly.

Paul Mango, from the US Department of Health and Human Services, also said he expected the country to have enough doses on hand to vaccinate the “most vulnerable” Americans before year’s end.

“By the end of January, we believe we’ll be able to vaccinate all seniors,” Mango said, adding that by March or April, “we believe we’ll be able to vaccinate any American who desires a vaccination.”

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Coronavirus vaccine: Oxford AstraZeneca trial volunteer dies in Brazil

The Brazilian newspaper O Globo, citing unnamed sources, reported that the volunteer was in a control group that did not receive the experimental vaccine and died of covid-19. The news service G1 said the volunteer was a 28-year-old physician who treated coronavirus patients in Rio de Janeiro.

The National Health Surveillance Agency said it was informed of the volunteer’s death Monday. The agency said AstraZeneca’s international safety committee had recommended the trial continue.

Under the trial’s protocol, half the participants receive the experimental vaccine, and half receive an established meningitis vaccine that has been proved safe. The trial, like others, is overseen by an independent board that reviews all adverse events. Any severe event that might have been caused by the vaccine would trigger a pause in the study for an investigation. The trial is not paused due to the death.

A spokesman for AstraZeneca said he could not comment on individual cases in an ongoing trial, citing confidentiality requirements and clinical trial rules. But he said there were no concerns that would lead the study to pause.

“We can confirm that all required review processes have been followed,” spokesman Brendan McEvoy said. “All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study.”

Oxford confirmed that the volunteer’s death was reviewed by an independent committee.

“Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial, and the independent review in addition to the Brazilian regulator have recommended that the trial should continue,” the university said in a statement.

The trial was suspended last month after a participant developed an unexplained illness. AstraZeneca has since resumed trials in Brazil, India, South Africa, Japan and Britain. It remains on hold in the United States.

In the global race for a vaccine, Brazil, which has been battered by the disease but has a long-standing openness to vaccines, has become one of the most crucial testing grounds. The country is hosting four vaccine trials — as many as anywhere in the world.

Brazil has watched vaccine development closely as the virus continues to lash the country. The official toll is now more than 5 million infections and over 150,000 deaths, second only to the United States. But as the tests near their conclusions, the issue of vaccinating people has become just one more issue for politicians to argue over.

São Paulo Gov. João Doria has said state health workers will begin receiving a Chinese vaccine before the end of the year. Other groups will then follow. Doria has said the vaccine will be obligatory in Brazil’s most populous state.

President Jair Bolsonaro, who has spent months touting the unvetted and potentially harmful anti-malarial drug hydroxychloroquine as a coronavirus cure, has been deeply suspicious of vaccines. He says the vaccine will not be mandatory, even though a law he signed

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