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AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints – The New York Times

Experts are concerned that the company has not been more forthcoming about two participants who became seriously ill after getting its experimental vaccine.

Credit…Vincenzo Pinto/Agence France-Presse — Getty Images

AstraZeneca revealed details of its large coronavirus vaccine trials on Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.

Polls are finding Americans increasingly wary of accepting a coronavirus vaccine. And scientists inside and outside the government are worried that regulators, pressured by the president for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine.

“The release of these protocols seems to reflect some public pressure to do so,” said Natalie Dean, a biostatistician and expert in clinical trial design for vaccines at the University of Florida. “This is an unprecedented situation, and public confidence is such a huge part of the success of this endeavor.”

Experts have been particularly concerned about AstraZeneca’s vaccine trials, which began in April in Britain, because of the company’s refusal to provide details about serious neurological illnesses in two participants, both women, who received its experimental vaccine in Britain. Those cases spurred the company to halt its trials twice, the second time earlier this month. The studies have resumed in Britain, Brazil, India and South Africa, but are still on pause in the U.S. About 18,000 people worldwide have received AstraZeneca’s vaccine so far.

AstraZeneca’s 111-page trial blueprint, known as a protocol, states that its goal is a vaccine with 50 percent effectiveness — the same threshold that the Food and Drug Administration has set in its guidance for coronavirus vaccines. To determine with statistical confidence whether the company has met that target, there will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots.

However, the plan anticipates that a safety board will perform an early analysis after there have been just 75 cases. If the vaccine is 50 percent effective at that point, it might be possible for the company to stop the trial early and apply for authorization from the government to release the vaccine for emergency use.

In allowing only one such interim analysis, AstraZeneca’s plan is more rigorous than the others that have been released, from Moderna and Pfizer, Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said in an interview. Moderna allows two such analyses, and Pfizer four.

He said the problem with looking at the data too many times, after a relatively small number of cases, is that it increases the odds of finding an appearance of safety and efficacy that might not hold up. Stopping trials early can also increase the risk of missing rare side effects that could be significant once the vaccine is given to millions of people.

Dr. Topol said AstraZeneca’s plan, like those of Moderna and Pfizer, had a problematic feature: All count relatively mild cases of Covid-19 when measuring efficacy, which may hamper efforts to determine whether the vaccine prevents moderate or severe illness.

Such plans are not usually shared with the public “due to the importance of maintaining confidentiality and integrity of trials,” Michele Meixell, a spokeswoman for AstraZeneca, said in a statement.

The company has released few details about the two cases of serious illness in its trial. The first participant received one dose of the vaccine before developing inflammation of the spinal cord, known as transverse myelitis, according to a participant information sheet for AstraZeneca’s vaccine from July. The condition can cause weakness in the arms and legs, paralysis, pain and bowel and bladder problems.

The case prompted a pause in AstraZeneca’s vaccine trials to allow for a safety review by independent experts. A company spokeswoman told the Times last week that the volunteer was later determined to have a previously undiagnosed case of multiple sclerosis, unrelated to the vaccine, and that the trial resumed shortly thereafter.

Transverse myelitis can sometimes be the first sign of multiple sclerosis, which involves more complex symptoms. But the myelitis alone can also occur after the body encounters an infectious agent like a virus.

The company said it had not confirmed a diagnosis in the second case, a participant who got sick after the second dose of the vaccine. A person familiar with the situation who spoke with The Times on the condition of anonymity said the participant’s illness had been pinpointed as transverse myelitis. The trial was paused again on Sept. 6 after she fell ill.

The condition is rare, but serious, and experts said that finding even one case among thousands of trial participants could be a red flag. Multiple confirmed cases, they said, could be enough to halt AstraZeneca’s vaccine bid entirely.

“If there are two cases, then this starts to look like a dangerous pattern,” said Mark Slifka, a vaccine expert at Oregon Health and Science University. “If a third case of neurological disease pops up in the vaccine group, then this vaccine may be done.”

A participant information sheet dated Sept. 11 on AstraZeneca’s trial in Britain lumped the two volunteers’ cases together, stating the illnesses were “unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine,” based on safety reviews. The next day, AstraZeneca announced that it had resumed the trial in Britain.

But the F.D.A. has so far not allowed the company to start up again in the United States.

A spokesman for the F.D.A. declined to comment. The National Institutes of Health said in a statement that it “remains to be seen” whether the onset of illness in trial participants was coincidental or tied to the vaccine, adding that “pausing to allow for further evaluation is consistent with standard practice.”

Dr. Mark Goldberger, an infectious disease expert at the Global Antibiotic Research and Development Partnership and a former F.D.A. official, said he found the rapid restarting of trials abroad to be “a little disturbing,” especially given the lack of details around the patients’ symptoms and the ambiguity around their connection to the vaccine. “Maybe this is the best they could do — it may not be possible to get more certainty at this time,” he said. “It is a question mark as to what’s going on.”

The company did not immediately inform the public about the neurological problems of either participant. Nor did it promptly alert the F.D.A. that it was again pausing its trials after the second U.K. volunteer developed illness and an independent safety board in the United States called for a temporary halt, according to multiple people familiar with the situation. The company’s chief executive told investors about the problems but did not discuss them publicly until the information was leaked and reported by STAT.

“The communication around it has been horrible and unacceptable,” said Dr. Peter Jay Hotez, a virologist with Baylor College of Medicine in Houston. “This is not how the American people should be hearing about this.”

Dr. Hotez also criticized obtuse statements released by government officials, including U.K. regulators who he said failed to supply a rationale for resuming their trials.

“Tell us why you came to that decision,” he said.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s advisory committee on vaccines, said that it’s unclear how the company — or the U.K. government — determined that the second case was not related to the vaccine.

He and other experts noted that transverse myelitis is rare, diagnosed in only about one in 236,000 Americans a year. The trial in Britain involved only about 8,000 volunteers, a spokesman for the Oxford researchers said last month.

The vaccine being developed by AstraZeneca, which formed a partnership with Oxford University scientists, uses a virus meant to carry coronavirus genes into human cells and trigger an immune response that will protect people from the coronavirus. This so-called vector is a modified form of an adenovirus that causes common colds in chimpanzees but is considered safe for people. Several other companies, including Johnson & Johnson and CanSino, are pursuing similar adenovirus-based approaches, although there are multiple types of adenoviruses, and specific ingredients differ from vaccine to vaccine.

While other adenovirus-based products have seen some success in the past, they have also been linked to serious adverse events. The most famous was the case of 18-year-old Jesse Gelsinger, who died in 1999 after receiving gene therapy through an adenovirus that sparked a lethal inflammatory response from his immune system.

If a serious side effect was definitively linked to AstraZeneca’s vaccine, scientists would need to determine if its root cause stemmed from the adenovirus vector, or perhaps the coronavirus genes it carried — connections that could raise concerns about other companies’ products that rely on the same components.

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Under 20s around half as susceptible to COVID-19: Study – AOL

LONDON, June 16 (Reuters) – People under 20 are around half as susceptible to COVID-19 as people aged 20 or above, according to research published on Tuesday, and clinical symptoms of the pandemic disease appear in only about a fifth of infections in children and teens.

The research, a modeling study using data from 32 locations China, Italy, Japan, Singapore, Canada and South Korea, found that by contrast, COVID-19 symptoms appear in 69% of infections in people aged 70 or older.

The findings suggest that school closures – introduced in many countries as part of lockdowns aimed at controlling the coronavirus pandemic – are likely to have a limited impact on transmission of the disease, the researchers said.

Published in the journal Nature Medicine, the study compared the effect school closures on simulated outbreaks of flu – which is known to spread swiftly in children – and of COVID-19, the disease caused by the new coronavirus.

“For COVID-19, there was much less of an effect of school closures,” said Rosalind Eggo, an infectious disease modeler at The London School of Hygiene and Tropical Medicine who co-led the study.

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States reopen, relax guidelines to prevent coronavirus spread

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NEW YORK, NEW YORK – MAY 06: An employee wearing a mask cleans the inside of the restaurant, Blue Stripes Cacao Shop as it prepares to reopen for takeaway and delivery orders after being closed for over a month amid the coronavirus pandemic on May 6, 2020 in New York City. Governor Andrew Cuomo made the announcement that all bars and restaurants must close by on March 16th unless it was takeout or delivery. COVID-19 has spread to most countries around the world, claiming over 263,000 lives with over 3.8 million cases. (Photo by Alexi Rosenfeld/Getty Images)

NEW YORK, NEW YORK – MAY 06: An employee wearing a mask cleans the inside of the restaurant, Blue Stripes Cacao Shop as it prepares to reopen for takeaway and delivery orders after being closed for over a month amid the coronavirus pandemic on May 6, 2020 in New York City. Governor Andrew Cuomo made the announcement that all bars and restaurants must close by on March 16th unless it was takeout or delivery. COVID-19 has spread to most countries around the world, claiming over 263,000 lives with over 3.8 million cases. (Photo by Alexi Rosenfeld/Getty Images)

THOUSAND OAKS, CA – MAY 06: A Cadillac Dealership displays a sign stating its reopened during the Coronavirus Pandemic on May 06, 2020 in Thousand Oaks, California. The coronavirus pandemic worldwide has claimed over 263,000 lives and infected over 3.7 million people. (Photo by Josh Lefkowitz/Getty Images)

HOUSTON, May 5, 2020 — Customers shop at a shopping mall in Frisco, on the outskirts of Dallas, Texas, the United States, May 5, 2020. After closed for several weeks due to the outbreak of COVID-19 pandemic, the shopping mall reopened with shortened business hours on Tuesday. (Photo by Dan Tian/Xinhua via Getty) (Xinhua/ via Getty Images)

HOUSTON, May 5, 2020 — Cars are parked in front of a shopping mall in Frisco, on the outskirts of Dallas, Texas, the United States, May 5, 2020. After closed for several weeks due to the outbreak of COVID-19 pandemic, the shopping mall reopened with shortened business hours on Tuesday. (Photo by Dan Tian/Xinhua via Getty) (Xinhua/ via Getty Images)

Dawson Padilla (L), owner of a protein shakes store, works behind the bar on May 5, 2020 in Stillwater, Oklahoma. – In the face of intimidation against employees and the threat of an armed attack by local residents wielding their individual liberties, the mayor of Stillwater had to give in: he gave up imposing the wearing of masks on customers in shops. This demand was included in a 21-page document that was supposed to accompany the gradual reopening of restaurants and shops from 1 May, as authorized by the state of Oklahoma. “About three and a half hours after the law came into effect” of the text, “we started receiving calls from stores claiming that employees were being threatened and insulted, and threatened with physical violence,” said Norman McNickle, the city’s director of services. (Photo by Johannes EISELE / AFP) (Photo by JOHANNES EISELE/AFP via Getty Images)

A worker of the Aspen Cafe wears a mask as she makes coffee on May 5, 2020 in Stillwater, Oklahoma. – In the face of intimidation against employees and the threat of an armed attack by local residents wielding their individual liberties, the mayor of Stillwater had to give in: he gave up imposing the wearing of masks on customers in shops. This demand was included in a 21-page document that was supposed to accompany the gradual reopening of restaurants and shops from 1 May, as authorized by the state of Oklahoma. “About three and a half hours after the law came into effect” of the text, “we started receiving calls from stores claiming that employees were being threatened and insulted, and threatened with physical violence,” said Norman McNickle, the city’s director of services. (Photo by Johannes EISELE / AFP) (Photo by JOHANNES EISELE/AFP via Getty Images)

Kelly Lyda, owner of the Aspen Cafe, stands in his Cafe on May 5, 2020 in Stillwater, Oklahoma. – In the face of intimidation against employees and the threat of an armed attack by local residents wielding their individual liberties, the mayor of Stillwater had to give in: he gave up imposing the wearing of masks on customers in shops. This demand was included in a 21-page document that was supposed to accompany the gradual reopening of restaurants and shops from 1 May, as authorized by the state of Oklahoma. “About three and a half hours after the law came into effect” of the text, “we started receiving calls from stores claiming that employees were being threatened and insulted, and threatened with physical violence,” said Norman McNickle, the city’s director of services. (Photo by Johannes EISELE / AFP) (Photo by JOHANNES EISELE/AFP via Getty Images)

Computer specialist Toby Angel drinks his coffee on May 5, 2020 in Stillwater, Oklahoma. – In the face of intimidation against employees and the threat of an armed attack by local residents wielding their individual liberties, the mayor of Stillwater had to give in: he gave up imposing the wearing of masks on customers in shops. This demand was included in a 21-page document that was supposed to accompany the gradual reopening of restaurants and shops from 1 May, as authorized by the state of Oklahoma. “About three and a half hours after the law came into effect” of the text, “we started receiving calls from stores claiming that employees were being threatened and insulted, and threatened with physical violence,” said Norman McNickle, the city’s director of services. (Photo by Johannes EISELE / AFP) (Photo by JOHANNES EISELE/AFP via Getty Images)

WESTPORT, CONNECTICUT – MAY 05: A cafe along a shopping street in the affluent community remains mostly empty of pedestrians and open stores on May 05, 2020 in Westport, Connecticut. A growing number of states have begun reopening parts of the economy amid demonstrations like the one yesterday that targeted the Connecticut state capital and the governor’s mansion in Hartford. (Photo by Spencer Platt/Getty Images)

WESTPORT, CONNECTICUT – MAY 05: A cafe along a shopping street in the affluent community remains mostly empty of pedestrians and open stores on May 05, 2020 in Westport, Connecticut. A growing number of states have begun reopening parts of the economy amid demonstrations like the one yesterday that targeted the Connecticut state capital and the governor’s mansion in Hartford. (Photo by Spencer Platt/Getty Images)

LAGUNA HILLS, CA – MAY 05: Customers maintain safety protocols at The BarberHood in Laguna Hills, CA, on Tuesday, May 5, 2020. The shop is one of the first to re-open and defy the state”u2019s stay-at-home order during the COVID-19 (coronavirus) lockdown. (Photo by Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

SAN CLEMENTE, CA – MAY 05: Visitors walk on the beach south of the pier in San Clemente, CA on Tuesday, May 5, 2020. The city opened its beaches for daily active use after coordinating with Gov. Gavin Newsom”u2019s office to maintain social distancing during the COVID-19 (coronavirus) lockdown. (Photo by Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

SAN CLEMENTE, CA – MAY 05: Surfers were back on the waves at T Street in San Clemente, CA on Tuesday, May 5, 2020. The city opened its beaches for daily active use after coordinating with Gov. Gavin Newsom”u2019s office to maintain social distancing during the COVID-19 (coronavirus) lockdown. (Photo by Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

KENMORE, WA – MAY 05: Lynette Fisher-Charles and her dog Gracie, a two-year-old springer spaniel, go for a hike in Saint Edward State Park on May 5, 2020 in Kenmore, Washington. The first phase to reopen the state begins today easing some restrictions including opening some parks, that were put in place during Governor Jay Inslees Stay Home, Stay Healthy order last March to help reduce the spread of COVID-19. Kenmore, WA is located northeast of Seattle. (Photo by Karen Ducey/Getty Images)

KENMORE, WA – MAY 05: Daryl Kline, a park ranger at Saint Edward State Park removes a sign saying the park is closed on May 5, 2020 in Kenmore, Washington. The first phase to reopen the state begins today easing some restrictions that were put in place during Governor Jay Inslees Stay Home, Stay Healthy order last March to help reduce the spread of COVID-19. Kenmore, WA is located northeast of Seattle. (Photo by Karen Ducey/Getty Images)

LAGUNA BEACH, CA – MAY 05: Lifeguards keep a lookout at Laguna Beach, CA after officials reopened access to the sand on Tuesday, May 5, 2020. The beach has been closed since March 23, 2020 due to the COVID-19 (coronavirus) outbreak. City parks along the beach are still closed and people cannot sit or linger on the sand. (Photo by Paul Bersebach/MediaNews Group/Orange County Register via Getty Images)

NEW YORK, May 4, 2020 — Photo taken on May 4, 2020 shows Times Square in New York, the United States.
Amid the ongoing COVID-19 pandemic, New York Governnor Andrew Cuomo on Monday outlined additional guidelines regarding when regions can reopen.
According to the Governor’s Press Office, the state will monitor four core factors to determine if a region can reopen: number of new infections, health care capacity, diagnostic testing capacity and contact tracing capacity. (Photo by Wang Ying/Xinhua via Getty) (Xinhua/Wang Ying via Getty Images)

NEW YORK, May 4, 2020 — A worker cleans a cafe’s signboard at Times Square in New York, the United States, May 4, 2020.
Amid the ongoing COVID-19 pandemic, New York Governnor Andrew Cuomo on Monday outlined additional guidelines regarding when regions can reopen.
According to the Governor’s Press Office, the state will monitor four core factors to determine if a region can reopen: number of new infections, health care capacity, diagnostic testing capacity and contact tracing capacity. (Photo by Wang Ying/Xinhua via Getty) (Xinhua/Wang Ying via Getty Images)

ASBURY PARK, NJ – MAY 4: People walk near the closed boardwalk due to the outbreak of COVID-19 in the state on May 4, 2020 in the Jersey Shore in New Jersey. Some towns at Jersey Shore expect the reopening of beaches soon. (Photo by Eduardo MunozAlvarez/VIEWpress/Corbis via Getty Images)

NORTH ANDOVER, MA – MAY 4: Although all golf courses in Massachusetts are still ordered to stay closed by governor Charlie Baker, workers at the North Andover Country Club in North Andover, MA work on the grass on May 4, 2020, getting the course ready for when they eventually are allowed to re-open. (Photo by Jim Davis/The Boston Globe via Getty Images)

LOS ANGELES, CA – MAY 04: Gov. Gavin Newsom announced select retail businesses will be allowed to reopen starting Friday in California during the coronavirus pandemic on Monday, May 4, 2020 in Los Angeles, CA. (Jason Armond / Los Angeles Times via Getty Images)

SANFORD, UNITED STATES – MAY 04, 2020: Customers enjoy a meal at Racks Billiards Sports Bar and Grill on the first day that retail stores and restaurants in all Florida counties except Palm Beach, Broward, and Miami Dade were permitted to reopen as COVID-19 restrictions are eased. Under phase one of the plan to reopen the state, stores and restaurants are limited to 25 percent of their indoor capacity.- PHOTOGRAPH BY Paul Hennessy / Echoes Wire/ Barcroft Studios / Future Publishing (Photo credit should read Paul Hennessy / Echoes Wire/Barcroft Media via Getty Images)

SANFORD, UNITED STATES – MAY 04, 2020: A customer leaves a Books-A-Million store on the first day that retail stores and restaurants in all Florida counties except Palm Beach, Broward, and Miami Dade were permitted to reopen as COVID-19 restrictions are eased. Under phase one of the plan to reopen the state, stores and restaurants are limited to 25 percent of their indoor capacity.- PHOTOGRAPH BY Paul Hennessy / Echoes Wire/ Barcroft Studios / Future Publishing (Photo credit should read Paul Hennessy / Echoes Wire/Barcroft Media via Getty Images)

BOZEMAN, MT – MAY 04: Sales staff wear masks at the reopened Schnee’s Boots, Shoes and Outdoors on Main Street on May 4, 2020 in Bozeman, Montana. Wyoming health officials today reported that the state’s confirmed coronavirus cases grew by nine to a total of 444. (Photo by William Campbell/Getty Images)

BOZEMAN, MT – MAY 04: Signs for restaurants and stores announce their reopenings on Main Street on May 4, 2020 in Bozeman, Montana. Wyoming health officials today reported that the state’s confirmed coronavirus cases grew by nine to a total of 444. (Photo by William Campbell/Getty Images)

JENSEN BEACH, FLORIDA – MAY 04: Cole Hunter carries Harper Hunter, 1, as Holly Hunter,4, follows along as they arrive at the beach on May 04, 2020 in Jensen Beach, Florida. Restaurants, retailers, as well as beaches and some state parks reopened today with caveats, as the state continues to ease restrictions put in place to contain COVID-19. The counties of Palm Beach, Broward and Miami Dade continue to maintain restrictions. (Photo by Joe Raedle/Getty Images)

JACKSONVILLE BEACH, FLORIDA – MAY 04: People are seen dining outside at Cruisers Grill as the state of Florida enters phase one of the plan to reopen the state on May 04, 2020 in Jacksonville Beach, Florida. Restaurants, retailers, beaches and some state parks reopen today with caveats, as the state continues to ease restrictions put in place to contain the coronavirus (COVID-19). (Photo by Sam Greenwood/Getty Images)

JACKSONVILLE BEACH, FLORIDA – MAY 04: People are seen at a department store as the state of Florida enters phase one of the plan to reopen the state on May 04, 2020 in Jacksonville Beach, Florida. Restaurants, retailers, beaches and some state parks reopen today with caveats, as the state continues to ease restrictions put in place to contain the coronavirus (COVID-19). (Photo by Sam Greenwood/Getty Images)

SAINT AUGUSTINE, FLORIDA – MAY 04: A mask is seen on the statue of Henry M. Flagler as the state of Florida enters phase one of the plan to reopen the state on May 04, 2020 in Saint Augustine, Florida. Restaurants, retailers, beaches and some state parks reopen today with caveats, as the state continues to ease restrictions put in place to contain the coronavirus (COVID-19). (Photo by Sam Greenwood/Getty Images)

A man works on power lines in Los Angeles, California on May 4, 2020, amid the coronavirus pandemic. – California governor Gavin Newsom earlier today announced the gradual reopening of the state later this week as dismal US employment figures are expected with the release of figures Friday May 8 for April’s US jobs report, as 30 million Americans filed for unemployment in the last six weeks. (Photo by Frederic J. BROWN / AFP) (Photo by FREDERIC J. BROWN/AFP via Getty Images)

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She added, however, that the findings come from simulated outbreaks and need to be reinforced with real-world research.

Using demographic data from the six countries, as well as from six studies on estimated COVID-19 infection rates and symptom severity across different age groups, the model showed that people under 20 are about half as susceptible to COVID-19 as people over 20, and that among 10 to 19 year-olds, only 21% of those infected had clinical symptoms.

The researchers also simulated COVID-19 epidemics in 146 capital cities around the world and found that the total expected number of clinical cases varied with median age.

“The age structure of a population can have a significant impact,” said Nicholas Davies, who co-led the work. “Countries with more young people may experience a lower burden of COVID-19.” (Editing by William Maclean)

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