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The most advanced Covid-19 vaccine trials won’t tell us if the shots save lives, expert notes

The most advanced trials for coronavirus vaccines cannot tell researchers if the shots will save lives, or even if they’ll prevent serious disease, a drug development expert pointed out Wednesday.



a woman smiling for the camera


© Reuters / University of Oxford


The ongoing trials are only designed to show if the vaccines prevent infection — and most infections are mild infections, Peter Doshi, an associate editor at the BMJ medical journal and a drug development specialist at the University of Maryland’s school of pharmacy, said.

“I think there are some pretty widely held assumptions about what we are getting out of Phase 3 studies,” Doshi told CNN.

“None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus,” Doshi wrote in the BMJ.

“Hospital admissions and deaths from Covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out.”

Four vaccines being developed in the US are in the most advanced, Phase 3 stage of development: those being made by Moderna, Pfizer, AstraZeneca and Johnson & Johnson. They’re “event-driven” trials, meaning that the goal is to keep them going until a certain number of volunteers become infected. If more infections are seen among people who got placebo, or dummy shots, it’s an indication the vaccines prevented infection.

But that doesn’t mean the vaccines saved people from serious disease or death, Doshi argued.

“Severe illness requiring hospital admission, which happens in only a small fraction of symptomatic Covid-19 cases, would be unlikely to occur in significant numbers in trials,” he wrote.

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee meets Thursday to discuss the ongoing coronavirus vaccine trials and what members would like the FDA to consider when reviewing any applications for either emergency use authorization for a vaccine, or full approval.

Doshi said they should consider asking the companies to reconfigure their trials to include data on preventing severe illness and death.

“People expect that the most severe part of the Covid iceberg — the ICU admissions and hospitalizations and deaths — that’s what a vaccine would put an end to,” he said.

But the current trials will just look for early infections. It’s possible to keep these current trials going and add onto them so that they will, eventually, answer the question of whether Covid vaccines save lives and prevent severe disease.

“The trials are ongoing,” he told CNN. “There’s a chance for that. It’s not too late.”

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Vaccine Trials ‘Can’t Detect’ Virus Risk Reduction: Expert

None of the trials of Covid-19 candidate vaccines can detect a reduction in serious outcomes such as hospitalisation or death, a leading public health expert said Thursday.

Writing in the BMJ medical journal, associate editor Peter Doshi warned that not even phase 3 trials under way in the race for a vaccine can prove their product will prevent people contracting Covid-19.

In a sobering essay, Doshi said those hoping for a breakthrough to end the pandemic would be disappointed, with some vaccines likely to reduce the risk of Covid-19 infection by only 30 percent.

“None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths,” he wrote.

“Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.”

The World Health Organization (WHO) has identified 42 candidate vaccines in clinical trials, ten of which are in the most advanced “phase 3” stage.

This is where a vaccine’s effectiveness is tested on a large scale, generally tens of thousands of people across several continents.

But Doshi, assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, said that even the most advanced trials are evaluating mild rather than severe disease.

The World Health Organization (WHO) has identified 42 candidate vaccines in clinical trials, ten of which are in the most advanced "phase 3" stage The World Health Organization (WHO) has identified 42 candidate vaccines in clinical trials, ten of which are in the most advanced “phase 3” stage Photo: AFP / Ludovic MARIN

This may be down to the numbers of people involved in trials, he said, pointing out that the majority of confirmed Covid-19 infections involve mild or no symptoms.

And few if any current trials are designed to find out whether there is a benefit among the elderly, a key at-risk constituency.

Without enrolling frail and elderly volunteers in trials in sufficient numbers, Doshi said “there can be little basis for assuming any benefit against hospitalisation or mortality.

He added that children, immunocompromised people and pregnant women had largely been excluded from trials, making it unlikely that the experiments will address key gaps in our understanding of how Covid-19 develops differently among individuals.

Several trials have already been halted after participants became ill.

Many countries plan to prioritise vulnerable people once a vaccine is available, but Doshi said that those hoping for a miracle end to the pandemic would have to wait.

He said that several pharmaceutical firms had designed their studies “to detect a relative risk reduction of at least 30 percent in participants developing laboratory confirmed Covid-19”.

Recent studies have also confirmed that it is possible for someone to be reinfected with Covid-19, a development that may impact how governments’ form their vaccination plans.

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US is nearing ‘rapid acceleration’ of Covid-19 cases, expert warns, as daily infections top 60,000

A leading health expert says US Covid-19 cases will begin to rapidly accelerate in a week as the country topped 60,000 new infections Tuesday — triple what the daily average was back in June, when restrictions had begun to ease.



a car parked in a parking lot: People in cars wait in line for Covid-19 testing in Reading, Pennsylvania, on Tuesday morning, October 13.


© Ben Hasty/MediaNews Group/Reading Eagle/Getty Images
People in cars wait in line for Covid-19 testing in Reading, Pennsylvania, on Tuesday morning, October 13.

The prediction comes after several state leaders reimposed some measures to help curb the spread of the virus, fueled by small gatherings increasingly moving indoors with the colder weather, as well as other factors such as college and school reopenings. The national seven-day case average has increased at least 18% since the previous week and is now a staggering 61% higher than what it was five weeks ago. And as multiple experts have warned, things will likely get worse before they get better.

“It’s going to be a difficult fall and winter,” Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, told CNBC Monday. “I think we’re about two or three weeks behind Europe — so we’re about a week away from starting to enter a period where we’re going to see a rapid acceleration in cases.”

The difference is many European countries were able to suppress their numbers of new cases over the summer, but the US entered the fall season with a relatively high baseline average of new infections — something experts warned wouldn’t help in containing another surge of cases. Dr. Anthony Fauci said earlier this week European Union countries were able to bring their baseline down because of strict and stringent lockdowns, adding the US did not “shut down nearly as much as our colleagues in Italy and Spain.”

Ahead of bleak outlooks of the coming weeks, hospitalizations in the US have also began to rise, with more than 39,000 Covid-19 patients nationwide, according to the COVID Tracking Project.

“We’re seeing hospitalizations go up in 42 states right now, cases are going up in 45 states, and there really is no backstop,” Gottlieb said. “This fall and winter season is when the coronavirus is going to want to spread.”

‘Get ready:’ 70,000 new infections daily

At least 26 US states are reporting more new Covid-19 cases than the previous week, according to data from Johns Hopkins University. And no states are trending in the right direction, according to the data.

By next week or the week after that, the US could be recording up to 70,000 new cases daily, Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said Tuesday. And the numbers could keep rising after that, he said.

“Look out for your mental health, because the normal response to this is people are going to get sad and upset, and maybe even depressed, so have access to mental health counseling,” Hotez said. “In other words, put those belts and suspenders in and get ready.”

Video: Infectious diseases expert blasts

‘More than one’ coronavirus vaccine will be ready in early 2021, Sage expert says

Sage expert Sir Jeremy Farrar has said he believes “more than one” coronavirus vaccine will be available by the beginning of next year.

Prof Farrar told Sky News’ Sophy Ridge On Sunday he believed that much stricter social distancing measures would be needed until the vaccine is ready.

The Wellcome Trust director said: “I do believe the vaccines will be available in the first quarter of next year, I do believe that monoclonal antibodies to treat patients and save lives will be available in the coming months.

“It’s with that context that I think we need to reduce transmission now and we need to get ourselves back to the beginning of September as a country, not in piecemeal, not in fragments across the country, but as a whole country.”

A scientist at work during a visit by the Duke of Cambridge to the manufacturing laboratory where a vaccine against COVID-19 has been produced at the Oxford Vaccine Group's facility at the Churchill Hospital in Oxford.
A scientist at work at the manufacturing laboratory where a vaccine against COVID-19 has been produced at the Oxford Vaccine Group’s facility at the Churchill Hospital in Oxford. (PA)

Prof Farrar added: “Christmas will be tough this year. I don’t think it’s going to be the usual celebration it is and all families coming together, I’m afraid.

“I think we have to be honest and realistic and say that we are in for three to six months of a very difficult period.

Read more: Northern Conservative MPs blast ‘ill-advised’ letter from fellow Tories to Manchester mayor over local lockdown

“The temperatures drop, we are all indoors more often, we have the other infections that come this time of year. It’s much better for us to be upfront and honest now.”

Elsewhere in the interview Prof Farrar said he believed that the government had made a mistake by not implementing a so-called “circuit breaker” short-term lockdown.

He claimed it was not too late to stem the large rise in infections and said the “second best time” for a national lockdown is now.

A couple wearing face masks cross Oxford Circus, past a social distancing notice, in London, England, on October 16, 2020. London is to be placed under 'Tier 2' coronavirus lockdown measures from midnight tonight, meaning 'high' alert for covid-19. Most notably the change will introduce a ban on people from different households from mixing anywhere indoors, prompting particular concern within the already badly-affected hospitality industry. (Photo by David Cliff/NurPhoto via Getty Images)
A couple wearing face masks in Oxford Circus, London. (Getty)

Prof Farrar said the scientific advice given to the government said that the best course of action would have been to impose a circuit breaker on around 20 September, but it was not followed.

“You either have to go very early and harder than you may think, and more geographically dispersed than you may think, or you go incrementally, one week after another or one fortnight after another to try and introduce the restrictions,” he said.

“I am in favour of going earlier, I think when you go earlier the restrictions can be less draconian and you can have a bigger impact on transmission, and critically get that R value to 1 and below 1.

“That’s what we’ve got to aim for – it has to be the objective.”

Watch: Can you catch the coronavirus twice?

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Infectious Disease Expert Contradicts Anthony Fauci, Reveals How Thanksgiving Travel Could Be Safe

While Dr. Anthony Fauci is warning against large family gatherings and travel for the upcoming Thanksgiving holiday in the U.S., another health expert is saying that those who utilize proper precautions should be okay to do some traveling over the holidays.

Speaking to WPTV, an NBC affiliate station, Dr. Kleper De Almeida, an infectious disease specialist with JFK Medical Center in Atlantis, Florida, said that he felt travel could take place over the holiday season, including Thanksgiving, so long as those choosing to travel did so in a smart and safe way.

“As long as people take the measures that we should be applying every day, it would be safe to travel,” he said. “We need to be very mindful of that while we travel to protect ourselves from exposure, and in doing so, minimizing the risk of bringing it back to our communities.”

De Almeida’s comments directly contradict ones made by Fauci, who is the head of the National Institute of Allergy and Infectious Diseases and has been seen as the face of COVID-19, as he repeatedly warns Americans of rising infection rates and encourages mask use and social distancing. However, while those measures can help slow the spread, he has warned against letting them be the sole means of protection when it comes to considering a larger gathering for Thanksgiving and even admitted that he was taking precautions by not spending the holiday with his own daughters.

“That is unfortunately a risk, when you have people coming from out of town, gathering together in an indoor setting,” Fauci said. It is unfortunate, because that’s such a sacred part of American tradition—the family gathering around Thanksgiving. But that is a risk.”

The CDC echoed Fauci’s concerns with their guidelines for the holiday season, and traditional events that draw large crowds, like the Macy’s Thanksgiving Day Parade in New York, are going virtual to try and prevent the spread.

The United States currently stands at more than 8 million total COVID-19 infections reported and 218,000 deaths, with more than 70,000 new cases reported Friday, the largest increase since July. According to statistics from the New York Times, a total of 29 states continue to report high numbers of cases, while 16 other states are starting to report upticks.

In the past seven days, states that have seen high surges in percentages of cases have been North and South Dakota, which have seen more than 500 cases per 100,000 residents, with Montana, Wisconsin and Nebraska also reporting high numbers, with more than 300 cases per 100,000 residents. Currently, the only states that have seen less than 100 infections per 100,000 people (less than 0.001 percent), have been Vermont, Maine, Hawaii, New Hampshire, New York, Oregon, California, Washington, New Jersey, Massachusetts, Maryland, Arizona, Pennsylvania, Connecticut, Virginia, Florida, Delaware, Georgia and Louisiana.

Fauci said the government would not make any future COVID-19 vaccine obligatory for the general public Fauci said the government would not make any future COVID-19 vaccine obligatory for the general public Photo: POOL / Al Drago

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The country reported its most cases in a day since July. Deaths may begin climbing, too, a leading expert says

The US reported at least 69,000 new Covid-19 infections Friday — the most in a single day since July — amid an alarming nationwide rise in cases that experts say marks the start of a fall surge.



a person sitting at a table with a cake: Nursing assistant Monica Brodsky, left, and nurse Taylor Mathisen work at a drive-thru testing site for COVID-19 in the parking lot at UW Health Administrative Office Building in Middleton, Wis., Monday, Oct. 5, 2020. A surge of coronavirus cases in Wisconsin and the Dakotas is forcing a scramble for hospital beds and raising political tensions, as the Upper Midwest and Plains emerge as one of the nation's most troubling hotspots. (Amber Arnold/Wisconsin State Journal via AP)


© AMBER ARNOLD/AP
Nursing assistant Monica Brodsky, left, and nurse Taylor Mathisen work at a drive-thru testing site for COVID-19 in the parking lot at UW Health Administrative Office Building in Middleton, Wis., Monday, Oct. 5, 2020. A surge of coronavirus cases in Wisconsin and the Dakotas is forcing a scramble for hospital beds and raising political tensions, as the Upper Midwest and Plains emerge as one of the nation’s most troubling hotspots. (Amber Arnold/Wisconsin State Journal via AP)

On July 29, the US reported more than 71,300 infections, about two weeks after the country’s peak daily case count of more than 77,000. That summer surge eventually waned, and daily averages dipped to a little more than 34,300 by September 12.

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But now, the country is averaging more than 55,000 new cases daily over the past week — up more than 60% since mid-September’s dip. The case upticks have prompted state leaders to push new measures in hopes of curbing the spread of the virus.

Nebraska Gov. Pete Ricketts announced changes to the state’s health measures, including requiring hospitals to reserve at least 10% of staffed general and ICU beds for Covid-19 patients. New Mexico Gov. Michelle Lujan Grisham this week ordered new mass gathering limitations and a 10 p.m. closing time for establishments serving alcohol. And in Kentucky, Gov. Andy Beshear said this month he instructed authorities to step up mask enforcement.

Hospitalizations are climbing nationwide. And they’ll likely be followed by a rise in daily Covid-19 deaths, says Dr. Francis Collins, director of the National Institutes of Health.

“This is a good moment for people to stop and ask themselves, ‘What can I do to try to be sure that we limit the further infections that otherwise seem to be looming in front of us as cold weather is kicking in and people are indoors, and those curves are going upward, in the wrong direction?’ ” Collins said Friday.

Researchers from the University of Washington’s Institute for Health Metrics and Evaluation project more than 2,300 Americans could be dying daily by mid-January and a total of more than 389,000 people could die from the virus in the US by February 1.

The country’s daily tallies of Covid-19 deaths have been steady recently — averaging around 700 per day across a week. That’s below the peak of the summer, when the daily average hovered above 1,000 from late July into mid-August.

More than 218,000 people have died from Covid-19 nationwide since the start of the pandemic. Just over 8 million US cases have been reported.

Experts say Americans can help get the virus under control by heeding basic public health guidelines touted by officials for months: avoiding crowded settings, keeping a distance, keeping small gatherings outdoors and wearing a mask.

The US reported the most Covid-19 cases in a day since July. Deaths may begin climbing, too, a leading expert says

The US reported at least 69,000 new Covid-19 infections Friday — the most in a single day since July — amid an alarming nationwide rise in cases that experts say marks the start of the fall surge.



a person sitting at a table with a cake: Nursing assistant Monica Brodsky, left, and nurse Taylor Mathisen work at a drive-thru testing site for COVID-19 in the parking lot at UW Health Administrative Office Building in Middleton, Wis., Monday, Oct. 5, 2020. A surge of coronavirus cases in Wisconsin and the Dakotas is forcing a scramble for hospital beds and raising political tensions, as the Upper Midwest and Plains emerge as one of the nation's most troubling hotspots. (Amber Arnold/Wisconsin State Journal via AP)


© AMBER ARNOLD/AP
Nursing assistant Monica Brodsky, left, and nurse Taylor Mathisen work at a drive-thru testing site for COVID-19 in the parking lot at UW Health Administrative Office Building in Middleton, Wis., Monday, Oct. 5, 2020. A surge of coronavirus cases in Wisconsin and the Dakotas is forcing a scramble for hospital beds and raising political tensions, as the Upper Midwest and Plains emerge as one of the nation’s most troubling hotspots. (Amber Arnold/Wisconsin State Journal via AP)

On July 29, the US reported more than 71,300 infections, about two weeks after a peak daily case count of more than 77,000 cases. The country was then at the height of the pandemic and several states were adding thousands of new cases each day. By mid-September, the summer surge had slowed and the US was averaging a little more than 36,000 daily cases.

But now, the country is averaging more than 53,000 new infections daily — up 14% from the previous week. The case upticks have prompted state leaders to push new measures in hopes of curbing the spread of the virus.

Nebraska Gov. Pete Ricketts announced changes to the state’s health measures, including requiring hospitals to reserve at least 10% of staffed general and ICU beds for Covid-19 patients. New Mexico Gov. Michelle Lujan Grisham this week ordered new mass gathering limitations and a 10 p.m. closing time for establishments serving alcohol. And in Kentucky, Gov. Andy Beshear said earlier this month he instructed authorities to step up mask enforcement.

Hospitalizations are climbing nationwide. And they’ll likely be followed by a rise in daily Covid-19 deaths, says Dr. Francis Collins, director of the National Institutes of Health.

“This is a good moment for people to stop and ask themselves, what can I do to try to be sure that we limit the further infections that otherwise seem to be looming in front of us as cold weather is kicking in and people are indoors, and those curves are going upward, in the wrong direction,” Collins said Friday.

Researchers from the University of Washington’s Institute for Health Metrics and Evaluation project more than 2,300 Americans could be dying daily by mid-January and a total of more than 389,000 people could die from the virus in the US by February 1.

More than 218,000 people have already died nationwide since the start of the pandemic. Just over 8 million have been infected.

But it’s not too late to turn things around. Experts say Americans can help get the virus under control by heeding basic public health guidelines touted by officials for months: avoiding crowded settings, keeping a distance, keeping small gatherings outdoors and wearing a mask.

‘We are in a new wave of rising positivity in Covid-19 cases’

At least 31 states —

Traditional Chinese medicine maker soars after top respiratory expert backs drug in potentially inhibiting coronavirus



a pile of food: Guangzhou Baiyunshan Pharmaceutical’s medicine made from Banlangen was found to be effective against the coronavirus in a series of in-vitro studies. Photo: Baidu


Guangzhou Baiyunshan Pharmaceutical’s medicine made from Banlangen was found to be effective against the coronavirus in a series of in-vitro studies. Photo: Baidu

Shares of a traditional Chinese medicine (TCM) company jumped after receiving validation from the nation’s top respiratory expert on its drug’s effect against the coronavirus, joining two other peers that have enjoyed huge gains this year.

Guangzhou Baiyunshan Pharmaceutical Holdings soared 13 per cent to HK$21.75 in Hong Kong and by 10 per cent to 34.18 yuan in Shanghai on Friday, after Zhong Nanshan, the public face of China’s fight against the Covid-19 pandemic, said one of its products could potentially inhibit the coronavirus.

Researchers led by Zhong found that Banlangen granules, a herbal medicine popular in China for treating common cold and flu, was effective against the virus in a series of in-vitro studies, Chinese newspaper Nanfang Daily quoted him as saying during a conference on Tuesday in Guangzhou. The drug was also widely used in the country during the 2003 severe acute respiratory syndrome (Sars) outbreak.

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Investors latched on to the hype surrounding the company even though the studies were still at an early stage and Zhong did not disclose whether or when any research paper or preclinical data will be published. The stock’s advance in Hong Kong marked its biggest daily jump since October 2018, while turnover ballooned 24 times to HK$240 million (US$31 million) from Thursday, according to Refinitiv data.



Zhong Nanshan smiling for the camera: Chinese respiratory specialist Zhong Nanshan said that one of Guangzhou Baiyunshan Pharmaceutical's products could potentially inhibit the coronavirus. Photo: Xinhua


© Provided by South China Morning Post
Chinese respiratory specialist Zhong Nanshan said that one of Guangzhou Baiyunshan Pharmaceutical’s products could potentially inhibit the coronavirus. Photo: Xinhua

Many pointed to the speculative nature of the surge on Friday. “In-vitro studies data is usually the weakest among preclinical data,” wrote Huang Jianping, general manager at asset management firm Shanghai Leader Capital, in a post published on online stocks forum Xueqiu.

Normally, pharmaceutical companies have to go through three phases of clinical trials on humans to establish the efficacy of the drugs, on top of evidence from animal experiments, he said. “If a Nasdaq-listed company said their drug was found to inhibit the virus in in-vitro studies, the company would be despised by the market.”

China relied heavily on traditional medicine to combat the virus earlier this year. Despite the government’s efforts to promote the use of such herbal remedies abroad, experts have warned that there is not enough evidence from clinical trials to establish their effectiveness.

Why it’s so hard for China to promote the use of traditional remedies abroad to treat Covid-19

And this is not the first time Zhong’s comments have contributed to a drug maker’s fortunes. Two Shenzhen-listed TCM companies, Shijiazhuang Yiling Pharmaceutical and Tianjin Chase Sun Pharmaceutical, reaped huge profits this year, after their drugs were included in the national standard therapy for Covid-19 patients and were recommended by Zhong.

Shares of Shijiazhuang Yiling have risen 94 per cent since a March