Rush for results could lead to inferior Covid vaccine, say scientists

Scientists have warned that early adoption of a Covid vaccine with only moderate effectiveness could disrupt efforts to test and create improved versions. Immunising against the disease is not going to be a simple business of turning off the virus once the first vaccine appears, they say. In fact, there could be considerable confusion as researchers struggle to pinpoint the best versions for different vulnerable groups, such as the elderly.



Photograph: David Cheskin/PA


© Provided by The Guardian
Photograph: David Cheskin/PA

“The vaccines coming through fastest are the most experimental. It is possible they won’t be all that great and that others – created using more tried-and-tested but slower methods – might be better,” said Professor Adam Finn of Bristol University. “But to prove that point will become very difficult if lots of individuals have already been given the first vaccine. It will need vast numbers of people to demonstrate which is best or if a different vaccine is more suitable for particular groups, like the elderly.”



Some of the vaccines that are coming through fastest are also the most experimental.


© Photograph: David Cheskin/PA
Some of the vaccines that are coming through fastest are also the most experimental.

Finn said such confusion could cause setbacks in dealing with Covid, adding: “We should be preparing to meet this challenge and work out ways to compare the effectiveness of early vaccines – but at present we are not doing that well enough.”

A total of 198 Covid vaccines are now under development across the globe with four key versions undergoing final phase 3 trials. These include Pfizer’s BNT162b2 and the Oxford AstraZeneca vaccine.

Results of those trials – in which each is compared with a placebo – are expected in weeks or months. Once the first vaccine that shows efficacy in countering Covid-19 is revealed, there will be enormous pressure to use it immediately. Key candidates would be healthcare workers who deal with Covid cases and others at high risk of becoming infected.

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But for groups such as the elderly, who tend to have weaker immune systems, caution will be required.

“The problem is that early vaccine trials are not likely to show how well these products work in these populations,” said Kanta Subbarao, a World Health Organization director, in an editorial in Nature last week. “We know vaccines often work better in young, healthy adults, which is why they are enhanced with a higher dose or an adjuvant to boost immunity for diseases such as flu and shingles. It is also unclear how well clinical trials will assess effectiveness in those in minority ethnic communities.”

In other words, by spring, several vaccines may have passed their trials without any mechanism being in place to select which is the most effective for different groups. Nor is the problem confined to the UK.

“The complexity and chaos and confusion that will happen in a few short months has hardly

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I watched my sister die, so I understand what Rush Limbaugh is going through

It appears that Rush Limbaugh is dying. He announced on his radio show Monday that his lung cancer had gotten worse and is “going in the wrong direction.”

I have never cared for Limbaugh’s kind of politics. I’ve always felt like the right-wing talk radio host’s sole purpose was to further polarize America and push conservatives further away from a middle ground.

In spite of that, I am saddened that his cancer is terminal. I would like to see his condition turn around, but he doesn’t seem to think that it will.

“It’s tough to realize that the days where I do not think I’m under a death sentence are over,” the 69-year-old host said.

“We all know that we’re going to die at some point,” he added. “But when you have a terminal disease diagnosis that has a time frame to it, then that puts a different psychological and even physical awareness to it.”

He described his life the past eight months as a roller coaster, with lots of ups and downs.

“Many people have experienced this,” he said. “If it isn’t lung cancer, it’s some kind of cancer. If it isn’t you, it is someone really close to you.”

My father died of lung cancer in 2006 at the age of 91. But it is my sister’s death in 1995 from myeloid metaplasia, a rare form of bone marrow cancer, that haunts me still. Patricia was only 54.

It is difficult to imagine what it must be like to learn that you are dying. For some, I suppose, such a diagnosis could be met with relief. After months of agonizing pain, there is respite in knowing that it will be over soon.

With such advance notice, there also is a rare opportunity to try to right what you have done wrong. To say to loved ones words that needed to be said. And to ask for forgiveness for the things you cannot change.

But for most, such news likely would cause overwhelming grief. Most of us, regardless of our age, feel as though we have much to live for and many more things to do. Taking that opportunity away seems unfair.

Like Limbaugh, Patricia understood that her illness was considered terminal. Still, she believed that she would somehow defy the odds and live past the maximum 10-year survival period of people with her form of cancer.

She thought that she could beat the monstrous illness if she fought hard enough. The idea that she wielded such control got her through the painful days and nights. She fought with every bit of strength she had — until she couldn’t.

She had grown thin and frail. Food wouldn’t stay down, but she kept trying to eat. She used to enjoy the broccoli casserole from Piccadilly cafeteria, and when she asked for some, I rushed out to get it. But even the aroma of it made her nauseous.

With her spleen filled with blood — one of the effects

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Rush Limbaugh says lung cancer has shown progression ‘in the wrong direction’

Conservative talk radio show host Rush Limbaugh says he’s had a setback in his fight against advanced lung cancer.

Limbaugh, 69, said recent scans show “some progression of cancer.” It’s “not dramatic, but it is the wrong direction,” he told listeners Monday, according to a transcript posted on his website.

The host said Monday that he has been diagnosed with stage 4 lung cancer.

On Feb. 3, he first disclosed that he was sick. The following day, President Donald Trump awarded Limbaugh the Presidential Medal of Freedom, the nation’s highest civilian honor, during the State of the Union address.

Limbaugh said that he had been reluctant to speak too much about his illness on-air, in part because “I’m not the only one that’s going through hardships, challenging times.”

“I want to stress here that I know countless numbers of you are experiencing the same thing. If it isn’t lung cancer, it’s some kind of cancer. If it isn’t you, it’s somebody really close to you. If it isn’t an illness, it’s something,” he said Monday.

Limbaugh said that prior to the recent scans that showed some progression, “the scans had shown that we had rendered the cancer dormant.”

“So we have to tweak the treatment plan, which we did, and the chemotherapy drugs in hopes of keeping additional progression at bay for as long as possible,” Limbaugh said. “The idea now is to keep it where it is or maybe have it reduce again. We’ve shown that that is possible.”

This story originally appeared on NBCNews.com.

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Rush Limbaugh gives cancer update: ‘Days where I do not think I’m under a death sentence are over’

Conservative talk radio legend Rush Limbaugh told listeners Monday that he can no longer deny he’s “under a death sentence” due to the progression of his stage 4 lung cancer.

Mr. Limbaugh, who first announced his diagnosis in February, said during his show that scans taken earlier this month showed “some progression of cancer” after it had initially been rendered “dormant.”

“It is cancer, it eventually outsmarts pretty much everything you throw at it,” Mr. Limbaugh said.

“From the moment you get the diagnosis, there’s a part of you every day, OK, that’s it, life’s over, you just don’t know when,” he said. “So, during the period of time after the diagnosis, you do what you can to prolong life, do what you can to prolong a happy life. You measure a happy life against whatever medication it takes.

“It’s tough to realize that the days where I do not think I’m under a death sentence are over,” he continued. “Now, we all are, is the point. We all know that we’re going to die at some point, but when you have a terminal disease diagnosis that has a time frame to it, then that puts a different psychological and even physical awareness to it.”

Mr. Limbaugh, who received the Presidential Medal of Freedom during President Trump’s State of the Union address in February, went on to say the progression of the cancer was “not dramatic” but still in the “wrong direction.” He said he’s now under a treatment plan aimed at keeping the progression at bay for as long as possible.

“I feel very blessed to be here speaking with you today,” he said. “Some days are harder than others. I do get fatigued now. I do get very, very tired now. I’m not gonna mislead you about that. But I am extremely grateful to be able to come here to the studio and to maintain as much normalcy as possible — and it’s still true,” he said. “You know, I wake up every day and thank God that I did. I go to bed every night praying I’m gonna wake up.”

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Pfizer says it will not have a coronavirus vaccine until late November, allaying fears of a rush for approval before Election Day

Chief executive Albert Bourla wrote in the letter that while the company projects it may have enough data to determine whether the vaccine is effective in October, there will not be sufficient safety follow-up to satisfy criteria laid out by the Food and Drug Administration until late November.

“A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use,” Bourla said. “Safety is, and will remain, our number one priority.”

The letter was welcomed by Eric Topol, a physician-scientist at Scripps Research Translational Institute who joined other experts in writing to Bourla in late September, asking the company not to seek authorization for a vaccine before late November. Topol recently had a virtual meeting with company executives to express his concerns and said he was frustrated they would not answer directly whether they would seek broader use of a vaccine before Nov. 3.

Bourla’s emphasis on having data in October “is what got many of us concerned, whether it was inadvertently playing into the political pressure or just because the incentives were aligned,” Topol said. “I thought [the letter] was very good. I wish it had been done potentially even earlier.”

Bourla made clear that while the company won’t seek approval until reaching the safety threshold, it could announce data on whether the vaccine candidate works before the election.

Pfizer’s trial will ultimately include 44,000 study subjects, with half receiving two shots of its experimental vaccine and the other half receiving placebo inoculations. Neither participants, study investigators nor company executives know who received a vaccine and who did not. But periodically throughout the trial, an independent committee is examining the data to see whether the vaccine is protecting participants from infection, as demonstrated by far fewer cases of covid-19, the disease caused by the virus, in those getting the shots than those receiving a placebo.

“In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us,” Bourla wrote.

The FDA in October issued guidance explaining the criteria for an emergency use authorization, saying a vaccine given to healthy people will be held to a higher standard than the typically low threshold that a medical product “may be effective” for emergency use. The agency put forth a requirement — despite White House objections — that vaccine candidates must have a minimum of two months of follow-up data on half of the participants in the study.

Pfizer will not have such data until the third week of November. Moderna, a biotechnology company, will not have enough safety data to apply for regulatory authorization until two days before Thanksgiving, according to spokesman Ray Jordan. Two other late-stage vaccine trials, from AstraZeneca and Johnson & Johnson, are paused because of potential safety concerns and have previously predicted readouts from their

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