The Tank

https://thepalladiumgroup.com/news/Pfiz ... Distancing

Katharina Cavano l Palladium - Nov 10 2020
Pfizer's Vaccine Won't Mean the End of Social Distancing

As the COVID-19 epidemic continues to break records in the United States (where cases have surged past 10 million with deaths at ~250,000), the drug maker Pfizer has announced that an early analysis of its vaccine trial was more than 90 per cent effective in preventing the virus.

Scientists have been hoping for a coronavirus vaccine that is at least 75 per cent effective, and White House coronavirus advisor Dr. Anthony Fauci has said that 50 or 60 per cent would be acceptable. This means Pfizer’s impressive 90 per cent efficacy rate has exceeded the broader medical community’s expectations.

Palladium’s Dr. Farley Cleghorn is cautiously optimistic, telling Bloomberg TV on Monday, “This is not conclusive news. It’s encouraging but it’s not conclusive.”

According to a press release, Pfizer’s interim analysis evaluated 94 confirmed cases of COVID-19 in a total of 43,538 trial participants. With plans to continue their clinical trials until they reach a total of 164 confirmed cases, Pfizer will submit for the Emergency Use Authorization to the U.S Food and Drug Administration once the required safety milestone of at least 2 months of follow-up for each volunteer is achieved towards the end of November.

These trials have moved rapidly thanks to the uptick in COVID-19 cases. “[Pfizer’s trials] are proceeding relatively quickly and the reason for that is because we have such a robust coronavirus epidemic in the U.S.,” Cleghorn said.

Cleghorn clarified that Pfizer’s vaccine uses a new and innovative technology called messenger RNA (mRNA) to produce an immune response in those who are vaccinated. “This allows antibodies and T-cell immune cells to be generated in response to the virus,” he explained. “But this vaccine does not prevent the transmission of the virus, it prevents the clinical outcome of the virus – COVID-19.”

Continuing Mitigation Behaviours

This means that even after distribution of a vaccine like Pfizer’s begins, our infection control measures (such as social distancing, hygiene, and mask-wearing) must continue.

“We will have to think very carefully about the impact that this vaccine will have on social distancing,” Cleghorn further told Times Radio. “We should all be encouraging people to continue avoiding transmission behaviours through Thanksgiving and Christmas. If this vaccine pans out, we’re well into next year or spring before we can reasonably distribute it to the people who need it most.”

Thinking Ahead to Distribution

Pfizer plans to take on both the manufacturing and distribution of the vaccine, which according to Cleghorn is a challenge on its own. But this vaccine presents a new challenge to the distribution process in that it must be stored and shipped at ultra-cold temperatures – minus 70 degrees Celsius to be exact.

“We’ve never had a situation like this where we need to transport a vaccine to people under super cold conditions. This is new,” he said.

This requirement poses an obstacle for even the most sophisticated hospitals and may severely limit where and to whom the vaccine can reasonably be administered.

Several allocation frameworks and guidelines exist for who should get the vaccine first, and Cleghorn recommends focusing on those who are most vulnerable and most likely to suffer the severe consequences of COVID-19.

“This vaccine does not stop the transmission itself; it reduces the morbidity and mortality associated with the virus. It’s very important for our frontline, healthcare and essential workers, as well as the elderly population to get access first.”

While many questions still remain on the vaccine’s long-term protection against COVID-19, the efficacy for those who have already contracted the virus, and how it will be distributed, Cleghorn remains hopeful that this is a step in the right direction.

https://www.self.com/story/fauci-masks-after-vaccine

September 24, 2020

COVID-19 (Coronavirus)

We’ll Likely Be Wearing Face Masks Even After a COVID-19 Vaccine Rolls Out, Dr. Fauci Says
We could be wearing masks through much of 2021.
By Sarah Jacoby

We'll have to keep wearing face masks through 2021 Dr. Fauci said.
Towfiqu Barbhuiya/EyeEm/Getty Images
Face masks have become a part of life for many of us to prevent the spread of COVID-19—and we’ll have to keep wearing them through much of 2021, Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, said in a recent interview with Business Insider.

In the interview, Dr. Fauci said that he’s “cautiously optimistic” about getting a safe and effective vaccine by the end of this year. And “if everyone gets vaccinated and we continue to implement the public-health measures that I have been talking about incessantly over the last several months,” he said, we may get to the point where the level of virus will be very low, and maybe even “close to absent” by the end of 2021.

But that doesn’t mean we’ll be able to immediately stop social distancing, wearing masks, and avoiding crowds—even when the vaccine is available. “I said a combination of an effective vaccine and adherence to certain public-health principles will get us to the point where we want to be, by the end of 2021,” Dr. Fauci said. “I never said just the vaccine. You never should abandon the public health measures.”

However, if your community has already gotten the local rate of infection down, you may be able to relax those other public health measures once there’s a vaccine in place. “The intensity of the public-health measures would depend on the level of infection in the community,” Dr. Fauci said. “If there’s almost no infection in the community, together with the vaccine, you might want to be able to say ‘I can safely congregate with people.’ You may want to do it with a mask, or without a mask. It’s all going to depend on the level of infection in the community, and how low you got it down with your vaccine.”

Dr. Fauci’s comments echo those of Tedros Adhanom Ghebreyesus, Ph.D., director-general of the World Health Organization (WHO), who said last month that, even with a vaccine, there may never be a “silver bullet” for COVID-19. For governments and public health officials, that means they need to be “testing, isolating and treating patients, and tracing and quarantining their contacts,” he said, as well as informing, empowering, and listening to communities. And “for individuals, it’s about keeping physical distance, wearing a mask, cleaning hands regularly, and coughing safely away from others. Do it all.”

That’s because simply having a vaccine is not enough to wipe out the coronavirus, even under the best of circumstances, SELF explained previously. There’s no guarantee that the vaccine will prevent or reduces the severity of every single case of COVID-19. (The Food and Drug Administration said it would consider approving a vaccine that works in just 50% of those who get it.) And once the vaccine is approved, it will take time for everyone who can get the vaccine to actually get it.

That means we all have to continue to do our part to do, well, everything. We need to maintain social distancing, wear face masks (especially in public places where social distancing isn’t easy to keep up), wash our hands frequently, and avoid crowds. And, as Dr. Fauci says, we won’t be able to stop those behaviors the moment a safe and effective vaccine is available. If you haven’t already, it’s time to invest in some reusable masks you find comfortable enough to wear for a while.

https://www.bbc.com/news/health-54371559

Covid: Vaccine will 'not return life to normal in spring'
By James Gallagher
Health and science correspondent

1 October 2020


Even an effective coronavirus vaccine will not return life to normal in spring, a group of leading scientists has warned.

A vaccine is often seen as the holy grail that will end the pandemic.

But a report, from researchers brought together by the Royal Society, said we needed to be "realistic" about what a vaccine could achieve and when.

They said restrictions may need to be "gradually relaxed" as it could take up to a year to roll the vaccine out.

More than 200 vaccines to protect against the virus are being developed by scientists around the world in a process that is taking place at unprecedented speed.

"A vaccine offers great hope for potentially ending the pandemic, but we do know that the history of vaccine development is littered with lots of failures," said Dr Fiona Culley, from the National Heart and Lung Institute at Imperial College London.

There is optimism, including from the UK government's scientific advisers, that some people may get a vaccine this year and mass vaccination may start early next year.

However, the Royal Society report warns it will be a long process.

"Even when the vaccine is available it doesn't mean within a month everybody is going to be vaccinated, we're talking about six months, nine months... a year," said Prof Nilay Shah, head of chemical engineering at Imperial College London.

"There's not a question of life suddenly returning to normal in March."

The report said there were still "enormous" challenges ahead.

Some of the experimental approaches being taken - such as RNA vaccines - have never been mass produced before.

There are questions around raw materials - both for the vaccine and glass vials - and refrigerator capacity, with some vaccines needing storage at minus 80C.

Prof Shah estimates vaccinating people would have to take place at a pace, 10 times faster than the annual flu campaign and would be a full-time job for up to 30,000 trained staff.

"I do worry, is enough thinking going into the whole system?" he says.

Early trial data has suggested that vaccines are triggering an immune response, but studies have not yet shown if this is enough to either offer complete protection or lessen the symptoms of Covid.

Unanswered questions
Prof Charles Bangham, chairman of immunology of Imperial College London, said: "We simply don't know when an effective vaccine will be available, how effective it will be and of course, crucially, how quickly it can be distributed.

"Even if it is effective, it is unlikely that we will be able to get back completely to normal, so there's going to be a sliding scale, even after the introduction of a vaccine that we know to be effective.

"We will have to gradually relax some of the other interventions."

And many questions that will dictate the vaccination strategy remain unanswered, such as:

will one shot be enough or will boosters be required?
will the vaccine work well enough in older people with aged immune systems?
The researchers warn the issue of long-term immunity will still take some time to answer, and we still do not know if people need vaccinating every couple of years or if one shot will do.

Commenting on the study, Dr Andrew Preston from the University of Bath, said: "Clearly the vaccine has been portrayed as a silver bullet and ultimately it will be our salvation, but it may not be an immediate process."

He said there would need to be discussion of whether "vaccine passports" are needed to ensure people coming into the country are immunised.

And Dr Preston warned that vaccine hesitancy seemed to be a growing problem that had become embroiled in anti-mask, anti-lockdown ideologies.

"If cohorts of people refuse to have the vaccine, do we leave them to fend for themselves or have mandatory vaccination for children to go to schools, or for staff in care homes? There are lots of difficult questions."

https://www.bbc.com/news/health-54949799

Covid-19: Normal life back next winter, says vaccine creator

Nov 17, 2020

Prof Ugur Sahin, BioNTech co-founder, also raised hopes the jab could halve transmission of the virus, resulting in a "dramatic reduction in cases".

Last week, BioNTech and co-developers Pfizer said preliminary analysis showed their vaccine could prevent more than 90% of people from getting Covid-19.

About 43,000 people took part in tests.

In an interview on BBC One's Andrew Marr Show, Prof Sahin said he expected further analysis to show the vaccine would reduce transmission between people as well as stop symptoms developing in someone who has had the vaccine.

"I'm very confident that transmission between people will be reduced by such a highly effective vaccine - maybe not 90% but maybe 50% - but we should not forget that even that could result in a dramatic reduction of the pandemic spread," he said.

The UK is expected to get 10 million doses of the BioNTech/Pfizer vaccine by the end of the year, with a further 30 million doses already ordered. The jab, which was trialled in six countries, is given in two doses, three weeks apart.

Older residents and staff in care homes are likely to be prioritised, followed by health workers and the over-80s. People would then be ranked by age.

The UK government announced another 24,962 confirmed Covid cases on Sunday, as well as a further 168 deaths within 28 days of a positive test.

After the announcement of the world's first effective vaccine came on Monday, Sir John Bell, regius professor of medicine at Oxford University, suggested life could be back to normal by spring.

"I am probably the first guy to say that, but I will say that with some confidence," he said.

However, Prof Sahin said it would take longer.

If everything continued to go well, he said, the vaccine would begin to be delivered at the "end of this year, beginning of next year".

He said the goal was to deliver more than 300 million doses worldwide by next April, which "could allow us to only start to make an impact".

He said the bigger impact would happen later, adding: "Summer will help us because the infection rate will go down in the summer and what is absolutely essential is that we get a high vaccination rate until or before autumn/winter next year."

Prof Sahin said it was essential that all immunisation programmes were completed before next autumn.

The vaccine has given a boost of confidence that an end to the pandemic is close, with the leading scientist behind it hopeful life could return to normal by next winter.

But there are some big uncertainties.

The vaccine needs approval from regulators - and they will only grant that if they're happy the jab is safe and works well. Early results look very good, but we await the full ones in the coming weeks.

There is also no data yet to show how well the jab works in those who need it the most - the elderly.

Nor do we know if it stops people spreading the disease, as well as getting sick.

And it's not clear how long immunity might last. People might need yearly boosters.

If the vaccine is rolled out, it will take time to immunise and protect enough people.

Other Covid-19 vaccines may come along that work just as well or even better than this new vaccine.

But it is possible that by the summer, mass immunisation will be well under way and we could start to reap the benefits.

Presentational grey line
Asked if the vaccine was as effective in older people as it is in younger people, he said he expected to have a better idea in the next three weeks.

He said it was not yet known how long immunity would last after the second dose of the vaccine is given.

However, he said, a booster immunisation "should not be too complicated" if it was found immunity was reduced significantly after one year.

Prof Sahin also said the "key side effects" of the vaccine seen so far were a mild to moderate pain in the injection site for a few days, while some participants had a mild to moderate fever over a similar period.

"We did not see any other serious side effects which would result in pausing or halting of the study," he added.

His vaccine is one of 11 currently in the final stages of testing.

It will not be released for use in the UK until it passes final safety tests and gets the go-ahead from the Medicines and Healthcare products Regulatory Agency (MHRA). The agency's head has said it would not lower its safety standards despite the need to get a vaccine quickly.

If it was approved, the NHS would be ready to roll out the vaccine from December, Health Secretary Matt Hancock said.

Prime Minister Boris Johnson has urged people not to slacken their resolve in the meantime, saying the vaccine's development "cleared one significant hurdle but there are several more to go"

Meanwhile, concerns have been raised that mutated forms of the virus might hamper the effectiveness of future vaccines.

It comes after 12 people were found with a mink-related strain of the virus following an outbreak in Denmark.

Virology professor Wendy Barclay, a scientific adviser for the government, said there was a "worry" that the vaccines currently under development "won't work quite so well as the virus continues to evolve".

This did not mean vaccines would not work at all, she added, but adaptable and fast-responding jabs could be the best option.

Earlier, Labour accused the government of not doing enough to "stamp out dangerous" anti-vaccine content online and called for emergency laws brought in.

It wants financial and criminal penalties for social media firms that do not remove false scare stories about vaccines.

Shadow health secretary Jonathan Ashworth said such content was "exploiting people's fears, their mistrust of institutions and governments and spreading poison and harm".

His party wanted to work with the government on a cross-party basis to build trust and help promote take-up of the vaccine, he said.

The government said it took the issue "extremely seriously" with "a major commitment" from Facebook, Twitter and Google to tackle anti-vaccine content.

Many social media platforms label false content as misleading or disputed - and all remove posts that contravene terms of service.

https://www.nytimes.com/2020/10/12/heal ... cines.html

By Carl Zimmer
Published Oct. 12, 2020
Updated Nov. 9, 2020


The United States may be within months of a profound turning point in the country’s fight against the coronavirus: the first working vaccine.

Demonstrating that a new vaccine was safe and effective in less than a year would shatter the record for speed, the result of seven-day work weeks for scientists and billions of dollars of investment by the government. Provided enough people can get one, the vaccine may slow a pandemic that has already killed a million people worldwide.

It’s tempting to look at the first vaccine as President Trump does: an on-off switch that will bring back life as we know it. “As soon as it’s given the go-ahead, we will get it out, defeat the virus,” he said at a September news conference. But vaccine experts say we should prepare instead for a perplexing, frustrating year.

The first vaccines may provide only moderate protection, low enough to make it prudent to keep wearing a mask. By next spring or summer, there may be several of these so-so vaccines, without a clear sense of how to choose from among them. Because of this array of options, makers of a superior vaccine in early stages of development may struggle to finish clinical testing. And some vaccines may be abruptly withdrawn from the market because they turn out not to be safe.


“It has not yet dawned on hardly anybody the amount of complexity and chaos and confusion that will happen in a few short months,” said Dr. Gregory Poland, the director of the Vaccine Research Group at the Mayo Clinic.

Some of this confusion is inevitable, but some is the result of how coronavirus vaccine trials were designed: Each company is running its own trial, comparing its jab with a placebo. But it didn’t have to be this way.

In the spring, when government scientists began discussing how to invest in vaccine research, some wanted to test a number of vaccines all at once, against each other — what’s known as a master protocol.

Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, was in favor of the idea. But these mega-trials pose a business risk for any given vaccine maker because they reveal how a vaccine stacks up against its competitors.

Instead, the government offered to bankroll large vaccine trials if companies agreed to some common ground rules and shared some data. The companies were still allowed to run the trials on their own.

“You have to have the total cooperation of the pharmaceutical companies to get involved in a master protocol,” Dr. Fauci said. “That — I don’t know what the right word is — didn’t turn out to be feasible.”

The vaccine vetting system wasn’t set up for this logjam. Typically, scientists take several years to prepare a vaccine before testing it on people. Early safety trials, known as Phase 1 and 2, may take several years.

If all goes well — and it typically doesn’t — then Phase 3, the final stage, can begin, comparing thousands of people who receive a vaccine with thousands who are given a placebo. It may take three more years to get these results. Only then — a decade or more after the research has begun — will a vaccine manufacturer build a factory to make the products.

When the coronavirus began to spread early this year, vaccine researchers around the world knew we could not afford to wait that long. The World Health Organization organized a group of experts to start what came to be known as the Solidarity Vaccines Trial. Several vaccines would be given at random to one large group of volunteers, while a smaller group would receive a placebo.

All of the vaccines would be tested against the same placebo group, and all of the volunteers would be living in the same circumstances. “You have a fully valid comparison, not only of each of those vaccines against placebo, but against each other,” said Thomas Fleming, a biostatistician at the University of Washington and a member of the Solidarity Vaccines Trial group.

It took nine months to get off the ground, but that trial will start later in October with a small study in Latin America.

Around the same time that the W.H.O. was hatching plans for its mega-trial, U.S. government officials were discussing how they could best invest in — and speed up — vaccine trials. Some researchers, including Dr. Fauci, advocated a design much like the W.H.O.’s.

But Moncef Slaoui, the chief adviser of Operation Warp Speed, the multiagency effort to hasten the development of coronavirus vaccines and treatments, said in a statement that such a trial would have been impractical. “If OWS had tested all vaccines under one master protocol, the operation would have had to wait months before starting and recruit 200,000 volunteers at the same time.”

In the end, the government opted for what it described as a “harmonized approach.” It would allow vaccine makers to run their own trials, but only if they used protocols that followed certain guidelines and let the National Institutes of Health test all of their volunteers in the same way. In exchange for following these rules, the companies would get to tap into to the N.I.H.’s large network of clinical testing sites, and receive major financial support for their trials. Through this program, the government has promised $10 billion to vaccine makers to date.

So far, AstraZeneca, Johnson & Johnson and Moderna have begun trials in the network. Novavax and Sanofi are expected to start their own Phase 3 studies in the next couple of months. But Pfizer, one of the front-runners, never joined the network, opting to run trials completely on its own.

If Pfizer’s results turn out well, many experts expect the company to ask the Food and Drug Administration for an emergency authorization of its vaccine, potentially for just one group of high-risk people. The company might then swiftly move to apply for a license, making it widely available.

The authorization of a vaccine will depend on how much protection the vaccine provides in the Phase 3 trial — what scientists refer to as its efficacy. In June, the F.D.A. set 50 percent efficacy as the target for a coronavirus vaccine.

But the efficacy in a trial may not necessarily match its effectiveness out in the real world. That’s because, like any statistical study, Phase 3 trials have margins of error. A vaccine that met the F.D.A.’s guidelines might actually be more than 50 percent effective, or might be less so. It might well turn out to be only 35 percent effective.

Whether it goes to Pfizer or another company, that first vaccine authorization could hamper ongoing trials of its competitors. Some volunteers, unsure of whether they had been given an experimental vaccine or a placebo, could drop out of an ongoing trial to get the authorized vaccine, slowing down the research. John Shiver, Sanofi’s global head of vaccine research and development, agreed that this scenario might play out for the company’s vaccine trial.

Things could be even worse for vaccines in earlier stages of testing. Those products might have to prove that they are better than the newly approved vaccine. The difference between two vaccines will be smaller than between a vaccine and a placebo. As a result, these trials may have to be bigger and run longer. The steep cost may be more than many of the small start-ups working on innovative vaccines can afford.

“That basically prevents the development of better vaccines,” said Dr. Naor Bar-Zeev, a vaccine expert at the Johns Hopkins University School of Medicine. “Given the massive taxpayer investment, the public should demand better.”

The F.D.A.’s guidelines raise the possibility of testing future vaccines against an authorized one, but they don’t give a clear sense of whether the agency would change the requirements for testing. “We cannot speculate on what may or may not happen in the future,” an F.D.A. spokeswoman said.

Dr. Slaoui of Operation Warp Speed said in a statement that once a vaccine is authorized, trials that had not yet started or had just begun recruiting volunteers would be restricted to groups that were not approved to receive the authorized vaccine. Because the first wave of vaccines is likely to go to health care workers or other high-risk groups, this policy could mean these groups would not be allowed to be part of new clinical trials.

By spring or summer, there may well be several coronavirus vaccines for American consumers to choose from. But that choice will be tough. A vaccine that showed 50 percent efficacy in one trial, for example, might actually be more protective than one showing 60 percent efficacy in a different trial.

“I can see people reading a lot into even minor differences that could just be statistical chance,” said Natalie Dean, a biostatistician at the University of Florida.

In a phone call with reporters on Friday, Paul Mango, an official at the Department of Health and Human Services, said that Operation Warp Speed was on track to have up to 700 million doses of various vaccines by March or April — enough, he said, for “all Americans who wish to get it.” As for who would get which vaccine, he said that would be left up to the Centers for Disease Control and Prevention’s vaccine advisory committee. “They will guide us as to which vaccine is most appropriate for which class of Americans,” he said.

But the advisory committee doesn’t have a plan for that yet, and Dr. Grace Lee, a professor of pediatrics at Stanford University School of Medicine and a member of that committee, warned it would have a hard time coming up with one. “It’s tough to do, given all the uncertainty with Covid vaccines,” she said.

Even moderately effective vaccines will be a huge help in reducing the cases of Covid-19 — but only if enough people take them, and only if they realize they could still get sick. “We’ll have to continue to use a mask for some of these vaccines,” said Dr. Poland of the Mayo Clinic.

The N.I.H.’s harmonized approach for all Phase 3 trials getting Operation Warp Speed funding is likely to bring some scientific insights. It’s possible, for example, that across all trials, some molecular signature in a vaccinated person’s blood would show that they were protected. Future trials could simply look for those signatures rather than wait for people to get sick.

There’s no guarantee that such a clear signature will emerge, however. And more uncertainty will come about as regulators continue to look for rare but dangerous side effects in authorized vaccines.

“You’re going to have random events,” Dr. Bar-Zeev said. For example, a group of older people could all have strokes shortly after being vaccinated, raising the question of whether the vaccine was the culprit. “It’s very possible that some vaccines will be withdrawn.”

The only way to manage this chaotic year, Dr. Poland said, is for scientists to talk honestly about how vaccines are tested, and for people to learn what lies ahead. “As long as you frame something in advance, people do better with it,” he said.

https://www.nationalheraldindia.com/hea ... -in-spring

COVID-19: Vaccine will not return life to normal in spring
Even an effective coronavirus (COVID-19) vaccine will not return life to normal in spring, a group of leading scientists has warned. A vaccine is often seen as the holy grail that will end pandemic

IANS
Published: 2 Oct 2020, 8:24 AM
Engagement: 0
Even an effective coronavirus (COVID-19) vaccine will not return life to normal in spring, a group of leading scientists has warned. A vaccine is often seen as the holy grail that will end the pandemic.

But a report, from researchers brought together by the Royal Society, said we needed to be "realistic" about what a vaccine could achieve and when. They said restrictions may need to be "gradually relaxed" as it could take up to a year to roll the vaccine out, the BBC reported on Thursday.

More than 200 vaccines to protect against the virus are being developed by scientists around the world in a process that is taking place at unprecedented speed.

"A vaccine offers great hope for potentially ending the pandemic, but we do know that the history of vaccine development is littered with lots of failures," said Dr Fiona Culley, from the National Heart and Lung Institute at Imperial College London.

"I do worry, is enough thinking going into the whole system?" he says.

Early trial data has suggested that vaccines are triggering an immune response, but studies have not yet shown if this is enough to either offer complete protection or lessen the symptoms of Covid.