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jkt abel  09:29:41 GMT - 11/26/2020  
red, you are saying that in UK they are using the elderly people as large scale proper clinical study next? since even health workers dare not taking it first? how unfilial society it is hahaha

london red  08:23:06 GMT - 11/26/2020  
in the uk vaccines are to be implemented in care homes early december, before even care workers get the jab. however as has been mentioned below, there isnt a queue of medical professionals jumping at the chance to take the jab, not before it can be tested over a longer period of time.
and brexit, i see ft100 down but they are buying international earning uk stocks that go up when sterling falls, also financials down a second day

dc CB  03:26:31 GMT - 11/26/2020  
add this piece to that one.

(last paragraph)
'These announcements by Pfizer and Moderna are encouraging. I certainly hope that these vaccines protect people from the harm of covid-19. I certainly hope that these vaccines are safe. If both of these conditions are true, nobody will need to be coerced into taking the vaccine. However, you should pay even more attention about what is left out of an announcement than about what is stated. The pharmaceutical companies are more than happy for patients to misunderstand what is meant by efficacy.

Pfizer recently announced that its covid vaccine was more than 90 percent “effective” at preventing covid-19. Shortly after this announcement, Moderna announced that its covid vaccine was 94.5 percent “effective” at preventing covid-19. Unlike the flu vaccine, which is one shot, both covid vaccines require two shots given three to four weeks apart. Hidden toward the end of both announcements, were the definitions of “effective.”

Both trials have a treatment group that received the vaccine and a control group that did not. All the trial subjects were covid negative prior to the start of the trial. The analysis for both trials was performed when a target number of “cases” were reached. “Cases” were defined by positive polymerase chain reaction (PCR) testing. There was no information about the cycle number for the PCR tests. There was no information about whether the “cases” had symptoms or not. There was no information about hospitalizations or deaths.

The Pfizer study had 43,538 participants and was analyzed after 164 cases. So, roughly 150 out 21,750 participants (less than 0.7 percent) became PCR positive in the control group and about one-tenth that number in the vaccine group became PCR positive.

The Moderna trial had 30,000 participants. There were 95 “cases” in the 15,000 control participants (about 0.6 percent) and 5 “cases” in the 15,000 vaccine participants (about one-twentieth of 0.6 percent). The “efficacy” figures quoted in these announcements are odds ratios.

There is no evidence, yet, that the vaccine prevented any hospitalizations or any deaths. The Moderna announcement claimed that eleven cases in the control group were “severe” disease, but “severe” was not defined. If there were any hospitalizations or deaths in either group, the public has not been told. When the risks of an event are small, odds ratios can be misleading about absolute risk. A more meaningful measure of efficacy would be the number to vaccinate to prevent one hospitalization or one death. Those numbers are not available.

An estimate of the number to treat from the Moderna trial to prevent a single “case” would be fifteen thousand vaccinations to prevent ninety “cases” or 167 vaccinations per “case” prevented which does not sound nearly as good as 94.5 percent effective. The publicists working for pharmaceutical companies are very smart people. If there were a reduction in mortality from these vaccines, that information would be in the first paragraph of the announcement.

There is no information about how long any protective benefit from the vaccine would persist. Antibody response following covid-19 appears to be short lived. Based on what we know, the covid vaccine may require two shots every three to six months to be protective. The more shots required, the greater the risk of side effects from sensitization to the vaccine.

There is no information about safety. None. Government agencies like the Centers for Disease Control (CDC) appear to have two completely different standards for attributing deaths to covid-19 and attributing side effects to covid vaccines. If these vaccines are approved, as they likely will be, the first group to be vaccinated will be the beta testers.

I am employed by a university-based medical center that is a referral center for the West Texas region. My colleagues include resident physicians and faculty physicians who work with covid patients on a daily basis. I have asked a number of my colleagues whether they will be first in line for the new vaccine. I have yet to hear any of my colleagues respond affirmatively. The reasons for hesitancy are that the uncertainties about safety exceed what they perceive to be a small benefit. In other words, my colleagues would prefer to take their chances with covid rather than beta test the vaccine. Many of my colleagues want to see the safety data after a year of use before getting vaccinated; these colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination.

What the Covid Vaccine Hype Fails to Mention
11/24/2020Gilbert Berdine, MD

Tallinn viies  02:19:00 GMT - 11/26/2020  

After year-long sprint, Covid-19 vaccines finally at hand

Less than a year after an unknown coronavirus that has claimed 1.4 million lives began spreading across the globe, a number of highly promising Covid-19 vaccines are on the cusp of release.

Health authorities could give a green light for emergency use within weeks, which would mark the most rapid vaccine development for a pandemic in history -- but many questions remain.
- When will a jab be available? -

After months without a visible breakthrough, everything sped up in November, when several pharmaceutical companies made encouraging preliminary announcements about the efficacy of their vaccines.

The European Medicines Agency (EMA), charged with overseeing drug approval in the European Union, told AFP that it could approve the first Covid-19 vaccines by the end of the year, or early in 2021. France, Spain and Italy have all sketched out distribution plans on that basis.

Across the Atlantic, vaccination campaigns could start in the United States as early as mid-December, assuming the US Food and Drug Administration (FDA) approves an accelerated timetable for rollout.

Chinese authorities have already begun jabbing high-risk patients, and in Russia two vaccines were validated for use even before the final phase of clinical trials had begun.

Researching, testing, approving, manufacturing and distributing a new vaccine usually takes a decade or longer.

The breakneck pace of development, resulting in half-a-dozen Covid-19 vaccines, saw an unprecedented blitzkrieg of public and private research backed by a huge sums of money and provisional orders for billions of doses.

But all parties involved insist that corners have not been cut.

The EU's regulatory agency, for example, acknowledged an effort "to speed up" the evaluation process, but insisted it was "ensuring the same high regulatory standards for quality, safety and efficacy" as for any other drug.

But this extraordinary achievement will not mean that a waiting world will be vaccinated right away.

"Initial supply of #COVID19 vaccines will be limited, so #healthworkers, older people and other at-risk populations will be prioritised," World Health Organization (WHO) head Tedros Adhanom Ghebreyesus recently tweeted.

The world's poorest countries, he warned, should not have to wait until wealthy ones that have reserved billions of doses are served.

"The urgency with which vaccines have been developed must be matched by the same urgency to distribute them fairly," he said, highlighting the risk that the poor and vulnerable will be "trampled in the stampede" to get inoculated.
- Which vaccine is best? -

Too early to say. Since November 9, four drug makers have announced that their vaccines work, most of them more than 90 percent of the time.

The first to report Phase 3 results was the US-German collaboration between pharmaceutical giant Pfizer and German biotech start-up BioNTech, followed by the US firm Moderna, a British partnership between AstraZeneca and Oxford University, and Russia's state-run Gamaleya Research Institute of Epidemiology and Microbiology.

But the rush for results in anticipation of a huge global market means the announcements were made by the companies themselves, and have yet to be backed up by publication in peer-reviewed journals, which can take months.

All the vaccines unveiled are near the end of so-called Phase 3 clinical trials, the final step in a process that tests safety and efficacy on tens of thousands of volunteers of different ages and ethnicities spread across the world.

Basically, the efficacy of a vaccine is determined by comparing the number of people who get sick with Covid-19 in a group of vaccinated volunteers compared to another group that receives a placebo instead of the active drug.

The threshold for releasing the findings -- the number of people infected with Covid-19 -- was different in each case: 170 for Pfizer/BioNTech, 95 for Moderna, 131 for AstraZeneca/Oxford, and only 39 for the Gamaleya Institute.

Pfizer reported 95 percent efficacy, with only eight of the 170 Covid-19 patients coming from the vaccinated group. For Moderna -- with 94.5 percent efficacy -- it was almost identical, while Gamaleya's Sputnik V vaccine reported 91.4 percent efficacy.

The calculations for AstraZeneca's two-dose vaccine were more complicated. Across two separate trials with slightly different protocols, the drug worked 70 percent of the time.

But in a group whose first jab was a half-dose rather than a full one, the efficacy rate rose to 90 percent, putting it in the same league as the others. The counter-intuitive result -- less vaccine conferring more protection -- stemmed from the reaction of the immune system, the company said.

But the success rate is not the only criterion in determining which vaccine will be adopted in different circumstances. Cost and logistics are also factors.

AstraZeneca's double jab, for example, is by far the least expensive, at about 2.5 euros ($3) per dose.

It also has a significant advantage when it comes to transport and storage. Moderna's vaccine must be kept at -20 degrees Celsius, while Pfizer's requires an even chillier -70C to remain viable. AstraZeneca's vaccine, by contrast, can be stored at the temperature of a normal fridge.
- What questions remain? -

There are plenty, including some big ones.

"We knew that a vaccine would be essential for bringing the pandemic under control," Adhanom Ghebreyesus noted. "But it's important to emphasise that a vaccine will complement the other tools we have, not replace them."

That said, the WHO chief, added, "the light at the end of this long, dark tunnel is growing brighter."

The biggest question mark hanging over all of these vaccines is how long immunity lasts. All the results were reported only a few weeks after the vaccines were administered.

"How long will protection last? Will vaccination result in virus 'escape' mutations which limit vaccine effectiveness over time?", Penny Ward, a visiting professor in pharmaceutical medicine at King's College London, told journalists, listing things we still need to know.

A handful of reinfections, in which people recovered from Covid-19 only to become infected by a slightly different strain, also raise questions about the duration of immunity.

Scientists also still don't know if the vaccines will be as effective with high-risk individuals, especially the elderly, who are far more susceptible to life-threatening symptoms.

Yet another "known unknown" is whether an effective vaccine simply eliminates the symptoms, or whether it also prevents someone from transmitting the virus to others.

In other words, even if it protects you from getting sick, will it protect others you come into contact with from catching the bug?

Here again, AstraZeneca may have an edge on the competition.

"The Oxford/AstraZeneca team has been collecting weekly nasal and throat swabs from all trial participants to look for asymptomatic infections," Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh, told the Science Media Centre in London.

The drug maker found "early indication" that the vaccine could reduce virus transmission.

Contacted by AFP, AstraZeneca noted that not all 23,000 people in their trial were tested for asymptomatic cases, but did not say how many were.
- How many in the pipeline? -

The World Health Organization (WHO) has identified 48 "candidate vaccines" at the stage of clinical trials in humans by mid-November, but only 11 at the most advanced Phase 3 stage.

Besides the four that announced results this month are several Chinese vaccines from state-run laboratories, made by Sinovac, Sinopharm and CanSino.

The WHO has identified another 164 vaccine projects that are still in the pre-clinical phase of development.
- What kind of vaccines? -

Some methods for making a vaccine are tried-and-tested, while others remain experimental.

Inactivated traditional vaccines use a virus germ that has been killed, while others use a weakened or "attenuated" strain.

These vaccines work when the body treats the deactivated pathogen as if it were a real threat, producing antibodies to kill it without endangering the patient with full infection.

So-called "sub-unit" vaccines contain a fragment of the virus or bacteria they are derived from to produce a similar immune response.

"Viral vector" varieties deliver fragments of viral DNA into cells, often hitching a lift off of other virus molecules.

For example, a measles virus modified with a coronavirus protein -- the apparatus SARS-CoV-2 uses to latch on to human cells -- can be deployed to provide immunity to Covid-19.

Both Pfizer's and Moderna's vaccines are based on cutting-edge technology that uses synthetic versions of molecules called messenger RNA to hack into human cells, and effectively turn them into vaccine-making factories.
- Is there a vaccine against mistrust? -

Whichever vaccine is the first to be distributed, there's a final question that scientists are powerless to answer but that could determine the success of their efforts: in an era of deep mistrust of authority, how many people will refuse to be vaccinated?

According to a study last month in the Royal Society journal Open Science, a significant percentage of people in many countries subscribe to conspiracy theories about the origin of the vaccines, or the virus itself.

In Mexico, for example, more than a fifth of those questioned said they thought the pandemic itself was "part of a plan to impose vaccinations worldwide".

A survey published earlier this month by the World Economic Forum covering 15 countries found that the number of people willing to be vaccinated had dropped since August from 77 to 73 percent.




(c) 2020 Agence France-Presse

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