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Questions raised over AstraZeneca “dosing mistake” in vaccine trials

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Questions raised over AstraZeneca “dosing mistake” in vaccine trials | The Thaiger
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British-Swedish pharmaceutical company AstraZeneca announced this week that their experimental coronavirus vaccine candidate is, on average, 70% effective. But since Monday’s announcement vaccine experts from around the world have questioned the methodology of the trials and transparency of the announced Phase 3 trial results.

The questions and uncertainty of the AstraZeneca vaccine trials will set back the timing for the vaccine to be authorised other parts of the world. Scientists are curious why the company has pooled results from different trials, saying that this “deviates from standard reporting on clinical trials”.

AstraZeneca announced last Monday that the participants in the UK had been given 2 different courses of the candidate vaccine.

The drugmaker, who co-developed the vaccine with the University of Oxford, didn’t explain why they used 2 different dosing regimens, or why the size of one group was significantly smaller than the other.

• In one group, 2,741 participants received a half-dose of the vaccine followed by a full dose at least 30 days later. This group was 90% protected against Covid-19.

• In the second group, 8,895 participants received a full dose followed by another full dose a month later. This group was only 62% protected.

The 2 trials, when averaged, according to AstraZeneca, gives their vaccine its reported 70% effectiveness. But epidemiologists say that the small number of people in the low dose group make it difficult to know if the effectiveness “was a statistical quirk”.

David Salisbury, from the global health program at London-based Chatham House, said another area of confusion was that the studies pooled results from the two groups to reach an average of 70% efficacy. Speaking to AP…

“You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses. I think many people are having trouble with that.″

Then, Mene Pangalos, head of biopharmaceuticals research and development at AstraZeneca, responded to Reuters saying that a “lab error” was the reason why some volunteers had received a smaller dose… the dose that proved to be 90% effective.

“The reason we had the half dose is serendipity, Researchers had underpredicted the dose of the vaccine by half.”

Then, the next day, University of Oxford chimed in in a statement… “dose selection for any new vaccine is a complicated area, and in exploring methods of dose selection, we discovered one gave a lower dose than expected.”

“A difference in the manufacturing process had led to the error.”

AstraZeneca say that these “manufacturing problems” have been corrected, noting that the UK regulator overseeing the trial had agreed to include “both approaches” in Phase 3.

Speaking to the Wall Street Journal on Wednesday, Menelas Pangalos said that the mistake is actually irrelevant.

“Whichever way you cut the data, even if you only believe the full-dose, full-dose data, we still have efficacy that meets the thresholds for approval with a vaccine that’s over 60% effective.”

The trial’s lead investigator at Oxford University, Professor Andrew Pollard, as part of the announcements on Monday, said that’s the issue is likely to do with the delicate balance of dosing someone just enough to trigger an immune response against the disease.

“What we’ve always tried to do with a vaccine is fool the immune system into thinking that there’s a dangerous infection there that it needs to respond to, but doing it in a very safe way.”

“So, it may be that the best way of kicking the immune system into action could be to give the body a small amount of the vaccine to begin with, and then follow up with a larger amount.”

Responding to whether he had genuine confidence that the half-dose group’s 90% success was not just a feature of a small sample size, Pollard said that result was “highly significant…even with the numbers that we have.”

Moncef Slaoui, a US-based researcher and former head of GlaxoSmithKline’s vaccines department who leads the US coronavirus vaccine program, says they were reviewing AstraZeneca’s vaccine data.

He noted that group that got the lower dose that yielded the 90% efficacy had been a younger group, with no one older than 55.

“That could potentially affect the strength of AstraZeneca’s findings, given that young people typically produce stronger immune responses to vaccines. We want it to be based on data and science.”

Natalie Dean, assistant professor of biostatistics at the University of Florida said that the AstraZeneca/Oxford University team “get a poor grade for transparency and rigour when it comes to the vaccine trial results”.

“This is not like Pfizer or Moderna where we had the protocols in advance and a pre-specified primary analysis was reported.”

AstraZeneca shares have fallen 12% since November 11.

SOURCE: Euro News | Reuters | CNN

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14 Comments

14 Comments

  1. Avatar

    EdwardV

    Friday, November 27, 2020 at 11:58 am

    Oops!

  2. Avatar

    SG666

    Friday, November 27, 2020 at 12:56 pm

    So, what we are talking about.

    A vaccine developed with an efficiency of 70percent…
    fulfilling the WHO requirement of 60percent…
    for a virus detected by PCR test which have a flaw of 30 percent…
    which kills around 0.018percent of the world population if you believe that the cause of death of each deceased is properly investigated.

    The biggest hoax in History to fill the pockets of the corrupt WHO and the pharma industry and increase and monitor governmental control over their citizens.

    • Avatar

      preesy chepuce

      Saturday, November 28, 2020 at 12:55 am

      Viruses don’t need to be “90+% effective” to be effective. What they need is to be practicable, and the AZ vaccine is just that: no silly temperature or procedures. Moreover, AZ has been reassuringly open about failures, unlike others. AZ gives me 100% confidence.

      • Avatar

        Issan John

        Saturday, November 28, 2020 at 10:14 am

        Ditto.

        Given that the AZ vaccine apparently prevents transmission while the other two apparently don’t, that alone makes their “62%”, at worst, as good / effective as the other two’s “95%”.

    • Avatar

      Issan John

      Saturday, November 28, 2020 at 10:18 am

      The last time you referred to Covid as “the biggest hoax in history” on the basis of an expert’s opinion, it turned out that he wasn’t referring to Covid-19 at all and was actually the CEO of a company producing tests for Covid-19!

  3. Avatar

    Nipral

    Friday, November 27, 2020 at 1:28 pm

    Unsurprisingly Thai moronic government picked the wrong horse !!! Anyone surprised ???????Probably the one that offered the best kick back !!!

    • Avatar

      Issan John

      Friday, November 27, 2020 at 8:59 pm

      As yet, no-one has any idea which vaccine will prove to be “best” for Thailand or anywhere else – to have bought either the Moderna or Pfizer/BioNTech vaccines at this stage given the high cost and distribution issues, though, really would have been not only “moronic” but something Thailand literally can’t afford.

      • Avatar

        preesy chepuce

        Saturday, November 28, 2020 at 12:57 am

        The Pfizer/Biontech one is bolox, it’s showing what’s possible; not what’s practicable. Normal flu jabs are about 60% effective, and they are plenty effective enough. Media morons overreporting details that punters don’t understand is unhelpful.

        • The Thaiger

          The Thaiger

          Saturday, November 28, 2020 at 10:04 am

          Be careful, or this “media moron” will block you.

  4. Avatar

    Ameila Leary

    Friday, November 27, 2020 at 1:39 pm

    Many vaccine companies are planning to fix their vaccine’s transport section and to make it to the next level to lower the temperature component, because AstraZeneca is running behind them because they do not hurry over this as a profit portion as per their authorities. But it is clearly showing that they can’t match the outputs of the Pfizer, Sputnik and Modern vaccines are so effective as their results are more than 90 percent efficient and are set to roll out all over.

    • Avatar

      preesy chepuce

      Saturday, November 28, 2020 at 12:59 am

      You are talking absolute rubbish. The Pfizer, Sputnik, and Moderna vaccines are for the labs only; they are not practicable vaccines really: too much conditionality. Efficacy at such high levels is not necessary for general efficacy. AZ is the realistic, affordable option.

  5. Avatar

    Issan John

    Friday, November 27, 2020 at 9:21 pm

    Pfizer and Moderna – agreed, they’re falling over themselves to get their vaccines out quickly, before Astra Zeneca complete Phase 3, but their “90%” claims seem questionable for those most at risk, and AFAIK they’re still to clarify if their vaccines reduce transmission.

    I’d suggest most developing countries are unlikely to invest the considerable amount required to store and transport either vaccine before joining the queue to buy them, some way down the list, as long as there’s a possibility that Astra Zeneca will prove as good at a far lower cost and without the logistic issues, probably in much the same time frame.

    Sputnik, though? By any normal standards, it hasn’t even completed Phase 3 trials, with a trial of only 18,000 that’s only just started, of whom some 4,000 are the ‘control’ group getting a placebo.

    • Avatar

      preesy chepuce

      Saturday, November 28, 2020 at 1:01 am

      In the end, if you were given an array of syringes each with a different vaccine in it, which would you pick? I would personally only pick AZ, because they are open about their failures; the others are hiding them. Think and read about the history of medicines.

  6. Avatar

    Issan John

    Saturday, November 28, 2020 at 10:30 am

    At the moment? AZ, beyond any shadow of a doubt, not only to protect myself but to protect others.

    I also couldn’t help being worried about whether the other two vaccines had been stored / transported properly, and if they hadn’t been at any stage I’d never know, nor would anyone else.

    TBH, though, I’d sooner wait until the middle of next year when the AZ dosage question has been resolved to everyone’s satisfaction and there’s been time for some more trials and tests.

    Luckily for me, the middle of next year looks likely to be when it’ll be available here …..

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Coronavirus (Covid-19)

Covid-19 travel pass to pilot on Etihad and Emirates Airways flights

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Covid-19 travel pass to pilot on Etihad and Emirates Airways flights | The Thaiger
PHOTO: Travel Daily

A travel pass for passengers inoculated against Covid-19 or who have tested negative will be piloted on flights for Dubai’s Emirates and Abu Dhabi’s Etihad Airways. With the travel pass issued by the International Air Transport Association, passengers can keep control of their data and share their test results with airlines and authorities for travel.

The travel pass will be offered on selected flights from Abu Dhabi in the first quarter, and will expand the pass to other destinations of the trail is successful. Emirates is going to implement phase 1 of the travel pass in April for flights departing from Dubai.

Recently, the IATA travel pass programme has been also tested in International Airlines Group and Singapore Airlines.

SOURCE: Reuters

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Outbreak in Samut Sakhon is “worrying,” CCSA spokesperson says

Caitlin Ashworth

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Outbreak in Samut Sakhon is “worrying,” CCSA spokesperson says | The Thaiger
PHOTO: Matichon

While the number of daily new Covid-19 cases continues to drop, health officials are still scrambling to contain the virus in the prime hotspot: Samut Sakhon. The outbreak in the coastal fishing province is “worrying,” according to Centre for Covid-19 Situation Administration spokesperson Taweesilp Visanuyothin.

Health officials rolled out a proactive mass testing campaign after a spike of Covid-19 cases in mid-December. The vast majority of cases were concentrated around the Central Shrimp Market in the Mahachai fishing hub, which affected a large migrant population. The virus has since spread to 61 of Thailand’s 77 provinces.

With the help of proactive testing, more than 4,000 cases were reported in Samut Sakhon. Field hospitals have been set up on the fly to treat and quarantine those that are infected.

But public health officials are still racing to test as many people in the province as possible with plans to inspect 600 factories and test 50 factory workers per day. There are 12,000 factories in Samut Sakhon and Taweeslip says health officials are speeding up testing to “isolate infected people as soon as possible.”

“The outbreak in Samut Sakhon is worrying. It is difficult to conduct active case-finding there. There are many obstacles, including the number of factories… Meanwhile, factory owners and workers must cooperate. There are more than 10,000 small factories where 1-200 people are employed.”

SOURCE: Bangkok Post

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Chiang Mai night markets reopening tomorrow

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Chiang Mai night markets reopening tomorrow | The Thaiger
PHOTO: Hotel.com

Night markets in Chiang Mai will be reopened tomorrow after the province went 6 consecutive days with no new Covid-19 cases.

According to Chiang Mai Governor, Charoenrit Sanguansat, the province and the provincial disease control committee agreed to ease up restrictions on social and business activities after the number of infections continually dropped and no new infections were reported during the past week.

As a result, flea markets, night markets, and walking streets across the province will be reopened tomorrow onwards.

However, the governor still reiterates that marketplaces and visitors must follow the disease control measures strictly.

Since the start of the second wave of Covid-19 in mid-December, Chiang Mai has tightened restrictions to prevent the virus spread in the province, with the order to close all markets and social activities for 14 days on January 6.

SOURCE: Nation Thailand

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