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International [U.S COVID Vaccines News] Novavax Applies for WHO Approval, Aiming to Supply Poorer Countries.

Discussion in 'The War Room' started by Arkain2K, Nov 26, 2020.

  1. Queen B Fully Vaccinated

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    Wow. Faster than I though. Few weeks ago they said early 2022

    This goes in time for NYC vaccine mandate. All businesses will feel comfortable to mandate once its approved
     
  2. jefferz Steel Belt

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    [​IMG]
     
  3. Arkain2K Si vis pacem, para bellum

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    Novavax again delays seeking U.S. approval for COVID-19 vaccine to Q4
    August 5, 2021


    (Reuters) - Novavax Inc on Thursday again delayed its timeline for seeking authorization for its two-dose vaccine in the United states, and the company now expects to file for emergency use authorization in the fourth quarter of 2021.

    It had previously said it would seek authorization from the U.S. Food and Drug Administration (FDA) in the third quarter of 2021.

    "It's a matter of getting validation work done" to demonstrate consistency in its vaccine manufacturing process to the FDA, said Chief Executive Officer Stanley Erck, adding that other countries' regulators have been more aggressive in moving Novavax's vaccine through the authorization process.

    Despite promising clinical data, the Maryland-based company has lagged rival vaccine makers such as Pfizer Inc and Johnson & Johnson. It has repeatedly delayed its regulatory filings and timeline for ramping up production as it struggled to access raw materials and equipment needed to make its vaccine.

    The company said it has filed for regulatory authorization of NVX-CoV2373 in India, Indonesia and the Philippines and expects to file for World Health Organization's emergency listing for its vaccine this month, which is a prerequisite for exports to numerous countries participating in the COVAX Facility.

    Erck told Reuters the company is on track to submit regulatory filing in the United Kingdom in September followed within weeks by submissions in Australia and Canada.

    He expects Novavax to emerge as a major distributor of vaccines to lower and middle-income countries in 2021.

    Separately, Novavax said a single booster shot of its vaccine given six months after an initial two-dose regimen, elicited a 4.6-fold increase in antibodies.

    According to Erck, the company will file a separate application with the FDA once its emergency use authorization submission is processed.

    The company said it remained on track to produce 100 million doses per month by the third quarter and 150 million doses by the fourth quarter.

    "We appear to have got past (certain) supply issues and are now being able to produce at scale," Erck said.

    https://finance.yahoo.com/news/novavax-again-delays-seeking-u-200500481.html
     
    Last edited: Aug 6, 2021
  4. Queen B Fully Vaccinated

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    J&J is effective against DELTA

    It doesnt fully protect you, but it turns the Delta into a basic flu



    [​IMG]
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    Another study

     
  5. Queen B Fully Vaccinated

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    NEW STUDY

    mRNA vaccines are only 50-60% effective against Delta, but still strong in preventing hospitalizations and death

     
    Krimzon likes this.
  6. Queen B Fully Vaccinated

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  7. Arkain2K Si vis pacem, para bellum

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    Florida, Georgia, Louisiana account for nearly 40% of US hospitalizations
    Lauren Verno, Associated Press | August 5, 2021​

    [​IMG]

    The number of people in the hospital in the U.S. has more than tripled over the past month, from an average of roughly 12,000 to almost 43,000, according to the Centers for Disease Control and Prevention. The variant has sent cases surging to 94,000 a day on average, a level not seen since mid-February.

    According to Johns Hopkins University, Florida accounts for 1 in 5 new COVID-19 cases.

    Florida, Georgia and Louisiana account for nearly 40% of all hospitalizations in the country.

    According to the White House COVID-19 Response Team, just Florida and Texas account for more than a third of hospitalizations nationwide.

    “Over the past seven days, Florida and Texas have accounted for one-third of new cases, and more than one-third of hospitalizations nationwide,” said White House COVID-19 Response Coordinator Jeff Zients. “Seven states alone -- Florida, Texas, Missouri, Arkansas, Louisiana, Alabama, and Mississippi, states with some of the lowest vaccination rates -- account for about half of new cases and hospitalizations in the past week despite making up a quarter of the population.”

    Florida leads the nation in the number of children and adults admitted to the hospital with COVID-19. CDC data shows at least 143 children are hospitalized with COVID-19 in Florida, while 140 are hospitalized in Texas. As for total adult COVID-19 hospitalizations, Florida leads the nation with 12,373 patients, followed by Texas with 7,727, according to CDC data.

    Louisiana and Georgia have some of the lowest vaccination rates, with 38% of their populations fully inoculated. Florida is closer to the national rate, at 49%. Most New England states are well over 60%.

    https://www.news4jax.com/news/2021/...for-40-of-us-hospitalizations/?outputType=amp
     
    Last edited: Aug 7, 2021
  8. Arkain2K Si vis pacem, para bellum

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    Sorry Tedros, elected governments will always take care of their own vulnerable people first, while giving what they can to other countries.

    On the other hand, every dose unwanted by the anti-vax population in the First World should be put to good use and donated to the countries in dire need for it.


    Ignoring WHO call, major nations stick to vaccine booster plans for their immunocompromised and elderly citizens first
    By Sudip Kar-gupta, Caroline Copley | August 5, 2021


    PARIS/BERLIN, Aug 5 (Reuters) - Germany, France and Israel will go ahead with plans to administer COVID-19 vaccine boosters, disregarding an appeal by the World Health Organisation to hold off until more people are vaccinated around the world.

    The decision to press ahead with booster shots despite the WHO's strongest statement yet highlights the huge inequities in responses to the pandemic as richer nations ramp up programmes to protect citizens from the more infectious Delta variant.



    French President Emmanuel Macron said France was working on rolling out third doses to the elderly and vulnerable from September.

    Germany intends to give boosters to immunocompromised patients, the very elderly and nursing home residents from September, the health ministry said.



    Israeli Prime Minister Naftali Bennett in a statement urged older citizens to get a third shot after the government last month kicked off a campaign to give booster doses.

    "Whoever is over the age of 60, and has yet to receive the third dose of the vaccine, is six times more susceptible to severe illness and - heaven forbid - death," Bennett said.

    In an online discussion with the public and journalists, Bennett said Israel's drive to give third doses of the Pfizer/BioNTech vaccine to people over 60 would provide vital information to the world on combating the Delta variant.

    Israel, with a population of 9.3 million, was a small country whose vaccine use "doesn't really affect the world supply significantly", he added.

    WHO chief Tedros Adhanom Ghebreyesus called on Wednesday for a halt to boosters until at least the end of September, saying it was unacceptable for rich countries to use more of the global vaccine supply. read more

    INEQUALITIES MOUNT



    High-income countries administered around 50 doses for every 100 people in May, and that number has since doubled, according to WHO. Low-income countries have only been able to administer 1.5 doses for every 100 people, due to lack of supplies.

    "I understand the concern of all governments to protect their people from the Delta variant. But we cannot accept countries that have already used most of the global supply of vaccines using even more of it," Tedros said.

    Germany rejected those accusations, saying it would also donate at least 30 million vaccine doses to poorer countries.

    "We want to provide the vulnerable groups in Germany with a precautionary third vaccination and at the same time support the vaccination of as many people in the world as possible," the health ministry said.

    Following Tedros' comments, the White House said on Wednesday it was prepared to provide booster shots if needed, suggesting it would not heed the WHO's call either. read more

    U.S. health regulators have said that more scientific evidence is needed to be certain boosters are needed, but have indicated they believe a third shot may be needed for people with compromised immune systems.

    Macron's government is trying to step up France's vaccination programme as the country faces a fourth wave of the virus and street demonstrations in protest against the government's COVID policies.

    France and Germany have so far given at least one dose of a COVID-19 vaccine to 64.5% and 62% of their respective populations, with 49% of the French and 53% of Germans fully vaccinated.

    https://www.reuters.com/world/europ...e-doses-likely-elderly-vulnerable-2021-08-05/
     
    Last edited: Aug 7, 2021
    Madmick and Ayin like this.
  9. Queen B Fully Vaccinated

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    Vaccines are working exceptionally well.

    The reason CDC is having everyone mask is to protect the unvaccinated

    Not anything we didnt already know

     
  10. jeremyemilio Silver Belt

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    Texas and Florida are at number 25 and 26 respectively for mortality rate. Right in the middle of the pack. Where do you figure they end up?

    (New Jersey, New York, and Massachusetts still firmly at 1, 2, and 3. Where do you figure they end up?)

    https://www.worldometers.info/coronavirus/country/us/
     
  11. Staph infection Glue historian

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    The masks worked so well during the first wave, they really kept the numbers down in states like California and New York when compared with red states Like Florida and Texas.
     
  12. Queen B Fully Vaccinated

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    Deaths, hospitalizations, and cases started dropping in New York immediately after Cuomo enforced the mask mandate.

    They had a smaller holiday surge 2021 because some people werent double masking
     
  13. Arkain2K Si vis pacem, para bellum

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    Just like any previous and current Covid waves around the world, where mortality rates end up is greatly depends how slammed the hospitals are at the height of that wave.

    If a city/county somehow manage to stem their rapidly-rising hospitalizations between now and this Fall/Winter, they still have the chance to save most of the people who intentionally putting themselves there. Once the ICUs in a particular region are full and couldn't take anymore severe cases, that's when the bodies start stacking up.

    I've been posting weekly news updates on how many ICU beds are remaining in the hard-hit counties in this very thread, you can look at that for your own forecast for the next few months.
     
    jeremyemilio likes this.
  14. Letssnuggle Brown Belt

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    Lots of hedging on your part. Drop your sack and say it if you think the mortality rate will skyrocket. Or please stop with the sky is falling ......tomorrow....crap.
     
    Xivirus and SBJJ like this.
  15. Joe :l

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    The vast majority of their deaths have been in the first months of the pandemic. Not to mention that new york has done twice as many tests as texas. So in reality the situation in texas is worse than we know.
     
  16. Queen B Fully Vaccinated

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    And this was at a time before we knew about airborne/masks.

    Stores were gouging hand sanitizers and we couldnt even get tested, didnt know about asymptomatic cases,etc. Not even remotely apples to apples
     
  17. Arkain2K Si vis pacem, para bellum

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    This is the News thread, to report Actual News on what's actually happening each day.

    if you are unable to comprehend what that actually means, GTFO and return to the Anti-Vax cave where facts don't matter.
     
    Ayin likes this.
  18. Arkain2K Si vis pacem, para bellum

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    South Africa says J&J vaccine highly effective against COVID hospitalizations and deaths
    Reuters | August 6, 2021

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    JOHANNESBURG, Aug 6 (Reuters) - Johnson & Johnson's COVID-19 vaccine is working well in South Africa, offering protection against severe disease and death, the co-head of a trial in the country said on Friday.

    The J&J vaccine was administered to healthcare workers from mid-February in a research study, which was completed in May, with 477,234 health workers vaccinated, joint lead investigator Glenda Gray told a media briefing.

    South Africa's health regulator approved the J&J shot in April, and it is being used in the national vaccine programme alongside Pfizer's.

    Gray said the single-shot J&J vaccine offered 91% to 96.2% protection against death, while offering 67% protection against hospitalisation when the Beta coronavirus variant dominates and about 71% protection against hospitalisation when the Delta variant dominates.

    "Consistently after receiving the vaccine, there was very little death occurring in the vaccinated group as compared to the control group and showing a remarkable up-to 96.2% protection against death," Gray said.

    "This was our primary endpoint and we are able to say this vaccine protected health workers against death," she added.

    South Africa's vaccination campaign got off to a shaky start in February after the government paused AstraZeneca vaccinations because of a small trial showing the shot offered minimal protection against mild to moderate illness caused by the Beta variant, which was dominant in the country at the time.

    Vaccinations have since ramped up, with over 8.3 million people vaccinated as of Thursday.

    https://www.reuters.com/business/he...t-death-co-lead-investigator-says-2021-08-06/
     
    Last edited: Aug 10, 2021
  19. jeremyemilio Silver Belt

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    But what about Michigan and Florida? That's pretty apples to apples. Michigan even had a head start in that Florida got hit harder earlier. And yet here we are. And you still refuse to address it.

    You form narratives that fit the one you already have in your head. You are simply explaining away data that runs counter to your narrative. And you are so deep in it that you can't even see it.
     
    Xivirus and PhitePhan like this.
  20. Queen B Fully Vaccinated

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    Florida didnt get hit hard until summer, and that couldve been avoided
     

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