Pfizer Vaccine on Track for Regulatory Review in October

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Pfizer Inc. and BioNTech SE said the Covid-19 vaccine they are jointly developing is on track to be submitted for regulatory review as early as October, as they released additional data from an early-stage study.

The companies said the vaccine was well tolerated with mild to moderate fever in fewer than 20% of the participants. The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany, they said in a statement.

The timeline would make the vaccine one of the fastest-moving in the world. Some analysts expect a vaccine to be approved for use by November in the U.S., a move which may give President Donald Trump a new foothold in the election.

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{Matzav.com}

2 COMMENTS

  1. This is from Pfizer’s website. Their vaccine is using mRNA technology, which has never yet been approved for use in a vaccine for human beings for an infectious illness.

    How exactly do mRNA vaccines work?
    mRNA – or messenger RNA – is a molecule, composed of nucleotides linked in a unique order to convey genetic information for the cells to produce the proteins or antigens encoded by the mRNA. Once mRNA in a vaccine is inside of the body’s cells, the cells use their genetic machinery to translate the genetic information and produce the antigens encoded by the mRNA vaccine. The antigens are then displayed on the cell surface, where they are recognized by the immune system which generates a response, including the production of antibodies against the antigen.

    How long does it take to develop a vaccine?
    The development of a novel vaccine is a complex and lengthy process that generally takes 10 to 15 years. Given the current global scale of the COVID-19 pandemic, we are working at an unprecedented speed to develop a potential vaccine in a safe and responsible way, collaborating closely with regulatory and health authorities around the world – compressing stages that have taken years into months, and those that have taken months into weeks.

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    A vaccine, which usually takes 10 to 15 years to develop and which uses a never before approved technology, is going to be available in less than a year?? This vaccine is only being tested in those 18 years and older in GOOD HEALTH (no cardiac issues, no diabetes, no respiratory issues, no one obese, no smokers, no nursing mothers, no pregnant women, no one on asthma medicine – if you fall into one of these categories or have other chronic health issues, be forewarned that your risk in taking this vaccine is not being studied.

    Watch from the 25:00 mark of this clip and learn about a possible safety problem with this vaccine, including information from Dr. Peter Hotez, a very pro-vaccine doctor:
    https://thehighwire.com/videos/covid19-connecting-the-dots/

    Please share this clip with others. Send it to your doctors and see what they think about it.

    • Was the disease validated with studies? Was it approved for people with cardiac issues, diabetes, etc etc? However, feel free to catch the disease, if so you prefer. I will stay away from the disease, and as for the vaccine, I will wait until it is thoroughly tested,

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