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FDA grants priority review to Pfizer/BioNTech Covid-19 vaccine

Agency official says approval decision expected within two months

Pfizer and BioNTech began the application for full approval of their Covid-19 vaccine in May, and have completed the submission. The companies are seeking approval for the two-dose series for people age 16 and older, and expects to apply for approval for people ages 12 to 15 when the data are available. Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research, wrote that the review of applications for full approval of the Covid-19 vaccines is "one of the highest priorities" at the FDA, but it requires the evaluation of extensive manufacturing and clinical information.

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    The delta variant of the coronavirus appears to cause more severe illness than earlier variants and spreads as easily as chickenpox, according to an internal federal health document that argues officials must “acknowledge the war has changed.”

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      How Immunity Generated from COVID-19 Vaccines Differs from an Infection 

      The new evidence shows that protective antibodies generated in response to an mRNA vaccine will target a broader range of SARS-CoV-2 variants carrying “single letter” changes in a key portion of their spike protein compared to antibodies acquired from an infection.

      These results add to evidence that people with acquired immunity may have differing levels of protection to emerging SARS-CoV-2 variants. More importantly, the data provide further documentation that those who’ve had and recovered from a COVID-19 infection still stand to benefit from getting vaccinated.

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        Credit for Moderna's COVID-19 vaccine belongs in part to discoveries dating back 15 years. The team behind it was inspired by two infant deaths. Click to read more.

        Association for Professionals in Infection Control and Epidemiology (APIC) among long list of Medical Groups Calling for Mandatory Vaccination for Healthcare Workers 

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          COVID-19 (coronavirus): Long-term effects

          Most people who have coronavirus disease 2019 (COVID-19) recover completely within a few weeks. But some people — even those who had mild versions of the disease — continue to experience symptoms after their initial recovery. These people sometimes describe themselves as "long haulers" and the conditions have been called post-COVID-19 syndrome or "long COVID-19." These health issues are sometimes called post-COVID-19 conditions. They're generally considered to be effects of COVID-19 that persist for more than four weeks after you've been diagnosed with the COVID-19 virus.

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            Joint Statement in Support of COVID-19 Vaccine Mandates for All Workers in Health Care

            Posted on: Jul 28, 2021

            Association for Professionals in Infection Control and Epidemiology (APIC)...

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            A dangerous new variant is on the rise in the US — but vaccines appear to provide good protection

            Posted on: Jun 30, 2021

            *This article originally posted on

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            New Metric Identifies Coronavirus Hotspots in Real Time

            Posted on: Jun 30, 2021

            During the pandemic, it’s been critical to track in real time where the...

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            COVID-19 mRNA Vaccines Safe, Effective for Pregnant Women Studies Confirm

            Posted on: Jun 02, 2021

            Posted on June 1st, 2021 by Dr. Francis CollinsClinical trials have shown...

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