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Pfizer Withdraws EUA Application for COVID Shot in India After Regulator Asks for Independent Safety Study

Pfizer Withdraws EUA Application for COVID Shot in India After Regulator Asks for Independent Safety Study

Pfizer, Inc. has withdrawn its emergency use authorization (EUA) application for its experimental BNT162b2 (also known as “Comirnaty”) messenger RNA (mRNA) COVID-19 biologic (developed in collaboration with Germany’s BioNTech) in India.1 Pfizer was the first pharmaceutical company to apply for an EUA to distribute a COVID biologic in India in 2021. However, India’s regulatory agency […]

FDA Approves BioNTech’s Comirnaty. Pfizer COVID Shot Remains Experimental.

On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) gave full approval to a Biologics License Application (BLA) submitted by BioNTech Manufacturing GmbH of Mainz, Germany on May 18, 2021 for a biologic drug called COVID Vaccine, mRNA. The FDA gave permission to BioNTech to label the product “Comirnaty” and market it in […]

State and Local Governments and Companies Offer Incentives to Get Vaccinated for COVID-19

State and Local Governments and Companies Offer Incentives to Get Vaccinated for COVID-19

Story Highlights As the demand for COVID-19 vaccines slows across the country, governments and businesses are offering a wide range of incentives to try to boost vaccination rates. In addition to a variety of cash lotteries, some of the offerings include air travel, college scholarships, state park passes, fishing or hunting licenses and complimentary food […]

Infant Boy in India Dies Hours After Getting Oral Polio Vaccine

Infant Boy in India Dies Hours After Getting Oral Polio Vaccine

A seven-month-old infant boy died on July 7, 2020 within hours of receiving the live attenuated oral polio vaccine (OPV) in Palghar, India. The baby was given one dose of the OPV drops in the evening and was found dead the following morning by his parents.1 2 3 According to a news report, government welfare […]

Infant Boy in India Dies Within Hours of Receiving Pentavalent Vaccine

Infant Boy in India Dies Within Hours of Receiving Pentavalent Vaccine

A five-month-old infant boy died on Feb. 12-13, 2020 within hours of receiving the “5-in-1” pentavalent (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type B) vaccine at a vaccination clinic in Arani, India.1 2 After he was vaccinated by the health nurse at the clinic, the boy was sent home with his parents. According to […]

Doctors in India and U.S. Get Big Money and Gifts from Pharma

Doctors in India and U.S. Get Big Money and Gifts from Pharma

The Madras High Court in India stated that 8,667 pharmaceutical companies have claimed income tax deduction on the freebies they give to doctors as “sales promotion expenses” and “gifts” in their tax return for the year 2019-20.1 In January 2020, the Court had taken suo motu cognizance (when courts in India take a case on […]

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