by Carolyn Hendler, JD, Theresa Wrangham and Marco Cáceres on
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 […]
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 […]
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 […]
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 […]
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 […]
Three-month-old Rohan Kumar died on Feb. 6, 2020 after receiving the “5-in-1” pentavalent (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type B) vaccine at a government health center in Ramgarh, India.1 2 An investigation into the infant boy’s death was ordered by the local health department. A rural child health officer was tasked with […]
A two-month-old infant boy died on Jan. 11, 2020, a day after receiving the “5-in-1” pentavalent (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type B) vaccine at a rural child care center in Hunshyal, India. The child was rushed to a nearby hospital after he fainted, but he died on the way.1 The child, […]
On Dec. 20, 2019, the government of Samoa announced that 94 percent of the island nation’s population of about 200,000 people had been vaccinated against measles as part of a government-led mandatory, mass vaccination campaign. As of Dec. 20, the Samoan Ministry of Health (MOH) had confirmed 5,463 reported cases with 1,762 hospitalizations and 78 […]
Opinion | Primum non nocere—“first, do no harm”—is a basic tenet of medical ethics. That is about to change in India. “Controlled Human Infection Method” (CHIM) studies are planned to be introduced here. Humans are to be deliberately infected with diseases to test the efficiency of experimental vaccines. It will provide a shortcut to vaccine licensing […]
Two-month-old Priyanka Biswal died on Sept. 5, 2019, a day after receiving the live attenuated oral polio vaccine (OPV), pentavalent (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type B) vaccine and vitamin supplements at a Community Health Center (CHC) in Naranapur, India.1 2 A report by the Orissa Post noted, “after intake of the polio […]