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 […]
One of the main rationales for why some U.S. health officials are referring to COVID-19 as a “pandemic of the unvaccinated” is the claim that 97 percent of Americans who have been hospitalized with symptoms of the illness are unvaccinated. During a White House press briefing on July 16, 2021, the director of the U.S […]
Health Canada, the Canadian government’s department responsible for national health policy, earlier this month updated the product information label for Pfizer/BioNTech’s experimental messenger RNA (mRNA) biologic (also known as BNT162b2 or “Comirnaty” vaccine) to reflect reported cases of Bell’s palsy—an immune mediated neurological disorder characterized by temporary muscle weakness or paralysis on one side of […]
Opinion | It is interesting to observe the mainstream media’s reporting of the recent news that Governor Greg Abbott of Texas has tested positive for the SARS-CoV-2 virus. For example, the headline of an article by CNBC reads, “Texas Gov. Abbott, who banned mask and vaccine mandates, tests positive for Covid.” Another headline by Yahoo! News reads, “Texas […]
Singapore’s Ministry of Health (MOH) announced on Aug. 16, 2021 that it had awarded S$225,000 (just over $165,000) to the family of a 16-year-old boy in Singapore who suffered a heart attack six days after receiving the first dose of Pfizer/BioNTech’s experimental messenger RNA (mRNA) COVID-19 biologic (also known as BNT162b2 or “Comirnaty” vaccine) on […]
A 22-year-old man in France died on July 26, 2021 nine hours after receiving the first dose of Pfizer/BioNTech’s experimental COVID-19 biologic (also known as BNT162b2 or “Comirnaty” vaccine). Maxime Beltra was vaccinated at about 2 pm in the southern French city of Sète and then went to a local restaurant with friends. At 10 […]
A new poll conducted Yahoo! News/YouGov during July 13-15, 2021 found that 37 percent of unvaccinated Americans are more fearful of the three experimental COVID-19 biologics currently available in the United States than they are of the SARS-CoV-2 virus that can cause the disease. The survey of 1,715 adults in the U.S. found that only […]
A recent study published by King’s College in London, which operates the ZOE COVID Study app to monitor COVID infection and vaccination rates, found that, as of July 15, 2021, there was an average of 15,537 new daily symptomatic cases of COVID-19 among partly or fully vaccinated people in the United Kingdom—an increase of 40 […]
Opinion | On July 8, 2021, Pfizer, Inc. announced it was developing a booster dose for its experimental messenger RNA (mRNA) BNT162b2 biologic for COVID-19. It said that it had observed waning immunity among people who received the standard two-dose regimen of the product. The company said it planned to begin clinical studies of the […]
“If you’re vaccinated, you’re protected. If you’re unvaccinated, you’re not protected.” These words, or some slight variation of them, are increasingly being used by U.S. government officials to encourage Americans to get vaccinated for COVID-19. In a July 4, 2021 interview on ABC’s “This Week,” White House COVID-19 response coordinator Jeff Zients was asked, “What does […]