The U.S. National Institutes of Health (NIH) has provided the University of Maryland with a $3.5 million dollar grant to develop a vaccine for Lyme disease.1 Principal investigators Utal Pal, PhD, professor at the Virginia-Maryland College of Veterinary Medicine at the University of Maryland College of Agriculture and Natural Resources and Matthias Schnell, PhD, director […]
There’s been a lot of talk lately about whether or not the fast-tracked COVID-19 vaccine will in fact be safe and effective. While vaccine makers insist that any vaccine reaching the market will have undergone rigorous testing, the way trial protocols are designed suggests these vaccines may leave a lot to be desired. As reported1 by […]
On Sept. 8, 2020, nine pharmaceutical companies working on COVID-19 vaccines signed a pledge saying they would not submit their experimental vaccines to the U.S. Food and Drug Administration (FDA) unless they were shown to be both safe and efficacious in the Phase 3 human clinical trials.1 2 3 4 5 The pledge, signed by […]
On Oct. 14, 2020, Pfizer, Inc. of New York City, New York announced it had received approval by the U.S. Food and Drug Administration (FDA) to enroll children in the Phase 3 human clinical trial on its experimental messenger RNA (ribonucleic acid) BNT162b1 vaccine for COVID-19. The trial, which last month was expanded to include adolescent […]
The American Academy of Pediatrics (AAP) is asking federal officials to include children in COVID-19 vaccine trials.1 On September 29, 2020, Sara Goza, MD, president of the AAP, wrote a letter addressed to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Commissioner Steven Hahn, MD stating, […]
If you look at the human clinical trials that have been conducted this year by drug companies developing experimental vaccines for COVID-19, the participants in those trials have all been “healthy adults.” Take, for example, Moderna’s Phase 1 clinical trial for its mRNA-1273 vaccine, which included 45 healthy adults 18 to 55 years old. The same […]
The government of Canada has signed deals to purchase COVID-19 vaccines from four pharmaceutical companies when their vaccines are approved to be given to the public. According to Canada’s Minister of Public Services and Procurement Anita Anand, the Canadian government has contracts with Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), Moderna, Novavax and Pfizer […]
Numerous polls have been conducted during the last few months asking Americans if they would get a COVID-19 vaccine were it approved by the U.S. government and offered to the public. Polls in April-May 2020 showed that about half or more of those surveyed said they would get the vaccine. More recent polling, however, has […]
When Moderna, Inc. announced on May 18, 2020 the results of a Phase 1 human clinical trial for its experimental mRNA-1273 vaccine for COVID-19, the biotechnology company said the vaccine had produced no “serious adverse events” (SAEs) among the 45 people who participated in the trial and that it considered the vaccine to be “generally […]
Pfizer and its German partner BioNTech on Monday announced two of their experimental coronavirus vaccines received Fast Track designation from the U.S. Food and Drug Administration, meaning the FDA may decide on an approval within six months. If a vaccine candidate gets the green light, the companies said they expect to make up to a […]