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 […]
In clinical trials of the experimental messenger RNA (ribonucleic acid) COVID-19 vaccine (BNT162b1), which is being developed by Pfizer, Inc. of New York and BioNTech SE of Mainz, Germany, adverse reactions have occurred in more than 50 percent of the adult participants. The Phase 1/2 human trials of BNT162b1 vaccine, which were conducted May-June 2020, […]
Drug shortages listed by the U.S Food and Drug Administration (FDA) are exposing some of the ramifications of responses to the COVID-19 pandemic, including state lockdowns and social distancing regulations.1 Zoloft (sertraline hydrochloride), an anti-depressant manufactured by Pfizer and its generic counterparts produced by other drug makers, have been added to the FDA’s list of […]
In an interview with the JAMA on June 2, 2020, Anthony Fauci, MD, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said that while he was “cautiously optimistic” about the effectiveness of the vaccines being developed for COVID-19, he was concerned that any protection the vaccines may provide might only be temporary. […]
Pfizer, Inc. of New York and BioNTech SE of Mainz, Germany have announced that human clinical trials for an experimental COVID-19 vaccine they have co-developed, known as BNT162, have begun in the United States.1 As part of a global clinical development program, the first human subjects in the U.S. Phase I and Phase clinical II […]