AAP Wants Children Enrolled in COVID-19 Vaccine Clinical Trials
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, […]
How Will Unhealthy Americans React to COVID-19 Vaccines?
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 […]
Poll: 69 Percent of Americans Worried Fast-Tracked COVID-19 Vaccines Won’t Be Safe
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 […]
A Grade 3 Vaccine-Related Adverse Event is Serious
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, BioNTech Get Experimental Coronavirus Vaccine ‘Fast Track’ from FDA
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 […]
Pfizer/BioNTech’s COVID-19 Vaccine Causes Adverse Reactions in Over Half of Clinical Trial Volunteers
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, […]
COVID-19 Vaccine Will Likely Be Given Multiple Times, Perhaps Annually
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 and BioNTech Begin Human Clinical Trials of COVID-19 Vaccine in U.S.
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 […]
Fauci Says Rushing COVID-19 Vaccine is Risky
During a remote online testimony before the U.S. Senate’s Health, Education, Labor and Pensions Committee on May 12, 2020, Anthony Fauci, MD warned that moving forward too quickly with the development of a vaccine for COVID-19 may produce a vaccine that could make the disease worse.1 2 Dr. Fauci, who is the director of the […]
Pfizer/BioNTech Target Fall 2020 for COVID-19 Vaccine Availability
In recent weeks Inovio Pharmaceuticals of Pennsylvania and representatives of the German biotechnology firm CureVac AG and the University of Oxford in the United Kingdom have announced that their experimental COVID-19 vaccines will be ready for use by September 2020. On Apr. 29, 2020, Pfizer, Inc. of New York stated in a news release that […]
