Author Archives: jbakerjrblog

Today the FDA Vaccines and Related Biological Products Advisory Committee approved the Moderna COVID-19 vaccine. The results are not surprising given the positive review of the Pfizer vaccine a week ago and the FDA’s very positive review of Moderna’s phase three data that was published two days ago. There were some similar concerns as wereContinue reading “The FDA AdCom approves Moderna’s vaccine”

New COVID-19 infections and deaths fell significantly in the United States over the past week. The reasons for this are not entirely clear but may be that we’re getting far enough out from Thanksgiving that those additional infections have resolved. The overall number of infections remains high, and there are still hot spots in placesContinue reading “COVID-19 infection numbers drop in the U.S. this past week.”

Today the FDA published its review of the phase three clinical trial for Moderna’s COVID-19 vaccine. The results were almost identical in both efficacy and safety to what Pfizer presented a week ago. There were, however, some interesting points that came from the review.  Overall efficacy was very similar to Pfizer’s data. As compared toContinue reading “FDA gives big thumbs up on Moderna’s COVID-19 vaccine”

I have been impressed by the input from the readers of this blog. Tonight I will address three issues raised by readers.  I have been watching video of people administering the new COVID-19 vaccine. They don’t appear to be injecting it correctly and are not trying to withdraw the syringe to make sure there’s noContinue reading “Are they injecting the vaccine correctly, and two other concerns raised by blog readers.”

This blog has purposely avoided any political commentary in favor of focusing the discussion on the scientific and medical aspects of the pandemic. However, I do think it’s important to identify problematic behavior by public figures that has contributed to failures in the pandemic response. Last week, daily COVID-19 death tolls in the U.S. setContinue reading “Dr. Redfield’s Pearl Harbor…”

At the end of the week when the most Americans yet died from COVID19, last night the FDA provided an Emergency Use Approval for the Pfizer-BioNTech Coronavirus vaccine. The approval (which is available here) is for individuals 16 years and older, and did not restrict the use of the vaccines unless the recipient has aContinue reading “The FDA approves Pfizer-BioNTech’s COVID Vaccine.”

This week in the Lancet, the data from the phase three trial of the Astra Zeneca/Oxford vaccine were published. The results had been previously announced in a press release and suggested that the efficacy was anywhere from 60 to 90%, dependent on the first dose of the vaccine. The data in Lancet finally clarify theContinue reading “Data released on AstraZeneca COVID Vaccine”

Late this afternoon, the FDA Vaccines and Related Biological Products Advisory Committee voted to approve the Pfizer and Biotech COVID-19 vaccine. The committee voted 17 in favor, 4 against, and 1 abstention on approving the vaccine. Despite not being unanimous, most of the negative votes came from those concerned about the lack of data on 16- andContinue reading “The FDA Vaccines Advisory Committee Approves the Pfizer Covid-19 Vaccine”

Media reports this morning are suggesting that two National Health Service workers developed symptoms of “anaphylactoid reactions” after receiving the new Pfizer/BioNTech vaccine for COVID-19. The pair “responded adversely” following their shots, and were part of the several thousand who were vaccinated in the UK on Tuesday, the first day of the mass vaccination rollout, National Health Service EnglandContinue reading “Confusing reports of “allergic reactions” to COVID-19 vaccine.”

The FDA today released its internal review of the Pfizer/BioNTech request for emergency use approval of their COVID-19 vaccine. The document, which stretches 53 pages, is available for download and remarkably complete. It reveals that the vaccine met all efficacy and safety milestones set by the agency and strongly suggests the vaccine will be approved byContinue reading “The FDA completes its formal review of the Pfizer/BioNTech COVID-19 vaccine”