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…”
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The FDA approves Pfizer-BioNTech’s COVID Vaccine.
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.”
Data released on AstraZeneca 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”
The FDA Vaccines Advisory Committee Approves the Pfizer Covid-19 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”
Confusing reports of “allergic reactions” to 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 completes its formal review of the Pfizer/BioNTech 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”
Lots of questions and a few answers on COVID-19 vaccines.
Over the weekend I tried to anticipate some of the questions people will have about the COVID-19 vaccines. I know the FDA cannot comment given their external review committee meets on Thursday to evaluate the Pfizer vaccine. But I had hoped there would be more info from government and local officials about prioritization and localContinue reading “Lots of questions and a few answers on COVID-19 vaccines.”
Sweden reverses course.
Sweden has long been viewed as the contrarian in COVID-19 management. The country took the tack of not employing social restrictions while attempting to protect vulnerable people who would be likely to get seriously ill or die. This allowed them to keep their economy open and avoid any mandatory restrictions. They were attempting to achieveContinue reading “Sweden reverses course.”
Answers to questions about the COVID-19 vaccines.
I continue to get questions about the COVID-19 vaccines and how individuals should approach their own vaccination. Today, I will comment on several questions that have general impact on individuals seeking COVID-19 vaccines. This does not substitute for your doctor’s specific advice. So, if you have any complexity to this situation I would suggest youContinue reading “Answers to questions about the COVID-19 vaccines.”
What is behind the CDC’s new universal indoor mask policy? Too little too late.
The Centers for Disease Control and Prevention today called for “universal mask use” indoors for the first time. This was presented as being in response to the record numbers of coronavirus hospitalizations and deaths the U.S. is currently experiencing. However, since it has been clear for a long time that transmission of COVID-19 is mostContinue reading “What is behind the CDC’s new universal indoor mask policy? Too little too late.”