What the FDA’s decision on Pfizer booster shots really means.

The FDA’s Vaccines and Related Biological Products Advisory Committee rejection of Pfizer’s proposed booster shots in all Pfizer vaccinated Americans was predicated entirely on the science. Despite the opportunity for Pfizer to make the case for vaccinating everyone 16 and older six months after they are fully vaccinated, and political support for this approach, theContinue reading “What the FDA’s decision on Pfizer booster shots really means.”

Do you need a booster dose of COVID-19 vaccine?

Yesterday an article in The Lancet provided an independent scientific assessment of the need for COVID-19 vaccine booster doses. The publication reviewed the current data on booster vaccines, which generally shows very good efficacy even with the Delta variant for the mRNA based vaccines from Pfizer and Moderna. The general tone of the article  suggestedContinue reading “Do you need a booster dose of COVID-19 vaccine?”

Questions that arise from yesterday’s CDC update on COVID-19

The CDC provided an update on the status of COVID-19 infection in the United States yesterday with a particular focus on the utility of the vaccines. It was a welcome message, including a formal analysis of breakthrough infections. The results showed that the vaccines continue to work even in the presence of the Delta variantContinue reading “Questions that arise from yesterday’s CDC update on COVID-19”

Refuting exaggerated reports of “breakthrough infections” and the “Mu” variant

Since mid-July when the CDC published its conclusions from the “Provincetown outbreak,” people have been incredibly concerned about breakthrough infections (infections that occur in fully vaccinated individuals). The CDC made these sound very common and suggested that PCR of viral material from the vaccinated individuals’ noses showed levels of virus similar to those from unvaccinatedContinue reading “Refuting exaggerated reports of “breakthrough infections” and the “Mu” variant”

How about that Israeli study touting “natural immunity” over vaccination?

Social media channels and prominent anti-vaxxers like Alex Berenson have been on fire with talk about an unreviewed Israeli study suggesting that infection with COVID-19 provides better immunity than the COVID-19 vaccines. It takes some effort find this study, since it is not published in any reputable journal and is only posted on the medRxiv website.Continue reading “How about that Israeli study touting “natural immunity” over vaccination?”

The Pfizer-BioNTech vaccine is approved but the media second guessing continues.

A Monday the FDA provided final approval to the Pfizer-BioNTech coronavirus vaccine. Dr. Janet Woodcock (acting FDA Director) noted that in the FDA’s “efforts to move as quickly as possible” in approving the Pfizer-BioNTech vaccine did not “sacrifice scientific standards, or the integrity of our process.” Maybe the most noteworthy part of the announcement was thatContinue reading “The Pfizer-BioNTech vaccine is approved but the media second guessing continues.”

The Delta wave. How we got here, how we exit and how we prevent it from happening again.

The United States finds itself in yet another wave of COVID-19 infection, this time caused by a Delta viral variant that is more infectious. I have previously explained how the Delta variant has mutated to become more infectious, but that really isn’t the issue at this point.  The real issue is how we got here,Continue reading “The Delta wave. How we got here, how we exit and how we prevent it from happening again.”

Misleading reports of COVID-19 vaccine “failures” from around the world.

On a day when the New York Times published an article on “vaccine breakthrough COVID-19 cases based on preliminary data,” several avid readers have sent me posts from other countries that inaccurately denigrate the efficacy of COVID-19 vaccines. Maybe it should make us feel better that negative vaccine stories are not restricted to our country.Continue reading “Misleading reports of COVID-19 vaccine “failures” from around the world.”

The FDA and CDC are failing our country.

The track record of the FDA and CDC during the COVID-19 pandemic has been spotty at best. With new leadership at the CDC and the opportunity to advance effective COVID-19 treatments and vaccines at the FDA, we all had hoped that the performance of both these agencies would improve. Unfortunately, the recent performance of bothContinue reading “The FDA and CDC are failing our country.”