Moderna seeks FDA authorization for a 4th COVID vaccine shot for all adults

”…Moderna on Thursday requested emergency use authorization from the Food and Drug Administration for a fourth dose of its COVID-19 vaccine as a booster for people 18 and over — a broader request than Pfizer made days ago for its vaccine…”


What New York Got Wrong About the Pandemic, and What It Got Right


1. Several former CDC Directors—representing 27 years, from 1990-2017—published an editorial in The Hill calling on the Congress to include provisions in the PREVENT Pandemics Act to “standardize and coordinate public health data” from the local to the national level. They draw a parallel to the National Weather Service, which relies on data gathered from a national network of radar sites and other local sources, even in the absence of a major storm or other weather event. They argue that the CDC needs the same capabilities to monitor for, identify, and respond to emerging outbreaks and epidemics. Efforts to modernize and coordinate US public health reporting systems are necessary for COVID-19 as well as a broad scope of existing and future threats.

2. PFIZER-BIONTECH VACCINE FOURTH DOSE On March 15, Pfizer and BioNTech submitted an application to the US FDA for an Emergency Use Authorization (EUA) for a second booster dose of its SARS-CoV-2. The application is specifically limited to fully vaccinated adults aged 65 years and older who have already received a booster dose of any approved or authorized SARS-CoV-2 vaccine, and not for the broader public. The request is based primarily on data from Israel, where a fourth dose of the Pfizer-BioNTech vaccine is available for a broader group of adults, including high-risk group such as individuals aged 60 years and older, individuals with compromised immune systems, healthcare workers, caregivers of high-risk individuals, and others who are at high risk of exposure because of their occupation. The Israeli data also include a non-randomized clinical trial of 154 adults aged 18 years and older who received a fourth dose, which showed an increased neutralizing antibody response (including against the Omicron variant), compared to individuals who received only 1 booster dose. Analysis of Israeli Ministry of Health records, which have not yet been peer-reviewed, was conducted while the Omicron variant was circulating widely, but additional data are needed to assess the duration of any increased protection. Additionally, it is unclear to what extent vaccine-induced protection against severe disease and hospitalization wanes over time.

Experts remain divided over the utility of administering additional doses of vaccine, with some advocating, instead, for a focus on developing vaccine candidates that could confer longer-duration protection or broader protection against future SARS-CoV-2 variants. To be sure, individual risk assessments remain an important factor in whether an additional booster dose is warranted, as some people, particularly those in the US who are immunocompromised, already are recommended to receive a fourth dose.

(J. Harris: If you are 65 or older or otherwise sickly, it seems like a good idea to get that 4th jab pdq. There will be more variants in the future. Fortunately, new vaccines are being manufactured with broader coverage for future use. However, “the future is now” for Covid.)



 Efficacy of Losartan in Hospitalized Patients With COVID-19–Induced Lung Injury


”…In this multicenter, blinded, and placebo-controlled randomized clinical trial, 205 hospitalized participants with COVID-19 and acute lung injury not already using RAAS inhibitors were randomized to oral losartan at the maximum dose approved by the US Food and Drug Administration to test the hypothesis that AT1R blockade improves pulmonary function. Despite a moderate to severely ill cohort, well-matched baseline Pao2:Fio2 ratios, and pharmacologically relevant steady-state concentrations, we found no evidence that treatment with losartan improved lung injury or clinical outcomes, nor significantly affected major circulating RAAS components…       It is important to note that we observed 2 potentially harmful effects of losartan on hemodynamics and kidney function….Not surprisingly, based on the mechanism of action, patients in the losartan group were more likely to require vasopressor support [medicine tor RAISE BP]. Furthermore, while the losartan group was more likely to meet acute kidney injury criteria by KDIGO, this finding may indicate expected physiologic changes in intraglomerular blood flow rather than actual tissue injury per se. Nevertheless, in the absence of benefit and potential for harm, we conclude losartan treatment is not indicated in this setting.[several other studies are mentioned in this short article]…”

(J. Harris: The AC Inhibitors and/or Angiotensin-Converting Enzyme Inhibitors are very commonly used medications for BP control. They are not expensive and work well. It would have been lovely if they have or had a protective or therapeutic effect with Covid. Many, many studies apparently are underway in the medical world using these drugs. To date, to my knowledge, none has been shown to be helpful in Covid treatment or prevention. Nevertheless, they are great for BP control, and I plan to continue taking mine unless my doctor tells me to stop.)


Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study

”…The Sisonke study, which was conducted during a period when both the delta and the beta variants of concern were circulating in South Africa, supports the real-world effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine [J + J VACCINE] in a large cohort of highly exposed health-care workers, many of whom have HIV. The vaccine was effective against severe outcomes, including COVID-19-related death (83%), COVID-19-related hospital admissions (67%), and COVID-19-related admission to CCUs or ICUs (75%). Most breakthrough infections in these highly exposed health-care workers were asymptomatic or mild, with less than 1% of health-care workers having a severe SARS-CoV-2 infection that resulted in hospitalisation or death…..This study was conducted during South Africa’s third and most deadly COVID-19 wave, and during the transition in dominance from one variant of concern (beta) to another (delta) up to 5 months after vaccination…Our study has important policy ramifications, especially for the sub-Saharan region, which has faced three variants of concern in quick succession, constrained access to effective vaccines against these variants, and logistical difficulties in rapidly scaling up delivery. We found that a single-dose vaccine provided good protection within 2–5 months after vaccination and this effectiveness was maintained with the emergence of a second variant of concern. Ad26.COV2.S remains an important vaccine in settings where alternative regimens impose cold-chain logistics or require people in remote areas or dependent on daily paid work to return for a second vaccination within a short timeframe. Single-dose regimens also offer an opportunity to move quickly and efficiently to protect susceptible populations. Real-world effectiveness studies have shown the loss of effectiveness of COVID-19 vaccines over time. This loss in effectiveness could be attributed to waning immunity or the emergence of a new variant of concern. The Sisonke study will add critical information to the durability of the single-dose regimen. The recent addition of a booster to the Sisonke study, per a protocol amendment on Oct 25, 2021, will provide critical information on effectiveness of booster doses administered from 6 to 9 months after initial vaccination. For the world’s most unvaccinated region, this single-dose vaccine provides a robust, practical, and effective emergency solution to mitigate the worst effects of COVID-19….”

(J. Harris: So there is definitely a place for the Johnso and Johnson Vaccine, and recent evidence indicates significantly heightened immunity after a second jab.)


1. Fauci anticipates US COVID-19 case increase

2. Signs of potential US surge warrant caution, not alarm: 4 expert thoughts

(J. Harris: Quick, direct reads — perhaps overly optimistic?)

LASTLY: I hope you had a good St. Pat’s day!


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