Tag: Covid-19

CDC Identifies Omicron as Covid-19 Variant of Concern

I’ve been seeing news items about the Omicron variant of Covid-19. The CDC only yesterday announced that it is now a Variant of Concern. Other CDC comments are here in a news release. There’s not a lot of solid information yet about how dangerous it is. Most of what I see on the internet are comments about the need for more information. Vaccine manufacturers don’t seem to agree on whether or not current vaccines would be effective against Omicron.

Interestingly, there seem to be about as many news articles about how to pronounce “Omicron” as there are about the variant itself.

When I compare the Omicron news to that of the recently identified Delta plus (AY.4.2) subvariant, I see very few references to the latter after late October. I never saw any CDC indications that the Delta plus was ever a Variant of Concern, although news items generally carried an alarming tone. As the CDC says, there will be variants. So far, as of yesterday, no U.S. cases have been found.

Great YouTube Q&A on Covid-19 Vaccine for Children Ages 5-11: It’s better than a stick in the nose!

There was a great live stream YouTube Q&A presentation today on the Covid-19 vaccine for kids ages 5-11 through the University of Iowa Stead Family Children’s Hospital this afternoon at 2:15 and it ran for about 30 minutes (scrub the play button forward to about a minute to start the recorded video). There were excellent questions and informative answers as well as helpful guidance for parents by Chief Medical Officer Dr. Theresa Brennan, MD and Pediatrician Dr. Rami Boutros, MD.

Parents have been eager to bring their kids in to the pediatric clinic to get the vaccine. Dr. Boutros shared a funny anecdote about his interaction with a child who had just got his shot yesterday. It’s about 34 minutes into the video. After the child received the shot, Dr. Boutros asked him, “How was it?” The child replied, “The vaccine is better than a stick in the nose!” Anybody who’s been tested for Covid-19 can relate to that.

How’s that for a meme? Get the vaccine; it’s better than a stick in the nose!

CDC Recommends COVID-19 Vaccine for Children Ages 5-11

Following the Advisory Committee for Immunization Practices (ACIP) vote yesterday recommending the Pfizer Covid-19 vaccine for children ages 5-11, CDC formally announced agreement with the committee’s decision after the meeting.

What You See is Not Always What You Get

A couple of days ago I thought of Gary Larson’s Far Side cartoon, the one with the toggle switch in a passenger airplane cabin seat with the message “Wings Stay On; Wings Fall Off.” I googled it just for fun and found that it spawned a lot of web articles obviously trying to reassure the flying public that airplane wings don’t just fall off.

What brought the “Wings Stay On; Wings Fall Off” cartoon to mind were a few events in the last two days. Day before yesterday, Sena took our lease car to one of the local dealership’s car wash. She does this all the time without incident but this time she noticed that the “soap” didn’t rinse off. She drove it home and still couldn’t get what appeared to be soap film off the car. She finally drove back to the dealership and discovered that the car wash attendant had accidentally pressed the hydraulic oil lubricant button instead of the detergent button. A number of other car wash customers also had been victims of the mishap and were complaining to dealership management.

So, what had looked like soap film actually turned out to be hydraulic lubricant meant for the car wash motors. It turns out that accidents like these can happen. Could the button for the lubricant have been situated so close to the detergent button that the attendant accidentally pressed the wrong one? By itself, that reminded me of the Larson cartoon. If the systems analysist for the car wash design was asleep at the desk on the day of manufacture, I guess all you can do is think before you act. And what you see is not always what you get.

The next day, Sena and I were at the dealership sitting in an agent’s office. We noticed a tipped over cup of coffee. I reached over to pick it up, mentioning that he must have had a little accident. Much to my surprise, both cup and mess came up as a spill prank, which I had never seen before, believe it or not. The joke capitalizes on our human tendency to sometimes act before we think.

Finally, a couple of on-line news items caught my eye this morning. They were both about white tail deer in Iowa, discovered by Iowa State University (ISU) researchers to have somehow picked up the Covid-19 virus. One story was much shorter than the other.

The longer story by the Des Moines Register had a lot more ISU research detail in it and didn’t stress certain facts that might reassure readers that there was low likelihood that humans might be vulnerable to catching the virus from deer.

The shorter story by the KCCI news network didn’t present as much of the ISU research details and basically said as long as you used gloves to dress the animal in the field and thoroughly cooked the meat, you were in no danger of infection. Both stories basically carried the same message that there was low likelihood of infection to humans. But there was a slight tendency to overemphasize the risk in one article and maybe a tendency to underemphasize it in the other. These might illustrate the “spin” phenomenon for which readers should just be on the alert.

By the way, the CDC web site carries a message saying the risk of catching Covid-19 from wild animals is generally low.

What you see is not always what you get, especially at first glance. And it pays to think before you act.

CDC Advisory Committee Meeting Today on COVID-19 Vaccine for Children Ages 5-11

Today the Advisory Committee on Immunization Practices (ACIP) had the meeting today to discuss the Pfizer Covid-19 vaccine for children aged 5-11 years of age. Presentation slides are here. The Policy Question to be voted on for today is:

“Should vaccination with Pfizer-BioNTech COVID-19 vaccine (2-doses, 10µg, IM) be recommended for children 5–11 years of age, under an Emergency Use Authorization?”

Dr. Kevin Chatham-Stevens’ presentation on implementation of the vaccination program for children in the age group was informative. Most children will likely be vaccinated in their regional doctors’ office. Dr. Woodworth presented very helpful, practical, and reassuring information about the practical aspects of vaccination, see slides from “Interim Clinical Considerations for COVID-19 Vaccine in Children Ages 5–11 Years.”

Dr. Oliver’s presentation “EtR Framework: Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years” as part of the evidence to framework details.

Ҥ Children are at least as likely to be infected with SARS-CoV-2 as adults

– Over 1.9 million reported cases; seroprevalence estimated ~38% among 5–11 years in Sept 2021

– Infections in children less likely to be reported as cases than infections in adults

§ Children 5-11 years of age are at risk of severe illness from COVID-19

– >8,300 COVID-19 related hospitalizations as of mid-October

– Cumulative hospitalization rate is similar to pre-pandemic influenza seasons

– Severity comparable among children hospitalized with influenza and COVID-19, with approximately 1/3 of children 5–11 years requiring ICU admission

– MIS-C most frequent among children 5–11 years

– Post-COVID conditions have been reported in children

§ Secondary transmission from young school-aged children occurs in household and school settings”

The negative impact on children is considerable, especially for those of color. Vaccine efficacy was 90.9% in the Pfizer randomized controlled trial. The bottom line was that the balance and risks is favorable for vaccinations of all children. Post authorization safety monitoring will continue. The Work Group proposed to recommend the intervention.

After discussion, the committee voted on the ACIP Interim Recommendation below:

“The Pfizer-BioNTech COVID-19 vaccine (2-doses, 10µg, IM) is recommended for children 5–11 years of age, in the U.S. population under the FDA’s Emergency Use Authorization.”

The vote on the interim recommendation passed unanimously (14 yes votes).

The meeting was adjourned at approximately 5:00 PM, ET.

CDC Advisory Committee Meeting November 2nd on Pfizer Covid-19 Vaccine for Children Ages 5-11

The Advisory Committee on Immunization Practices (ACIP) have scheduled a meeting for November 2, 2021 from 10 AM-5 PM, ET to discuss the Covid-19 vaccine for children ages 5-11.

This follows the FDA authorization for the vaccine in this age group, which was announced today on their web site.

Two Way Street Between Medicine and Psychiatry in Covid-19

I just found out that, as of the middle of this month, a new category, mental health disorders, has been added to the CDC list of medical conditions associated with higher risk for severe Covid-19 disease and thus, qualifies those in the category for receiving the COVID-19 vaccines . It makes sense. Mood, anxiety, and other neuropsychiatric disorders are known to be connected to a variety of medical conditions, such as diabetes mellitus, thyroid disease, and heart disease. Substance use disorders was already on the list previously. There are medical literature references supporting this:

Fond G, Nemani K, Etchecopar-Etchart D, Loundou A, Goff DC, Lee SW, Lancon C, Auquier P, Baumstarck K, Llorca PM, Yon DK, Boyer L. Association Between Mental Health Disorders and Mortality Among Patients With COVID-19 in 7 Countries: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 Jul 27:e212274. doi: 10.1001/jamapsychiatry.2021.2274. Epub ahead of print. PMID: 34313711; PMCID: PMC8317055. https://pubmed.ncbi.nlm.nih.gov/34313711/

Ceban F, Nogo D, Carvalho IP, Lee Y, Nasri F, Xiong J, Lui LMW, Subramaniapillai M, Gill H, Liu RN, Joseph P, Teopiz KM, Cao B, Mansur RB, Lin K, Rosenblat JD, Ho RC, McIntyre RS. Association Between Mood Disorders and Risk of COVID-19 Infection, Hospitalization, and Death: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 Oct 1;78(10):1079-1091. doi: 10.1001/jamapsychiatry.2021.1818. PMID: 34319365; PMCID: PMC8319830. https://pubmed.ncbi.nlm.nih.gov/34319365/

It’s also interesting that a large randomized controlled trial of the antidepressant fluvoxamine showed that the agent reduced the need for hospitalization in high-risk outpatients diagnosed with early Covid-19:

Gilmar Reis, Eduardo Augusto dos Santos Moreira-Silva, Daniela Carla Medeiros Silva, Lehana Thabane, Aline Cruz Milagres, Thiago Santiago Ferreira, Castilho Vitor Quirino dos Santos, Vitoria Helena de Souza Campos, Ana Maria Ribeiro Nogueira, Ana Paula Figueiredo Guimaraes de Almeida, Eduardo Diniz Callegari, Adhemar Dias de Figueiredo Neto, Leonardo Cançado Monteiro Savassi, Maria Izabel Campos Simplicio, Luciene Barra Ribeiro, Rosemary Oliveira, Ofir Harari, Jamie I Forrest, Hinda Ruton, Sheila Sprague, Paula McKay, Alla V Glushchenko, Craig R Rayner, Eric J Lenze, Angela M Reiersen, Gordon H Guyatt, Edward J Mills,

Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial,

The Lancet Global Health, 202, ISSN 2214-109X, https://doi.org/10.1016/S2214-109X(21)00448-4.

(https://www.sciencedirect.com/science/article/pii/S2214109X21004484)

Abstract: Summary

Background

Recent evidence indicates a potential therapeutic role of fluvoxamine for COVID-19. In the TOGETHER trial for acutely symptomatic patients with COVID-19, we aimed to assess the efficacy of fluvoxamine versus placebo in preventing hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to a tertiary hospital due to COVID-19.

Methods

This placebo-controlled, randomised, adaptive platform trial done among high-risk symptomatic Brazilian adults confirmed positive for SARS-CoV-2 included eligible patients from 11 clinical sites in Brazil with a known risk factor for progression to severe disease. Patients were randomly assigned (1:1) to either fluvoxamine (100 mg twice daily for 10 days) or placebo (or other treatment groups not reported here). The trial team, site staff, and patients were masked to treatment allocation. Our primary outcome was a composite endpoint of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19 up to 28 days post-random assignment on the basis of intention to treat. Modified intention to treat explored patients receiving at least 24 h of treatment before a primary outcome event and per-protocol analysis explored patients with a high level adherence (>80%). We used a Bayesian analytic framework to establish the effects along with probability of success of intervention compared with placebo. The trial is registered at ClinicalTrials.gov (NCT04727424) and is ongoing.

Findings

The study team screened 9803 potential participants for this trial. The trial was initiated on June 2, 2020, with the current protocol reporting randomisation to fluvoxamine from Jan 20 to Aug 5, 2021, when the trial arms were stopped for superiority. 741 patients were allocated to fluvoxamine and 756 to placebo. The average age of participants was 50 years (range 18–102 years); 58% were female. The proportion of patients observed in a COVID-19 emergency setting for more than 6 h or transferred to a teritary hospital due to COVID-19 was lower for the fluvoxamine group compared with placebo (79 [11%] of 741 vs 119 [16%] of 756); relative risk [RR] 0·68; 95% Bayesian credible interval [95% BCI]: 0·52–0·88), with a probability of superiority of 99·8% surpassing the prespecified superiority threshold of 97·6% (risk difference 5·0%). Of the composite primary outcome events, 87% were hospitalisations. Findings for the primary outcome were similar for the modified intention-to-treat analysis (RR 0·69, 95% BCI 0·53–0·90) and larger in the per-protocol analysis (RR 0·34, 95% BCI, 0·21–0·54). There were 17 deaths in the fluvoxamine group and 25 deaths in the placebo group in the primary intention-to-treat analysis (odds ratio [OR] 0·68, 95% CI: 0·36–1·27). There was one death in the fluvoxamine group and 12 in the placebo group for the per-protocol population (OR 0·09; 95% CI 0·01–0·47). We found no significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups.

Interpretation

Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital.

Funding

FastGrants and The Rainwater Charitable Foundation.

Translation

For the Portuguese translation of the abstract see Supplementary Materials section.

Covid-19 pneumonia affects the brain by causing hypoxia and inflammatory reactions, leading to neurologic dysfunction. Mental health disorders may be partly caused by inflammation. Depressed persons may not protect themselves from Covid-19 because they’re apathetic and hopeless. It’s a two-way street. It’s like Dr. Wes Ely, MD, MPH says:

The lung bone is connected to the brain bone

E. Wesley Ely, MD, MPH

FDA Advisory Committee Meeting Today on Pfizer COVID-19 Vaccine for Children Ages 5-11

The meeting will go from 7:30 AM-5:00 PM, ET, and the Voting Question will be:

“Based on the totality of scientific evidence available, do the benefits of the Pfizer BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age.” Please vote yes or no.

This is about extending the EUA for the Pfizer vaccine for this age group. It would be administered as a 2-dose vaccine, 10 micrograms each, 3 weeks apart. COVID-19 causes substantial morbidity and mortality in this age group.

Unlike the other recent FDA presentations I’ve seen, today there was a reminder that, in view of the polarized opinions pro and con about this question, all participants should do their best to observe the utmost civility at all times during the proceedings.

Dr. Fiona Havers presented the epidemiology of COVID-19 in this age group. It showed increasing infections and severe disease and hospitalization rates, which were higher among African American and other minority children than among white. Secondary transmission can and does occur among children and adults. See the slides.

Dr. Matthew Oster’s presentation on mRNA vaccine associated myocarditis showed that myocarditis is a rare but important adverse event following COVID-19 vaccination. See the slides.

Break.

The Pfizer presentation highlighted safety and efficacy data for the vaccine. See Dr. Gruber’s briefing document and slides. The FDA presentation by Dr. Leslie Ball, MD, summarized the immunogenicity and safety data (see summary slides 34 and 35). The supplemental descriptive efficacy analysis showed 90.7% vaccine effectiveness against symptomatic COVID-19 after the second dose. There were no cases of myocarditis/pericarditis after the data cutoff time.

FDA presenter Dr. Hong Yang, PhD presented the Benefit-Risk Analysis. Slide 22 summary:

“• For Scenarios 1 (Base), 2 (Recent COVID-19 Peak Incidence), 4 (Higher Vaccine Efficacy), 5 (Higher COVID-19 Death Rate), and 6 (Lower Excess Myocarditis Rate) the model predicts that benefits of the Pfizer-BioNTech COVID-19 Vaccine 2-dose primary series clearly outweigh the risks for ages 5-11 years.

• For Scenario 3 (The Lowest COVID-19 Incidence), the model predicts more excess hospitalizations and ICU stays due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations and ICU stays due to COVID-19 in males and in both sexes combined.

• Considering the different implications and length of stay for COVID-19 hospitalization versus hospitalization for vaccine-associated myocarditis/pericarditis, and benefits related to prevention of cases of COVID-19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario.

• If the myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in the model, the benefit-risk balance would be even more favorable.”

“Major Limitations of the Benefit/Risk Model:

• Model assumption about constant incidence rate generates great uncertainty on the estimate of benefits.

• Vaccine efficacy may change due to new emerging variants of virus

• Hospitalizations and ICU stays from COVID-19 and myocarditis are not equivalent and cannot directly compared

• The benefit of reducing COVID related multisystem inflammatory syndrome in children may not be fully captured by preventable hospitalizations, ICU stays and deaths due to COVID-19

• This BR risk assessment does not consider potential long-term adverse effects due to either COVID-19 or myocarditis

• This BR assessment does not include secondary benefits (reducing COVID-19 disease transmission) and risks”

Break.

There were complicated questions about the applicability of the Benefit/Risk model assumptions, partly because it can be influenced by a low incidence of disease-readily acknowledged by the presenter, Dr. Yang. After extensive discussion, including the about the number of doses (One or Two?), concern for the difficult decisions this presents to parents (not just related to side effects), concern about the FDA approval being interpreted as a mandate, discomfort with the binary choice-type question.

A representative from the CDC Advisory Committee (ACIP) expressed that it seems the benefits outweigh the risks. The ACIP representative summarized the safety monitoring and reporting systems available, including but not limited to Vaccine Adverse Effects Reporting System (VAERS). The FDA can make a broad authorization; the ACIP (which may meet on this issue as soon as next week) can make implementation recommendations that could be more restrictive but could not be broader. University of Iowa representative, coronavirus expert with over 40 years’ experience and temporary voting member Dr. Stanley Perlman, indicated, in light of the thorough discussion, that he would vote in favor of the question.

“Based on the totality of scientific evidence available, do the benefits of the Pfizer BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age.” Please vote yes or no.

The Vote: The votes were 94% (17) Yes, and there was one abstention, out of 18 votes.

The meeting was formally adjourned at 4:35 PM, ET.

FDA Advisory Committee Reminder: Meeting October 26, 2021 to Discuss COVID-19 Vaccine for Children Ages 5-11

This is just a reminder of the FDA Advisory Committee meeting scheduled for tomorrow, October 26, 2021, 8:30 AM-5:00 PM, ET, to discuss the Pfizer COVID-19 vaccine for children, ages 5-11. Some documents are available to preview, including the FDA briefing document. Section 8 is the Benefit-Risk Assessment summary, beginning on page 32.

FDA Advisory Committee to Discuss Pfizer COVID-19 Vaccine for Children 5 Through 11 Years of Age

On October 26, 2021 the FDA Vaccines and Related Biological Products Advisory Committee will meet to discuss the extension of the Pfizer EUA for the COVID-19 vaccine for children 5 through 11 years of age. Some event materials are already available. The meeting is scheduled for at 8:30 AM-5:00 PM, ET.