Paper and Threads

On Thursday the FDA VRBPAC Advisory Committee met to review a request from Moderna for an EUA for a 3rd dose of the Moderna vaccine.  Moderna tested a 50 ug dose instead of 100ug which is used for the 2 dose vaccination.   There were scientific presentations most of the day, including one by the Moderna scientists, and one in which all of the data submitted by Moderna was reviewed by FDA scientists.  When the delta variant became the dominant and then the sole variant for SARS-CoV-2, the efficacy of the vaccines had to be reassessed - including the potential need for booster doses for fully vaccinated individuals. 

Moderna was requesting approval for 3rd doses at least 6 months after their 2nd dose: for 1. Individuals 65 years of age and older, 2. Individuals 18-64 years of age at high risk of severe Covid-19 and 3. individuals whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at higher risk of serious complications of Covid-19 including severe Covid-19.  Data had to be presented that the 50 ug dose was as immunogenic and met the criteria for antibody production and safety, and much of the information presented was confirmation of both.  The 3rd dose in individuals who received the two dose vaccination schedule 4 weeks apart did not have any more symptoms than after they had received the 2nd dose - and no new safety signals were seen.  The advisory committee unanimously approved Moderna's application and now the CDC ACIP advisory committee will meet next week for additional scientific reviews and then vote on the EUA for a 3rd dose of Moderna for the outlined groups. See Below:  

The Moderna and Pfizer vaccines are still both very effective in younger groups, but there was concern that the 65+ aged adults were starting to show waning immunity against the delta variant.  They presented some data that convinced me that we older adults should receive a 3rd dose.  Moderna was able to study 2 groups of patients from their original 30,000 plus Clinical Trial - the group that initially received the vaccine (early group - median time since vaccination 13 months) and the people who were in the placebo group, but after approval of the vaccine in Dec. 2020 were vaccinated (late group - median time since vaccination 7.9mos).  There were significantly more breakthrough cases after the delta variant spread in the "early" group, than in the "later" group, including some severe cases.  This is real world evidence that the vaccine is still efficacious against the variants, but not as good in older adults who have a lower immune response than those less than 65 years.  Some virologists think it may be a "3 dose vaccine" in order to have long lasting immunity, but only time will tell.

Posted by Shirley at 6:10 AM | Permalink | Comments (0)

Bloomberg News published an article this week entitled "Can I Put Away My Hand Sanitizer?"  For months after the pandemic began we were all scrupulous about washing our hands and using hand sanitizer because of the fear of viral spread.  Scientists are now publishing data about the primary transmission of the virus by droplets and aerosols when in close contact with infected people.  Virus that is present on groceries, boxes, door knobs etc is usually in a degraded state and not infectious.

In this article they state that the CDC estimates the chance of contracting Covid-19 from a surface to be less than 1 in 10,000.  Linsey Marr of Virginia Tech, an expert on airborn transmission, says that wearing masks indoors is far more important.  N95 or K95 are recommended as the best types of masks to reduce infection.  She does still recommend continued hand washing or sanitizer if you've been out in public and touching lots of surfaces.  See Below  

We all have to decide what level of risk we are willing to take - based on our ages, comorbidities and vaccination status.  I'm still wearing a mask when I'm walking outside each day, but in part this is due to the fact that I've discovered that my seasonal Fall allergies are greatly improved when I do.    

Posted by Shirley at 6:22 AM | Permalink | Comments (0)

This week the FDA granted an EUA for an over-the-counter (OTC) at-home rapid test for Covid-19: FlowFlex by ACON. The test detects the nucleocapsid protein on the surface of the virus and uses lateral flow technology, similar to that used for home pregnancy tests - with results available in 15 minutes.  The tests are best for asymptomatic people who need to know if they are infected and contagious before going to work, school, and other events. The test becomes positive within 3-5 days after an exposure. ACON will increase production making 100 million tests per month available starting now and 200 million per month by February.  Two tests are in each package and ACON recommends doing two tests 36 hours apart since the test catches the time of greatest transmission of the virus. In clinical studies the test sensitivity was 97% and specificity 99%.  President Biden wants to increase the availability and decrease the costs with the government investing $1 billion in "home testing" which wasn't pursued earlier in the pandemic.  Many countries have made similar tests free to the population. Abbot's BiVaxNow test is similar but currently costs $24 for a kit, and is hard to find on pharmacy shelves right now.  Make sure you always search for the kits by brand name.      

The use of these tests allows you to ask "Do I have a lot of virus in my nose right now and am I contagious?"  Dr. Michael Mina, an epidemiologist at Harvard, says "When I go to visit my parents, I always bring rapid tests with me.  Right before I walk into the house I use the test in my car."  If you have a reason to doubt a positive test, do another one with a test made by another manufacturer.

SAY YES, COVID TEST:  Dr. Francis Collins, Director of NIH, just published an article about a new study being conducted to evaluate how best to implement home testing.  Eight week pilot programs were done in 4 communities in the Spring and Summer, and they will now study 4 new communities.  Participants can order 8 free home kits and have an easy to use website for reporting their results.  They are using kits made by another company - Quidel Quick Vue At-Home Covid-19 tests to see whether these tests can control the spread of Covid.  Univ of NC, Duke, and UMass, Amherst will analyze the data. 

Posted by Shirley at 6:16 AM | Permalink | Comments (0)

"Covid is once again in retreat" wrote David Leonhardt in the New York Times on Oct 4th.  He wrote several NYT articles in the last few months about a 2 month Covid surge cycle that began early in the pandemic.  The number of cases rise quickly over 2 months and then decrease over two months.  It was observed several times here and in other countries globally.  A surge of Covid cases began in our Southern States this June and began receding there in August.  It then began to spread more broadly in other states in July and cases now decreased 35% since Sept 1st. One Hypothesis: the virus needs 2 months to circulate through an average-size community and then moves on to other susceptible people.  

Epidemiologists don't understand why this two month pattern has occurred in different countries and at different times. I listen to Michael Osterholm's podcasts and he regularly says that we need humility to follow the SARS-CoV-19 virus and are just following its behavior, and learning from it. It doesn't appear to be due to laxness in mitigation factors.  Another possibility is a change in human behavior, i.e. people take fewer risks for infections once there is a rapid increase in case numbers.  The two month cycles also occur during different seasons.  There is no guarantee that the two month cycles will continue - vaccinations are continuing which will decrease the infections and at any time another variant can appear and it may not be as susceptible to our vaccines.  Hopefully as vaccinations continue to increase based on mandates, any two month surge in the future will have many fewer cases, hospitalizations, and deaths.  

Posted by Shirley at 6:04 AM | Permalink | Comments (0)

The first oral drugs against Covid-19 were reviewed here on Sept. 11, 2021. 

http://www.paperandthreads.com/2021/09/pills_for_covid_19.php 

Yesterday early results from the Merck Phase 3 trial of Molnupiravir were announced in a Press Release:  Oral antiviral Molnupiravir reduced the risk of hospitalization or death by approximately 50% compared to placebo for patients with mild or moderate Covid-19.  This was a phase 3 trial of Covid positive subjects who had developed symptoms 5 or less days before randomization and had at least one risk factor for severe disease.  Volunteers were randomized between oral Molnupiravir and placebo every 12 hours for 5 days.  The study was double blind so none of the subjects nor investigators knew what subjects were taking.  But there were study monitors from an advisory group who were allowed to see planned interim data just to make sure that there were no unsuspected events or harm to patients.   See Below

Data from 775 subjects were analyzed on Day 29  and 28/385 (7.3%) patients on Molnupiravir and 53/377 (14.1%) on placebo were hospitalized (P=0.0012).  On day 29 there were no deaths in the Molnupiravir group vs 8 patients who died in the placebo group.  There was also efficacy against Gamma, Delta, and Mu variants in subjects who had genomic sequencing. Drug-related adverse effects were similar in the treatment and placebo groups.  The independent Data Monitoring Committee in consultation with the FDA recommended that the study be halted due to these findings and plans are being made to apply for an EUA to use the drug in Covid positive patients with <5 days of symptoms.  By the time of the interim analysis 90% of the 1550 planned subjects in the enrollment group were enrolled, so more data will be forthcoming after their 29 day assessments.    

Posted by Shirley at 5:21 AM | Permalink | Comments (1)