October 23, 2021

Booster Shots for Moderna and J and J Vaccines

Last week the FDA VRBPAC scientific advisory committee met and approved both the Moderna and Johnson & Johnson vaccine booster doses. The CDC then met this Thursday and spent the entire day listening to presentations by the companies and many CDC scientists who independently reviewed the data submitted by each company.  After a full day of analyzing and considering the efficacy and safety of the proposed booster doses, there was unanimous approval of both vaccine boosters.  Final approval was granted by Rochelle Walensky, Director of the CDC. 

The Moderna booster is one half the dose of the original two doses - 50ug instead of 100ug.  This dose had vaccine efficacy that was the same as the original vaccination dose and no increased symptoms following the injection. The booster doses were approved for the same group as the Pfizer booster: people 65 yrs or older at least 6 months after their 2nd dose, individuals 18-64 years of age at high risk of severe Covid-19, and individuals whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at higher risk of serious complications of Covid-19.  The J & J vaccine was approved as a 2nd dose, to be given more than 2 months after the initial dose for all age groups.     See Below  

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The Committee also reviewed all of the data from the NIH  "Mix and Match Vaccine Study" that was just reviewed here on my blog earlier this week, and they approved all 3 vaccines for the booster doses.   That means that each patient can select the booster dose type that they want, based on availability, or personal preference.  The Mix and Match study demonstrated that all of the heterologous and homologous booster doses produced a good immunologic response - and getting a second vaccine type was safe. 

The only way that this pandemic will be controlled is through vaccination of most of our citizens.  We are very lucky that we have very effective vaccines - please get a vaccination if you are still one of the unvaccinated.  Next week I'm looking forward to following the full day FDA meeting about the vaccine for children age 5-11.  The CDC meeting for these vaccinations is in the first week of November.

 

October 20, 2021

Booster Doses - Mix or Match

The NIH NIAID reported preliminary results from an ongoing study of mixed and matched booster doses.  There were 458 subjects in 3 primary groups.  One group was vaccinated with Moderna (2 doses), one received Pfizer (2 doses) and the 3rd one received J and J (one dose).  At least twelve weeks after their primary vaccination, and without any history of a Covid-19 infection, each of the 3 groups were further divided into 3 groups (about 50 each) and those groups each received a booster dose- either Moderna, Pfizer, or J and J.  Thus there were 9 final groups.  For example, the group vaccinated with Moderna could have been boosted with Moderna at half the original dose (homologous), or Pfizer (heterologous). or J and  J (heterologous).

See Below  

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Preliminary Results:  There was an anamnestic antibody response with all of the boosters, but the study wasn't set up to compare the antibody and neutralizing antibody titers among groups.  In addition, the cellular component of an immune response (memory B cells and T cells) is being analyzed, but is not yet complete. 

But there were no differences between the reactogenicity, local and systemic symptoms, in the heterologous vs the homologous booster doses and most were mild. Knowing that the mixing of vaccines is safe makes this a possibility moving forward.  There are many ways that this will make the booster dose easier to deliver:  patients who may have had an allergic reaction to one of the vaccines can be given one of the others.  It also will make it easier to go into a congregant care facility and boost all patients with just one vaccine type.  The FDA and CDC will now have to analyze and approve this plan to mix and match!  Stay tuned for the final approval and ongoing booster plans to be determined by the CDC and their scientific advisory committee.

  

October 16, 2021

FDA Approves Moderna 3rd Vaccine Dose for 3 Groups

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:  

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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.

October 13, 2021

You Don't Have to Wipe Boxes Anymore

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  

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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.    

October 9, 2021

Finally! Another Rapid Covid-19 Home Test

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.      

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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. 

October 6, 2021

Mysterious Two Month Covid Surges

"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.  

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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.  

October 2, 2021

Encouraging Results for the First Oral Drug Developed for Covid 19

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

 

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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.    

September 29, 2021

Masks Do Reduce Covid Spread

A recent CDC Morbidity and Mortality Weekly Review article was discussed on a podcast I listen to and I thought the information was worth sharing.  St. Louis University instituted a program to reduce Covid spread among students during in-person instruction.  These measures included physical distancing. mask use, vaccination, contact tracing, case investigation and quarantine.  The University also instituted a modified quarantine regimen which depended on whether students were masked or unmasked during contact with an infected student.  The study took place from January through May 2021 so the effects of the delta variant weren't captured during the study.

There were 265 students who developed Covid-19, and 375 students who were named as close contacts to the infected student. Close contact exposures were defined as a single exposure in which the two persons were within 6 feet of each other for >15 minutes during a 24 hour period.  The number of exposures were then calculated for each close contact.  Mask use was calculated for each exposure - if either the patient or the contact were unmasked, it was considered an unmasked exposure.  Only unvaccinated close contacts with unmasked exposure had to quarantine, the rest were asked to monitor their symptoms.  Eighty-nine % of students were unvaccinated and 70% of the students lived on-campus.   See Results Below

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Only 7.7% of subjects developed Covid-19 if they had masked exposures, and 32.4% developed Covid-19 if their exposures were unmasked - a statistically significant difference.  There was no information provided about the types of masks worn, which means that fabric masks and surgical masks were probably the predominant types worn based on the types of masks seen most commonly.  Surveillance testing was randomly done on approximately 10% of on-campus students. These types of studies are difficult to conduct but this one, before the spread of delta, provides a rationale for universal mask wearing.  

September 25, 2021

3rd Doses of the Pfizer Covid Vaccine

It is really difficult to collect real world data to clarify whether there are waning vaccine levels and decreasing vaccine efficacy or whether some increase in cases among the fully vaccinated people over 65 are due to the Delta Variant.  Pfizer presented some data on subjects from their Phases 1 and 3 Clinical trials.  After the trial unblinding the placebo group was able to request a vaccination and the two groups can be compared based on the length of time since each group was vaccinated.  All of the volunteers analyzed were 18-55 years old, so the data they wanted to assess is not available for the oldest people.  But both the FDA and CDC advisory boards said there was enough suggestive data that people older than 65 (including those in long term care facilities) had some decrease in vaccine efficacy and were vaccinated very early in the vaccine rollout in Dec, Jan, Feb.  There were excellent responses to the 3rd dose and adverse effects were less than following dose 2. 

Some very experienced scientists think this may be one of the 3 dose vaccines, with dose 3 spaced at least 6 months following dose 2.  It would be wonderful if the duration of protection is years, as is seen in the current non-Covid 3 dose vaccines!  I watched both the all day FDA meeting, and the two day CDC Meeting and feel as if the advisors very carefully assessed the scientific data re: vaccine efficacy and analyzed the safety data from those who received 3rd doses already (in trials or due to immunodeficiency).  The reactogenic symptoms following the 3rd dose were actually a little less than the 2nd dose symptoms, and no new "safety signals" were found.  The mRNA vaccines can cause myocarditis-pericarditis, but it occurs primarily in young males.  It is very rare, very mild, and resolves quickly in the majority of the vaccinated.  CDC link summarizes the current  recommendations (note the "should" and "may" language: See Below

https://www.cdc.gov/media/releases/2021/p0924-booster-recommendations-.html

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I think that one of the major observations made during these two meetings was as follows:  The pandemic will not change substantially because of the 3rd doses that will be given. The current vaccines are still really effective, especially preventing severe infections, hospitalizations, and death. In places with a low vaccination rate, the stress on the health care system due to unvaccinated ICU patients is now affecting the patients who need non-Covid care and deaths of these people are increasing.   The only way for the pandemic to change is to increase the number of people who get vaccinated with the standard 2 dose regimens NOW.  If you have a chance to change a mind, please discuss the need for a vaccine whenever and wherever you can.  I will never understand the people who don't want to put "unknown vaccine ingredients" into their body, but have no problem taking doses of Ivermectin meant for cows and horses (poisonous), putting hydrogen peroxide in vaporizers (a toxin for lungs when inhaled) or swallowing betadine (Toxic).   

 

Shirley Parker Levine
New York City

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