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September 22, 2021

Pfizer Vaccine for Children 5 to 11Years

This week Pfizer announced that they will be submitting an EUA request to the FDA for their vaccine for children ages 5 to 11.  There was a 240% increase in the number of Covid cases in children since July when the delta variant increased dramatically in the US.  Data from the Phase 3 clinical trial will be submitted and hopefully the FDA and CDC with their advisory boards will approve the efficacy and safety by the end of October.  Many parents were very concerned about these children going back to school and already there are many schools who had to close down classrooms because of Covid infections.

Different doses of vaccine need to be tested in children, and the immune response, as measured by antibody studies must be as good as the results in a control group.  For this study 2268 participants who were 5-11 years old were given two 10ug doses of vaccine 21 days apart.   Antibody levels measured 1 month after the second dose were comparable to those measured in the 16-25 year old control group who received two 30 ug doses 1 month apart in the Pfizer adult study. In addition to assessment of the immune response the vaccine must have no significant safety concerns.  Pfizer reports that the vaccine was "safe, well tolerated and showed robust neutralizing antibody responses."    See Below

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Pfizer will submit all of their data from the 5-11 year old children and the FDA will review the immunologic and safety data for each participant.  The FDA will present the information to their scientific advisory groups for discussion and hopefully approval.  The CDC will then review the same data and present it to their advisory board.  Only then will the vaccine be released to children in this age group. 

 

September 18, 2021

FDA Meeting Re: Pfizer Booster

The scientific advisory committee to the FDA listened to a full day of presentations about the Pfizer vaccine - its vaccine efficacy against infection and its safety.  Data was presented by a scientist from the UK, scientists from Israel, the CDC, FDA, and Pfizer.  The vaccine is still effective against severe infections, hospitalizations, and deaths.  By the end of the day agreement was reached that there was some data demonstrating that vaccine efficacy was waning in older patients with exposure to the delta variant.  When given a 3rd dose their relevant Covid antibodies increased 10-fold. In each of these studies it was still unclear whether vaccine efficacy was waning or the arrival of the delta variant, or a combination of both.   

Safety information was also reviewed in these presentations, and the advisory committee members didn't think they had enough data yet on third boosters in the younger groups of males who are at increased risk of developing myocarditis-pericarditis.  There were no new safety issues, and even though the heart side effect was rare and mild, the committee recommended that the 3rd dose be held until there is more data. Other side effects were very similar to those associated with 2nd doses.  

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The original question to be answered was whether a 3rd dose of the Pfizer vaccine should be given 6 months after dose 2 to people 16 years or older.  That vote didn't pass.  But each member of the committee felt that the 3rd dose should be given to 1.) fully vaccinated people 65+ years old, at least 6 months after dose 2.  2.)  People who were at high risk because of their occupational exposures. This proposal passed unanimously.  Meanwhile more data will be accumulated and analyzed - both to see if the vaccine efficacy is dropping and to make sure that 3rd doses are safe in younger people.  That proposal passed unanimously.

It is so interesting to watch a full day of scientific data presentations and to learn from experts on vaccine efficacy and safety.  I watch every one of these advisory committee meetings and will get my 3rd dose (because I'm 65+) as soon as the CDC advisory committee meets next week to review the data and approve the FDA decision.

 

September 15, 2021

Covid Sniffer Dogs Working in Miami Airport

The dogs identification of coronavirus is almost instantaneous. Sniffer Dogs have 50 times as many receptors in their nose as humans and dogs can be trained to recognize drugs, explosives, many other items and now coronavirus infections.  I wrote about 10  Covid sniffer dogs in Helsinki in October 2020 (http://www.paperandthreads.com/2020/10/sniffer_covid19_dogs.php) and learned that if they were already trained with other scents, it took only a short time to train them to recognize Covid infections.  Then there wasn't any other news that I saw about the use of sniffer dogs since then.  Now 2 purebred and 2 "pound puppies" were trained and will be used in a 2 month pilot study in the Miami Airport, the first in the US.  In the beginning they are identifying infected airport and airline employees as they report to work.  Then they will be moved to other areas in the airport to check passengers.  The passenger dog testing will be voluntary. 

Cobra and One Betta (a Belgian Malinois and a Dutch Shepherd) spend their shift sniffing employees' face masks to detect coronavirus in sweat, breath, and scents that develop in an infected human body.  If the dog detects the virus, a rapid virus test is done for confirmation. Florida International University researchers did a double blind trial with the dogs and found that One Betta's accuracy rate was 98.1% and Cobra's was 99.4% accurate.   

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Sniffer dog screening, when certified, could reduce the time needed to screen passengers before flights. The Miami Airport is one of the busiest in the US.so the pilot program should have lots of opportunity to collect more data on the sensitivity and specificity of the sniffer dogs during the study.  The dogs have a favorite ball they like to play with, and when they see it they know they will go to work and then get their playtime!

September 11, 2021

Pills For Covid 19?

Now that we are certain that SARS-CoV-2 will be an endemic virus, it is essential that scientists continue to look for medications that might control the infection once symptoms develop.  This week there was an announcement that two "protease inhibitors" that block virus replication in cells are entering Phase 3 trials,   Phase 1 trials assess safety and often test multiple doses.  Phase 2 trials also look for safety and simultaneously look for drug efficacy.  Phase 3 trials are randomized between volunteers receiving the "treatment" and volunteers receiving placebo (RCT).  They are also double blind meaning neither the patient nor the investigators know who is receiving which pills. The trials have just started enrolling subjects.  See Below

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Clinical Trials:

Merck is testing the efficacy and safety of the drug Molnupiravir (EIDD-2801) in 1850 non-hospitalized subjects with mild-moderate symptoms, who have test confirmed Covid-19 with at least 1 risk factor for severe disease.  Half of the subjects will receive placebo. Each group will take the medicine every 12 hours for 5 days.

Merck also convened a randomized placebo-controlled trial to test the drug in adults who reside in the same home with an infected Covid-19 patient. The end point will be development of Covid-19 infection in the household contacts within 14 days.

Pfizer is testing their investigational drug Pf-07321332 with Ritonavir (another protease inhibitor) in a randomized placebo controlled double blind trial in 3000 non-hospitalized high risk adult patients with PCR positive Covid-19. Half the volunteers will take placebo.  Subjects will take the pills every 12 hours for 5 days and the efficacy and safety will be assessed.    

September 8, 2021

"Children Are at Low Risk, BUT Not at No Risk"

This is a quote from Dr. Daniel Griffin who says the above on his Podcast every week.  My Grandchildren are going back to school.  Six of them are vaccinated, but two of them are under twelve and will be unvaccinated.  Therefore only classroom mitigation strategies will protect them in school.  There is a mask mandate in NYC schools, but social distancing at 6 feet will be impossible.  And how many schools really have cross ventilation or hepa filters in the classroom?  Most important, how many faculty and staff are vaccinated?  There is a new publication that is worth reading in which an unvaccinated teacher was the source of a delta Covid cluster in Marin County CA.  She only removed her mask to read to the students.  Read below to see the results of very careful studies that were done  

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The unvaccinated teacher became symptomatic on May 19th, but thought it was allergies.  She continued to work for 2 days and then had a Covid test on May 21st - which was positive.  On occasion during this time the teacher sometimes read to students without her mask and she was one of 2 teachers in the school who were not vaccinated. There were 12 Covid infections in her students that were confirmed in the class within 5-7 days.  Eight of the 10 students who sat in the first two rows and 4 of 14 students in the last 3 rows developed Covid.  There were also secondary infections of siblings and parents of the original students for a final total of 27 Covid cases. Eighty-one % were symptomatic.  These students all wore masks throughout the day and their desks were 6 feet apart.  Each classroom also had high-efficiency particulate air filters and doors and windows were left open.  Genomic sequencing of 18 of these cases were positive for the delta variant.  Unfortunately the teachers sample could not be retrieved. I hope that school systems will do everything they can to protect the unvaccinated students as schools open all over the country - vaccination mandates and mask mandates as a minimum.