Paper and Threads

More Good News!  This week Moderna published antibody levels measured over 6 months after the 2nd dose in their Phase 1 trial and they were excellent and durable.  All of the tests were done at NIH-NIAID.  These were the volunteers that participated in the very first human studies.  Phase 1 clinical vaccine trials are done to assess safety and to establish a dose range that produces a good antibody response.  Now this small patient group has been observed and their antibody production measured regularly for just over 6 months from their vaccination.  In contrast, Phase 3 clinical vaccine studies assess the ability of vaccination to prevent symptomatic infection in vaccinated subjects compared to subjects given placebo - and then vaccine efficacy is calculated. 

In the current report antibody production to the "spike proteins" and the efficacy of the subjects serum to neutralize the virus was assessed serially by 3 different types of tests on 33 volunteers over a 6 month period.  There were 3 age groups tested: 18-55 years, 56-70 years, and 71+ years.  There was an excellent antibody response in all subjects and it remained high over 6 months in all age groups, although the amount of antibodies decreased with advancing age.  The antibody amounts that best correlate with vaccine efficacy are not currently known, but this patient cohort will continue to be monitored, and will even be given a booster dose to assess its effect on antibody production against the virus and the variants.   Even more good news: see below.

Yesterday Pfizer submitted a request to the FDA to extend their EUA for approval of their vaccine for 12-15 year old children.   There were ~2000 children studied and there was an immune response in 100% of the children.  Antibody levels were even higher than in older groups. That means 3 more of our grandchildren will be eligible!

Posted by Shirley at 6:41 AM | Permalink | Comments (0)

There was a CDC Vaccination Study Published in the Morbidity and Mortality Weekly Report from April 2 - and the results are very encouraging.  Health Care Workers, 1st responders, and other essential/frontline workers (N=3950 subjects) were randomized between Moderna/Pfizer vaccinations and placebo.  Eight locations in 6 states participated in the Heroes-Recover study from Dec. 14, 2020 to Mar. 13, 2021 (AZ, FL, MN, OR, TX, and UT).  The subject ages included 72% 18-49 years and 28% >50. 

All of the subjects were Covid-19 PCR test negative prior to their vaccinations and then a  nasal swab Covid-19 PCR test was repeated weekly for 13 weeks and if they developed symptoms during that time. The symptoms surveyed include fever, chills, cough, shortness of breath, sore throat, diarrhea, myalgias, and/or loss of taste or smell.  The Phase 3 Clinical Trials for both vaccines studied volunteers when they developed symptoms and this study provides data for the protection against asymptomatic and symptomatic subjects.  Thirty-one percent had at least 1 comorbidity.  See Below for Results

The Good News:  Subjects who were >2 weeks following their 2nd dose (N=2470 subjects) had 90% efficacy preventing symptomatic and asymptomatic Covid-19 compared to placebo.  For those that were >2 weeks after just a single dose (N=477 subjects) had an efficacy of 80%. 

Posted by Shirley at 6:49 AM | Permalink | Comments (0)

Great News!  Pfizer just updated their Covid Vaccine Phase 3 clinical trial data after 6 months.  This information was published in a company press release.  They found 927 cases of symptomatic and confirmed cases of Covid-19 in their clinical trial subjects- 850 cases in the placebo group and 77 in the vaccinated group - for an efficacy of 91.3%  Protection against severe disease in vaccinated subjects was 100% using the CDC criteria (32 cases) and 95.3% using the FDA criteria of severe disease (21 cases).  There were safety data on more than 12,000 vaccinated subjects who were followed for at least 6 months after their 2nd dose and the safety profile was still favorable.  These data will make it possible to apply for a Biologic License Approval (BLA) from the FDA - based on their 6 month safety follow-up.  A BLA is required for commercial advertising and distribution. 

In the US trial there were 647 Covid cases in the placebo group, 50 in the vaccine group for an efficacy of 92.6%  In the S. African trial of about 800 volunteers there were 9 cases of Covid-19 in the placebo group, 6 of whom had the S. African variant.  There were no safety issues in the full trial of approximately 44,000 volunteers.  All vaccinated volunteers will be followed for a full 24 months to collect additional data. Read Below 

The Pfizer vaccine EUA was granted one week before the Moderna vaccine, so we may see the 6 month followup data for the Moderna vaccine shortly.  One of the requirements for submitting an application for a BLA is having 6 months of follow-up safety data.  The Moderna trial will also be carried out for a full 24 months.  This is deemed important for all clinical trials because very rare side effects could still be seen.

Posted by Shirley at 6:51 AM | Permalink | Comments (1)