Authors: Mark Terry Published: Mar 01, 2022  BIOSPACE

Pfizer-BioNTech Vaccine Only 12% Effective Against Omicron in 5-11-Year-Olds 

In a new study that is yet to be peer-reviewed, the New York State Department of Health found that the Pfizer–BioNTech vaccine was only about 12% effective for children ages 5 to 11 years against the Omicron variant. In that age group, it was about 68% effective against Delta, but the effectiveness dropped significantly during the Omicron surge from Dec. 13, 2021, to Jan. 24, 2022. Protection against hospitalization also plummeted from 100% to 48% in the same period. 

The authors of the report think this drop may be the result of the lower dosage the children received. They were dosed with two 10-microgram shots, compared to 30-microgram doses for children 12 to 17 years of age.  

“Given rapid loss of protection against infections, these results highlight the continued importance of layered protections, including mask-wearing, for children to prevent infection and transmission,” the authors wrote. 

Pfizer-BioNTech Vaccine Integrates into Liver Cells in Cell Cultures 

Researchers at Lund University in Sweden conducted research into the Pfizer-BioNTech COVID-19 vaccine and human liver cell lines to determine what kind of effect the vaccine might have on liver cells. The research was published in Current Issues in Molecular Biology. The authors, noting the safety and efficacy of the vaccine against COVID-19, also point out that long-term studies have not been conducted. They note pharmacokinetics data provided by Pfizer to the European Medicines Agency (EMA) showed that the “injection site and the liver were the major sites of distribution, with maximum concentrations observed at 8-48 hours post-dose.

Furthermore, in animals that received the BNT162b2 injection, reversible hepatic effects were observed, including an enlarged liver, vacuolation, increased gamma-glutamyl transferase levels, and increased levels of aspartate transaminase (AST) and alkaline phosphatase (ALP).” They add that transient liver effects caused by the lipid nanoparticle (LNP) delivery systems used with mRNA vaccines have been previously reported, although LNP with no mRNA in it doesn’t cause any significant liver injury. 

Working with the specific human liver cell line Huh7 and the Pfizer-BioNTech vaccine, they found that the vaccine was able to enter the cell line as quickly as six hours after exposure. They cite a report saying some people who received the vaccine developed autoimmune hepatitis, and they question if the human liver cells, integrating the vaccine mRNA, produce SARS-CoV-2 spike protein that then catches the attention of the body’s immune system, inadvertently attacking the liver.

However, there does not appear to have been many other cases of this happening, which would make it extremely rare, assuming it was actually caused by the vaccine and not something else. 

The researchers note, “At this stage, we do not know if DNA reverse transcribed from BNT162b2 is integrated into the cell genome. Further studies are needed to demonstrate the effect of BNT162b2 on genomic integrity, including whole genome sequencing of cells exposed to BNT162b2, as well as tissues from human subjects who received BNT162b2 vaccination.” 

Adamis’ COVID-19 Trial Surpasses Enrollment Expectations 

San Diego-based Adamis Pharmaceuticals reported that due to the acceleration of enrollment in its Phase II/III study for Tempol for COVID-19, its Data Safety Monitoring Board (DSMB) decided the study could continue. No safety or clinical problems were observed. The data from the first 50 participants will be reviewed again in March as part of the first planned interim analysis. 

Tempol has strong, broad in vitro anti-cytokine activity, and in animal studies, appeared to have anti-inflammatory effects in the lungs. 

“We are pleased with the progress of the trial, which has already exceeded the required number of subjects (124) for the second planned interim DSMB analysis,” said Dr. Dennis J. Carlo, president and CEO of Adamis. “We appreciate the feedback from the DSMB. Following the first planned interim analysis, if the DSMB advises for the study to continue, we will also report on the second planned DSMB review following its completion, which may provide additional insight into the safety and clinical results at that time.”