Pfizer-BioNTech Vaccine Effective Long-Term in Teens; US Vaccine Data in 2076?

News on COVID-19 vaccine developments and disease studies continue to deliver highs and lows. Here are some of the more recent happenings.

Pfizer-BioNTech Vaccine Demonstrates 100% Efficacy for 12-15 Age Group

Pfizer said its COVID-19 vaccine, developed with BioNTech, demonstrated 100% effectiveness in the 12 to 15-year-old age group after four months. Data collected from November 2020 to September 2021 from participants who received two doses of the vaccine (at 30-µg per dose) showed total efficacy across gender, race and ethnicity demographics, comorbidity, and obesity status. The participants were observed seven days after their second dose and in the over four months that followed. Any adverse events seen were consistent with the drug’s clinical safety data, and no serious safety issues arose.

“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age. The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our COVID-19 vaccine across adolescent and adult populations,” said Ugur Sahin, chief executive officer and co-founder of BioNTech, in a statement.

Findings from this latest study will strengthen the planned application for the supplemental Biologics License Application (sBLA) to be submitted to the U.S. Food and Drug Administration (FDA). So far, the Pfizer-BioNTech vaccine is available for the 12 to 15-year-old age group under emergency use authorization (EUA), which was granted in May 2021.

SyneuRx Anti-viral Drug Candidate Prepares to Go Into Phase III Trial

SyneuRx International, the pharmaceutical firm focused on anti-viral and central nervous system drugs, announced that its oral SARS-CoV-2 anti-viral candidate is ready to go into Phase III trial after a successful seven-month Phase II run.

Pentarlandir has botanical origins and is based on highly purified isomers of tannic acid. It works by targeting the main protease, 3CL-protease, which turns viral protein into the necessary components that enable the replication of new viral particles that help inhibit TMPRSS2 and HAT for viral entry. This dual function makes it a good candidate for so-called “twindemic” situations as it can address both COVID-19 and influenza.

Pentarlandir is given orally to patients suffering from breakthrough cases of the virus (among those who had been previously infected or vaccinated). It is also indicated as a possible first-line treatment for those who are unvaccinated and might face hospitalization or death.

“Our researchers have devoted several years to the discovery, isolation and development of Pentarlandir and we are very pleased with the progress of the Phase II trial. We are actively developing this candidate drug and remain hopeful that we will continue our positive track record to date,” commented Guochuan ‘Emil’ Tsai, M.D., Ph.D., MAS, the founder and CEO of SyneuRx.

The drug is expected to be widely available worldwide within one to two years after the Phase III study is completed.

Pregnant Women With COVID-19 At Risk for Stillbirths

A new study by scientists from the Centers for Disease Control and Prevention (CDC) has shown that pregnant women diagnosed with COVID-19 are at increased risk for stillbirth compared to those without the virus. The danger is even higher if the woman is carrying the Delta variant.

Based on information collected from the Premier Healthcare Database Special COVID-19 Release (PHD-SR), a large U.S. hospital-based administrative database, the CDC observed that many of the stillbirths recorded from March 2020 to June 2021 and July to September 2021 were of women who had COVID-19 at the time of delivery. Many of the cases were also strongly linked during the predominance of the Delta variant.

“Although stillbirth was a rare outcome overall, a COVID-19 diagnosis documented during the delivery hospitalization was associated with an increased risk for stillbirth in the United States, with a stronger association during the period of Delta variant predominance. Among deliveries with COVID-19 documented during the delivery hospitalization, certain underlying medical conditions and markers of maternal morbidity, including the need for intensive care, were associated with stillbirth. Additional studies are warranted to investigate the role of maternal complications from COVID-19 on the risk for stillbirth,” noted the CDC research.

Although the CDC admitted several limitations to its research, including lack of laboratory details and reliance on data from hospital discharge alone, the findings add to the growing evidence between COVID-19 in pregnancy and maternal conditions. The CDC said that this highlights the need for further investigation into treatment and prevention strategies.

FDA Says Access to its Full Vaccine Records OK, But Wait ‘Til 2076

The FDA this week said that it could take over 55 years for the agency to review and release a complete report on the vaccine-related documentation it currently holds in response to a lawsuit filed by scientists demanding to see the complete records.

A group of over 30 professors and scientists from different universities filed a lawsuit in September with the U.S. District Court for the Northern District of Texas seeking expedited access to the FDA’s vaccine files. According to the filing, the call for transparency is meant to assuage skepticism over the safety and effectiveness of the Pfizer vaccine, which the FDA has supported for almost all age groups and demographics.

However, in a joint status report dated November 22, the FDA and the Department of Justice said that it’s not easy to turn over the wholesale documents. Each file must be reviewed thoroughly to redact any confidential details and trade secrets that might leak if the process is rushed.

The FDA proposed to release 500 pages per month on a rolling basis, not only because they only have 10-person team capable of getting it done, but also because this same team is processing around 400 other similar FOIA requests. As of this writing, the FDA assessed that there are over 329,000 pages that could fulfill the group’s request.

“As should be apparent, the review conducted by FDA scientists when considering to approve a product is entirely different from the review conducted by FDA government information specialists when considering whether FDA must keep certain information confidential. Moreover, FDA’s FOIA office does not have nearly the same level of personnel or resources dedicated to process FOIA requests as FDA has marshaled to review license applications for life-saving products in the middle of a pandemic,” said the statement.

The plaintiffs have requested the Court to require the FDA to produce all documents on or before March 3, 2022.

“The FDA should welcome making these documents available to the Plaintiff if it is confident in the analysis and review it conducted. The fact that it has fought tooth and nail and taken such an absurd and unconscionable position of waiting until the year 2076 to complete the production further heightens the grave need to have these documents produced forthwith. To require less (than 108 days) is to render FOIA meaningless, the FDA’s promise of transparency a lie,” said the plaintiffs.