Reminder: FDA Advisory Committee Meeting Thursday January 26, 2023 on Future of Covid-19 Vaccination Regimens

Remember, the 178th Annual Meeting of the FDA Advisory Committee on the future of Covid-19 Vaccination Regimens is this Thursday from 8:30 AM-5:30 ET.

The details so far include the voting question:

“Simplification of current COVID-19 vaccine use:

  • Vaccine composition: Does the committee recommend harmonizing the
    vaccine strain composition of primary series and booster doses in the U.S.
    to a single composition, e.g., the composition for all vaccines administered
    currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

FDA Advisory Committee Meeting to Discuss Future Covid-19 Vaccine Regimens

The FDA 178th Meeting of the Vaccine and Related Biological Products Advisory Committee will meet in open session January 26, 2023 to discuss future Covid-19 vaccination regimens. The meeting will run between 8:30 AM-5:30 PM ET.

CDC Identifies Preliminary Covid-19 Vaccine Safety Signal

The CDC announced that a prelimary Covid-19 Vaccine Safety signal has been identified in a recent update on their website:

“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

  • A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke
  • A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine
  • The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine
  • Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
  • Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines”

The CDC says it’s “very unlikely  that the signal in VSD represents a true clinical risk…” The data and additional analyses will be discussed at the January 26, 2023 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No changes are recommended to the current Covid-19 vaccination practice:

“CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries:

  • Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine.
  • Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated.
  • Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine.

Overall safety data for the bivalent COVID-19 vaccines are available here.

Once again, no change is recommended in COVID-19 vaccination practice, which can be found here.”

Bivalent Covid-19 Booster Protects Us

University of Iowa Health Care participated in research which demonstrates that people over age 65 who got the updated bivalent Covid-19 vaccine booster:

  • “84% less likely to be hospitalized with COVID-19 compared with unvaccinated people 
  • 73% less likely to be hospitalized with COVID-19 compared with people who received monovalent mRNA vaccination alone but had not received the bivalent booster dose.”

Listen to Dr. Wes Ely, MD on Talk Radio Europe Discuss His Book: Every Deep-Drawn Breath

Listen to Dr. Wes Ely on the show Talk Radio Europe as he talks about the devastating consequences of severe disease that results in admission to critical care units, specifically in the context of the Covid-19 Pandemic.

The title of the presentation is “Understanding the Long Shadow of COVID and ICU Care.”

Rounding@Iowa Presentation on Covid-19 Bivalent Vaccine Boosters

Give a listen to the Rounding@Iowa presentation “Update on Covid-19 Bivalent Vaccine Boosters. While these presentations are mainly directed to health care providers, they are very helpful for members of the community at large.

Single Administration Therapeutic Interfering Particle (TIP) Reduces Covid-19 Viral Shedding & Pathogenesis in Hamsters

Proceedings of the National Academy of Sciences (PNAS) recently published a study showing:

Abstract

“The high transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a primary driver of the COVID-19 pandemic. While existing interventions prevent severe disease, they exhibit mixed efficacy in preventing transmission, presumably due to their limited antiviral effects in the respiratory mucosa, whereas interventions targeting the sites of viral replication might more effectively limit respiratory virus transmission. Recently, intranasally administered RNA-based therapeutic interfering particles (TIPs) were reported to suppress SARS-CoV-2 replication, exhibit a high barrier to resistance, and prevent serious disease in hamsters. Since TIPs intrinsically target the tissues with the highest viral replication burden (i.e., respiratory tissues for SARS-CoV-2), we tested the potential of TIP intervention to reduce SARS-CoV-2 shedding. Here, we report that a single, postexposure TIP dose lowers SARS-CoV-2 nasal shedding, and at 5 days postinfection, infectious virus shed is below detection limits in 4 out of 5 infected animals. Furthermore, TIPs reduce shedding of Delta variant or WA-1 from infected to uninfected hamsters. Cohoused “contact” animals exposed to infected, TIP-treated animals exhibited significantly lower viral loads, reduced inflammatory cytokines, no severe lung pathology, and shortened shedding duration compared to animals cohoused with untreated infected animals. TIPs may represent an effective countermeasure to limit SARS-CoV-2 transmission.”

Is Treatment with Antibodies a Substitute for Vaccination for Covid-19?

I read the news article about scientists publishing a study which shows it’s possible to make antibodies that may neutralize most of the Covid-19 variants. I read this after failing to find any local facility in my area that has the updated bivalent Covid-19 vaccine booster available yet. Sena and I plan to get the booster, which would be our 5th shot.

I don’t have a clue how to evaluate the study itself, which was published in an Open Access journal, Communications Biology. I didn’t understand the peer reviewers’ comments and suggestions because I lack the scientific background to make sense of them.

I was under the impression that using antibodies for Covid-19 has to be prompted by getting infected first. In fact, the lead author of the study actually points out in the news article in published in the Jerusalem Post,

“In our view, targeted treatment with antibodies and their delivery to the body in high concentrations can serve as an effective substitute for repeated boosters, especially for at-risk populations and those with weakened immune systems. COVID-19 infection can cause serious illness, and we know that providing antibodies in the first days following infection can stop the spread of the virus.

“It is, therefore, possible that by using effective antibody treatment, we will not have to provide booster doses to the entire population every time there is a new variant,” Freund concluded.

I understand that immunity wanes after vaccination and that’s frustrating because apparently you need another booster every few months.

But I’m not sure I see how the antibody treatment would be a replacement for vaccines, if that’s the implication.

The interventions sound complementary. Wouldn’t it be better to have vaccine-induced immunity and use the antibodies as a backup treatment when you get infected?

I got the impression from reading about monoclonal antibody treatments that they have to be administered by infusions in specialty clinics. And you have to catch it in the first few days. And the indication for it is getting infected with the virus—which I thought could be avoided in the first place by getting vaccinated.

The plan now seems to be to manufacture vaccines annually to target important variants of Covid-19, similar to what we’ve been doing for influenza. We’ve been getting flu shots every year for a long time. Maybe we won’t need to get boosters every few months.

It makes sense to use antibodies for immunocompromised persons, though, because they don’t respond as well to vaccines.

Why would we “substitute” monoclonal antibody infusions administered in clinics to treat infections for vaccines which can prevent severe disease and death?

I’m not knocking the study; I’m just a retired psychiatrist, not an infectious disease scientist. Am I missing something?

CDC ACIP Meeting Today and Tomorrow: Covid-19 Vaccine Omicron Bivalent Booster Candidates

The CDC ACIP will meet today and tomorrow about the Covid-19 Vaccine Omicron Bivalent Booster candidates from Pfizer and Moderna. A vote is expected this afternoon.

Update: The committee voted by a majority to upvote the approval of the Pfizer and Moderna bivalent boosters this afternoon. There was one dissenting vote because there was no clinical data to present. There was a clinical study using the bivalent vaccine booster, but results would not have been available until November or December.

However, there was a complicated statistical predication model which showed that if the boosters were rolled out this month, many thousands of hospitalizations and deaths could be prevented as opposed to waiting a few more months. That got prioritized in order to approve the boosters now rather than wait for the clinical study results.

There was a lot of concern about the packaging of the boosters resembling other boosters which might lead to mistakes in administration. Pfizer has a booster vial that looks very similar to that of their bivalent Omicron booster, unless you closely read the tiny print on the vial which says it’s BA.4/BA.5.

The committee voted to cancel tomorrow’s meeting since they completed the goal today.

CDC ACIP Meeting for September 1-2 on Bivalent Omicron Covid-19 Vaccine Boosters

The CDC ACIP have an agenda posted indicating that the advisory committee will discuss Covid-19 Bivalent Omicron vaccine candidates on September 1-2, 2022. A vote is scheduled on September 1, 2022.

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