What the Vax?!: Part 3
I’m back! And two days before New Year’s Eve!! In my previous article, “What the Vax?!: Part2b”, I made a challenge to myself, publicly, so I would follow through.
I just want to remind everyone that I’m not sharing my personal opinion nor trying to change anyone’s mind about the topic. I’m merely sharing the information I learned “straight from the horse’s mouth”, as it were.
This article picks up where the previous one left off…with Sharon Alroy-Preis & Ron Milo from Israel sharing their findings.
- 2:00:52: *Summary: Booster dose in Israel was effective and so far had safety profile similar to the other doses •Booster dose shows ~ 10-fold improved protection against confirmed infection and severe COVID-19 •Post-booster efficacy against Delta similar to pre-waning efficacy against Alpha •Booster dose adverse events not more accute than first or second dose •Based on the above for ages 60+ (and then 50+), the vaccine safety & effectiveness committees in Israel approved booster dose 5 months after 2nd dose for ages 12+ •Administration of booster dose helped Israel dampen severe cases in the 4th wave 2:06:20: “…or every 6 months are you going to have to keep boosting these people?” [The way it was said made me giggle! 😄] 2:06:43: “It’s not clear where this is going.” 2:08:05: “There is some increased risk of myocarditis in younger males.” 2:11:29: “In our vaccinated households, we are starting to see spread into our younger populations who are no longer seemingly protected by herd immunity around them.” [So…does herd immunity work, then? Or doesn’t it?] 2:18:00: Break 2:25:56: *BNT162b2 [COMIRNATY (COVID-19 Vaccine, mRNA)] Booster (Third) Dose 2:27:05: Donna Boyce, MS, Senior Vice President Global Regulatory Affairs Pfizer Inc.
2:32:15: *Benefit-Risk of Booster Dose is Favorable •The demonstrated safety and effectiveness of a third dose of BNT162b2 supported adding a single booster dose to the vaccination schedule •Global RWE demonstrate that the reduction in VE is likely due to waning effectiveness, and Israeli data supports that a booster dose can restore high levels of protection with an acceptable safety profile •Pfizer/BNT is requesting licensure of a single booster dose of BNT162b2 administered intramuscularly at least 6 months after the primary series in individuals > 16 years of age 2:33: William C. Gruber, MD, Senior Vice President Vaccine Clinical Research and Development Pfizer Inc. *Public Health Need *BNT162b2 Vaccine is Highly Protective Against COVID-19 but Duration of Protection Wanes Over Time •Data from the pivotal Phase 3 clinical study (C4591001) showed that 2 doses of BNT162b2 vaccine administered 3 weeks apart confers protection against both symptomatic and severe COVID-19 •Duration of protection of BNT162b2 is currently unknown •Analysis of efficacy up to six months after Dose 2 shows that initial vaccine efficacy slightly wanes over time in the pre-Delta period — 96.2% from 7 days after Dose 2 to < 2 months after Dose 2 — To 90.1% from > 2 months to < 4 months after Dose 2 — To 83.7% for > 4 months up to ~ 6 months after Dose 2 2:35:49: *Waning of immunity has been observed across the world coinciding with penetration of Delta variant •Delta became widespread globally in June and July of 2021 •Reports describing reduced effectiveness of BNT162b2 (and other COVID-19 vaccines) against SARS-CoV-2 infections caused by Delta have surfaced from Israel, the United States, and Qatar [So…are they going to stop using BNT162b2, then….?]•Recently in Israel, reduction in VE has been observed against hospitalization and severe infection after a two-dose BNT162b2 primary series •VE studies to date have not adequately differentiated the impact of Delta from potential waning immunity on recent reductions of vaccine effectiveness •In collaboration with Kaiser Permanente Southern California, Pfizer evaluated overall and variant-specific real-world effectiveness of BNT162b2 against SARS-CoV-2 infections and COVID-19-related hospitalizations by time since vaccination
2:38:52: *In all age groups, vaccine effectiveness wanes over time against infections but not against hospitalizations 2:41:08: “Effectiveness against severe disease and hospitalizations has begun to decline in Israel.” [Wait! These two statements seem to contradict each other.] 2:41:43: “We may see similar increases in hospitalizations and severe disease in weeks and months for those individuals vaccinated early in the US campaign.” [Why? Because the vaccine wasn’t ready? Because they took it too early? Was it administered wrong??] 2:42:02: •Vaccine effectiveness wanes over time irrespective of the variant concern •Adjusted VE against *SARS-CoV-2 infections*, KPSC members > 12 years of age
2:46:47: Public Health Need for a Booster: Conclusions •Israel and the United States RWE suggest that VE against COVID-19 infection wanes approximately 6 to 8 months following the second dose when the Delta variant is predominant [But, above it said that it wanes regardless of the variant….]•A retrospective KPSC suggests that VE reductions are primarily due to waning vaccine induced immunity rather than due to Delta escaping vaccine protection •Waning vaccine effectiveness is further supported by the recent FDA requested post-hoc analysis of breakthrough cases in the C4591001 pivotal Phase 3 clinical study •While waning VE against hospitalization was not observed in the US, this should be carefully monitored, as data from Israel suggest that reduced effectiveness against severe disease could eventually follow reductions in VE against SARS-CoV-2 infections 2:47:59: Overview of Clinical Program
[So…they already knew we’d have all these other variants…? I’m confused 😕]
2:52:21: Summary of Data for BNT162b2 Booster (3rd Dose) Administered in C4591001: Phase 1 2:52:43: Post-Dose 3 BNT162b2 GMTs Indicate a Substantial Boost and Reduced Gap Between WT and and Beta Neutralization 2:54:47: “Our interpretation…*perhaps* improved protection” 2:56:24: Post-Dose 3 BNT162b2 GMTs Indicate a Substantial Boost to the Delta Variant Similar to Wild Type 2:57:56: Local Reactions by Maximum Severity Within 7 Days of 3rd Dose Similar to Post-Dose 2
2:58:57: Summary of Data for BNT162b2 Booster (3rd Dose) Administered in C4591001: Phase 3 2:59:33: Basis for Extrapolation of Phase 3 3rd Dose Data to 16-17 and > 55 Year Olds •Immunogenicity — “Studies…may be conducted in a single age group (e g., adults 18-55 years of age), with extrapolation of results to other age groups for which the prototype vaccine has been authorized…” •Safety — 16-17 year olds - based upon post-dose 2 data: *Reactogenicity would be expected to be similar to 18-55 yo — 55 year olds: *Local reactions and systematic events in participants > 55 years after dose 2 were lower than those in younger adults [It seems to be hitting younger people harder]*This predicts lower reactions after the third dose in > 55 yos based on the lower reactogenicity profile seen after the third dose compared to the second dose in 18-55 year olds
Dr. Gruber isn’t done! But I think I need to leave the rest for my next article…he’s confusing! 😉
(Link to the video: https://youtu.be/ysV7sY2OMEU)