This should come as no surprise, as an article in leading journal JAMA found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of the Pfizer jab. So, what did they conclude? If it fails, just keep on doing the same thing, with the findings: “support rolling out additional booster shots to vulnerable people as the variant drives an uptick in new cases across the country.” It is not specified how many boosters will be needed to produce protection, with three failing, why should four of more succeed?
“Second and third doses of Pfizer’s COVID-19 vaccine provide protection against the Omicron variant for only a few weeks, according to peer-reviewed research published today in JAMA Network Open.
“Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of [the Pfizer-BioNTech] BNT162b2,” the authors of the research letter wrote.
The authors said their findings “could support rolling out additional booster shots to vulnerable people as the variant drives an uptick in new cases across the country,” Forbes reported.
Danish researchers studied adults who received two or three doses of BNT162b2 between January 2021 and October 2021, or were previously infected prior to February 2021 and then vaccinated.
They found that after an initial increase in Omicron-specific antibodies after the second Pfizer shot, levels dropped rapidly, from 76.2% at week 4, to 53.3% at weeks 8 to 10, and 18.9% at weeks 12 to 14.
After the third shot, neutralizing antibodies against Omicron fell 5.4-fold between week 3 and week 8.
A preprint study released in February showed Pfizer’s two-dose regimen of its COVID-19 vaccine for children was only 12% effective against Omicron in children ages 9 to 11, and the effectiveness of the vaccine “declined rapidly” for children 5-11.
Researchers at the New York State Department of Health and the University at Albany School of Public Health examined the effectiveness of the vaccine in children 5 to 11 and adolescents 12 to 17 from Dec. 13, 2021 to Jan. 30, 2022.
The authors of the New York study wrote:
“In the Omicron era, the effectiveness against cases of BNT162b2 declined rapidly for children, particularly those 5-11 years. However, vaccination of children 5-11 years was protective against severe disease and is recommended.”
FDA admits boosters ineffective at preventing infection, but continues to support strategy
The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel met April 6 — a week after authorizing a second booster dose for people over age 50 and the immunocompromised — to discuss the FDA’s booster strategy amid reports of waning effectiveness.
After nine-and-a-half hours, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) failed to reach a consensus.
Dr. Peter Marks, director of the FDA’s vaccine division, Center for Biologics Evaluation and Research, admitted during the meeting that the fourth booster dose approved March 29 was a “stopgap measure” — in other words, a temporary measure to be implemented until a proper solution may be found in the future.
The FDA’s lead scientist for the strategy session, Doran Fink, admitted COVID-19 vaccine efficacy is waning for severe outcomes.
A Jan. 19 report from the Centers for Disease Control and Prevention (CDC) showed natural immunity against COVID-19 was at least three times as effective as vaccination alone at preventing people from becoming infected with the Delta variant.
Overall, the CDC study showed natural immunity outperformed vaccine immunity when it came to preventing infection and hospitalization from Delta. The agency late last month said almost 60% of Americans have had COVID-19.
A batch of Pfizer documents released April 1 confirmed Pfizer knew natural immunity was as effective as the company’s COVID-19 vaccine at preventing severe illness, The Defender reported last month.
U.S. Food and Drug Administration officials earlier this month suggested annual vaccines against COVID-19 may be necessary in the future.”
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2792295
Research Letter
Infectious Diseases
May 13, 2022
Neutralizing Antibodies Against the SARS-CoV-2 Omicron Variant (BA.1) 1 to 18 Weeks After the Second and Third Doses of the BNT162b2 mRNA Vaccine
Ria Lassaunière, PhD1; Charlotta Polacek, PhD1; Anders Frische, MSc1; et alLasse Boding, PhD2; Susanne Gjørup Sækmose, MD, PhD3; Morten Rasmussen, PhD1; Anders Fomsgaard, MD, DMSc1
Author Affiliations Article Information
JAMA Netw Open. 2022;5(5):e2212073. doi:10.1001/jamanetworkopen.2022.12073
Introduction
The SARS-CoV-2 Omicron variant of concern1 (VOC) is highly resistant to vaccine-induced antibody neutralization2 and associated with a decline in vaccine efficacy within the first 3 months following the primary 2-dose regimen of the SARS-CoV-2 BNT162b2 (Pfizer/BioNTech) mRNA vaccine3,4 and from 10 weeks after a third BNT162b2 dose.4 To associate Omicron-specific neutralizing antibody levels with reported vaccine efficacies, we performed a temporal analysis of virus neutralization responses against an ancestral strain (D614G), the Delta VOC, and the Omicron VOC (BA.1) following 2 or 3 doses of the BNT162b2 vaccine.
Methods
This cohort study includes Danish adults who received 2 or 3 doses of BNT162b2 between January 2021 and October 2021 or were previously infected prior to February 2021 and then vaccinated. In the latter group, given the timeframe, individuals became infected with ancestral SARS-CoV-2 strains before VOCs became dominant in Denmark. We determined 50% serum neutralization titers using a live virus microneutralization assay5 (eAppendix in the Supplement). Paired and nonpaired numerical measurements were compared using the Wilcoxon matched-pairs signed rank test and Mann-Whitney U test, respectively. The association between continuous variables were assessed using the Spearman correlation analysis. This study constitutes national infectious disease surveillance performed on excess biological material by Statens Serum Institut, an institute under the Danish Ministry of Health, according to Section 222 of the Danish Health Act and following data protection regulations. This study is therefore exempt from ethical review and did not require patient consent. We followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.
Results
The study cohort included 128 vaccinated individuals who received either 2 doses of BNT162b2 (n = 73; median [IQR] age: 51 [37-68] years; 32 [43.8%] male individuals) or 3 doses of BNT162b2 (n = 55; median [IQR] age: 70 [58-79] years; 21 [38.9%] male individuals) administered 4 to 9 months after dose 2 (median [IQR]: 6.9 [6.2-7.5] months). The infected-then-vaccinated individuals (n = 7) were male individuals between 47 and 65 years of age (median [IQR]: 57 [53-62] years). Four weeks after BNT162b2 dose 2, neutralization geometric mean titers (GMTs) against the Omicron variant measured 14-fold lower compared with GMTs against D614G (P < .001) (Figure 1A). Relative to D614G and the Delta variant, the proportion of detectable Omicron-specific neutralizing antibody responses declined rapidly from 76.2% (16 of 21 individuals) at week 4 to 53.3% (16 of 30 individuals) at weeks 8 to 10 and 18.9% (3 of 16 individuals) at weeks 12 to 14 (Figure 1A). After BNT162b2 dose 3, GMTs against the Omicron variant increased 20.6-fold at week 3 and 7.7-fold at week 4 compared with GMTs after dose 2 at week 4 (P < .001). A third BNT162b2 dose elicited detectable neutralizing antibody responses in the majority of individuals for at least 8 weeks; however, between week 3 and week 8, neutralizing antibody GMTs declined by 4.9-fold for D614G, 5.6-fold for Delta, and 5.4-fold for Omicron. When stratified according to age, GMTs for Omicron-specific neutralizing antibody responses differed significantly between individuals aged less than or equal to 65 years and greater than 65 years after dose 2 (P = .02), but not after dose 3 (Figure 1B). However, for the 5 individuals aged greater than 65 years studied at week 8 after dose 3, Omicron-specific GMTs were undetectable for 2 individuals and low (GMT: 30-79) for 3 individuals (Figure 2). Overall, neither age nor interval between doses 2 and 3 were associated with neutralization titers measured between 2 and 4 weeks after dose 3. Similar to a third BNT162b2 dose after the primary 2-dose series, vaccination following a prior infection significantly increased Omicron-specific GMTs (P = .02; Figure 1C).
Discussion
SARS-CoV-2 neutralizing antibodies are correlated with protection against infection and disease.6 Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of BNT162b2. A limitation of our study is that its cross-sectional design precludes evaluation of antibody decrease rates on an individual level. Nevertheless, the observed decrease in population neutralizing antibody titers corresponds to the decrease in vaccine efficacy against polymerase chain reaction–confirmed Omicron infection in Denmark and symptomatic Omicron infection in the United Kingdom.3,4 Taken together, vaccine-induced protective antibody responses following a second and third dose of BNT162b2 are transient and additional booster doses may be necessary, particularly in older people; however, conserved T-cell immunity and nonneutralizing antibodies may still provide protection against hospitalization and death.”