Predicted Symptomatic Effectiveness of Pfizer-BioNTech BNT162b2 Vaccine Against Omicron Variant of SARS-CoV-2

  1. Oleg Volkov

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Abstract

This paper presents predictions of the symptomatic effectiveness of the Pfizer-BioNTech BNT162b2 (Comirnaty) vaccine against Omicron B.1.1.529, the latest SARS-CoV-2 variant of concern. They were obtained assuming fold decreases in Omicron neutralisation by vaccine-induced antibodies versus neutralisation of the virus Wild Type. A 25-fold decrease was assumed based on Omicron pseudovirus neutralisation study by Pfizer and BioNTech; a 94-fold, based on live-Omicron neutralisation study in South Africa; and 40, 80 and 120 folds, hypothesised based on genetic information. The effectiveness of two vaccine doses was predicted as 66% (42, 86), 48% (25, 72) and 42% (20, 66) for up to five months starting 2-4 weeks after the second dose, for the 25, 80 and 120 folds, respectively. The effectiveness of booster vaccination was predicted under a highly conservative assumption that the third dose would increase neutralisation by only 3.3 folds compared to the second dose. The predictions of effectiveness for up to five months, starting 2-4 weeks after the third dose, were 81% (59, 95), 67% (43, 87) and 61% (37, 82) for the 25, 80 and 120 folds, respectively. Despite the large fold decreases considered, the vaccine could still provide substantial protection, particularly after a booster and against severe disease. The paper is accompanied by free software which can be used to predict the symptomatic effectiveness of Comirnaty against Omicron under different neutralisation folds, including those obtained experimentally.

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    With the above caveats, we could make the following conclusions. Despite a 40-fold decrease in virus neutralisation, full primary vaccination with Comirnaty could be highly protective against Omicron, with the symptomatic effectiveness almost 60% for up to 5 months. Even with the Worst-Case scenario (120x decrease), two doses could still have a sizeable effectiveness of 42% (although note a potentially high prediction uncertainty at low titres). This implies that boosters might not need to be radically sped up for every population group. Protection after the third dose would be substantially stronger across all the scenarios considered, given the likely neutralisation increase relative to the second dose. In fact, the assumed 3.3-fold increase could be too conservative, given the 20x (15, 27) increase reported in Atmar et al. [2021] for homological Comirnaty boosting, and the 25x increase from the early data in Pfizer/BioNTech [2021] on Omicron pseudovirus neutralisation. The symptomatic effectiveness, predicted here for general adult populations, is likely to be higher in adolescents and young adults. The effectiveness against severe disease, hospitalisation and death is likely to exceed the predicted symptomatic effectiveness. If the early reports, such as [Chutel et al., 2021], that Omicron causes milder disease are confirmed, then the effectiveness could increase across the board. Still, waning protection, especially after primary vaccination, will put a downward pressure...

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  2. Version published to 10.1101/2021.12.09.21267556v1 on medRxiv