Study highlights safety of second booster with BNT162b |
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the route to achieving a significant impact on disease progression leading to hospitalisation and death , despite being vaccinated , many patients continue to experience breakthrough infections which can be problematic among those at-risk . An important question , therefore , is whether the effectiveness of either sotrovimab or molnupiravir persists among vaccinated , at-risk patients with a breakthrough infection . In the present study , UK researchers undertook an observational study of at-risk adults , who were treated with either sotrovimab or molnupiravir and did not require hospitalisation for COVID-19 . The researchers excluded those who had previously been treated with any other monoclonal antibody or anti-viral agents for COVID-19 . The primary outcome was admission to hospital with COVID-19 or death from COVID-19 within 28 days of starting either treatment . The main secondary outcome was hospital admission or death within 60 days of the start of treatment .
A total of 6020 patients with a mean age of 52 years ( 59 % women ) were treated with either sotrovimab ( 3331 ) or molnupiravir and of whom , 87.6 % had received three or more COVID-19 vaccinations .
Overall , 1.45 % of the entire cohort was hospitalised or died from COVID-19 within 28 days of starting treatment . Compared to molnupiravir , treatment with sotrovimab was associated with a substantially lower risk of the primary outcome ( hazard ratio , HR = 0.54 , 95 % CI 0.33 – 0.88 , p = 0.01 ). For the secondary outcome , there was also a significant reduction in hospital admission for death within 60 days and which favoured sotrovimab ( HR = 0.50 , 95 % CI 0.31 – 0.81 ).
The authors concluded that in routine care , sotrovimab was a superior to molnupiravir at lowering the risk of severe COVID-19 outcomes .
Reference 1 Zheng B et al . Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe COVID-19 outcomes in patients in the community : Observational cohort study with the OpenSafely Platform . BMJ ; 379 : e071932 .
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Many countries are now offering a fourth dose of the COVID vaccine . Available data suggests that a fourth vaccination dose provides additional protection against both hospitalisation and severe disease when compared to three doses . Despite this , for many , vaccine hesitancy persists and one factor associated with this stance is safety thus warranting the collection of further data to enhance uptake .
Israeli researchers have analysed the safety of the first booster dose retrospectively and then prospectively following the second booster . For the retrospective analysis , they focused on adults ( 18 years of age and older ) who had received their first booster with BNT162b between December 2021 and July 2022 . For the prospective study , individuals received smartwatches and a dedicated mobile phone app and used these watches to continuously record data such as heart rate and for the analysis , the team compared heart rate levels one week before and 0 – 42 days after vaccination . The app also enabled the collection of data from self-reported questionnaires on any local or systemic reactions to the vaccine . Using individual patient ’ s medical records , the researchers looked at 25 potential adverse events and again , compared the incidence of these before and after vaccination .
The retrospective analysis included 94,169 individuals with a median age of 47 years ( 52 % women ) who had the first booster and 17,814 ( median age 69 , 50.2 % women ) who received the second booster . When comparing the two , the second booster was not associated with any of the 25 adverse events including myocardial infarction ( risk difference , RD = 2.25 events / 10,000 individuals ) or Bell ’ s palsy ( RD = -1.68). In the prospective study there were 1785 individuals ( median age 52 , 51.5 % women ) who received the first and 699 ( median age 62 , 50.2 % women ) who received the second booster . There was a significant increase in mean heart rate compared to before vaccination during the first three days after the second booster but this returned to pre-baseline levels by day 6 . In terms of adverse events , 67 % of individuals did not report any problems after the second dose .
The authors concluded that their findings highlighted the short-term safety of a second booster dose with BNT162b .
Reference 1Yechezkel M et al . Safety of the fourth COVID-19 BNT162b mRNA ( second booster ) vaccine : a prospective and retrospective study . Lancet Respir Med 2022 ; November 18 .
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38 | Issue 102 | hospitalpharmacyeurope . com |