12/12—UK issues warning on Pfizer vaccine after adverse reactions
UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions
[Media report.] Britain’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine.
Confirmation of guidance to vaccination centres on managing allergic reactions following COVID-19 vaccination with the Pfizer/BioNTech vaccine
[UK gov press release.] Following two reports of anaphylaxis and one report of a possible allergic reaction following immunisation […] any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer/BioNTech vaccine.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine [Pfizer/BioNTech]
A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) [AstraZeneca/Oxford]
Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs 71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010).
Canada’s COVID-19 Immunization Plan
[See also Guidance on the prioritization of vaccines.] The goal of Canada’s COVID-19 immunization response is to enable as many Canadians as possible to be immunized as quickly as possible against COVID-19, while ensuring that high risk populations are prioritized.
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