The potential side effects of COVID-19 vaccines
Efficacy vs. side effects
Our facts page about the COVID-19 vaccines highlights the efficacy of the three main vaccines available to date (Pfixer-BioNTech, Moderna, and Oxford-AstraZeneca) and explains how those data were obtained. All trials involved the same basic design: participants were randomly assigned to a control (placebo) group or to the vaccination group. The Pfizer-BioNtech trial involved 43,448 individuals; the Moderna trial involved 30,420 participants; and the Oxford-AstraZeneca trial recruited 23,848 participants of whom 11,636 were included in the interim analysis that has been published. Altogether more than 80,000 people were enrolled in those trials, and so there was considerable opportunity to observe side effects.
A useful summary of the known side-effects of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines --- the two which are authorised for use in the UK as of 1st Jan 2021--- can be found in the “Green Book”, which is a U.K. manual for healthcare workers who administer vaccines:
Local reactions at the injection site are fairly common after Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2, primarily pain at the injection site, usually without redness and swelling. Systemic events reported were generally mild and short lived (Walsh et al, 2020). In the final safety analysis of over 21,000 participants 16 years and older, the most common events were injection site pain (>80%), fatigue (>60%), and headache (>50%). Myalgia, arthralgia and chills were also common with fever in 10-20%, mainly after the second dose. Most were classified as mild or moderate. Lymphadenopathy was reported in less than 1%. (Polack et al, 2020). Four cases of Bell's palsy were reported in vaccine recipients in the trial. Although within the expected background rate, this will be monitored closely post-implementation. Side effects were less common in those aged over 55 than those aged 16 to 55 years. Severe systemic effects, defined as those that interfere with daily activity, included fatigue in 4% and headache in 2%. There was no signal to suggest that prior vaccination led to enhanced disease with only 1 case of severe COVID-19 in the 8 vaccine failures. (Polack et al, 2020).
From early phase trials, mild pain and tenderness at the injection site was common with AstraZeneca COVID- 19 vaccine occurring in 88% of 18-55 year olds, 73% of 56-69 year olds and 61% of people aged 70 years or over; similar levels were reported after each dose. Short lived systemic symptoms including fatigue and headache were also common but decreased with age, being reported in 86%, 77%, and 65% of those aged 18-55, 56-69 and 70 years or over respectively; most of these were classified as mild or moderate. These reactions were unusual after the second dose (Ramasamy et al, 2020). Mild fever (>38 ̊C) was recorded in the first 48 hours for around a quarter of younger participants and but was not reported in those over 55 years of age or in any age group after the second dose (Ramasamy et al, 2020). Fever can be modified by the prophylactic use of paracetamol, which does not affect the immune response to this vaccine (Folegatti et al, 2020). In the phase 3 study, injection site reactions, mild fever, headache, myalgia and arthralgia occurred in more than 10% of vaccinees. Less than 1% reported lymphadenopathy or an itchy rash. Only one serious adverse event was reported as possibly linked to the vaccine; this was a case of transverse myelitis which occurred 14 days after dose 2. There was no signal to suggest that prior vaccination led to enhanced disease. (Voysey et al, 2020).