Side-effects of jab ‘are minor and do not last’
Risk of a bad reaction to Covid-19 vaccine is very low, say authorities
THE Covid-19 vaccination is probably the biggest global roll-out of its kind in history. So drugs regulatory authorities will inevitably get an unprecedented surge in reports about suspected reactions to the jabs.
Surveillance will be equally tight and the European Medicines Agency (EMA) has said it is getting nearly real-time safety monitoring in addition to the usual checks. It will publish its first safety report at the end of this month.
So far the Pfizer/BioNTech vaccine has been used in the majority of people here, mostly healthcare workers and longterm care residents as well as staff. Nearly 2,000 Moderna doses have been administered to GPs.
EXPECTED SIDE-EFFECTS
According to the National Immunisation Advisory Committee the trial results from the Pfizer vaccine found the most frequent adverse reactions were pain at the injection site, fatigue, headache, chills, joint pain and high temperature.
Symptoms were usually mild to moderate and resolved within a few days. Typically, these reactions were more common after the second dose and in younger patients. The vaccine was generally well tolerated.
REPORTS TO MEDICINES WATCHDOG
The Health Products Regulatory Authority (HPRA) said it had received 81 reports – a relatively small number – of suspected adverse reactions up to January 11 associated with the Pfizer vaccine.
Chief executive Lorraine Nolan said the reports were consistent with its known safety profile and typical events associated with vaccination and had not raised concern. The most frequently reported include headache, dizziness, fever, fatigue, rash, injection site reactions, itching, and other mild-to-moderate symptoms of feeling unwell. They passed quickly and generally do not need medical treatment.
The product information for each vaccine includes known side-effects and is available from the HPRA and the EMA websites. The benefits continued to outweigh the risks, it said.
ALLERGIC REACTIONS
Suspected allergic reactions have been uncommon. In the US there were 21 cases of severe reactions from December 14-23 after 1.9 million people had received a first dose of the Pfizer vaccine.
Anaphylaxis is a serious allergic reaction but it is very rare. It has a one in a million incidence but is higher in these vaccines and is more in line with one in 100,000.
It was under close review, said Ms Nolan, and so far no confirmed reports had been made here. But reports are expected as more people are inoculated.
A small number of Bells Palsy cases have been reported and the expected incidence is one in 10,000. It is temporary and reports are expected here also.
ELDERLY WITH SEVERE DISEASE
The reports from Norway show that for elderly patients with severe frailty and who
may be terminally ill, the regular side-effects such as fever and nausea may have a serious effect.
The Norwegian Medicines Agency said 23 very elderly people with severe disease died after getting the vaccine. Post-mortem exams were carried out on 13 and suggested common side-effects could aggravate underlying illness.
It does not mean the fatality was caused by the vaccine and there are no reported deaths from the vaccine. There is no certain link and authorities say there is no cause for alarm or worry.
However, this kind of feedback allows for more precise guidance to be given to health staff overseeing vaccinations.
Health staff here have been told that if an elderly person with severe disease will not live longer than it takes for the vaccine to work – up to 14 days after each dose – then the should not get the jab and the emphasis instead is on their comfort and care.