First safety data on Novavax released

The first safety data on the rollout of the Novavax vaccine, the fourth to be approved for use in Australia, has been released in the latest Therapeutic Goods Administration (TGA) safety report.
 
The report covers the initial stages of the rollout up until 6 March, in which around 35,500 doses of the protein-based vaccine had been administered, with the TGA receiving 78 reports of suspected adverse events.
 
There have been no safety signals identified ‘based on the limited number of reports’ received so far, the TGA states.
 
Reactions logged in the TGA database include paraesthesia, headache, chest pain, fatigue and dizziness.
 
According to AusVaxSafety, a National Centre for Immunisation Research and Surveillance-led initiative that runs more proactive surveillance of COVID-19 vaccines, the most common reactions have been fatigue, injection site reaction and headache.
 
‘These are expected side effects which were also seen in the clinical trials,’ the TGA report states.  
 
Most of the doses given so far have been given as the initial part a primary vaccination course.
 
The vaccine first became available in mid-February this year, with the Australian Technical Advisory Group on Immunisation (ATAGI) recommending a minimum gap of three weeks between doses.
 
Take-up of the vaccine was expected to be relatively limited due to its approval at a late stage of the vaccine rollout and many general practices opted not to offer the vaccine.
 
Earlier this month, ATAGI took the unusual step of giving a green light to the vaccine’s use as a booster ‘if no other COVID-19 vaccine is considered suitable for that individual’, prior to its approval by the TGA.
 
Vaccination for 5–11-year-olds
The TGA report also contains more detail on the vaccine rollout for the youngest age group, which is continuing along similar lines as reported previously.
 
Up until 6 March, there were 836 adverse event reports for the youngest age group from around 1.2 million Pfizer doses administered. The majority of those were for nausea, and pain around the injection site.
 
The latest summary says that of 17 reports of possible myocarditis in that age group, none were deemed likely to be that condition.
 
Two adverse event reports involving 10-year-olds could possibly represent mild pericarditis when measured against international reporting standards, the report states.
 
The TGA says the rate of adverse reactions in the age group is lower than in older Australians, with the vaccine assessed to be ‘well tolerated’.
 
Recently the speed of the rollout for young children has come into focus, with the percentage of the age group taking up the vaccine slowing.
 
According to the latest vaccine rollout statistics, just over 51% of eligible children have had a first dose so far.
 
Booster update
Of around 11.9 million third vaccine doses delivered up to 6 March, there have been around 5000 adverse event reports, with the most common being swollen lymph nodes – as reported in initial safety data – as well as headache, fatigue, chest pain and muscle pain.
 
‘These reports do not suggest any emerging safety concerns with the use of a booster dose that is different to the first and second vaccine doses received,’ the TGA states.
 
The rates of myocarditis being reported for booster doses is also lower for all age groups when compared to the earlier doses.
 
The latest TGA report includes some observations on mixed vaccine schedules, while noting some limitations in the current data.
 
It reports most people aged under 50 have had three doses of an mRNA vaccine. Those aged 50–60 is roughly evenly split, while those aged above 60 are more likely to have had an mRNA booster following an AstraZeneca primary course.
 
The report says the TGA often does not receive details about which COVID-19 vaccine was received as part of a primary course when adverse events are reported for the booster.
 
‘Taking into account the limitations in this reporting data, we have not observed any patterns of adverse events which suggests different vaccine combinations are more likely to lead to serious adverse events,’ it states.
 
The TGA also encourages people reporting adverse events to give as much detail as possible, including information on the vaccine used for the primary course.
 
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boosters Novavax Pfizer TGA Therapeutic Goods Administration vaccine rollout