COVID-19 vaccine adverse events

Information on these pages is being updated and will be move to the Australian Immunisation Handbook shortly.

Reporting adverse events

Report any adverse events after COVID-19 vaccination through the usual reporting mechanisms.

The TGA and state and territory governments will actively monitor COVID-19 vaccine safety.

Pfizer and Moderna COVID-19 vaccines – adverse events reported in clinical trials

Pfizer (Comirnaty)

Injection site reactions

In clinical trials of Pfizer original formulation, injection site reactions were very common (see Table 1a). They were more common in adults than in children, and slightly more common in adults aged 55 years and under than in adults aged over 55 years.¹

Severe pain was rare, and reported in <1% of participants aged 16 years and over in the initial phase II/III trial.¹ In a later phase III trial, severe pain was reported in 1.5% of adolescents aged 12 to 15 years, compared with 3.5% in young adults aged 16 to 25 years.²

Local adverse events were generally milder in children aged 5 to 11 years than in people aged 16 to 25 years.³

Local adverse events were milder and less commonly reported in children aged 6 months to 4 years than in any other age group, and generally occurred at similar frequencies after any dose. Localised swelling was less commonly reported in children aged 6 months to 4 years than in children aged 5 to 11 years and people aged 16 to 25 years.⁴

These local reactions were generally mild to moderate, had a median onset of 1 to 2 days following vaccination, and resolved within 1 to 2 days of each dose.

Systemic adverse events

Most systemic adverse events were mild to moderate and did not affect daily activities. Systemic adverse events were more common after the second dose of Pfizer than the first dose in both adolescents and adults, and occurred at similar frequencies in children (see Table 1a).^1,2 They were generally milder and less frequent in older adults (>55 years) than in those aged 16 to 55 years.

The median onset of systemic adverse events in adults was 1 to 2 days after vaccination. Symptoms resolved in a median of 1 to 2 days.⁵

Fatigue and headache were the most frequently reported systemic adverse events among people aged 2 to 25 years (Table 1a).²

Irritability, drowsiness, and decreased appetite were the most frequently reported systemic adverse events among children aged 6 to 23 months (see Table 1c). Children aged 6 months to 4 years who received a 3-dose primary series did not show a pattern of increasing systemic adverse events with each subsequent dose.⁴

Similar rates of fever were reported after each of the 3 doses in children aged 6 to 23 months (7%) and aged 2 to 4 years (5%). The median onset of fever was 2 to 5 days after vaccination, and usually resolved within 1 to 1.5 days after the dose. In the phase II/III clinical trial in children aged 6 months to 4 years, 0.1% to 0.3% of participants reported a fever >40.0^oC. There were 5 febrile convulsions reported in the trial vaccine recipients (out of 3,013 vaccine recipients), but only one of these (in a 6 month old participant) was considered possibly related to the Pfizer vaccination, and may also have been caused by a concurrent viral infection.⁴

Adverse events following booster doses and bivalent formulations

Adverse event rates after a booster dose with Pfizer original formulation in the booster clinical trial were similar to rates following the second primary course dose of Pfizer original formulation. Both local and systemic adverse events after the booster (third) dose were mainly mild to moderate.^6,7 The Pfizer bivalent formulations as a booster dose had similar rates of adverse events to primary doses or first or second boosters of the Pfizer original formulation (see Tables 1a and 1b).

In children aged 5 to 11 years, headache, muscle pain and use of antipyretic or pain medication were reported slightly more frequently after a booster dose of Pfizer original formulation than after dose 2.⁸

Table 1a: Frequency of select common adverse events reported within 7 days following each dose of Pfizer original formulation in the phase II/III trial ^3-5,9

Table 1b: Percentage of participants reporting common adverse events within 7 days following a booster dose of Pfizer bivalent formulations in adults^10,11

Table 1c: Frequency of select common adverse events reported within 7 days following each dose of Pfizer in the phase II/III trial in infants and very young children⁴

Uncommon adverse events

In the clinical trials of Pfizer original formulation, lymphadenopathy was reported in <1% of people aged 16 and older, in 0.8% of people aged 12 to 25, 0.9% of children aged 5 to11, 0.1% of children aged 2 to 4 years and 0.2% of children aged 6 to 23 months.^1,2

In the phase II/III study of children aged 5 to 11 years, safety data were reported up to 1 month after dose 2. There were 4 cases of rash (on the arm, torso, face, or body with no consistent pattern) in children aged 5 to 11 years. The rashes occurred more than 7 days after vaccination and were considered to be related to vaccination. Rashes were mild and self-limiting.⁹

In the phase II/III study of children aged 6 months to 4 years, safety data were reported up to 1 month after dose 3. Hypersensitivity reactions were reported by 2.1% of vaccine recipients and 2.0% of placebo recipients aged 6 to 23 months, and 0.9% of vaccine recipients and 0.4% of placebo recipients aged 2 to 4 years. Most hypersensitivity reactions reported were common skin disorders for these age groups, such as rash, eczema, and dermatitis.⁴

Rare adverse events

The clinical trials for Pfizer original formulation were not powered to detect rare adverse events. From post-licensure data, rare adverse events associated with Pfizer original formulation vaccines include anaphylaxis (refer to Contraindications and precautions) and myopericarditis (refer to Myocarditis and pericarditis after mRNA COVID-19 vaccines).

There were 4 cases of Bell’s palsy (acute peripheral facial paralysis) reported in the clinical trial in people aged 16 years and older who received the vaccine (out of 18,860 vaccine recipients).¹² However, this observed frequency was consistent with the expected background rate of Bell’s palsy in the general population. It may not have a causal relationship to vaccination.

The clinical trial of Pfizer original formulation in children aged 6 months to 4 years included safety data from around 4,526 children. This trial was not powered to detect any rare unanticipated adverse events, or to assess the rate of myocarditis or pericarditis in this age group. No cases of myocarditis or pericarditis, vaccine-related anaphylaxis, Bell’s palsy, PIMS-TS (paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2), or Kawasaki disease were reported during the clinical trial in children aged 6 months to 4 years.⁴

Moderna (Spikevax)

Moderna (Spikevax) original formulation is no longer available in Australia. Information on its safety is presented here for reference and because Moderna bivalent formulations still contain the active ingredient from the original formulation.

In the phase III trial of Moderna original formulation, adverse reactions in the first 7 days after vaccination were very common in people aged 18 years and over. These reactions were generally mild to moderate and well tolerated.¹³ In the phase II/III trials of Moderna bivalent original/Omicron BA.1  and Moderna bivalent original/Omicron BA.4/5 formulations in people aged 18 years and over, adverse reactions were similar to the first or second booster of the Moderna original formulation, and to the second dose of the primary series of the Moderna original formulation. ^14,15

The adverse reaction profile of Moderna original formulation in adolescents aged 12 to 17 years was generally similar to that among young adult participants aged ≥18 years.¹⁶ 

In children aged 6 to 11 years,¹⁷ local and systemic adverse reactions occurred with similar frequencies to young adults aged 18 to 25 years. The exception was fever (including grade 3 fever), which was more common among 6-to-11-year-old children than young adults.¹⁷

The adverse reaction profile of Moderna 6 months to 5 years formulation was generally similar to that  in children aged 6 to 11 years, adolescents and young adults. The exception was fever (including grade 3 fever) after any dose, which was more common among children aged 6 months to 5 years than in adolescents and young adults. Fever was seen more frequently after dose 2 than dose 1 in this age group, although it was seen after both doses. The rate reported after dose 1 was also higher in infants and children aged 6 months to 5 years than in any other age group.¹⁸

Local adverse events

Adverse reactions at the injection site were very common after both doses of Moderna original formulation in all age groups (see Table 2). Injection site pain was the most common adverse event reported after both doses in all age groups Injection site pain was also the most common local adverse event reported in infants and children 6 months to 5 years, but it was reported less frequently than in other age groups (see Table 2).^16,18  

Most local adverse reactions were grade 1 (did not interfere with activities) or grade 2 (interfered with activities or required repeated use of over-the-counter pain relief) in severity. The proportion of grade 2 reactions was higher after the second than the first dose. Most local adverse reactions occurred within 1 to 2 days of vaccination and resolved within 2 to 3 days of a dose.¹⁸

Delayed-onset injection site reactions that started after the first 7 days, including pain, redness or swelling, occurred in 0.8% of adults after the first dose, and 0.2% after the second dose. These reactions resolved after a mean of 4 to 5 days.¹³

Axillary or groin lymphadenopathy (swelling of the lymph nodes) within 7 days of vaccination was a solicited adverse event in the Moderna original formulation trials. It occurred in 10% of vaccine recipients aged 18 years and over after the first dose and 14% after the second dose. It was more common in adolescents aged 12 to 17 years, occurring in 23% (first dose) and 21% (second dose) of recipients. Lymphadenopathy was also common in children aged 6 to 11 years, occurring in 15.5% (first dose) and 18% (second dose). It was less common in infants aged 6 to 23 months, occurring in 6% (first dose) and 9% (second dose); and in young children aged 2 to 5 years, occurring in 7% (first dose) and 9% (second dose). However, lymphadenopathy was slightly more common in children aged 6 months to 5 years who had a previous SARS-CoV-2 infection (7.4% to 10.9%) than in children who did not have a previous SARS-CoV-2 infection (5.6% to 9.5%) before vaccination.¹⁸

Systemic adverse events

Systemic adverse reactions were more frequent after the second (79%) than the first dose (55%) of Moderna original formulation, and were more common in participants aged under 65 years than in those aged 65 years or over (Table 2).

In participants aged 2 years and older, the most commonly reported systemic reactions were fatigue, headache and myalgia.¹⁸ In infants and toddlers aged 6 to 36 months, the most commonly reported systemic reactions were irritability/crying, sleepiness and loss of appetite.¹⁸ The majority of systemic reactions were grade 1 (did not interfere with activities) or 2 (interfered with activities or required repeated use of over-the-counter pain relief) in severity. The proportion of grade 2 and grade 3 (prevented daily activities or required use of prescription pain relief) systemic reactions were higher after dose 2 than dose 1. Most systemic adverse reactions occurred within 1 to 3 days of vaccination and resolved within 2 to 3 days of a dose.¹⁹

Fever rates after dose 2 were high for most age groups. Relative to other ages, children aged 6 months to 5 years had higher rates of fever overall when considering rates of fever after both dose 1 and dose 2. Most fevers occurred within 2 days of vaccination, with 1 in 3 children who received the vaccine requiring anti-pyretic medication, although the duration was short (median 1 day). Additionally, children who had previously had SARS-CoV-2 infection were more likely to have a fever than those who had not previously had SARS-CoV-2 infection.¹⁸

Table 2a: Frequency of select common adverse events reported within 7 days following each dose of Moderna original formulation in the phase III trial^13,16

Table 2b: Frequency of select common adverse events reported within 7 days following each dose of Moderna original formulation in the phase II/III trial in infants and very young children¹⁸

Adverse events following booster and bivalent formulations

In a clinical trial using Moderna original formulation as a booster dose (using a dose of 50 micrograms), adverse events were generally mild to moderate, and similar to rates seen after the primary 2-dose series in phase II and III trials.¹⁹ Moderna bivalent original/Omicron BA.1 and Moderna bivalent original/Omicron BA.4/5 as booster doses had similar rates of adverse events to the first or second booster of Moderna original formulation, and to the second dose of the primary series Moderna original formulation.^14,15

Table 3: Frequency of select common adverse events reported within 7 days following each dose of Moderna bivalent original/Omicron BA.1 and BA.4/5 formulations in the phase II/III trials in adult^14,15

Uncommon adverse events

Lymphadenopathy occurred in 1.1% of adult vaccine recipients, 4.3% of adolescent vaccine recipients and 0.4% of adolescent placebo recipients aged 12 to 17 years overall. It was less common overall in children aged 6 to 11 years (1.9% of Moderna original formulation recipients), young children aged 2 to 5 years (0.9% of Moderna original formulation recipients) and in infants aged 6 to 23 months (1.5% of Moderna original formulation recipients).¹⁸ Most lymphadenopathy was mild to moderate and resolved within 1 to 2 days. 

Hypersensitivity-related adverse reactions were slightly more common in people who had the vaccine than in people who had the placebo among adults (1.5% versus 1.1%) and among children aged 2 to 5 years (3.5% versus 2.5%), but not infants aged 6 to 23 months (3.9% versus 5.3%).¹⁸ These reported anaphylactic or severe hypersensitivity reactions did not occur in close timing with the vaccine. There were no events clinically concerning for anaphylaxis in the 6-month to 5-year age group within the trial. The rates of occurrence of these reactions among children aged 6 to 11 years are currently unknown, as this vaccine has not yet been used at a population level.

There was a small imbalance in the number of participants with Bell’s palsy (3 in the vaccine arm on day 22, 28 and 32, compared with 1 in the placebo arm on day 17). All cases were judged as unrelated to the administration of either the vaccine or placebo. Two participants, both with a history of facial dermal filler cosmetic injection, experienced facial swelling within 2 days of receiving the vaccine.

Young children may rarely experience febrile convulsions (also called febrile seizures) after vaccination. One vaccine-related febrile convulsion was reported during the trial in children aged 6 months to 5 years. This occurred in a 17-month-old female child, one day after dose 1. There were 2 non-febrile seizures reported in vaccine recipients aged 2 to 5 years, which were considered not related to vaccination. Children with a history of febrile convulsions were excluded from participating in this trial, therefore the rate of potential febrile convulsions in this group is unknown.¹⁸

Pfizer and Moderna COVID-19 vaccines – adverse events reported in post-licensure use

Post-licensure surveillance is undertaken for all vaccines to identify signals for rare, population-specific events.

Reactogenicity

Injection site pain and systemic adverse events such as fatigue, headache and muscle ache following Pfizer original formulation have been commonly reported in routine use at similar or lower rates than reported in clinical trials. A small proportion of individuals have reported missing work, study or routine term duties for a short period following vaccination with Pfizer original formulation (6.7% following dose 1 and 21.2% following dose 2).²⁰

Data on booster doses from the V-safe and Vaccine Adverse Event Reporting Systems (VAERS) show no unexpected patterns of adverse events.^21,22 These data mainly involve the same mRNA vaccine as the primary course given as a booster dose. For Pfizer original formulation, local and systemic reactions were reported less frequently after dose 3 than dose 2. For Moderna, local reactions were reported slightly more frequently and systemic reactions slightly less frequently after dose 3 than dose 2.

Myocarditis and pericarditis

Myocarditis and pericarditis have been reported very rarely in people vaccinated with Pfizer and Moderna vaccines.^23-27 Myocarditis and/or pericarditis can occur after Novavax. A small number of cases of myocarditis and pericarditis have been reported in the clinical trial and in Australia. The TGA assessed these Australian cases as likely vaccine-related. The risk of myocarditis or pericarditis after receiving Novavax vaccine is not yet known. Myocarditis and pericarditis can also occur following COVID-19 disease. Post-COVID-19 condition (’long COVID’) is also associated with cardiovascular complications.²⁸

Data from Canada, Israel, Australia, the United Kingdom, the United States and some European countries suggest that the incidence of myocarditis and pericarditis associated with Moderna vaccines is higher than with Pfizer vaccines. The severity of cases does not appear to differ.  Evidence from Canada suggests that an extended interval of 8 weeks between dose 1 and dose 2 may reduce the risk of myocarditis and/or pericarditis.

For detailed information on myocarditis and pericarditis refer to the ATAGI Guidance on myocarditis and pericarditis after COVID-19 vaccine.

Pfizer and Moderna COVID-19 vaccines – safety and adverse events in pregnancy

In a prospective cohort study of more than 35,000 pregnant women who received an mRNA COVID-19 vaccine (54% received Pfizer original formulation, 46% received Moderna original formulation), the adverse event profile was similar to that of non-pregnant women.^29,30 Pregnant women were slightly more likely to report injection site pain, and less likely to report generalised symptoms such as fever or tiredness. Fever of 38°C or above was reported by less than 1% of pregnant women after the first dose of Pfizer or Moderna original formulations, less than 5% after the second dose of Pfizer, and less than 12% after the second dose of Moderna. Fever of 39°C occurred in <0.05% of pregnant participants after the first dose, and 0.5% after the second dose. The findings from this large study are supported by other smaller observational studies.^29-31

Pregnancy outcomes after vaccination

The same study reported on pregnancy and neonatal outcomes in 827 women who received an mRNA COVID-19 vaccine in pregnancy. The study did not identify any safety concerns.³² Complications such as preterm delivery, stillbirth, small for gestational age infants and congenital anomalies occurred at a similar rate to what is seen in the general population.

In the clinical trial for the Pfizer original formulation, 23 women became pregnant during the study period, of which 11 had received Pfizer.³³  In the clinical trial for the Moderna original formulation, 13 women were unknowingly pregnant or became pregnant during the trial, of which 6 received the vaccine.³⁴ Information about the outcomes of their pregnancies is awaited.

Animal studies of Pfizer and Moderna original formulations have not shown any negative effects on fertility or pregnancy.^34-37

A phase II/III randomised controlled trial of Pfizer original formulation in pregnant women is underway in the United States.³⁸

AstraZeneca (Vaxzevria)

Thrombosis with thrombocytopenia syndrome (TTS) is a rare condition that has been reported after AstraZeneca. TTS has occurred in several countries, including Australia. It appears to be causally linked to vaccination.³⁹

For detailed information refer to the Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca.

Myocarditis and pericarditis

 A study from the United Kingdom in December 2021 found an increased risk of myocarditis and pericarditis associated with AstraZeneca. The risk was observed for males and females for any dose. The risk was highest in men aged under 40 years, 8 to 14 days after dose 2 (estimated excess of 14 cases per million doses, 95% CI 8–17.⁴⁰ Yellow Card reports from the United Kingdom also indicate a risk associated with AstraZeneca, with rates reported in young adults aged 18 to 29 years of 10 per million doses after dose 1 and 16 per million doses after dose 2.⁴¹

However, the risk of myocarditis and pericarditis after AstraZeneca remains smaller than that for mRNA vaccines. In similar age groups from the same reporting system, the rate for Pfizer original formulation after dose 2 was 27 per million doses and 70 per million doses after a second dose of Moderna original formulation.⁴¹ No data are available on the rate of myocarditis and/or pericarditis following AstraZeneca in Australia.

Immune (idiopathic) thrombocytopenic purpura (ITP)

ITP has been reported following AstraZeneca. In Australia, the observed incidence of ITP after AstraZeneca was found to be 8 per million doses, twice the expected background rate of 4.1 per million.⁴² One fatal case in Australia has been causally linked to vaccination.⁴³ One study from Scotland suggested an association between AstraZeneca and ITP with an estimated risk of 1.13 cases per 100,000 doses.⁴⁴

People should seek medical attention if they experience unusual bruising, petechiae or bleeding. People who develop ITP within 42 days after receiving AstraZeneca should consult a haematologist about whether to proceed with the second dose using the same or an alternative vaccine, and the timing of the second dose.⁴⁵

Capillary leak syndrome 

Capillary leak syndrome has been reported rarely following AstraZeneca in the United Kingdom and Europe,⁴⁵ including in people with a history of capillary leak syndrome. One case has been reported in Australia, but a causal link with the vaccine could not be established.⁴⁶ Capillary leak syndrome is a rare but severe relapsing-remitting condition where capillary fluid leaks into surrounding tissues. 

AstraZeneca is contraindicated in people with a history of capillary leak syndrome. 

Guillain–Barré syndrome

Cases of Guillain–Barré syndrome (GBS) have been reported following AstraZeneca. GBS is a rare immune disorder that often follows a viral infection.^47-51The European Medicines Agency concluded that a relationship with AstraZeneca could be possible.

Transverse myelitis

In a combined interim analysis of 4 clinical trials, one case of transverse myelitis was reported in the vaccine arm. This occurred 14 days after dose 2.⁵² An independent neurological committee reviewed the case and the likely diagnosis was idiopathic short segment spinal cord demyelination.

Two additional cases of transverse myelitis were considered unlikely to be related to vaccination, with one case subsequently attributed to pre-existing but previously unrecognised multiple sclerosis. The other case was reported in the control group.

Nuvaxovid (Novavax)

In the phase II/III trials of Novavax, adverse events within 7 days of vaccination were very common in people aged 18 years and older. Most were generally mild to moderate and well tolerated.

Preliminary data on the safety of Novavax in adolescents aged 12 to 17 years are available from the ongoing phase III trial. The adverse reaction profile was generally similar to that among adult participants aged 18 years and older. The exception was fever (including grade 3 fever), which was more common among adolescents aged 12 to 17 years than among adults. The frequency of local and systemic reactions was generally similar among participants aged 12 to 14 years and those aged 15 to 17 years.⁵³

There were no substantive differences in the frequency of adverse events overall observed in the clinical trial by sex, race, ethnicity, medical comorbidities or baseline SARS-CoV-2 status.

Local adverse events

Local adverse events were very common, particularly after dose 2, in both adolescents (76%) and adults (79%) (see Table 5). Injection site tenderness and pain were the most common adverse events reported after both dose 1 and dose 2. Local adverse events were more frequent among younger participants (age 18 to 64 years) than in older participants.

Most local adverse reactions were grade 1 (did not interfere with activities) or grade 2 (interfered with activities, or required repeated use of over-the-counter pain relief) in severity. Grade 3 events (interfered basic activities like eat or get dressed, may also require medical attention) were uncommon and the proportion of grade 3 reactions was higher after the second than the first dose. The median duration of injection site reactions was 2 days or less after any dose.⁵³

Systemic adverse events

Systemic adverse events were reported in 47.7% of Novavax recipients after dose 1, and 69.5% after dose 2 in people aged 18 years and older.⁵⁴ In adolescents aged 12 to 17 years, systemic adverse events were reported in 55% of Novavax recipients after dose 1, and 75% after dose 2. The most common solicited systemic adverse events were headache, myalgia, fatigue and malaise. Systemic adverse events were more frequently reported after dose 2, and in younger people aged 12 to 17 years than in adults aged 18 years and older (Table 5).^53,55

Fever was more common in adolescents aged 12 to 17 years, with 1% of adolescents reporting fever after the first dose, and 17% after the second dose (2% Grade 3). This is compared with 0.4% of adults after first dose and 6% of adults after second dose (0.4% Grade 3).^53,55

Most systemic adverse reactions were grade 1 (did not interfere with activities) or grade 2 (interfered with activities, or required repeated use of over-the-counter pain relief) in severity. Grade 3 events (interfered basic activities like eat or get dressed, may also require medical attention) were uncommon. In adolescents aged 12 to 17 years, there was only one correctly recorded grade 4 event (required medical intervention, or required hospitalisation), which was a case of headache following dose 2 in a Novavax recipient. The median duration of systemic adverse events was 1 to 2 days after any dose.^53,55

Table 5: Frequency of select common adverse events reported within 7 days following each dose of Novavax in the phase III trial^53,55-57

Uncommon and rare adverse events

There was a numerical imbalance in the reported incidence of hypertension in older adults during the 3 days following vaccination (1% in Novavax recipients and 0.6% in placebo recipients).⁵⁴ Hypertension was not reported in the adolescent population in the clinical study.⁵³

Potential immune-mediated medical conditions were numerically higher in the Novavax group than in the placebo group in participants 18 to 64 years of age but numerically lower in the Novavax group than in the placebo group in participants older than or equal to 65 years of age. There were no potential immune mediated medical conditions reported in adolescents aged 12 to 17 years which were considered related to vaccination. Lymphadenopathy was uncommon in both adolescents and adults (experienced by less than 1 in 100 participants).⁵⁵

Myocarditis and/or pericarditis can occur after Novavax. Cases of myocarditis and pericarditis following Novavax have been reported in clinical trials and in Australia.⁵⁸

A total of 3 cases of myocarditis were reported in the 2 phase III trials.^56,57 Of these, 2 occurred in the vaccine group and 1 in the placebo group.⁵⁴ Of the 2 cases in the vaccine group, 1 was a young healthy participant with onset 3 days after dose 2, and the other was a participant aged over 65 years. There is currently no published additional information on these cases and these cases are not necessarily attributable to the vaccine.

Up to 30 June 2022, 3 cases of myocarditis and 12 cases of pericarditis from 160,000 doses administered in Australia had been reported to the TGA and were assessed as being likely to be vaccine-related. The small number of total doses given globally prevents the calculation of a precise risk at this time. ATAGI will continue to monitor data as it emerges and update advice accordingly.

It is recommended that all COVID-19 vaccine recipients should be aware of the potential signs and symptoms of myocarditis or pericarditis, and should be counselled about when to seek medical attention. For more information, see ATAGI guidance on myocarditis and pericarditis.

Adverse events identified in post-licensure use

There are limited data on post-licensure use of the Novavax. ATAGI will continue to monitor and evaluate evidence on the safety of Novavax as it emerges.

Further reading

1. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med 2020;383:2603-15.
2. Frenck RW, Jr., Klein NP, Kitchin N, et al. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. N Engl J Med 2021;385:239-50.
3. United States Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Document. 2021. (Accessed 20 November 2021). https://www.fda.gov/media/153409/download
4. United States Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee Meeting June 15, 2022, FDA Briefing Document: EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age. 2022. (Accessed 7 December 2022). https://www.fda.gov/media/159195/download
5. United States Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine (Comirnaty, PF-07302048) Vaccines and Related Biological Products Advisory Committee Briefing Document. 2020. (Accessed 10 December 2020). https://www.fda.gov/media/144246/download
6. United States Food and Drug Administration. Vaccines and related biological products advisory committee briefing document: BNT162b2 [Comirnaty (COVID-19 vaccine, mRNA)] - evaluation of a booster dose (third dose). 2021. (Accessed 28 October 2021). https://www.fda.gov/media/152161/download
7. Falsey AR, Frenck RW, Jr., Walsh EE, et al. SARS-CoV-2 neutralization with BNT162b2 vaccine dose 3. N Engl J Med 2021;385:1627-9.
8. US Centers for Disease Control and Prevention. ACIP update to the evidence to recommendations for a Pfizer-BioNTech COVID-19 booster in children ages 5-11 years. 2022. (Accessed 19 September 2022). https://www.cdc.gov/vaccines/acip/recs/grade/pfizer-biontech-covid19-booster-children-etr.html
9. Walter EB, Talaat KR, Sabharwal C, et al. Evaluation of the BNT162b2 COVID-19 vaccine in children 5 to 11 years of age. N Engl J Med 2022;386:35-46.
10. Swanson K. Pfizer/BioNTech COVID-19 Omicron-modified bivalent vaccine: ACIP meeting presentation, 01 September 2022. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-09-01/07-covid-swanson-508.pdf
11. Pfizer Australia Pty Ltd. Australian product information – Comirnaty original/Omicron BA.4/5 COVID-19 vaccine. 2023. (Accessed 2/02/2023). https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-PI-01101-1&d=20230202172310101
12. European Medicines Agency. Comirnaty: EPAR – Product information (last updated 6 December 2022). 2022. (Accessed 12 December 2022). https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf
13. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med 2021;384:403-16.
14. Chalkias S, Harper C, Vrbicky K, et al. A bivalent Omicron-containing booster vaccine against COVID-19. N Engl J Med 2022;387:1279-91.
15. Chalkias S, Whatley J, Eder F, et al. Safety and immunogenicity of Omicron BA.4/BA.5 bivalent vaccine against COVID-19. medRxiv 2022:2022.12.11.22283166.
16. Ali K, Berman G, Zhou H, et al. Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents. N Engl J Med 2021;385:2241-51.
17. Therapeutic Goods Administration (TGA). AusPAR: Elasomeran – Australian Public Assessment Report. Canberra: TGA; 2022. (Accessed 23 February 2022). https://www.tga.gov.au/auspar/auspar-elasomeran-1
18. United States Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee Meeting June 14-15, 2022, FDA Briefing Document: EUA amendment request for use of the Moderna COVID-19 Vaccine in children 6 months through 17 years of age. 2022. (Accessed 23 August 2022). https://www.fda.gov/media/159189/download
19. Choi A, Koch M, Wu K, et al. Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. Nat Med 2021;27:2025-31.
20. AusVaxSafety. COVID-19 vaccines active surveillance safety data. Sydney, Australia: 2021. (Accessed 9 September 2021). https://www.ausvaxsafety.org.au/safety-data/covid-19-vaccines
21. Hause AM. Early safety monitoring for additional COVID-19 vaccine doses: Reports to VAERS and v-safe. 2021. (Accessed 28 October 2021). https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-10-20-21/05-COVID-Hause-508.pdf
22. Hause AM, Baggs J, Gee J, et al. Safety monitoring of an additional dose of COVID-19 vaccine - United States, August 12-September 19, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1379-84.
23. Abu Mouch S, Roguin A, Hellou E, et al. Myocarditis following COVID-19 mRNA vaccination. Vaccine 2021;39:3790-3.
24. Kim HW, Jenista ER, Wendell DC, et al. Patients with acute myocarditis following mRNA COVID-19 vaccination. JAMA Cardiol 2021;6:1196-201.
25. Marshall M, Ferguson ID, Lewis P, et al. Symptomatic acute myocarditis in 7 adolescents after Pfizer-BioNTech COVID-19 vaccination. Pediatrics 2021;148.
26. Montgomery J, Ryan M, Engler R, et al. Myocarditis following immunization with mRNA COVID-19 vaccines in members of the US military. JAMA Cardiol 2021;6:1202-6.
27. Rosner CM, Genovese L, Tehrani BN, et al. Myocarditis temporally associated with COVID-19 vaccination. Circulation 2021;144:502-5.
28. Xie Y, Xu E, Bowe B, Al-Aly Z. Long-term cardiovascular outcomes of COVID-19. Nat Med 2022;28:583-90.
29. Gray KJ, Bordt EA, Atyeo C, et al. Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study. Am J Obstet Gynecol 2021;225:303.e1-.e17.
30. Collier AY, McMahan K, Yu J, et al. Immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating women. JAMA 2021;325:2370–80.
31. Kadali RAK, Janagama R, Peruru SR, et al. Adverse effects of COVID-19 messenger RNA vaccines among pregnant women: a cross-sectional study on healthcare workers with detailed self-reported symptoms. Am J Obstet Gynecol 2021;225:458-60.
32. Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary findings of mRNA COVID-19 vaccine safety in pregnant persons. N Engl J Med 2021;384:2273-82.
33. Perlman S. Another decade, another coronavirus. N Engl J Med 2020;382:760-2.
34. United States Food and Drug Administration. Moderna COVID-19 vaccine: Emergency Use Authorization (EUA) for an unapproved product review memorandum. 2021. (Accessed 12 August 2021). https://www.fda.gov/media/144673/download
35. Bowman CJ, Bouressam M, Campion SN, et al. Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine. Reprod Toxicol 2021;103:28-35.
36. Orvieto R, Noach-Hirsh M, Segev-Zahav A, et al. Does mRNA SARS-CoV-2 vaccine influence patients' performance during IVF-ET cycle? Reprod Biol Endocrinol 2021;19:69.
37. Safrai M, Rottenstreich A, Herzberg S, et al. Stopping the misinformation: BNT162b2 COVID-19 vaccine has no negative effect on women’s fertility. 2021. (Accessed 9 September 2021). https://www.medrxiv.org/content/10.1101/2021.05.30.21258079v1
38. ClinicalTrials.gov. Study to evaluate the safety, tolerability, and immunogenicity of SARS CoV-2 RNA vaccine candidate (BNT162b2) against COVID-19 in healthy pregnant women 18 years of age and older. United States of America: National Institutes of Health; 2021. (Accessed 10 June 2021). https://clinicaltrials.gov/ct2/show/NCT04754594
39. Medicines and Healthcare products Regulatory Agency. Coronavirus vaccine - weekly summary of Yellow Card reporting. 2021. (Accessed 26 April 2021). https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
40. Patone M, Mei X, Handunnetthi L, et al. Risk of myocarditis after sequential doses of COVID-19 vaccine and SARS-CoV-2 infection by age and sex. Circulation 2022;146:743-54.
41. Medicines and Healthcare products Regulatory Agency. Research and analysis: coronavirus vaccine - weekly summary of Yellow Card reporting. London: UK Government; 2022. (Accessed 11 February 2022). https://www.gov.uk/government/publications/coronavirus-covid-19-vaccineadverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
42. Gordon S, Clothier H, Morgan H, et al. Immune thrombocytopenia following immunisation with Vaxzevria ChadOx1-S (AstraZeneca) vaccine, Victoria, Australia. Vaccine 2021;39:7052–7.
43. Therapeutic Goods Administration (TGA). TGA weekly report 26 August 2021. Australian Government Department of Health; 2021. (Accessed 9 September 2021). https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-26-08-2021
44. Simpson CR, Shi T, Vasileiou E, et al. First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland. Nat Med 2021;27:1290-7.
45. UK Medicines and Healthcare products Regulatory Agency. Coronavirus vaccine - weekly summary of Yellow Card reporting. 2 September 2021. (Accessed 9 September 2021). https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
46. Therapeutic Goods Administration (TGA). COVID-19 vaccines weekly safety report: 15 July 2021. Australian Government Department of Health; 2021. (Accessed 9 September 2021). https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report
47. Allen CM, Ramsamy S, Tarr AW, et al. Guillain-Barré Syndrome Variant Occurring after SARS-CoV-2 Vaccination. Annals of Neurology 2021;90:315-8.
48. Maramattom BV, Krishnan P, Paul R, et al. Guillain-Barré Syndrome following ChAdOx1-S/nCoV-19 Vaccine. Annals of Neurology 2021;90:312-4.
49. European Medicines Agency (EMA). Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021 5-8 July 2021. (Accessed 9 September 2021). https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-july-2021
50. Therapeutic Goods Administration (TGA). COVID-19 vaccine weekly safety report - 02-09-2021. 2021. (Accessed 9 September 2021). https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report/current
51. World Health Organization (WHO). Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on reports of Guillain-Barré Syndrome (GBS) following adenovirus vector COVID-19 vaccines. Geneva: WHO; 26 July 2021. (Accessed 9 September 2021). https://www.who.int/news/item/26-07-2021-statement-of-the-who-gacvs-covid-19-subcommittee-on-gbs
52. Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021;397:99-111.
53. Therapeutic Goods Administration (TGA). Australian Public Assessment Report for Nuvaxovid. Canberra: TGA; 2022. (Accessed 23 August 2022). https://www.tga.gov.au/auspar/auspar-sars-cov-2-rs-matrix-m-adjuvant-nvx-cov2373
54. European Medicines Agency. CHMP assessment report: Nuvaxovid. 2022. (Accessed 11 February 2022). https://www.ema.europa.eu/en/documents/assessment-report/nuvaxovid-epar-public-assessment-report_en.pdf
55. European Medicines Agency. Nuvaxovid: EPAR. 2022. (Accessed 23 August 2022). https://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovid
56. Heath P, Galiza E, Baxter D, et al. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. N Engl J Med 2021;385:1172-83.
57. Dunkle L, Kotloff K, Gay C, et al. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. N Engl J Med 2022;386:531-43.
58. European Medicines Agency. Nuvaxovid: safety updates. 2022. (Accessed 23 August 2022). https://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovid#safety-updates-section