Safety Updates on COVID-19 Vaccine (Comirnaty®)

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Introduction

According to World Health Organisation (WHO), vaccination will be an important tool to stop the COVID-19 pandemic. Now, a year after the pandemic erupted, more than 60 COVID-19 vaccine candidates had been developed and some of them had been granted authorisations in hope to end the battle against this devastating pandemic soon.1-3

Mass COVID-19 vaccination campaigns are currently underway across the globe and Comirnaty® (BNT162b2) is among the COVID-19 vaccines being deployed in those national campaigns.4-6 Unlike other conventional vaccines, Comirnaty® employs a novel genetic technology known as mRNA, which takes advantage of the process that host cells use in order to make proteins to trigger an immune response and subsequently contributes protection against SARS-CoV-2, the virus that causes COVID-19.2 Although Comirnaty® is among the first mRNA vaccines being authorised for human use, the technology is actually not entirely new as there was previous clinical trial of cancer vaccine using the same mRNA technology and safety had been demonstrated in the trial.7

In January 2021, Comirnaty® had been granted a conditional registration in Malaysia, with indication of active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.8 Comirnaty® will be integrated in the National COVID-19 Immunization Campaign which is scheduled to begin at the end of February 2021.9

 

Safety Data of Comirnaty® Post Authorisation

Continuous and proactive safety monitoring of Comirnaty® post authorisation is utmost important to ensure that it continues to be safe for use. As more and more doses of Comirnaty® had been administered around the globe, safety data are now available for analysis to determine its safety profile in real-world settings.

In general, the current post marketing safety data for Comirnaty® is in line with the known side effects detected during clinical trials and the benefit of Comirnaty® in preventing COVID-19 infection continues to outweigh any known risks. To date, there is no new confirmed safety signal with Comirnaty®.4,5

For instance in United Kingdom (UK), as of 31 January 2021, 20 ,319 reports have been reported for Comirnaty® with overall reporting rate around 3 to 4 reports per 1,000 doses administered. The vast majority of reports involved injection-site reactions and generalised symptoms such as headache, chills, fatigue, nausea, fever, dizziness and aching muscles. These reactions generally happen shortly after vaccination and are not associated with more serious or lasting illness.4

Severe allergic reaction (anaphylaxis) and fatal outcome in frail elderly individuals were among the recent safety concerns of Comirnaty® that emerged following its widespread use. Nevertheless, experts’ analysis concluded that there is no new aspect regarding the nature of severe allergic reaction and no specific safety concern has been identified for vaccine use in frail elderly individuals.10

 

Recent Safety Concerns of Comirnaty®                                     

1. Severe allergic reaction (anaphylaxis)

Severe Allergic Reaction (Anaphylaxis) is a known but rare side effect of Comirnaty®. As with other vaccines, there will always be a very small proportion of susceptible individuals who might experience severe allergic reactions to the active ingredients or the excipients of the vaccine following its administration. In view of this risk, the Product Registration Holder (PRH) had advised that vaccinees to be closely observed for at least 15 minutes upon vaccination and the second dose should not be administered to those who have experienced anaphylaxis to the first dose of Comirnaty®.8

In USA, 50 cases of anaphylaxis had been detected after administration of 9,943,247 doses of Comirnaty® from 14 December 2020 to 18 January 2021 (5.0 cases per million doses) and 74% of those cases occurred within 15 minutes of vaccination. A similar reporting rate was also observed in UK, where a total of 130 reports of anaphylaxis and anaphylactoid reactions had been received after more than 7 million doses of Comirnaty® had been administered (between 1 to 2 cases per 100,000 doses). No death from anaphylaxis were reported after receipt of Comirnaty® in both countries.4-5

Comparing to USA & UK, the incidence rate of anaphylaxis post Comirnaty® administration was found to be higher in Singapore (about 2.7 cases per 100,000 doses administered). Nevertheless, the variations in the incidence rate are not alarming and to be expected, as the numbers vaccinated in Singapore during that period are relatively small. All vaccinees who experienced anaphylaxis had been promptly detected, treated, and recovered after observation or treatment.11 

In summary, the risk of anaphylaxis had been identified even prior to Comirnaty® authorisation and the assessment of those anaphylaxis reports to date did not identify new aspects regarding the nature of this side effect. This identified risk has also been addressed with the appropriate cautionary warning and advices (refer Product Information).8,10

 

2. Risk of fatal outcome in frail elderly individuals

In January 2021, the Norwegian Medicines Agency (NOMA) had reported that there had been 23 deaths associated with Comirnaty® vaccination among severely frail elderly people in Norway. These 23 deaths occurred within six days after vaccination and the initial report by NOMA suggested that common adverse reactions to Comirnaty®, such as fever and nausea may have contributed to a more serious course and subsequent fatal outcome in those frail people.12,13

In response to this cluster of death cases, the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 Vaccine Safety subcommittee had conducted a review based on the available information and data related to these death cases. The committee concluded that the available information did not confirm a contributory role for Comirnaty® in the reported fatal events and the reports were in line with expected all-cause mortality rates and causes of death in the sub-population of frail elderly individuals.14

Similar review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency. The PRAC’s assessment concluded that progression of (multiple) pre-existing diseases seemed to be a plausible cause of death for these individuals, and in some cases, palliative care had already been initiated prior to vaccination. Based on the current data, there was no new safety concern and no change regarding how Comirnaty® should be used, including in frail elderly individuals.10

 

Action by NPRA

NPRA will continue to monitor the safety of Comirnaty® and other COVID-19 vaccines as they are rolled out in Malaysia.

 

References:

  1. World Health Organisation (WHO). COVID-19 vaccines [Internet]. 2021. [Cited 2021 February 12]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines.
  2. European Medicines Agency (EMA). EMA recommends first COVID-19 vaccine for authorisation in the EU [Internet]. 21 December 2020 [Cited 2021 February 12]. Available from: https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu.
  3. United States Food and Drug Administration (FDA). FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine [Internet]. 11 December 2020. [Cited 2021 February 12]. Available from: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.
  4. United Kingdom Medicines & Healthcare Products Regulatory Agency (UK MHRA). Coronavirus vaccine - weekly summary of Yellow Card reporting [Internet]. 11 February 2021 [Cited 2021 February 12]. Available from: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting.
  5. United States Centers for Disease Control and Prevention (CDC). COVID-19 vaccine safety update [Internet]. 27 January 2021 [Cited 2021 February 12]. Available from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-01/06-COVID-Shimabukuro.pdf.
  6. British Medical Journal. Covid-19: Indian health officials defend approval of vaccine. [Internet] 7 January 2021 [Cited 2021 February 12]. Available from: https://www.bmj.com/content/372/bmj.n52.
  7. Ugur S, Evelyna D, Matthias M, Björn-Philipp K, Petra S, Martin L, Valesca B, Arbel DT, Ulrich L, Barbara S, Tana O, Mathias V, Christian A, Anna P, Andreas K, Janina B, Sandra H, Katharina S, Felicitas M, Inga O, Isabel V, Eva G, Sebastian A, Richard R, Andrea B, Claudia T, Martin S, Goran M, Alexander H, Patrick S, Jan D, Janko C, Olga W, Alexandra B, Meike W, Martina Z, Andree R, Barbara K, David L, Stefanie B, Mustafa D, Sebastian K, Romina N, Christoffer G, Stephan G, Christoph H, Jochen U, Christoph H, Carmen L, Özlem T. Personalized RNA mutanome vaccines mobilize poly-specific therapeutic immunity against cancer. Nature [Internet]. 2017 [Cited 2021 February 12]; 547: 222-226. Available from: https://www.nature.com/articles/nature23003.
  8. National Pharmaceutical Regulatory Agency. The Malaysian Quest 3+ Database [Internet]. 2021 [Cited 2021 February 12]. Available from: https://www.npra.gov.my.
  9. Martin C, Jo T. Covid-19: Malaysia's 'largest vaccination programme ever' to begin by month's end. The Star [Internet]. 4 February 2021 [Cited 2021 February 12]. Available from: https://www.thestar.com.my/news/nation/2021/02/04/covid-19-malaysia039s-039largest-vaccination-programme-ever039-to-begin-by-month039s-end.
  10. European Medicines Agency (EMA). COVID-19 vaccine safety update [Internet]. 28 January 2021 [Cited 2021 February 12]. Available from: https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-january-2021_en.pdf.
  11. Ministry of Health Singapore. Update on covid-19 vaccination programme [Internet]. 28 January 2021 [Cited 2021 February 12]. Available from: https://www.moh.gov.sg/news-highlights/details/update-on-covid-19-vaccination-programme.
  12. Norwegian Institute of Health. International interest about deaths following coronavirus vaccination [Internet]. 19 January 2021 [Cited 2021 February 12]. Available from: https://www.fhi.no/en/news/2021/international-interest-about-deaths-following-coronavirus-vaccination/.
  13. Norwegian Medicines Agency. Reported suspected adverse reactions to COVID-19 vaccines as of January 14 [Internet]. 15 January 2021 [Cited 2021 February 12]. Available from: https://legemiddelverket.no/nyheter/reported-suspected-adverse-reactions-to-covid-19-vaccines-as-of-january-14.
  14. World Health Organisation (WHO). GACVS COVID-19 Vaccine Safety subcommittee meeting to review reports of deaths of very frail elderly individuals vaccinated with Pfizer BioNTech COVID19 vaccine, BNT162b2 [Internet]. 22 January 2021 [Cited 2021 February 12]. Available from: https://www.who.int/news/item/22-01-2021-gacvs-review-deaths-pfizer-biontech-covid-19-vaccine-bnt162b2 

 

16 February 2021

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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