The NPRA received 369 AEFI reports for every one million doses of the Covid-19 vaccines
Just like any other medication, vaccines too can have side effects, often referred to as adverse events following immunisation (AEFIs). Any untoward medical occurrence that occurs after administering a vaccine but may not necessarily be causally related to the vaccine itself is referred to as an AEFI.
Therefore, continuous Covid-19 vaccine safety surveillance has emerged as a key area of concern for healthcare professionals and regulators to assess the benefit-risk of immunisation continuously.
The development of the Covid-19 vaccines was accelerated by years of prior research, increased production capacity and efficiency, massive funding that allowed for multiple parallel trials, and quicker-than-usual regulatory action.
Since it had been established that the Covid-19 vaccines are effective in preventing serious illnesses and deaths brought on by Covid-19 infection, countries started launching mass vaccination campaigns. In Malaysia, the mass vaccination roll-out was initiated on Feb 24, 2021 under the National Immunisation Programme for Covid-19 (PICK).
It proved to be a huge success and by the end of that year, Malaysia ranked among the Top 10 globally for the highest vaccination rate. By September, nearly 80 per cent of the population was fully vaccinated. The highest daily jabs administered was 556,404 doses on July 29, 2021.
Monitoring the safety risks
In Malaysia, the Ministry of Health Malaysia (MoH), through the National Pharmaceutical Regulatory Division (NPRA), continuously monitors the safety risks of all registered drugs and vaccines used in Malaysia, including the Covid-19 vaccine through the adverse drug reaction (ADR) and AEFI reports.
According to the latest Covid-19 Vaccines AEFI Summary Report, as of Sept 20, 2022, only Comirnaty (Pfizer), CoronaVac (Sinovac), Vaxzevria (AstraZeneca), Convidecia (Cansino), and Covilo (Sinopharm) vaccines were used under PICK. As of Sept 20, 2022, a total of 72,091,311 Covid-19 vaccine doses had been administered (Fig 1).
NPRA receives and processes all types of AEFI reports suspected or likely to be due to vaccines. AEFI reports are collected via the existing NPRA Reporting System. NPRA receives all medicines adverse event reports, including AEFIs from pharmaceutical companies, healthcare professionals in government and private health institutions and consumers in Malaysia.
Majority of cases are minor and non-harmful
The NPRA Reporting System received 370 AEFI reports for every one million doses of the Covid-19 vaccines (Fig 2).
In addition to the regular reporting system, the MySejahtera Application on the vaccine recipients’ smartphones collects notifications of minor AEFIs during PICK. A total of 13,574 minor AEFI responses were reported via the MySejahtera application for every one million doses.
Of these, 93 per cent of AEFI reports received were minor, short-term, and did not pose any potential risk to the health of the vaccine recipients. Most minor AEFI side effects reported through the NPRA Reporting System and MySejahtera were consistent with those commonly observed following vaccination.
These include injection site pain and discomfort, headache, fatigue, muscle or joint pain, lethargy and fever, all of which usually recovered in a few days with or without treatment. The reporting trend for these common side effects remained consistent throughout the monitoring period.
In March 2022, the government had approved a pay-out of RM195,000 for 17 cases where individuals had experienced adverse effects after being vaccinated for Covid-19.
Serious AEFI events are rare
The rate of serious AEFIs reported via the NPRA Reporting System is small at 26 reports per one million doses. Only 1,865 or seven per cent of the total AEFI reports received were categorised as serious AEFIs, indicating that serious adverse events following Covid-19 vaccination rarely occurred.
Anaphylactic reactions, palpitations, chest pain, and shortness of breath were the most frequently reported serious AEFIs. These serious cases only needed short-term hospitalisation for treatment or further observation. At the time of AEFI reporting, most affected recipients had already recovered or were in the process of doing so.
And following detailed investigations and reviews, it has been determined that these incidents were not directly brought on by the vaccines administered. As a result, the Covid-19 vaccines registered in Malaysia continue to have a very favourable benefit-to-risk ratio.
The safety of Covid-19 vaccines in the Malaysian population is continuously monitored by the NPRA. Through pharmacovigilance activities such as continuous ADR and AEFI monitoring and screening of drug alerts and early signals of previously unrecognised risks and harms of medicines, the NPRA strives to ensure the safety of medicines. – The Health