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THE HEALTH | JANUARY-FEBRUARY , 2023
| Hot Topic |
No major potential risks to vaccine recipients
The NPRA received 370 AEFI reports for every one million doses of the Covid-19 vaccines
BY KHIRTINI K KUMARAN
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
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 .”
( 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