Covid-19: Over RM2.5mil paid to 150 people who suffered serious side effects to vaccine, says Dr Zaliha

KUALA LUMPUR: A total of RM2.556mil in compensation was paid out to a total of 150 eligible applicants who suffered serious side effects related to Covid-19 vaccines, says the Health Ministry.

In a parliamentary written reply, Health Minister Dr Zaliha Mustafa revealed that a total of 318 individuals had applied for "Special Financial Assistance Adverse Effects of Covid-19 Vaccine” as of May 15, 2023.

"Out of the total, 150 applications have been approved by the main committee for Special Financial Assistance for Adverse Effects of the Vaccine, involving a total payment of RM2.556mil," she said in reply to a question from Teresa Kok (PH-Seputeh) who asked the Health Ministry to state the number of complaints received related to the side effects of Covid-19.

She also wanted to know the amount of compensation given to the eligible applicants.

Dr Zaliha said that since the National Covid-19 Immunisation Programme started in Feb 2021 until April 30, 2023, a total of 72.6 million doses of the Covid-19 vaccine have been administered.

"The National Pharmaceutical Regulatory Agency (NPRA) received a total of 26,716 reports of Adverse Events Following Immunization (AEFI) for the Covid-19 vaccine through the NPRA Reporting System.

"The rate of AEFI reporting received is equivalent to 368 reports per million doses administered," she said.

She highlighted that the majority of AEFI reports (93%) that have been reported were non-serious and usually can be resolved within a few days without or with treatment.

"Out of the 26,716 AEFI reports received, only 1,869 reports (7 reports per million doses) have been classified as serious," she added.

Dr Zaliha explained that the payment would be made to those who are eligible and had experienced serious (AEFI) or permanent disability, as well as the next-of-kin of those who passed away.

"The payment under the special financial assistance adverse effects of Covid-19 is given based on the government's concern and is not an acknowledgement of any liability by the government and not as compensation," she said.

She added that 30 applications are still under evaluation, while 138 applications have been rejected.

"Out of those 30 applications, 12 applications are under evaluation by the Covid-19 Vaccine Special PharmacoVigilance Committee (JFK), while six applications are under evaluation by the Medical Technical Committee (JTP).

"The remaining 12 applications are under evaluation by the Main Committee for Special Financial Assistance for Adverse Effects of the Covid-19 Vaccine," she said.

She also listed out several considerations and criteria to be eligible that need to be fulfilled, including the AEFI must be categorised as 'serious' based on the assessment report by the Covid-19 Vaccine Special PharmacoVigilance Committee and that confirmed AEFI reports must be submitted to the National Pharmaceutical Regulatory Agency (NPRA) by healthcare providers treating the patients.

"The serious AEFI cases must have occurred within three months of receiving the vaccine while for death cases, autopsy reports or relevant medical records indicating that the cause of death is related to the Covid-19 vaccine injection must be included.

"The applications to receive this assistance will only be considered if submitted within one year from the occurrence of AEFI. Relevant evidence and documentation should also be provided," she noted.

She further noted that the Special Financial Assistance for Adverse Effects of the Covid-19 Vaccine payment may be considered if the investigation and assessment determine that the harm is confirmed to be caused by the Covid-19 vaccine or there is a possibility that is it caused by the Covid-19 vaccine cannot be ruled out.