THE Health Ministry (MOH) is currently awaiting approval from the Attorney-General’s Chambers (AGC) on bivalent Covid-19 vaccines, Health Minister Dr Zaliha Mustafa said.

She said MOH is in talks with Pfizer (M) Sdn Bhd, which will be marketing it.

“We have discussed the matter with Pfizer (as) it is the one marketing the bivalent (vaccine).

“The agreement is still in progress; we are waiting for (the) AGC,” she told reporters at the launch of CRM Trial Connect 2023 in Kuala Lumpur today. 

The AGC’s approval is a standard step in the Covid-19 vaccine procurement process.

In January, then health director-general Dr Noor Hisham Abdullah said the detection of a possible link to stroke from the bivalent Covid-19 vaccine is merely a safety signal notification.

He said all safety signals must be properly investigated and evaluated.

“So far, no ischaemic stroke safety signal has been detected through other safety monitoring systems in the United States (like the Vaccine Adverse Event Reporting System), which is a follow-up to the use of the Comirnaty bivalent Covid-19 vaccine,” he said.

Further analysis also did not confirm the safety signal, he said.

The vaccine was given its conditional registration approval on December 13 during the MOH’s Drug Control Authority meeting.

Dr Noor Hisham said then that Pfizer must submit its latest safety data for post-vaccination effects.

He said the National Pharmaceutical Regulatory Agency will continue its close monitoring of the Covid-19 vaccines in use in Malaysia.

Dr Noor Hisham’s explanation on the vaccine comes after Reuters published an article on January 15 titled “US FDA, CDC see early signal of possible Pfizer bivalent Covid shot link to stroke”.

In the article, it was stated that a vaccine database detected a possible safety issue for those aged 65 and above, who were more likely to get an ischaemic stroke 21 days after receiving the Pfizer-BioNTech bivalent vaccine. – May 11, 2023.