DCA approves Pfizer’s updated Covid-19 shots

 

The Drug Control Authority (DCA) has granted conditional approval for Pfizer’s updated Covid-19 vaccines, paving the way for them to be rolled out as booster shots in Malaysia.

The new formulation of the Cominarty vaccine is a bivalent vaccine containing components of the original Covid-19 strain that was first detected in Wuhan in 2020, as well as the more recent BA.4-5 Omicron subvariants.

The previous formulation was a monovalent vaccine based only on the Wuhan strain.

“It is to be used among individuals aged 12 and above who have received their primary vaccination using an approved mRNA Covid-19 vaccine or adenoviral vector vaccines, at least three months after completing the primary vaccination or the last booster dose,” said Health director-general Dr Noor Hisham Abdullah today.

The decision was made during the DCA’s meeting today.

Limiting the updated vaccines to those who previously received mRNA or adenoviral vaccines means only those who previously received Pfizer, Moderna, AstraZeneca or CanSino’s Covid-19 vaccines for their primary vaccination are eligible for the updated booster, but not those who previously received Sinovac or Sinopharm vaccines.

However, Noor Hisham (above) did not say when will the new vaccines become available at healthcare facilities in the country and how to get them.

Previously, the then-health minister Khairy Jamaluddin had said the bivalent vaccine will arrive in Malaysia during the third or fourth week of November.

It was reported that the new booster provided improved protection against the BA.5 Omicron subvariant compared to the original formulation, though its performance with newer variants such as XBB and BQ.1 is still being studied.

Meanwhile, Noor Hisham said the DCA has also granted conditional approval for Solution Biologics Sdn Bhd to manufacture CanSino’s Convidecia vaccine against Covid-19. It is the second manufacturing facility to be granted approval to produce the vaccine for Malaysia, after the approval of Cansino’s own facility in China in June 2021.

The conditional approvals for both the updated Pfizer vaccine and the new Cansino vaccine plant require the National Pharmaceutical Regulatory Agency to continuously monitor the vaccines’ quality, safety, and efficacy, he said, to ensure the benefits of these vaccines outweigh their risks. - Mkini