DCA approves Sinovac vaccine for children, Pfizer's Covid pill

 

The Drug Control Authority (DCA) has extended the approval of Sinovac’s Covid-19 vaccine to children aged 5 to 11 years, making it the second vaccine approved in Malaysia for this age group.

In addition, it has approved Pfizer’s antiviral pill Paxlovid for the treatment of certain Covid-19 patients who are at high risk of developing severe symptoms later on.

The approval of both products is provisional in nature, which requires pharmaceutical companies to continuously provide updates on its quality, safety, and efficacy to the National Pharmaceutical Regulatory Agency (NPRA).

This is to ensure the benefits of these interventions will always outweigh its risks, said Health Ministry (MOH) director-general Dr Noor Hisham Abdullah in a statement today.

Both decisions were made at DCA’s 370th meeting today.

Prior to this decision, the Sinovac vaccine Coronavac was approved for adolescents and adults.

However, its use in the National Immunisation Program among adolescents was not widespread as the MOH preferred to use the Pfizer vaccine due to its higher efficacy.

The MOH reserved the Sinovac vaccine for those who are unable to take the Pfizer vaccine for medical reasons.

It is understood that the Coronavac vaccine approved for children aged 5 to 11 years is the same as the one used on adolescents and adults. This contrasts with the Pfizer vaccine Comirnaty, where a low-dose version of the adolescent/adult vaccine is used for this age group.

The child version of the Pfizer vaccine was approved on Jan 6 and began to be used in the vaccination campaign from Feb 4 onwards.

As for Pfizer’s antiviral pill Paxlovid, Noor Hisham said it is approved for Covid-19 patients above 18 years old who do not need oxygen therapy (i.e. those below Category 4 in severity) but are at risk of developing more severe disease.

“Paxlovid is not intended to replace Covid-19 vaccination and public health interventions, particularly SOP compliance,” Noor Hisham said.

The MOH has previously indicated that it is procuring supplies of Paxlovid as well as its Merck rival Molnupiravir after clinical trials show that it can prevent some Covid-19 patients with mild-to-moderate symptoms from progressing into severe disease.

Merck previously released interim data showing that its drug can reduce hospitalisations and death by 50 percent, but later revised it to around 30 percent. Some scientists have also raised safety concerns about the drug, and it is not recommended for pregnant women.

Meanwhile, Pfizer had reported that Paxlovid could reduce hospitalisations and death by around 89 percent.

However, it is not suitable for patients taking certain medications for other medical conditions such as irregular heart rate, migraine, and high cholesterol.

A fact sheet issued by the company warns that interactions between Paxlovid and a list of such drugs may cause “serious or life-threatening side effects or affects how Paxlovid works”. No such drug interactions have been reported for Molnupiravir.

For now, however, only Paxlovid is the only antiviral drug approved for use in Malaysia that was specifically developed to treat Covid-19. Molnupiravir is only approved in the country for testing purposes as part of a late-stage international study sponsored by Merck since Dec 14 last year. - Mkini