Malaysia Using Off-Label Mix-And-Match Covid-19 Vaccines For Elderly

Health DG Dr Noor Hisham Abdullah says NPRA has approved off-label use for a Pfizer booster shot for senior citizens aged 60 years and above who received two Sinovac doses.

KUALA LUMPUR, Oct 21 — Malaysia will administer off-label use of heterologous Covid-19 inoculation with Pfizer-BioNTech boosters for senior citizens double vaccinated with Sinovac.

Health Minister Khairy Jamaluddin told a press conference today that the administration of heterologous vaccination for people aged 60 years and older would be studied as a subgroup of the Recovam real-world study on Covid-19 vaccine efficacy led by the Institute for Clinical Research (ICR).

Off-label use means that a drug or a vaccine is prescribed for an unapproved use to treat or prevent a medical condition.

The National Pharmaceutical Regulatory Agency (NPRA) has approved both Pfizer and Sinovac vaccines to prevent Covid-19. However, the regulatory body has only authorised Pfizer boosters for people who previously received two doses of the same mRNA vaccine.

Nonetheless, Health director-general Dr Noor Hisham Abdullah, at the same press briefing with Khairy, said that NPRA has approved off-label usage for the mix-and-match combination of Pfizer boosters for Sinovac recipients.

“ICR will conduct an observation study for a year to look at the efficacy and side effects,” he said.

“This is the combination of work from NPRA, ICR, and NIH (National Institutes of Health) to get the latest data to convince us on whether mix-and-match can be used and we can share the data with other agencies or at the global level.”

Khairy said the Pfizer booster shot would be offered to Sinovac recipients aged 60 years and older at least three months after their second dose.

As of October 19, a total of 47,728 Pfizer recipients have received an additional dose of the mRNA vaccine. Pfizer recipients that are currently prioritised for booster shots, at least six months after their second jab, are health and security frontline workers, individuals aged 60 years and above, and those with comorbidities.

The health minister cited recommendations from the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) at a meeting from October 4 to 7 to back heterologous vaccination for Sinovac recipients.

Eligible Sinovac recipients are expected to start receiving their booster shots from October 22 in phases nationwide. They will be offered their shots via MySejahtera or SMSes. The booster rollout will be managed by private medical practitioners under ProtectHealth Corporation’s purview. Malaysia’s entire booster programme under the National Covid-19 Immunisation Programme (PICK) is voluntary and free of charge for recipients.

Sarawak minister Dr Sim Kui Hian announced yesterday that the state is now offering Pfizer booster shots to senior citizens double vaccinated with Sinovac, an inactivated vaccine from China.

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