NPRA Approves Pfizer Booster Shot For All Adults

Health DG’s statement did not specify if the National Pharmaceutical Regulatory Agency gave regulatory approval for heterologous vaccination with a Pfizer booster dose.

KUALA LUMPUR, Oct 8 — The National Pharmaceutical Regulatory Agency (NPRA) today gave blanket approval for all adults to receive a booster dose with Pfizer-BioNTech’s Covid-19 vaccine at least six months after their second jab.

Health director-general Dr Noor Hisham Abdullah’s statement on NPRA’s conditional approval for use of a third dose with the mRNA vaccine on everyone aged 18 and above did not specify whether NPRA gave regulatory approval for heterologous vaccination with the Pfizer booster, meaning whether those who were previously vaccinated with a different vaccine (AstraZeneca-Oxford, Sinovac, or CanSino) could receive a third shot with Pfizer.

“This is the first Covid-19 vaccine approved for booster doses in this country,” Dr Noor Hisham said in a brief statement.

His statement also did not contain any recommendations by NPRA on which groups should get the booster shot. 

With the adolescent vaccination programme, on the other hand, NPRA made explicit recommendations that Sinovac be prioritised for teenagers without underlying health conditions and who have allergies or are contraindicated to receive Pfizer.

In response to CodeBlue’s questions on the lack of explicit regulatory approval from the NPRA for heterologous vaccination, the Ministry of Health (MOH) said the Special Committee on Ensuring Access to Covid-19 Vaccine Supply (JKJAV) would discuss the mix-and-match policy next week.

“The manner of how it will be delivered will be discussed as well. The context of this statement is only to inform that PBKD has given conditional approval for Pfizer to be used as a booster dose,” said MOH, referring to the Drug Control Authority (PBKD) that is under the NPRA, adding that NPRA is also part of the JKJAV. 

Health Minister Khairy Jamaluddin said last Monday that JKJAV’s technical sub-committee headed by Dr Kalaiarasu Peariasamy has recommended JKJAV to allow heterologous vaccination.

Khairy said yesterday that booster shots would not be made mandatory, but that the government strongly recommends for high-risk individuals like the elderly, those with comorbidities, frontline health care workers, and people with suppressed immune systems to get a third dose.

National Recovery Council chairman Muhyiddin Yassin said last month that the government has procured sufficient coronavirus vaccines to offer boosters to all adult residents in Malaysia.

Immunologists and virologists previously told CodeBlue that there was no evidence to justify a mass booster vaccination programme, saying that two vaccine doses still gave strong protection against severe disease and death. They said a third dose should only be required for immunocompromised people, such as elderly persons, HIV patients, transplant patients, and cancer patients. 

Malaysia’s Recovam real-world study on vaccine efficacy, led by the Institute for Clinical Research, found that double vaccination with Pfizer, AstraZeneca, or Sinovac was highly effective in preventing infection, symptomatic disease, intensive care unit (ICU) admission, and death.

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