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KUALA LUMPUR (Nov 28): Malaysia’s preliminary purchase agreement with pharmaceutical company Pfizer will be voided if the latter’s Covid-19 vaccine is not registered with the US Food and Drug Administration (FDA) and Malaysia National Pharmaceutical Regulatory Agency (NPRA), Health Director General (DG) Tan Sri Dr. Noor Hisham Abdullah said today.
Noor Hisham said this via Twitter today following news yesterday that the Malaysian government, through the Ministry of Health (MoH), had signed the agreement with Pfizer to obtain 12.8 million doses of its Covid- 19 to meet the immunization needs of 20% or 6.4 million Malaysians.
Called, citing Prime Minister Tan Sri Muhyiddin Yassin, reported that the agreement, signed on Tuesday, was intended to ensure that the government had access to data to assess the quality, safety and efficacy of the vaccine, while ensuring access to a once it is ready for distribution.
However, Muhyiddin was reported to have said that Pfizer would still need FDA approval and regulatory approval from the producing country, in addition to NPRA approval for the vaccine to be used in Malaysia.
“Pfizer stated on November 9 that the first interim data analysis showed that the efficacy of the vaccine was 95%. Through this agreement, Pfizer committed to administer one million doses, 1.7 million doses, 5.8 million doses and 4.3 million doses of Covid-19 vaccines in the first, second, third and fourth quarters of 2021.
“The government also wants to assure people that the vaccine to be used in Malaysia must pass the strict conditions set by the NPRA. The government will never compromise on this matter, ”he said yesterday at a virtual press conference in Putrajaya.
Today, Azrul Mohd Khalib, Executive Director (CEO) of the Galen Center for Health and Social Policy, said that the news of Malaysia’s agreement with Pfizer represents a major step forward in the race to improve the management of the epidemic of coronavirus among the population of Malaysia.
However, the fight against Covid-19 is a marathon and the agreement between Malaysia and Pfizer is only the first stage of the race, according to Azrul.
“The Pfizer and BioNTech Covid-19 vaccine, a two-dose regimen like most of the major vaccine candidates, is expected to be priced at $ 19.50 (approximately $ 79.36) per dose. This would mean Malaysia has agreed to pay an estimated US $ 249.6 million (more than RM 1 billion) for 12.8 million doses.
“However, the investment is worth it if we are able to quickly prioritize and ensure the protection of our personnel working in essential public services, such as in the health, law enforcement, sanitation and utilities sectors, as well as the vulnerable, such as the elderly and patients with non-communicable diseases, ”he said.
Azrul said that Galeno is also concerned about the logistics burden that the Ministry of Health must assume because the vaccine requires ultra-cold storage of -70 °C, a capacity beyond most existing primary health care centers.
Therefore, the Ministry of Health would depend on the availability of adequate storage units at the state level to ensure that the cold chain of vaccines is not interrupted, according to him.
“We hope that the most challenging part of the process will be delivering vaccines to rural areas. Due to limitations and pragmatic concerns, will urban areas be prioritized over rural ones?” Azrul asked.
Azrul said Malaysia needs to review its budget allocations for 2021, especially those related to Covid-19 vaccination because the scheme involves more than just the cost of the vaccine, but also supporting infrastructure expenses.
He said the country must ensure that the Ministry of Health obtains the necessary funds and manpower to start operating when the vaccine becomes available in 2021, especially since this vaccine has specific logistical and storage requirements that require investment in infrastructure and related training.
“Are we purchasing the special ice boxes from Pfizer? Have we allocated for the record-keeping system? As is, we do not believe the existing allocations are fit for purpose. The allocations for health need to be reviewed and increased.” . Azrul said.
Read also:
Covid-19: 30% of Malaysians are expected to get vaccinated next year
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