S’pore Health Sciences Authority approves Pfizer-BioNTech COVID-19 vaccine; first shipment expected by end of December

The Health Sciences Authority of Singapore has approved the COVID-19 vaccine developed by United States pharmaceutical giant Pfizer and German firm BioNTech, said Prime Minister Lee Hsien Loong.

In a televised address on Monday (14 December), Mr Lee said that the first shipment of the vaccine is expected to arrive in Singapore by the end of this month.

The HSA approved the Pfizer-BioNTech vaccine “after studying the scientific evidence and clinical trial data”, he said.

Singapore is one of the first countries to obtain this vaccine, noted Mr Lee.

Other vaccines are also expected to arrive in Singapore in the coming months, he added.

“If all goes according to plan, we will have enough vaccines for everyone in Singapore by the third quarter of 2021,” Mr Lee said.

The prime minister also said that the committee of doctors and experts established by the Ministry of Health (MOH) has recommended that Singapore’s “entire adult population should be vaccinated”.

“First priority will be given to those who are at greatest risk — healthcare workers and frontline personnel, as well as the elderly and vulnerable.

“Thereafter, the committee proposes to progressively vaccinate the rest of the population and to cover everyone who wants a vaccination by the end of next year,” said Mr Lee.

He noted, however, that the committee proposed that vaccinations are to be “voluntary”.

“The Government has accepted these recommendations. I have personal confidence in our experts,” said Mr Lee.

Vaccinations, said Mr Lee, will be “free for all Singaporeans and for all long-term residents who are currently” in the country.

“So I strongly encourage you to get vaccinated too, when the vaccine is offered to you. Because when you get yourself vaccinated, you are not just protecting yourself.

“You are also doing your part to protect others, especially your loved ones. The more of us are vaccinated, the harder it will be for the virus to spread, and the safer we will all be as a society,” he said.

“My colleagues and I, including the older ones, will be getting ourselves vaccinated early. This is to show you, especially seniors like me, that we believe the vaccines are safe,” he assured.

MOH in a statement today said that the Expert Committee on COVID-19 Vaccination has reviewed the Pfizer-BioNTech vaccine’s safety and efficacy data for different population segments in Singapore.

It said that it has also been briefed by HSA on its full range of considerations in granting interim authorisation, and is thus satisfied with its safety and efficacy.

“The vaccine demonstrated a high vaccine efficacy of 95%, and its safety profile is consistent with the high standards set for other registered vaccines used in the immunisation against other diseases,” said MOH.

While the Ministry agrees with HSA’s recommendation for the suitability of its use in individuals aged 16 years and above in Singapore, “pregnant women, immunocompromised persons and those under the age of 16 should not receive the vaccine yet, until more data is available”.

HSA in a separate statement said that the data submitted by Pfizer-BioNTech on its vaccine “was robustly and thoroughly reviewed by HSA’s regulators, and international scientific standards were applied during the evaluation”.

“The vaccine was only granted interim authorisation after the data submitted by Pfizer-BioNTech was assessed by HSA to demonstrate that the vaccine meets the required safety, efficacy and quality standards, and that the benefits of the vaccine outweigh the known risks,” said HSA.

Mimi Choong May Ling, Chief Executive Officer of HSA, said that HSA’s regulators “were able to complete the evaluation of the Pfizer-BioNTech COVID-19 vaccine in the shortest possible time by working expeditiously on the available rolling data, instead of waiting for the full data set to be submitted before starting our evaluation”.

This was done “while upholding high standards of quality, safety and efficacy, and following the same rigorous processes as used to register vaccines in normal times”, she said.

“HSA’s assessment and recommendations were also supported by our Medicines Advisory Committee and Panel of Infectious Diseases Experts before granting the interim authorisation to meet public health needs,” Dr Choong added.

HSA’s Pandemic Special Access Route (PSAR) interim authorisation is similar to the emergency use authorisation framework currently adopted by other regulatory jurisdictions such as Canada, Switzerland, the United States and the United Kingdom, said HSA.

PSAR is a regulatory pathway that facilitates access to critical novel vaccines, medicines and medical devices during a pandemic such as the current COVID-19 pandemic.

The Authority may terminate PSAR authorisation at any time, for example, if new data suggest that the benefits no longer outweigh the risks.

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