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Data on Pfizer-BioNTech COVID-19 vaccine 'robustly and thoroughly reviewed', says HSA

Data on Pfizer-BioNTech COVID-19 vaccine 'robustly and thoroughly reviewed', says HSA

FILE PHOTO: Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/File Photo

SINGAPORE: The data submitted by Pfizer-BioNTech on its COVID-19 vaccine was “robustly and thoroughly reviewed” by Singapore regulators, said the Health Sciences Authority (HSA) on Monday (Dec 14). 

This follows the announcement by Prime Minister Lee Hsien Loong that the agency has approved the COVID-19 vaccine, with the first shipment due to arrive in Singapore by the end of December.

"As with other new vaccines, the data submitted by Pfizer-BioNTech was robustly and thoroughly reviewed by HSA’s regulators, and international scientific standards were applied during the evaluation," said HSA.

"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."

READ: Pfizer-BioNTech COVID-19 vaccine approved by Singapore, first shipment expected by end-December

In a media release, HSA noted that the vaccine developed by US pharmaceutical giant Pfizer and German firm BioNTech demonstrated a high efficacy rate of 95 per cent.

Two doses are required to be administered 21 days apart, in people aged 16 years and above, according to the vaccination regime submitted by Pfizer-BioNTech.

The safety profile of the vaccine is “generally consistent” with other registered vaccines, said HSA, which means some people may experience side effects such as pain, redness, swelling at the injection site, as well as fatigue, headache and muscle ache after vaccination. 

While not everyone will experience these side effects, they are "common and expected" as part of the body’s natural response to build immunity against COVID-19, explained HSA.

Pregnant women, people with compromised immune systems and those under the age of 16 should not receive the vaccine as the safety and efficacy data on these groups of people are not yet available, it said.

In addition, people with a history of anaphylaxis or the rapid onset of severe allergic reactions should not receive the Pfizer-BioNTech vaccine as a precautionary measure.

Speaking at a COVID-19 multi-ministry task force press conference, Minister for Health Gan Kim Yong said that any vaccine administered to Singaporeans would need to meet "strict standards".

“Over the past months, the world has witnessed an astonishing speed of progress in vaccine development. But while the timelines for the COVID-19 vaccine trials have been accelerated, they must go through all the requisite clinical trials and safety checks to ensure that safety is not compromised,” he said.

“They must also meet the World Health Organization's guidelines, as well as international standards. I want to assure all Singaporeans that only vaccines that meet strict standards of safety, quality and effectiveness will be used for our population.”

READ: Singapore to start Phase 3 of COVID-19 reopening on Dec 28

READ: COVID-19: Social gatherings of up to 8 people allowed from Dec 28, further reopening of activities in Phase 3


The vaccine was granted interim authorisation under the Pandemic Special Access Route (PSAR), said HSA. It is similar to the emergency use authorisation framework adopted by other countries such as Canada, Switzerland and the United States. 

This regulatory pathway facilitates access to critical novel vaccines, medicines and medical devices during a pandemic.

"Using PSAR, HSA can start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, as and when real-time data is submitted by companies on a 'rolling', or staggered basis, instead of waiting for the full data set to be submitted before starting our evaluation," added HSA.

This gives the agency more time to review the submitted data while companies continue with further clinical trials and development concurrently, it said.

"The clinical trials have also been designed to be innovative and efficient, enabling the companies to conduct multiple trials concurrently, while maintaining the scientific rigour. Such regulatory agility and flexibility allow for speedier development and evaluation," noted HSA.

“HSA 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, while upholding high standards of quality, safety and efficacy, and following the same rigorous processes as used to register vaccines in normal times,” added Dr Mimi Choong, HSA's chief executive officer.

READ: Hong Kong to get Sinovac, Pfizer-BioNTech COVID-19 vaccines in first quarter

As a condition for the interim authorisation under PSAR, Pfizer and BioNTech will need to monitor the longer term efficacy of the vaccine to determine the duration of protection against COVID-19, said HSA.

"This will augment the available data which shows that the vaccine continues to be effective for at least two months, with no signs of waning protection," it noted.

Pfizer and BioNTech are also required to continue to follow up on the safety of the vaccine for a longer period of time to determine its full safety profile. 

"The companies must continue submitting the longer term follow up data to HSA to assure the continued effectiveness and safety of the vaccine. HSA will actively review the data to ensure that the benefits of the vaccine continue to outweigh the known risks," said HSA.


In a separate press release, an expert committee on COVID-19 vaccination which reviewed the vaccine’s safety and efficacy data said it agreed with the HSA's recommendation.

The expert committee also recommended that Singapore should achieve "as comprehensive a coverage of COVID-19 vaccination as possible" across its entire population. 

Everyone who is "medically eligible" should be vaccinated, it said, but vaccination should remain voluntary.

Priority will be given to those at greatest risk, such as frontline and healthcare workers, as well as the elderly.

More details on the committee's complete set of recommendations to the Government on the use and priority groups for vaccination will be provided in the coming weeks, the committee added.

The Ministry of Health's director of medical services Kenneth Mak also urged all Singaporeans who are eligible to be vaccinated.

"Vaccination is one of the key enablers that will protect us and our loved ones against COVID-19 infection and allow the economy to open up, for social activities to resume and having this community immunity will help us to be able to safely and quickly return back to normalcy," said Associate Professor Mak. 

"And we encourage therefore everyone in Singapore to take up the vaccination when it is offered to you."

At the same time, Assoc Prof Mak noted that vaccinations should not be seen as a "silver bullet" that would end the pandemic.

"Safe distancing and safe management measures continue to be critical until such a time when sufficient numbers of our population are protected," he said. 

"The COVID-19 vaccine will expedite our recovery from the pandemic. But it is going to be some time before the world returns to a pre-COVID normalcy. The key is not to let our guard down, and (not) to let our painstaking efforts in the past few months go to waste."

READ: In full: PM Lee's address on the COVID-19 situation

Singapore is one of the first countries to obtain the Pfizer-BioNTech vaccine, said the Prime Minister in his televised address to the nation on Monday.

Other vaccines are also expected to arrive in Singapore in the coming months, and the country “will have enough vaccines for everyone” by the third quarter of next year if all goes according to plan, he added. 

The Ministry of Health said Singapore has also signed Advance Purchase Agreements with Moderna and Sinovac, and are in discussions with a few other pharmaceutical companies.

In a press release on Monday, Pfizer and BioNTech said that the agreement to supply their vaccine to Singapore comes after emergency use authorisation from the US Food and Drug Administration and interim authorisation for pandemic supply from HSA.

Financial details of the agreement with Singapore were not disclosed, but the terms were based on the timing of delivery and the volume of doses, said the two companies.

"As requested by the Government of Singapore, deliveries are planned through 2021," they added.Pfizer and BioNTech said that their combined manufacturing network has the potential to supply up to 1.3 billion doses globally by the end of 2021.

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Source: CNA/mt(gs)


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