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.
AdvertisementAdvertisement"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."
[h=3]READ: Pfizer-BioNTech COVID-19 vaccine approved by Singapore, first shipment expected by end-December[/h]In a media release, HSA noted that the vaccine developed by US pharmaceutical giant Pfizer and German firm BioNTech demonstrated a high efficacy of 95 per cent.
AdvertisementAdvertisementThe vaccination regime submitted by Pfizer-BioNTech requires two doses of vaccine to be administered 21 days apart, in people aged 16 years and above.
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 also not receive the vaccine as the safety and efficacy data on these groups of people are not yet available, it said.
AdvertisementIn 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.
[h=3]READ: Singapore to start Phase 3 of COVID-19 reopening on Dec 28[/h]INTERIM AUTHORISATION
The vaccine was granted interim authorisation under the Pandemic Special Access Route (PSAR), said HSA. This 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.
[h=3]READ: Hong Kong to get Sinovac, Pfizer-BioNTech COVID-19 vaccines in first quarter[/h]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.
"As vaccine supply will arrive in Singapore in batches over several months as manufacturers ramp up their production of vaccines, we recommend that vaccination should start with groups who are at greater risk and hence most in need of COVID-19 vaccination, including healthcare workers and COVID-19 frontline workers, as well as vulnerable groups at greater risk of severe disease from COVID-19 infection, such as the elderly," it said.
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, it added.
[h=3]READ: In full: PM Lee's address on the COVID-19 situation[/h]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.
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