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SINGAPORE: Data submitted by Pfizer-BioNTech on its COVID-19 vaccine was “rigorously and comprehensively reviewed” by Singapore regulators, the Health Sciences Authority (HSA) said on Monday (Dec 14). .
This follows Prime Minister Lee Hsien Loong’s announcement that the agency has approved the COVID-19 vaccine, with the first shipment arriving in Singapore in late December.
“As with other new vaccines, the data presented by Pfizer-BioNTech was rigorously and comprehensively reviewed by HSA regulators, and international scientific standards were applied during the evaluation,” HSA said.
“The vaccine only received a provisional authorization after the HSA evaluated the data submitted by Pfizer-BioNTech 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 of December
In a press release, HSA noted that the vaccine developed by the US pharmaceutical giant Pfizer and the German company BioNTech demonstrated a high efficacy of 95 percent.
The vaccination regimen presented by Pfizer-BioNTech requires that two doses of the vaccine be administered 21 days apart, in persons 16 years of age and older.
The vaccine’s safety profile is “generally consistent” with other registered vaccines, HSA said, meaning that some people may experience side effects such as pain, redness, swelling at the injection site, as well as fatigue, headache. and muscle pain after vaccination. .
While not all people will experience these side effects, they are “common and expected” as part of the body’s natural response to building immunity against COVID-19, HSA explained.
Pregnant women, people with compromised immune systems and those under the age of 16 should also not receive the vaccine, as safety and efficacy data on these groups of people are not yet available, he said.
Also, people with a history of anaphylaxis or the rapid onset of severe allergic reactions should not receive the Pfizer-BioNTech vaccine as a precaution.
READ: Singapore to begin Phase 3 of COVID-19 reopening on December 28
PROVISIONAL AUTHORIZATION
The vaccine received a provisional clearance under the Pandemic Special Access Route (PSAR), the HSA said. This is similar to the emergency use authorization framework adopted by other countries such as Canada, Switzerland, and the United States.
This regulatory pathway facilitates access to new critical vaccines, drugs and medical devices during a pandemic.
“With PSAR, the HSA can begin evaluating new vaccines, drugs, and medical devices early in clinical trials, as companies submit real-time data on a ‘rolling’ or tiered basis, rather than waiting for the whole of data that must be submitted before we begin our assessment, “HSA added.
This gives the agency more time to review the data presented as the companies continue with more clinical trials and development at the same time, he said.
“Clinical trials are also designed to be innovative and efficient, allowing companies to conduct multiple trials at the same time, while maintaining scientific rigor. Such regulatory agility and flexibility allows for faster development and evaluation,” HSA noted.
“HSA regulators were able to complete the evaluation of the Pfizer-BioNTech COVID-19 vaccine in the shortest time possible by working expeditiously with the ongoing data available, rather than waiting for the full dataset to be submitted before starting. our evaluation, while maintaining high standards of quality, safety and efficacy, and following the same rigorous processes used to register vaccines in normal times, ”added Dr. Mimi Choong, Executive Director of HSA.
READ: Hong Kong to Receive Sinovac, Pfizer-BioNTech COVID-19 Vaccines in Q1
As a condition for provisional authorization under PSAR, Pfizer and BioNTech will need to monitor the long-term efficacy of the vaccine to determine the duration of protection against COVID-19, the HSA said.
“This will add to the available data showing that the vaccine remains effective for at least two months, with no signs of decreased protection,” he noted.
Pfizer and BioNTech are also required to continue to monitor the safety of the vaccine over a longer period of time to determine its full safety profile.
“Companies should continue to submit longer-term follow-up data to the HSA to ensure the continued efficacy and safety of the vaccine. The HSA will actively review the data to ensure that the benefits of the vaccine continue to outweigh known risks,” he said HSA.
In a separate press release, a COVID-19 vaccination expert committee that 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 “the widest possible vaccination coverage against COVID-19” across its entire population.
“As the vaccine supply will arrive in Singapore in batches over several months as manufacturers increase their vaccine production, we recommend that vaccination start with the groups most at risk and therefore most in need of the COVID vaccine. -19, including healthcare workers and COVID-19 front-line workers, as well as vulnerable groups most at risk of serious illness from COVID-19 infection, such as the elderly, “he said.
More details on the full set of the committee’s recommendations to the government on use and priority groups for vaccination will be provided in the coming weeks, he added.
READ: In full: PM Lee’s speech on the COVID-19 situation
Singapore is one of the first countries to get the Pfizer-BioNTech vaccine, the prime minister said 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 Health Ministry said Singapore has also signed advance purchase agreements with Moderna and Sinovac, and is in talks with some other pharmaceutical companies.
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