Singapore Approves Moderna's Covid-19 Vaccine, First Delivery in March 2021
Bisnis.com, JAKARTA – The Health Sciences Authority (HSA) has granted temporary authorization for the Moderna COVID-19 vaccine to be used in Singapore for people 18 years and over.
The vaccination regime proposed by Moderna requires two doses of vaccine to be administered within a 28 day interval.
The first deliveries are expected to arrive around March if there are no disruptions to delivery schedules, the Health Ministry (MOH) said, adding that they would “gradually roll out” the vaccine.
“HSA’s review of available clinical data found that the benefits of Moderna’s COVID-19 vaccine outweigh any known risks,” the agency said in a press release as reported by Channel News Asia.
“The vaccine shows high vaccine efficacy of 94 percent.”
The HSA said it reviewed data from pre-clinical studies, clinical trials on human volunteers, and manufacturing and quality control.
Two expert groups from the HSA Drug Advisory Committee and an infectious disease expert panel were also consulted during the review to ensure that the vaccine is “safe, efficacious and of good quality” based on data submitted to date, and that the benefits outweigh any known risks to the population. .
The Committee on Vaccination Experts on COVID-19 said it had independently reviewed the safety and efficacy data for the Moderna vaccine for various segments of the population in Singapore.
“The Committee of Experts will continue to monitor and review the use of the COVID-19 vaccine in Singapore as more data becomes available over time,” the committee said.
Moderna’s COVID-19 vaccine is the second vaccine given temporary authorization under the Pandemic Special Access Route (PSAR).
Pfizer-BioNTech is the first to be licensed for use in Singapore.
Under PSAR, HSA can start evaluating new vaccines, drugs and medical devices from the early stages of clinical studies, as more data is available in real-time, without having to wait for the complete data set to be submitted before starting the evaluation.
“This gives HSA more time to review submitted data while the company continues concurrently with clinical trials and further development.
“Clinical trials have also been designed to be innovative and efficient, enabling companies to carry out multiple trials simultaneously, while maintaining scientific rigor,” said the authorities.
More doses of Pfizer-BioNTech and Moderna will arrive during this year, the health ministry said.
“We will continue to monitor our supply closely to ensure that we will have enough vaccines for all Singaporeans and long-term residents in Singapore by the third quarter of 2021,” the MOH added.
As of February 2, more than 175,000 people have received the first dose of the COVID-19 vaccine.
About 6,000 of them have also received a second dose of the vaccine and completed a complete vaccination regimen.
“Within two weeks, they will be adequately protected from COVID-19,” said the Ministry of Health.
WHO DOESN’T HAVE TO GET THE VACCINE?
Based on data obtained from clinical trials to date, the safety profile of the Moderna COVID-19 vaccine is generally consistent with other registered vaccines used in immunization against other diseases, said HSA.
People receiving the vaccine may experience some of the common side effects, including pain, swelling at the injection site, fatigue, headache, muscle aches, fever, chills, vomiting and joint pain after vaccination.
Some of these symptoms, such as fatigue, headaches and muscle or joint pain, may be more severe in a small number of people.
“This symptom is a reaction that is generally associated with vaccination and is expected to be part of the body’s natural response so that it can build immunity against COVID-19. These side effects usually resolve on their own within a few days, “says HSA.
As with all vaccines, there will always be a small proportion of people who develop a severe allergic reaction after vaccination, authorities say.
They include people with a history of anaphylaxis, onset of a rapid, severe allergic reaction or severe or multiple allergies to drugs and food.
In such cases, immediate medical attention should be sought, the HSA said.
“As a precautionary measure, anyone with a history of anaphylaxis or severe or multiple allergies to drugs or food should not receive the Moderna COVID-19 vaccine,” the authorities said.
Pregnant women, people with severe immune disorders and those under 18 years of age should also not receive the vaccine because safety and efficacy data for this group are not yet available.
Those who develop anaphylaxis or a severe allergic reaction to the first dose of the COVID-19 vaccine should not receive the second dose, said the HSA.
An HSA review of available clinical data found that Moderna’s COVID-19 vaccine demonstrated 94 percent efficacy. This meant that there was a 94 percent reduction in symptoms of COVID-19 in the vaccinated cohort, compared to the same size group of unvaccinated people, he said.
The efficacy is based on Phase 3 clinical trials conducted in more than 30,000 clinical trial participants aged between 18 and 95 years.
One of the terms of the provisional authorization under PSAR requires Moderna to monitor the long-term efficacy of the vaccine to determine the duration of protection against COVID-19.
“This will augment the available data showing that the vaccine continues to be effective within two months of the completion of the vaccination regime, without signs of fading protection,” said HSA.
Companies are also required to continue to follow up on vaccine safety for a longer period of time to determine a “full safety profile”, added HSA. Pharmaceutical companies will also continue to study vaccine safety in certain “subpopulations,” such as children.
Authorities said they would “actively review” data submitted by Moderna to ensure that the vaccine’s benefits continue to outweigh any known risks.
When sufficient data is available for full registration, Moderna will be asked to submit an application to move the product status from temporary authorization of PSAR to full registration, said HSA.
He added that the PSAR authorization could be terminated at any time, for example, if new data showed “the benefits no longer outweigh the risks”.
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