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SINGAPORE: The Health Sciences Authority (HSA) has granted interim authorisation for Moderna's COVID-19 vaccine to be used in Singapore for people aged 18 years and above, it announced on Wednesday (Feb 3).
The vaccination regime submitted by Moderna requires two doses of the vaccine to be administered 28 days apart.
The first shipment is expected to arrive around March if there are no disruptions to the shipment schedule, said the Ministry of Health (MOH), adding that it would "progressively roll out" the vaccine.
"HSA’s review of the available clinical data found that the benefits of the Moderna COVID-19 vaccine outweigh the known risks," said the agency in a press release.
"The vaccine demonstrated a high vaccine efficacy of 94 per cent."
READ: People who need to travel have to wait turn to be vaccinated for COVID-19: MOH
HSA said it reviewed data from pre-clinical studies, clinical trials in human volunteers, as well as manufacturing and quality controls.
Two groups of experts from HSA's Medicines Advisory Committee and panel of infectious disease experts were also consulted during the review to ensure that the vaccine is "safe, efficacious and of good quality" based on the data submitted to date, and that the benefits outweigh the known risks for the population.
The Expert Committee on COVID-19 Vaccination said it has independently reviewed the Moderna vaccine's safety and efficacy data for different population segments in Singapore.
It was also briefed by HSA on its full range of considerations in granting interim authorisation, and is satisfied with its safety and efficacy, said the committee in a separate press release.
"The Expert Committee will continue to monitor and review the use of COVID-19 vaccines in Singapore as more data becomes available over time," the committee said.
The Moderna vaccine has also been authorised in several other countries, including the United States, Canada, Israel, and the United Kingdom.
MORE VACCINES TO ARRIVE OVER THE COURSE OF THE YEAR: MOH
Moderna's COVID-19 vaccine is the second vaccine to be granted interim authorisation under the Pandemic Special Access Route (PSAR).
The Pfizer-BioNTech vaccine was the first to be authorised for use in Singapore.
Under PSAR, HSA can start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, as more data becomes available on a real-time basis, without having to wait for the full data set to be submitted before starting evaluation.
READ: All polyclinics to offer COVID-19 vaccination from Feb 1
"This gives HSA more time to review the submitted data while companies continue with further clinical trials and development concurrently.
"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," said the authorities.
More doses from both Pfizer-BioNTech and Moderna will arrive over the course of the year, said the health ministry.
"We will continue to monitor our supplies closely to ensure that we will have enough vaccines for all Singaporeans and long-term residents in Singapore by the third quarter of 2021," MOH added.
It also encouraged those who are medically eligible for vaccination to get vaccinated when offered.
"Vaccination is critical to protect us and our loved ones against COVID-19. (It) also protects those in our community who cannot be vaccinated due to medical reasons," said the health ministry.
READ: More than 113,000 people in Singapore receive first dose of COVID-19 vaccine: MOH
As of Feb 2, more than 175,000 people have received their first dose of the COVID-19 vaccine.
About 6,000 of them have also received their second dose of the vaccine and completed the full vaccination regimen.
"In two weeks’ time, they will be adequately protected against COVID-19," said MOH.
WHO SHOULD NOT TAKE THE VACCINE?
Based on data accrued from clinical trials to date, the safety profile of the Moderna COVID-19 vaccine was generally consistent with other registered vaccines used in immunisation against other diseases, said HSA.
People who received the vaccine may experience some common side effects, including pain, swelling at the injection site, fatigue, headache, muscle ache, fever, chills, vomiting and joint pain after vaccination.
Some of these symptoms, such as fatigue, headache and muscle or joint ache, may be more severe in a small number of people.
READ: Should I take the COVID-19 vaccine if I have allergies? Anaphylaxis is rare, say experts
"These symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response so as to build immunity against COVID-19. These side effects usually resolve on their own within a few days," said HSA.
As with all vaccines, there will always be a small proportion of people who experience severe allergic reactions upon vaccination, said the authority.
They include people with a history of anaphylaxis – the rapid onset of severe allergic reactions – or severe or multiple allergies to medicines and food.
In such cases, immediate medical attention should be sought, said HSA.
"As a precautionary measure, anyone with a history of anaphylaxis or severe or multiple allergies to medicines or food should not receive the Moderna COVID-19 vaccine," said the authority.
Pregnant woman, severely immunocompromised people and those under the age of 18 should also not receive the vaccine as the safety and efficacy data for these groups are not available yet.
READ: 4 out of 155,000 people vaccinated had severe allergic reactions, all have recovered
READ: Worried about anaphylactic reactions and side effects? Experts answer FAQs on COVID-19 vaccination
Those who develop anaphylaxis or severe allergic reactions to the first dose of the COVID-19 vaccine should not receive the second dose, said HSA.
MODERNA REQUIRED TO MONITOR LONGER TERM EFFICACY OF VACCINE
HSA's review of the available clinical data found that Moderna's COVID-19 vaccine showed an efficacy of 94 per cent. This means there is a 94 per cent reduction of symptomatic COVID-19 disease in a vaccinated group of people, compared to a similar sized group of people who were not vaccinated, it said.
The efficacy was based on a Phase 3 clinical trial conducted in more than 30,000 clinical trial participants aged between 18 and 95 years old.
One of the conditions for interim authorisation under the PSAR requires Moderna to monitor the longer-term efficacy of the vaccine so as to determine the duration of protection against the COVID-19.
"This will augment the available data which shows that the vaccine continues to be effective at two months following the completion of the vaccination regime, with no signs of waning protection," said HSA.
The company is 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", added HSA. The pharmaceutical firm will also continue to study the safety of the vaccines in certain "subpopulations", such as children.
The authority said it would "actively review" the data submitted by Moderna to ensure that the benefits of the vaccine continue to outweigh the known risks.
When sufficient data is available for full registration, Moderna will be required to file an application to transit the status of the product from PSAR interim authorisation to full registration, said HSA.
It added that it may terminate the PSAR authorisation at any time, for example, if the new data suggests the "benefits no longer outweight the risks".
It may also terminate PSAR authorisation at any time; for example, if new data suggest that the benefits no longer outweigh the risks.
Associated Professor Chan Cheng Leng, group director of Health Products Regulation Group, HSA said the authority will continue to monitor for "safety signals" from the COVID-19 vaccines used in Singapore.
"HSA will also continue to work with MOH and the Expert Committee on COVID-19 Vaccination to review the existing strict criteria for vaccination where necessary," said Assoc Prof Chan.
"Today’s authorisation is another important step in the global fight against COVID-19,” said Moderna CEO Stéphane Bancel, adding that he wanted to thank MOH and HSA for their "collaboration and for the confidence they have demonstrated" in the company's vaccine.
www.channelnewsasia.com
The vaccination regime submitted by Moderna requires two doses of the vaccine to be administered 28 days apart.
The first shipment is expected to arrive around March if there are no disruptions to the shipment schedule, said the Ministry of Health (MOH), adding that it would "progressively roll out" the vaccine.
"HSA’s review of the available clinical data found that the benefits of the Moderna COVID-19 vaccine outweigh the known risks," said the agency in a press release.
"The vaccine demonstrated a high vaccine efficacy of 94 per cent."
READ: People who need to travel have to wait turn to be vaccinated for COVID-19: MOH
HSA said it reviewed data from pre-clinical studies, clinical trials in human volunteers, as well as manufacturing and quality controls.
Two groups of experts from HSA's Medicines Advisory Committee and panel of infectious disease experts were also consulted during the review to ensure that the vaccine is "safe, efficacious and of good quality" based on the data submitted to date, and that the benefits outweigh the known risks for the population.
The Expert Committee on COVID-19 Vaccination said it has independently reviewed the Moderna vaccine's safety and efficacy data for different population segments in Singapore.
It was also briefed by HSA on its full range of considerations in granting interim authorisation, and is satisfied with its safety and efficacy, said the committee in a separate press release.
"The Expert Committee will continue to monitor and review the use of COVID-19 vaccines in Singapore as more data becomes available over time," the committee said.
The Moderna vaccine has also been authorised in several other countries, including the United States, Canada, Israel, and the United Kingdom.
MORE VACCINES TO ARRIVE OVER THE COURSE OF THE YEAR: MOH
Moderna's COVID-19 vaccine is the second vaccine to be granted interim authorisation under the Pandemic Special Access Route (PSAR).
The Pfizer-BioNTech vaccine was the first to be authorised for use in Singapore.
Under PSAR, HSA can start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, as more data becomes available on a real-time basis, without having to wait for the full data set to be submitted before starting evaluation.
READ: All polyclinics to offer COVID-19 vaccination from Feb 1
"This gives HSA more time to review the submitted data while companies continue with further clinical trials and development concurrently.
"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," said the authorities.
More doses from both Pfizer-BioNTech and Moderna will arrive over the course of the year, said the health ministry.
"We will continue to monitor our supplies closely to ensure that we will have enough vaccines for all Singaporeans and long-term residents in Singapore by the third quarter of 2021," MOH added.
It also encouraged those who are medically eligible for vaccination to get vaccinated when offered.
"Vaccination is critical to protect us and our loved ones against COVID-19. (It) also protects those in our community who cannot be vaccinated due to medical reasons," said the health ministry.
READ: More than 113,000 people in Singapore receive first dose of COVID-19 vaccine: MOH
As of Feb 2, more than 175,000 people have received their first dose of the COVID-19 vaccine.
About 6,000 of them have also received their second dose of the vaccine and completed the full vaccination regimen.
"In two weeks’ time, they will be adequately protected against COVID-19," said MOH.
WHO SHOULD NOT TAKE THE VACCINE?
Based on data accrued from clinical trials to date, the safety profile of the Moderna COVID-19 vaccine was generally consistent with other registered vaccines used in immunisation against other diseases, said HSA.
People who received the vaccine may experience some common side effects, including pain, swelling at the injection site, fatigue, headache, muscle ache, fever, chills, vomiting and joint pain after vaccination.
Some of these symptoms, such as fatigue, headache and muscle or joint ache, may be more severe in a small number of people.
READ: Should I take the COVID-19 vaccine if I have allergies? Anaphylaxis is rare, say experts
"These symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response so as to build immunity against COVID-19. These side effects usually resolve on their own within a few days," said HSA.
As with all vaccines, there will always be a small proportion of people who experience severe allergic reactions upon vaccination, said the authority.
They include people with a history of anaphylaxis – the rapid onset of severe allergic reactions – or severe or multiple allergies to medicines and food.
In such cases, immediate medical attention should be sought, said HSA.
"As a precautionary measure, anyone with a history of anaphylaxis or severe or multiple allergies to medicines or food should not receive the Moderna COVID-19 vaccine," said the authority.
Pregnant woman, severely immunocompromised people and those under the age of 18 should also not receive the vaccine as the safety and efficacy data for these groups are not available yet.
READ: 4 out of 155,000 people vaccinated had severe allergic reactions, all have recovered
READ: Worried about anaphylactic reactions and side effects? Experts answer FAQs on COVID-19 vaccination
Those who develop anaphylaxis or severe allergic reactions to the first dose of the COVID-19 vaccine should not receive the second dose, said HSA.
MODERNA REQUIRED TO MONITOR LONGER TERM EFFICACY OF VACCINE
HSA's review of the available clinical data found that Moderna's COVID-19 vaccine showed an efficacy of 94 per cent. This means there is a 94 per cent reduction of symptomatic COVID-19 disease in a vaccinated group of people, compared to a similar sized group of people who were not vaccinated, it said.
The efficacy was based on a Phase 3 clinical trial conducted in more than 30,000 clinical trial participants aged between 18 and 95 years old.
One of the conditions for interim authorisation under the PSAR requires Moderna to monitor the longer-term efficacy of the vaccine so as to determine the duration of protection against the COVID-19.
"This will augment the available data which shows that the vaccine continues to be effective at two months following the completion of the vaccination regime, with no signs of waning protection," said HSA.
The company is 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", added HSA. The pharmaceutical firm will also continue to study the safety of the vaccines in certain "subpopulations", such as children.
The authority said it would "actively review" the data submitted by Moderna to ensure that the benefits of the vaccine continue to outweigh the known risks.
When sufficient data is available for full registration, Moderna will be required to file an application to transit the status of the product from PSAR interim authorisation to full registration, said HSA.
It added that it may terminate the PSAR authorisation at any time, for example, if the new data suggests the "benefits no longer outweight the risks".
It may also terminate PSAR authorisation at any time; for example, if new data suggest that the benefits no longer outweigh the risks.
Associated Professor Chan Cheng Leng, group director of Health Products Regulation Group, HSA said the authority will continue to monitor for "safety signals" from the COVID-19 vaccines used in Singapore.
"HSA will also continue to work with MOH and the Expert Committee on COVID-19 Vaccination to review the existing strict criteria for vaccination where necessary," said Assoc Prof Chan.
"Today’s authorisation is another important step in the global fight against COVID-19,” said Moderna CEO Stéphane Bancel, adding that he wanted to thank MOH and HSA for their "collaboration and for the confidence they have demonstrated" in the company's vaccine.
Moderna's COVID-19 vaccine authorised for use in Singapore, first shipment expected around March
SINGAPORE: The Health Sciences Authority (HSA) has granted interim authorisation for Moderna's COVID-19 vaccine to be used in Singapore for people aged 18 years and above, it announced on Wednesday (Feb 3).The vaccination regime submitted by Moderna requires two doses of the vaccine to
