SINGAPORE: The Health Sciences Authority (HSA) has granted interim authorisation for Novavax’s Nuvaxovid COVID-19 vaccine to be used in Singapore, it announced on Monday (Feb 14).
The vaccine will be allowed for use in individuals aged 18 and above on Feb 3. The vaccination regimen comprises two doses of 5 micrograms three weeks apart.
The first batch of the vaccine is “expected to arrive in Singapore in the next few months”, HSA said.
The interim authorisation was granted under the Pandemic Special Access Route (PSAR).
“HSA has reviewed that the vaccine meets the quality, safety and efficacy standards, and that the benefits outweigh the risks for the Singapore population," it added.
“Two groups of experts from HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts were also consulted and agreed with HSA’s recommendation for PSAR authorisation.”
HSA’s clinical review was based on two Phase 3 clinical studies conducted in the United States, Mexico and the United Kingdom, comprising more than 40,000 clinical trial participants aged between 18 and 95, it said.
"The results showed that Nuvaxovid demonstrated a vaccine efficacy of approximately 90 per cent against symptomatic COVID-19 and 100 per cent in preventing severe COVID-19," HSA added.
"It showed consistent efficacy against the Alpha variant, but there was no data on the Delta and Omicron variants, as these variants were not prevalent at the time Novavax conducted the clinical trials."
Based on the data from the clinical trials to date, the safety profile of Nuvaxovid was "generally consistent with other registered vaccines in Singapore", said the authority.
Common side effects that recipients may experience include injection site pain and/or tenderness, fatigue, headache and muscle pain.
"These symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response to build immunity against COVID-19," said HSA.
"These side effects usually resolve on their own within a few days."
As with all vaccines, there will always be a small proportion of susceptible persons who may experience severe allergic reactions upon vaccination, including those with a history of anaphylaxis, said HSA.
"In such cases, immediate medical attention should be sought. "Persons who develop anaphylaxis to the first dose of Nuvaxovid should not be given the second dose," added the authority.
"Safety and efficacy data in severely immunocompromised persons and those under the age of 18 are not available yet. Hence, no recommendation can be made for the use of the vaccine in these individuals."
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The vaccine will be allowed for use in individuals aged 18 and above on Feb 3. The vaccination regimen comprises two doses of 5 micrograms three weeks apart.
The first batch of the vaccine is “expected to arrive in Singapore in the next few months”, HSA said.
The interim authorisation was granted under the Pandemic Special Access Route (PSAR).
“HSA has reviewed that the vaccine meets the quality, safety and efficacy standards, and that the benefits outweigh the risks for the Singapore population," it added.
“Two groups of experts from HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts were also consulted and agreed with HSA’s recommendation for PSAR authorisation.”
HSA’s clinical review was based on two Phase 3 clinical studies conducted in the United States, Mexico and the United Kingdom, comprising more than 40,000 clinical trial participants aged between 18 and 95, it said.
"The results showed that Nuvaxovid demonstrated a vaccine efficacy of approximately 90 per cent against symptomatic COVID-19 and 100 per cent in preventing severe COVID-19," HSA added.
"It showed consistent efficacy against the Alpha variant, but there was no data on the Delta and Omicron variants, as these variants were not prevalent at the time Novavax conducted the clinical trials."
Based on the data from the clinical trials to date, the safety profile of Nuvaxovid was "generally consistent with other registered vaccines in Singapore", said the authority.
Common side effects that recipients may experience include injection site pain and/or tenderness, fatigue, headache and muscle pain.
"These symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response to build immunity against COVID-19," said HSA.
"These side effects usually resolve on their own within a few days."
As with all vaccines, there will always be a small proportion of susceptible persons who may experience severe allergic reactions upon vaccination, including those with a history of anaphylaxis, said HSA.
"In such cases, immediate medical attention should be sought. "Persons who develop anaphylaxis to the first dose of Nuvaxovid should not be given the second dose," added the authority.
"Safety and efficacy data in severely immunocompromised persons and those under the age of 18 are not available yet. Hence, no recommendation can be made for the use of the vaccine in these individuals."
Continue reading...