HSA grants interim authorisation for Novavax's Nuvaxovid Covid-19 vaccine
THE Health Sciences Authority (HSA) has granted an interim authorisation for the Nuvaxovid Covid-19 vaccine produced by American biotechnology company Novavax on Feb 3, the authority said on Monday (Feb 14).
The vaccine will be made available for individuals aged 18 years and above and comprises 2 5-microgram doses, which are to be administered 3 weeks apart.
The first batch is slated to arrive in Singapore in the next few months.
HSA had reviewed the vaccine's quality, safety and efficacy standards and consulted 2 groups of experts from its Medicines Advisory Committee and Panel of Infectious Diseases Experts before recommending the interim authorisation under the Pandemic Special Access Route.
"Based on the data accrued from the clinical trials to-date, the safety profile of Nuvaxovid was generally consistent with other registered vaccines in Singapore," the statement said, adding that it may cause side effects such as fatigue and muscle pain that are common in other registered Covid-19 vaccines.
In a separate statement on Monday, the health ministry's expert committee on Covid-19 vaccinations said it has independently reviewed the Nuvaxovid vaccine's safety and efficacy data and recommends Nuvaxovid as an alternative to the mRNA vaccine, although it still prefers the mRNA ones for their higher efficacy and stronger immune response generated.
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Nuvaxovid was also found to be an acceptable booster vaccination, with 1 booster dose to be administered 5 months after the last primary dose.
The expert committee also preferred Nuvaxovid to the Sinovac-Coronavac vaccine for those medically ineligible to receive the mRNA vaccines, adding that Sinovac-CoronaVac should only be used by persons who are medically ineligible for all other approved Covid-19 vaccines.
Additionally, the multi-ministry taskforce has accepted the recommendations of the expert committee to include Nuvaxovid in the National Vaccination Programme for use as a primary vaccine and as a booster.
Under HSA's interim authorisation, Novavax is required to monitor the longer-term efficacy of Nuvaxovid to determine the duration of protection against Covid-19, HSA said.
The company is also required to follow up on the safety of the vaccine over a longer period to determine its overall safety profile, including in special populations such as immunocompromised persons, pregnant women and children.
HSA will actively review evolving vaccine effectiveness and safety data to ensure that the benefits of the vaccine continue to outweigh the known risks, adding that PSAR interim authorisation may be terminated at any time.
To obtain full registration, Novavax will need to submit the complete dataset based on prevailing international standards, it said.
HSA also cautioned that a small proportion of persons may experience severe allergic reactions upon vaccination and does not recommend those individuals take the vaccination.
On Feb 3, the authority had announced that it granted an interim authorisation for oral tablet Paxlovid, which is produced by American pharmaceutical company Pfizer. Pfizer produces the Comirnaty vaccine, which is also known as the Pfizer-BioNTech Covid-19 vaccine.
Singapore had reported a total of 9,420 Covid-19 cases on Sunday. Of these, 9,195 of them were local ones, down from 10,325 local cases reported on Saturday.
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- China approves use of Pfizer's Covid drug Paxlovid
- Singapore's HSA to vet Sinovac vaccine before public roll-out
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