COVID-19 vaccine allowed for use only if HSA assesses it to be ‘sufficiently efficacious and safe’: Gan Kim Yong
SINGAPORE: COVID-19 vaccines will be allowed to be used only if the Health Sciences Authority (HSA) assesses it to be “sufficiently efficacious and safe for use”, and only if the benefits of the vaccine outweigh the risk of any potential adverse effects, said Health Minister Gan Kim Yong on Monday (Jan 4).
Mr Gan delivered a ministerial statement in Parliament in response to questions by Members of Parliament (MP) on the COVID-19 vaccines, addressing concerns about its safety, side effects and effectiveness.
MPs’ concerns are “understandable”, he said, given the “extraordinary speed” at which the vaccines have been developed and brought to the market.
“The speed achieved is the result of a strong and concerted global response to a major pandemic, rather than a compromise of safety standards,” he said, adding that the safety and well-being of Singaporeans are of “top priority”.
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He highlighted HSA’s approval process, which involves applying “strict international standards” to assess the vaccines to ensure they meet “the stipulated high standards of quality, safety and efficacy”.
These standards are the same as those used for full vaccine evaluations, except that longer-term data from clinical trials will only be evaluated later as more data becomes available.
The data reviewed include those from pre-clinical studies from laboratories, clinical trials on volunteers, manufacturing and quality control, and the ongoing experience from actual use of the vaccine.
The assessment and recommendations for the vaccines are also reviewed by HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts.
The Pfizer-BioNTech vaccine has been put through this “rigorous review process” process by HSA and has been authorised for use in Singapore, said Mr Gan. The Moderna and Sinovac vaccines are also going through this review process, he added.
Following HSA’s approval for the Pfizer-BioNTech vaccine, an independent expert committee appointed by the Ministry of Health (MOH) has also reviewed the clinical data and was briefed by the HSA on the full range of considerations in granting “interim authorisation”.
It agreed with the HSA’s conclusions that the vaccine is suitable for use in Singapore for people aged 16 and above.
On whether the vaccines are effective against a new strain of COVID-19 virus reported in the UK and Europe, Mr Gan said “there is currently no evidence that current COVID-19 vaccines are less effective against this strain”.
“Experts have said that it is unlikely that these mutations would impact the effectiveness of current vaccines,” said the Health Minister.
Vaccine producers are also undertaking studies to formally confirm this, and MOH will evaluate the data as it emerges.
Some potential side effects from the Pfizer-BioNTech vaccine include pain in the injection site, fatigue, fever, muscle aches or headaches.
“These are similar to the side effects for other established vaccines and they usually resolve on their own in a few days,” said Mr Gan, adding that HSA and the expert committee have factored potential side effects into their evaluation of the vaccine.
However, as with all medications and established vaccines, there is a “small risk of very rare but serious adverse events” that may occur after vaccination, including allergic reactions, said the minister.
As such, HSA and the expert committee have recommended that those with known severe allergies should not be vaccinated. All vaccine recipients should be observed on-site for 30 minutes after vaccination to ensure that any severe allergic reactions can be detected and treated promptly.
MOH will also introduce a vaccine injury financial assistance programme to support those who suffer a "serious adverse event" that is assessed to be related to COVID-19 vaccines administered in Singapore, he said.
"While we expect few to need this, the programme will give peace of mind to those taking the vaccination," he added.
More details will be released in due course, the Health Minister said.
HSA requires vaccine manufacturers to submit new information continually for active review by the authority and the expert committee, said Mr Gan.
It will include data on different population groups, such as those younger than 16, those with immunosuppression, or pregnant women who were excluded from initial clinical trials. HSA and the expert committee will also look at long-term safety data.
“This ongoing monitoring is the norm expected for any vaccines that first come into use,” said Mr Gan.
He said there is no need to separate blood collected from donors who have and have not received COVID-19 vaccinations, as the vaccine does not cause infection.
ENCOURAGING UPTAKE OF VACCINATIONS
While vaccinations are voluntary, the Government “strongly encourages” everyone who is medically eligible to get vaccinated.
“This will not only protect yourself, but also indirectly protect others who cannot be vaccinated due to medical reasons,” said Mr Gan.
“This collective protection will be more effective the more people are vaccinated. In case of a fresh outbreak, with more people vaccinated we can keep the number of cases low, minimise the stress on our healthcare system, ensure that those who are ill get the treatment they need, and allow us to return to normalcy sooner.”
Although some people might feel there is no urgency to get vaccinated due to the current low number of community cases and the local situation being under control, Singapore residents “must not be complacent or wait till an outbreak and then rush to be vaccinated”, he said.
There are hidden cases in the population, and more contagious variants have emerged, he added.
“Any of these cases has a risk of sparking a major outbreak as we have seen in other countries,” said the Health Minister.
“The best time to vaccinate is now. If people wait till an outbreak has happened to get themselves vaccinated, it will be too late, both to protect themselves and to prevent the outbreak in the first place.”
COVID-19 vaccination will be free for all Singaporeans, permanent residents and long-term residents, including holders of an employment pass, S pass, work permit, dependant’s pass, long-term visit pass or student pass. It will also be free for foreign domestic workers.
Singapore residents would not be allowed to choose their vaccines if more than one has been approved for use.
“The allocation of vaccines will largely be based on medical indications of the different vaccines and the suitability of the vaccine for the different population groups, as well as availability of the vaccines,” said Mr Gan.
“Any COVID-19 vaccine that is approved for use will have to meet stringent safety and efficacy requirements. Allowing individuals to have choice of vaccines will unnecessarily complicate this already complex vaccination programme.”
On whether employees who are not vaccinated would be redeployed to reduce their exposure to the virus, the minister said that it would not be necessary, unless there is a resurgence of local cases.
However, all workers should continue taking the necessary precautions where required. For those working directly on the virus or “face very high risk of exposure” to infected individuals, MOH and the Ministry of Manpower (MOM) are reviewing the issue and will provide more advice later.
Anyone who is vaccinated will receive a physical vaccination card to remind them of their appointment to return for a second dose. It will indicate which vaccine was administered and provide brief post-vaccination advice.
Those vaccinated will also have their record updated in the National Immunisation Registry and they can check their vaccination status online, Mr Gan said.