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SINGAPORE: The use of COVID-19 vaccines will be allowed only if the Health Sciences Authority (HSA) evaluates that it is “sufficiently effective and safe for use”, and only if the benefits of the vaccine outweigh the risk of possible adverse effects, said Health Minister Gan Kim Yong on Monday (January 4).
Mr. Gan delivered a ministerial statement in Parliament in response to questions from Members of Parliament (MPs) on COVID-19 vaccines, addressing concerns about their safety, side effects and efficacy.
Parliamentarians’ concerns are “understandable,” he said, given the “extraordinary speed” at which vaccines have been developed and brought to market.
“The speed achieved is the result of a robust 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 “highest priority.” .
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He highlighted the HSA approval process, which involves the application of “strict international standards” to evaluate vaccines to ensure they meet “the stipulated high standards of quality, safety and efficacy.”
These standards are the same as those used for comprehensive 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 preclinical laboratory studies, clinical trials with volunteers, manufacturing and quality control, and ongoing experience of the actual use of the vaccine.
Vaccine evaluation and recommendations are also reviewed by HSA’s Drug Advisory Committee and Infectious Diseases Expert Panel.
The Pfizer-BioNTech vaccine has undergone this “rigorous review process” by the HSA and has been licensed for use in Singapore, Mr. Gan said. The Moderna and Sinovac vaccines are also going through this review process, he added.
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Following the approval of the HSA for the Pfizer-BioNTech vaccine, a committee of independent experts appointed by the Ministry of Health (MOH) also reviewed the clinical data and informed the HSA of the full range of considerations for granting a “provisional authorization” .
He agreed with the HSA’s conclusions that the vaccine is suitable for use in Singapore for people 16 years of age and older.
On whether the vaccines are effective against a new strain of the COVID-19 virus reported in the UK and Europe, Mr Gan said that “there is currently no evidence that current COVID-19 vaccines are less effective against this strain.”
“Experts have said that these mutations are unlikely to affect the effectiveness of current vaccines,” said the Minister of Health.
Vaccine producers are also conducting studies to formally confirm this, and the Ministry of Health will evaluate the data as it emerges.
SIDE EFFECTS
Some potential side effects of the Pfizer-BioNTech vaccine include injection site pain, fatigue, fever, muscle aches, or headaches.
“These are similar to the side effects of other established vaccines and generally resolve on their own within a few days,” said Mr. Gan, adding that the HSA and the expert committee have considered potential side effects in your evaluation of the vaccine.
However, as with all established drugs and vaccines, there is a “small risk of very rare but serious adverse events” that may occur after vaccination, including allergic reactions, the minister said.
As such, the HSA and the expert committee have recommended that people with known severe allergies not get vaccinated. All vaccine recipients should be observed on site for 30 minutes after vaccination to ensure that any serious allergic reaction can be quickly detected and treated.
The Health Ministry will also introduce a vaccine injury financial assistance program to support those suffering from a “serious adverse event” deemed related to COVID-19 vaccines administered in Singapore, it said.
“While we hope that few will need this, the program will give peace of mind to those who get vaccinated,” he added.
More details will be released in due course, the health minister said.
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The HSA requires vaccine manufacturers to continually submit new information for the authority and the expert committee to actively review, Gan said.
It will include data on different population groups, such as those under the age of 16, those with immunosuppression, or pregnant women who were excluded from the initial clinical trials. The HSA and the expert committee will also review the long-term safety data.
“This continuous monitoring is the expected norm for any vaccine that is used for the first time,” said Mr. Gan.
He said that it is not necessary to separate the collected blood from donors who have and have not received the COVID-19 vaccine, as the vaccine does not cause infection.
ENCOURAGE THE TAKING OF VACCINES
While vaccines are voluntary, the government “strongly encourages” all medically eligible people to get vaccinated.
“This will not only protect yourself, but it will also indirectly protect other people who cannot be vaccinated for medical reasons,” Gan said.
“This collective protection will be more effective the more people are vaccinated. In the event of a new outbreak, with more vaccinated people we can keep the number of cases low, minimize stress on our health system, make sure that patients receive the treatment they need and allow us to return to normal sooner ”.
Although some people may feel that vaccination is not urgent due to the current low number of community cases and the local situation under control, Singaporeans “should not be complacent or wait until an outbreak and then rush to get vaccinated,” he said. said.
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There are hidden cases in the population and more contagious variants have emerged, he added.
“Any of these cases has the risk of causing a major outbreak as we have seen in other countries,” said the Minister of Health.
“The best time to vaccinate is now. If people wait for an outbreak to get vaccinated, it will be too late, both to protect themselves and to prevent the outbreak in the first place. “
The COVID-19 vaccine will be free to all Singaporeans, permanent residents, and long-term residents, including holders of an employment pass, S pass, work permit, dependent pass, long-term visit pass, or student pass. . It will also be free for foreign domestic workers.
Singapore residents will not be allowed to choose their vaccines if more than one has been approved for use.
“Vaccine allocation will be based largely on the medical indications for different vaccines and the suitability of the vaccine for different population groups, as well as the availability of the vaccines,” said Mr. Gan.
“Any COVID-19 vaccine that is approved for use must meet strict safety and efficacy requirements. Allowing people a choice of vaccines will unnecessarily complicate this already complex vaccination program. “
On whether employees who are not vaccinated would be reassigned to reduce their exposure to the virus, the minister said it would not be necessary, unless there is a resurgence of local cases.
However, all workers must continue to take necessary precautions when necessary. For those who work directly with the virus or “face a very high risk of exposure” to infected people, the Ministry of Health 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 Immunization Registry and will be able to check their vaccination status online, Gan said.
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