Covid-19 is an unprecedented pandemic, and the Covid-19 vaccines have been developed at a record pace too.

But Health Minister Gan Kim Yong explained in detail the lengths that the Singapore authorities have gone to ensure the safety and efficacy of any vaccine approved to fight Covid-19.

In a Ministerial Statement on Jan. 4, he elaborated on the rigorous quality control process that the authorities had put in place before approval for a vaccine is granted.

Vaccine evaluation explained

Firstly, Gan explained that the speed of developing Covid-19 vaccines, including Pfizer-BioNTech, is the result of a strong and concerted global response, and not a compromise of safety standards.

Under HSA’s Pandemic Special Access Route (PSAR), HSA’s scientific and clinical experts apply strict international standards to assess Covid-19 vaccines to ensure that they meet the 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 be only be evaluated later, as the data becomes available.

HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts also assess vaccine data and make recommendations.

Data reviewed includes those from pre-clinical studies done in laboratories, clinical trials on human volunteers, manufacturing and quality controls, and on-the-ground experience as people are beginning vaccination programmes.

HSA will only approve a vaccine if it is sufficiently efficient, safe for use, and if the potential benefits outweigh any potential adverse effects.

Gan added that the Cabinet will take the lead and get vaccinated themselves to encourage the public to get vaccinated too:

"As PM has said, we have every confidence in our experts and the process that has been put in place. PM and our Cabinet colleagues, including myself, will lead on this. We will be getting ourselves vaccinated as early as possible when our turn comes."

Independent expert committee weighs in

After HSA's approval, the independent expert committee appointed by the Ministry of Health (MOH) also reviewed the clinical data, and took into account four key considerations:

• Vaccine safety
• Vaccine efficacy
• Vaccine tolerability
• Data adequacy of clinical trials

The committee therefore assessed that the Pfizer vaccine demonstrated a high efficacy of 95 per cent in reducing symptomatic Covid-19 disease among persons aged 16 and older, and its safety profile is consistent with that of other established and registered vaccines used against other diseases.

Gan said, "The Expert Committee concurs with HSA -- that the vaccine is suitable for use in Singapore, for persons aged 16 years and older, for the prevention of Covid-19."

HSA will also require vaccine manufacturers to continually submit new information for active review. HSA and the committee will continue to monitor vaccine data, in both the local population and overseas.

This includes data on specific population subgroups such as those below age of 16, persons with immunosuppression, or pregnant women who were excluded from initial clinical trials.

Potential side-effects and financial assistance programme

Potential side-effects were factored into the approval process. Most people may experience mild side effects such as fatigue, fever, muscle aches or headaches.

This is similar to side effects for other kinds of vaccines, and subside after a few days.

But there is a small risk of adverse side effects, such as a severe allergic reaction. So both HSA and the committee recommended that people with known severe allergies should not be vaccinated.

All vaccine recipients should also be observed on-site for 30 minutes to watch out for severe allergic reactions, and be treated if necessary.

The Ministry of Health (MOH) will also introduce a vaccine injury financial assistance programme, to help support people who suffer a serious adverse event assessed to be related to Covid-19 vaccines administered in Singapore.

Added Gan, "While we expect few to need this, the programme will give peace of mind to those taking the vaccination. Further details on the programme will be provided in due course."

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Top image from Gov.sg YouTube.