Singapore ensuring multiple safety checks in place before Covid-19 vaccine roll-out: Experts

Once late-stage clinical trials have concluded, the data will be reviewed again by the Health Sciences Authority.
Once late-stage clinical trials have concluded, the data will be reviewed again by the Health Sciences Authority.PHOTO: ST FILE

SINGAPORE - The urgency in tackling the Covid-19 pandemic has seen a quickened process in developing, and approving, a vaccine, but experts say multiple steps have been taken to ensure that any vaccine rolled out in Singapore is safe.

The first shipment of Covid-19 vaccines arrived in Singapore on Monday night (Dec 21), marking the first time the country is buying in large quantities drugs that have been approved for use in a pandemic.

The vaccine by Pfizer-BioNTech was granted authorisation for use here by the Health Sciences Authority (HSA) under the pandemic special access route. It is the only one the HSA has approved so far, although others are being studied.

But even during these unprecedented times, steps have been taken to ensure the safety of vaccines that will be used here, said two experts during a press conference on Monday. Associate Professor Tan Say Beng and Professor Benjamin Seet both sit on an expert panel that advises the Government on therapeutics and vaccines.

They point to many safety checks along the vaccine development process.

First, the data must point to safety in animal studies before the vaccine is allowed to be tested on humans. Even when clinical trials begin, there are numerous phases involved.

Once late-stage clinical trials have concluded, the data will be reviewed again by HSA.

"During the whole process, there are many vaccine candidates and many may drop out along the way - some animal studies show (the vaccine) may not be safe enough, for example; some make it to human studies but they don't make it through all the different phases of clinical trials," said Prof Tan, executive director of the Health Ministry's National Medical Research Council.

"So you can think of it as there being multiple safety checks all along the way."

The first two phases of clinical trials, known as early-phase trials, are mainly carried out among smaller groups of up to hundreds of volunteers to test the safety and efficacy of a vaccine. In these stages, researchers look out for dangerous side effects and analyse patient samples to see how the human immune system is responding to the vaccine.

Phase three trials are much larger, usually involving thousands to tens of thousands of people. These are often held across multiple jurisdictions or countries.

Prof Tan said: "Many agencies in many countries are confident that the clinical trial process was abided by, even though things were quickened in terms of urgency. It was not at risk of compromising the integrity of the study."

For instance, phase three trials must be sized correctly, he said, so that the results could be considered representative of a larger group. This condition has been met.

The phase three trial of the Pfizer-BioNTech vaccine, for instance, involved over 43,000 people. Another leading Covid-19 vaccine front runner, developed by Moderna, had a phase three trial involving over 30,000 people.

But responding to a question on why other reactions to the vaccine - such as severe allergic reactions reported in the United States, for instance - were only picked up after these trials, Prof Seet, who oversees the expert panel, said some reactions were very rare.

This is not unique to Covid-19 vaccines, but applies to all types of drugs or shots, he said.

"Because some side effects are very rare, you may need to involve hundreds of thousands, or sometimes even a million or two million people before you actually see these very very rare events, and the only way you can pick that up is actually through post-implementation (monitoring)," he said.

That is why the Government will continue to monitor the situation as the vaccine is rolled out here.

But Prof Seet, who is deputy group chief executive for education and research at the National Healthcare Group, noted that not all side effects were dangerous.

The concept of safety refers to something that will actually cause harm to the individual, he said.

Tolerability, on the other hand, refers to experiencing symptoms like fever or headache after the shot. "So that is quite different from safety. So some people will experience some of these side effects - but that doesn't affect overall safety," he explained.