HSA grants interim authorisation for Pfizer-BioNTech Covid-19 vaccine in Singapore

THE Health Sciences Authority (HSA) has on Monday given the green light for the Pfizer-BioNTech Covid-19 vaccine to be used in Singapore, for the prevention of Covid-19.

In view of the HSA's approval, the Expert Committee on Covid-19 Vaccination appointed by the Ministry of Health has issued a statement urging all medically eligible persons to be vaccinated - though vaccinations should remain voluntary - starting with groups at greater risk, such as healthcare workers and the elderly.

"The Expert Committee has reviewed the Pfizer-BioNTech vaccine's safety and efficacy data for different population segments in Singapore, and been briefed by HSA on its full range of considerations in granting interim authorisation, and is thus satisfied with its safety and efficacy," said the Committee in its statement.

The Pfizer-BioNTech vaccine requires two doses of vaccine to be administered 21 days apart, in individuals aged 16 years and above. Pregnant women, immunocompromised persons and those under the age of 16 should not receive the vaccine at this time, as safety and efficacy data on these groups are not yet available.

As a precautionary measure, persons with a history of anaphylaxis (the rapid onset of severe allergic reactions) should also not receive the vaccine. This is because in rare instances, as with other established vaccines, a person who receives the vaccine may experience severe allergic reactions.

The vaccine has demonstrated an efficacy rate of 95 per cent in its clinical trials on over 40,000 participants aged between 16 to 91 years, and its safety profile is "generally consistent" with other registered vaccines, according to a statement released by the HSA.

Possible side effects cited by the HSA included pain, redness, swelling at the injection site, fatigue, headache, muscle ache, fever, vomiting, diarrhoea and joint pain. These side effects are "common and expected as part of the body's natural response so as to build immunity against Covid-19" and "usually resolve within a few days", said the HSA.

The HSA added that in granting its approval, it had reviewed data from pre-clinical studies, clinical trials on human volunteers, and manufacturing and quality controls; and considered the conditions for the safe distribution and supply of the vaccine.

It had also consulted two groups of experts from HSA's Medicines Advisory Committee and Panel of Infectious Diseases Experts, comprising medical doctors and infectious diseases specialists.

The HSA's green light was enabled under the Pandemic Special Access Route (PSAR), a regulatory pathway that allows access to critical novel vaccines, medicines and medical devices during a pandemic such as Covid-19. This is similar to emergency use authorisation frameworks in other jurisdictions such as Canada, Switzerland, the United States and the United Kingdom.

PSAR allowed the HSA to start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, instead of waiting for full data sets to be submitted.

As a condition for the interim authorisation granted under PSAR, Pfizer and BioNTech will be required to monitor the longer-term efficacy of the vaccine to determine the duration of protection against Covid-19. The available data so far suggests the vaccine is effective for at least two months, with no signs of waning protection.

Pfizer and BioNTech will also be required to follow up on the safety on the vaccine, including to study its safety for groups such as pregnant women and children. To date, data on the vaccine's safety has been accrued for about 20,000 vaccine recipients, with a median follow-up duration of two months.

"To safeguard our vaccine recipients, HSA will actively monitor the safety profile of Pfizer-BioNTech Covid-19 vaccine," said Chan Cheng Leng, group director of the HSA's health products regulation group.

"We will draw on our network of healthcare professionals and international regulatory counterparts, as well as use data analytics to enable us to detect early safety signals. This will enable HSA to take swift regulatory actions should any safety concern emerge," Assoc Prof Chan added.