SINGAPORE — A total of 432 adverse events from the Pfizer-BioNTech COVID-19 vaccine were reported by healthcare professionals in Singapore to the Health Sciences Authority (HSA) as of Wednesday (27 January), of which three were cases of anaphylaxis, a rapid onset of severe and potentially life-threatening allergic reactions.
Those cases of severe allergic reactions were quickly resolved by healthcare professionals, said the Ministry of Health (MOH) on Thursday in a press release.
The three individuals, in their 20s and 30s, had developed multiple symptoms such as rash, breathlessness, lip swelling, throat tightness and giddiness.
All of them had a history of allergies, including allergic rhinitis and food allergy such as to shellfish, but none had a history of anaphylaxis which would have precluded them from receiving the vaccine, added the MOH.
“Anaphylaxis can be controlled when detected and treated in a timely manner. As all vaccinated persons in Singapore are closely monitored, the symptoms in these three individuals were promptly detected and treated. All have recovered from the episode and were discharged from the hospital after a day’s observation or treatment,” said the MOH.
Apart from the three cases of anaphylaxis, most of the reports were for regular symptoms such as injection site pain and swelling, fever, headache, fatigue, body aches, giddiness, nausea, and allergic reactions such as itch, rash, swelling of eyes, and lip.
“These symptoms are reactions generally associated with all vaccinations and they generally resolved on their own within a few days,” added the ministry.
More than 113,000 people in Singapore have received the Pfizer-BioNTech vaccine. This currently brings the incidence rate of anaphylaxis locally to about 2.7 per 100,000 doses administered, said the MOH.
The ministry also noted that incidence rates reported abroad are around one to two per 100,000 doses administered, after they have administered millions of vaccine doses. In the US, allergic reactions are occurring at a rate of 11.1 per 1 million vaccinations, according to local health officials. By comparison, flu vaccines cause about 1.3 such reactions per million doses administered.
“Variations in the incidence rate are to be expected initially as the numbers vaccinated in Singapore to-date are relatively small,” it added.
The MOH and the HSA said it will continue to work with the expert committee on COVID-19 vaccination to closely monitor the safety of the vaccine and ensure the vaccines used in Singapore are safe for population groups here, as the vaccination programme is being rolled out.
Director of Medical Services at MOH Kenneth Mak noted that anaphylaxis is a known but rare side effect of the Pfizer-BioNTech COVID-19 vaccine.
As with all vaccines, there will always be a small proportion of susceptible persons who experience severe allergic reactions upon vaccination, he added.
“We have put in place precautionary measures such as pre-vaccination screening and post- vaccination observation, to ensure that our vaccination programme can be carried out safely,” said Associate Professor Mak.
“Healthcare professionals in Singapore generally have a high rate of reporting of adverse events, which reflects their vigilance and promptness to report any adverse events. We will continue to work with them and our partners to ensure that vaccinations are performed safely,” he added.
He stressed that vaccination remains safe for those who are eligible, and encouraged all Singaporeans and long-term residents to be vaccinated when their turn comes.
Vaccine injury financial assistance to be introduced
The MOH said it will introduce a vaccine injury financial assistance programme for COVID-19 vaccination (VIFAP) to provide financial assistance for affected individuals, in the rare event of serious side effects that are assessed to be related to COVID-19 vaccines administered in Singapore.
While the ministry “expect few to need this”, the programme will give a greater peace of mind for those taking the vaccination, it added.
The VIFAP will provide the following tiers of financial support:
A one-time pay-out of up to $10,000 will be provided to an eligible individual who is hospitalised requiring care in the high dependency or intensive care unit but subsequently recovers from medically significant serious side effects
A one-time pay-out of $225,000 will be provided to an individual who dies or suffers permanent severe disability as a result of COVID-19 vaccination
Any individual who experiences serious side effects after the COVID-19 vaccination can also continue to concurrently receive support through applicable healthcare schemes, such as MediShield Life and subsidies at our public healthcare institutions.
To qualify for the VIFAP, individuals must be a Singaporean, a permanent resident or a long-term pass holder who has received the COVID-19 vaccination in Singapore.
They must also have experienced a serious side effect that is potentially life-threatening or fatal, and has required inpatient hospitalisation or has caused persistent incapacity or disability.
The serious side effects must be assessed by a doctor to be linked to the individual’s COVID-19 vaccination.
“As the severity of serious side effects can be broad, and assessment by the treating doctors may vary, the MOH has appointed an independent clinical panel comprising experts in relevant fields such as neurology, immunology and infectious diseases, to assess and adjudicate VIFAP applications,” added the MOH.
The ministry stressed the importance of vaccination and called it a “collective protection” which will become more effective as more people are vaccinated as well as a key enabler allowing Singapore to return to normalcy.
However, it noted that even as the population is progressively vaccinated, vaccination is not a silver bullet.
“We must continue to adhere to the safe management measures to help us mitigate the spread and keep community transmission low,” said the MOH.
Over 50 individuals in Singapore have received their second dose of the vaccine and completed the full vaccination regimen.
The ministry said these numbers are expected to rise substantially in the coming weeks as authorities continue to ramp up vaccination operations safely.
Updates on vaccination for elderly
The first day of COVID-19 vaccination for seniors aged 70 years old and above took place with two pilots at Ang Mo Kio and Tanjong Pagar on Wednesday, with more than 250 seniors vaccinated, the MOH said.
The sign-ups for COVID-19 vaccination by seniors have been encouraging, and the ministry said it expects more seniors to do so in the coming days as letters are progressively being sent to invite them to book an appointment for their vaccination.
As of Wednesday, letters to more than 10,000 seniors in Ang Mo Kio and Tanjong Pagar have been sent, and more than one-third of them have booked their appointments within two days of receiving the letter.
More of the letters will be progressively sent out to seniors across Singapore starting from mid-February.
Besides the vaccination centres, the polyclinics and selected Public Health Preparedness Clinics (PHPCs) will also serve as vaccination sites.
Currently, seniors can be vaccinated at nine polyclinics and 21 PHPCs. Come 1 February, all 20 polyclinics across Singapore will also begin offering COVID-19 vaccinations.
To reach out to seniors with mobility issues and hence may find it challenging to visit a vaccination site in-person, mobile vaccination teams will be set up to deliver the vaccines to these individuals, said the MOH.
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