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04 Jun 2021

4th Jun 2021

1. Singapore’s vaccination efforts continue to make good progress. A total of about 4.2 million doses have been administered, and almost 2.4 million people here have received at least one dose of the COVID-19 vaccine. The exercise for students has got off to an encouraging start.

2. On 31 May 2021, the press release for Multi-Ministry Taskforce announced that:

a) The Expert Committee on COVID-19 Vaccination (EC19V) is reviewing the restriction on persons with a history of anaphylaxis taking the Pfizer-BioNTech and Moderna vaccines, with a view to relax it; and

b) The Ministry of Health (MOH) will open up access to other COVID-19 vaccines under the Special Access Route (SAR) in order to enhance overall vaccination coverage.

This media release provides an update to the two issues.

Removal of Restrictions on Persons with Anaphylaxis

3. Our primary consideration is to protect all Singaporeans, by ensuring that our population has access to vaccines that meet strict standards of safety, quality and effectiveness.

4. Currently, there are about 32,000 individuals who are not able to take the mRNA vaccines due to severe allergies. The EC19V has been reviewing local and international safety data on vaccinating people with a history of anaphylaxis due to food and other medicines, with a view to allowing this group to receive the mRNA vaccines safely.

5. After careful study of the data both globally and locally, the EC19V has recommended that persons with a history of anaphylaxis or allergic reactions to other drugs, food, insect stings, or unknown trigger (idiopathic) can be vaccinated with the mRNA vaccines. Persons with a history of anaphylaxis or allergic reactions to other vaccines can be referred to an allergist for further evaluation fully subsidised by the government and may be vaccinated, if deemed suitable. MOH accepts the EC19V recommendation and will remove this restriction from 5 June 2021.

Alternate Vaccines

6. With this change, we expect a large majority of the 32,000 individuals will now be able to take the mRNA vaccines under our national vaccination programme. A minority will still not be eligible, if they have a history of anaphylaxis or allergic reactions to other vaccines.

7. There are also approximately 2,000 individuals who had developed anaphylaxis or allergic reactions (hives, face/ eyelid/ lip/ throat swelling, generalised rash within 7 days after vaccination) due to the first dose of an mRNA COVID-19 vaccine. This group should not receive an mRNA-based vaccine again.

8. To protect them against COVID-19, we are also evaluating and will bring in non-mRNA vaccines that are more suitable for them. We expect to do this before the end of this year after the vaccines are authorised by the Health Sciences Authority (HSA) for use in our national vaccination programme. We will provide more details later when these vaccines are available.

Special Access Route


9. However, if this group of individuals are not able to wait for the alternate non-mRNA vaccines, they can consider taking a vaccine under the SAR, which MOH has recently announced that it will open for COVID-19 vaccines.

10. Under the SAR, COVID-19 vaccines approved by the World Health Organization (WHO) for its Emergency Use List (EUL), can be imported and supplied by private healthcare providers as unregistered vaccines, to be administered to individuals in Singapore.

11. On 1 June, the WHO approved the Sinovac-CoronaVac vaccine for its EUL1. This means that the WHO EUL now comprises the following COVID-19 vaccines: Pfizer-BioNTech, Moderna, Astra-Zeneca, Johnson&Johnson, Sinopharm and Sinovac-CoronaVac. More than ten other vaccines are still being evaluated by WHO.

12. As MOH has Sinovac-CoronaVac vaccine in stock, MOH will be inviting private healthcare institutions licensed under the Private Hospitals and Medical Clinics Act (PHMCA) to apply to be licensed providers for the Sinovac-CoronaVac vaccine under the SAR, and draw on our existing stock of 200,000 doses. We will select around 20 private clinics around the island, who can demonstrate the ability to administer the vaccines safely, properly and efficiently. The clinics can provide the vaccine to all Singapore Citizens, Permanent Residents and persons holding Long-Term Visit Passes, who for one reason or other wish to receive Sinovac-CoronaVac instead of a vaccine which is available on the national programme.

13. The vaccines from our current stock will be released for free to successful providers. Providers will be allowed to charge patients receiving the vaccine a fee to cover their costs. For the 34,000 individuals who were previously rejected from taking the mRNA vaccines or who were allergic to the mRNA vaccine, the government will reimburse them this fee if they decide to receive Sinovac-CoronaVac. Details will be made known to these individuals in the coming week.

14. This is ultimately a private arrangement, though facilitated by the government. MOH will draw up guidelines on proper counselling, informed consent and safe management of patients. However, as the vaccine remains unregistered, it cannot be covered by the Vaccine Injury Financial Assistance Programme (VIFAP). Individuals who wish to receive vaccination under SAR should discuss with their doctor in these appointed providers the risks and benefits of using these vaccines, and jointly make an informed decision.

15. Private healthcare institutions who are keen to apply to the licensed providers for our existing stock of 200,000 doses can apply at https://go.gov.sg/zue5s4 from today onwards. The application will close by 11 June 2021, 1200 hours.

Vaccines Approval

16. Some members of the public have suggested that HSA should simply approve the Sinovac-CoronaVac vaccine to be part of our national vaccination programme, now that WHO has included it in its EUL.

17. We would like to clarify that the WHO EUL pathway focusses on the needs of low- and middle-income countries with limited access to COVID-19 vaccines. It is a risk-based process that expedites the assessment of vaccines for use in a pandemic especially in these countries, where the benefits are deemed to outweigh the risks, despite uncertainties about the safety and efficacy of the vaccine. Healthcare regulators in many developed jurisdictions, including Singapore, typically conduct further rigorous evaluations beyond WHO EUL approval before approving a vaccine for general use.

18. We wish to reiterate that HSA evaluates all applications, regardless of their country of origin, based on the same standards and requirements. Currently HSA is still awaiting outstanding data on Sinovac-CoronaVac from Sinovac for it to complete its independent and thorough evaluation of the quality, safety and efficacy of the vaccine for inclusion in our national vaccination programme.
 
MINISTRY OF HEALTH
4 JUNE 2021



[1]  For Sinovac-CoronaVac, WHO said in its statement, “Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalisation in 100% of the studied population.” WHO also revealed that few older adults (over 60 years old) were enrolled in these clinical trials and that the studies also do not cover those with comorbidities. Nevertheless, WHO does not restrict the use of the vaccine to these groups as “there is no reason to believe that the vaccine has a different safety profile in older and younger population.”