Private Healthcare Providers Can Use COVID-19 Vaccines That Have Not Been Approved By HSA Under “Special Access Route”

With Prime Minister (PM) Lee Hsien Loong and the ever-familiar faces of the Ministerial Task Force (MTF) appearing on our screens once again, many of us tuned in yesterday afternoon (31 May) to listen to the updates on the COVID-19 situation in Singapore.

Unfortunately, there was no magic cup or vaccination slots for people under 39 years of age. Sigh.

Despite this, I would like to thank PM Lee and his ministers for holding the press conference so that I don’t have to write a “Top 10 Places to Vaccinated At” article.

Relaxing COVID-19 Vaccinates Rules

The Ministry of Health (MOH) has announced that it would be relaxing the vaccine regulations so as to allow private healthcare providers to administer vaccines that have not yet been approved in Singapore.

Health Minister Ong Ye Kung said that this move is aimed at providing more flexibility to the use of alternative COVID-19 vaccines here. Currently, Singapore has only approved two vaccines—the mRNA-based Moderna and Pfizer-BioNTech COVID-19 vaccines.

However, the alternatives will not be subsidised by the government, and individuals who are keen on taking them will do so at their own risk. He also mentioned that the primary target was residents in Singapore, not tourists.

Unlike individuals who choose to take the Pfizer-BioNTech and Moderna vaccines, locals will not be eligible for MOH’s vaccine injury financial assistance programme, a scheme that supports people who suffer from adverse effects from vaccine shots.

But what exactly are the alternative vaccines available for use?

MOH noted that the unapproved vaccines allowed are those on the World Health Organisation’s (WHO) Emergency Use Listing (EUL). These are the COVID-19 vaccines developed by:

• Oxford-AstraZeneca
• Johnson & Johnson
• India’s Covishield
• China’s Sinopharm

Once a vaccine is approved on the EUL, a private licensed healthcare institution can use it to administer to individuals in Singapore.

This applies to China’s Sinovac vaccine, which is undergoing approval.

Sinovac Updates

WHO is currently assessing the Sinovac vaccine, which will be put on the EUL once it has been authorised. The decision is expected to come in early June.

“If WHO approves the Sinovac vaccine into its EUL, then a healthcare provider can apply to have access to use the 200,000 doses that we have and then use it to administer to individuals in our population who wants to have it,” explained Mr Ong at the MTF’s press conference.

Addressing Unmet Medical Needs

Why the need to increase the flexibility in administering vaccines?

Though Singapore has approved of the Pfizer-BioNTech and Moderna vaccines, Mr Ong revealed that nearly 30,000 individuals are unable to take these vaccines due to medical reasons.

The MOH expert committee on COVID-19 vaccines is still reviewing the guidance for the two approved mRNA-based vaccines to allow more people with a history of anaphylaxis, allergic reactions to seafood and to certain drugs to take it.

In fact, there “has been interest to access alternate vaccines used in other countries” due to the limitations of Singapore’s approved vaccines. However, there has either been no applications for approval of these alternate vaccines in Singapore, or evaluation is still ongoing.

Therefore, the decision to use alternative vaccines on the EUL has opened up under the “special access route”, which allows the import and supply of unregistered vaccines to tackle unmet medical needs.

“Like all other medicines supplied under the special access route, the doctor administering the vaccine and the patient should discuss the risks and benefits of using vaccines not registered or authorised by the HSA and jointly make an informed decision,” emphasised MOH.

MOH will also determine whether those vaccinated under the pandemic special access route will be exempted from testing or public health restrictions as more data is made available in the future.

Feature Image: CEPTAP / Shutterstock.com