S'pore expert panel clears mRNA vaccines for those with allergies

This was recommended by the expert committee on Covid-19 vaccination, after careful study of data both globally and locally. PHOTO: REUTERS

SINGAPORE - Individuals with a history of anaphylaxis and allergic reactions to other drugs, food, insect stings or unknown triggers can now be vaccinated with mRNA vaccines, the Ministry of Health (MOH) said on Friday (June 4).

The expert committee on Covid-19 vaccination had recommended allowing this group of people to take mRNA vaccines after careful study of data both globally and locally. This restriction will be removed from Saturday (June 5).

A large majority of the 32,000 people here who have not been able to take the Pfizer-BioNTech and Moderna mRNA vaccines because of medical reasons will now be able to do so under the national programme, MOH said.

But a minority with a history of anaphylaxis or allergic reactions to other vaccines will still not be eligible.

Another 2,000 people who developed allergic reactions after receiving the first dose of an mRNA Covid-19 vaccine should not receive an mRNA-based vaccine again, the ministry added.

MOH said it is evaluating and will bring in non-mRNA vaccines which are more suited to these individuals.

It expects to do so before the end of the year after the vaccines are approved by the Health Sciences Authority (HSA).

In a separate statement, the expert committee on Covid-19 vaccination said it had adopted a cautious stance in recommending earlier that people should not take mRNA vaccines if they have a history of anaphylaxis - a potentially life-threatening allergic reaction. This was in the light of overseas and local reports of anaphylaxis with the mRNA vaccines in people with a history of allergies, when those vaccines were first introduced.

It noted that local and international data has been reassuring and no safety issues have been found after inoculating people with a history of anaphylaxis to other triggers, such as medicine and food.

It stressed that those with a history of serious allergic reactions to any component of the mRNA Covid-19 vaccine are still not advised to receive it, and those who have an anaphylatic reaction after the first dose should not receive the second dose.

"Non-mRNA vaccines may be authorised for use by HSA and be made available in the future, hence these individuals are advised to wait for these vaccines instead," said the committee.

It added that it will continue reviewing safety data to see if more people who are currently not eligible to receive mRNA vaccines can be inoculated with them.

At the same time, Singaporeans, permanent residents and long-term visit pass holders who were unable to get the Pfizer-BioNTech and Moderna vaccines due to allergies and want to take the Sinovac vaccine will be able to get it for free at private clinics under the Special Access Route (SAR), MOH said.

About 20 private medical centres here will be selected to be licensed providers to administer the Chinese vaccine, about 200,000 doses of which arrived in February. The vaccines ​from the current stock ​will be released for free​.

Providers will be allowed to charge patients a fee to cover their costs, and the Government will reimburse this fee to any of the 34,000 individuals who opt for Sinovac after they were previously rejected from taking mRNA vaccines or were allergic.

MOH noted that while the Government will facilitate arrangements to take the Sinovac vaccine through licensed providers, this is ultimately a private arrangement. The ministry said it 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. 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," MOH said.

Private healthcare institutions can apply from Friday to be licensed providers of the existing stock of Sinovac vaccine doses. Applications will close by noon on June 11.

Responding to calls from some quarters for the Health Sciences Authority (HSA) to approve the Sinovac vaccine as part of Singapore's national vaccination programme, given that the World Health Organisation (WHO) has included it in its Emergency Use List, MOH noted that the list focuses 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," said the ministry.

It noted that healthcare regulators in many developed jurisdictions, including Singapore, typically conduct further rigorous evaluations beyond the WHO Emergency Use List approval before approving a vaccine for general use.

"We wish to reiterate that HSA evaluates all applications, regardless of their country of origin, based on the same standards and requirements," it said, adding HSA is still awaiting outstanding data on Sinovac-CoronaVac from Sinovac for it to complete its evaluation.

MOH has so far authorised only the Pfizer-BioNTech and Moderna jabs for use in the government vaccination programme in Singapore.

Both Pfizer and Moderna vaccines use mRNA technology to give instructions to the body's cells to produce a harmless piece of the spike protein found on the surface of the coronavirus that causes Covid-19. This allows the body to protect itself from the disease.

The Sinovac jab uses a more traditional vaccine technology, where an inactivated form of the coronavirus - or a "killed virus" - teaches the body to protect itself from the Covid-19 virus.

There are currently six vaccines on the WHO Emergency Use List - Moderna, Pfizer-BioNTech, Johnson & Johnson, AstraZeneca, Sinopharm and most recently Sinovac.

Professor Teo Yik Ying, dean of the National University of Singapore's Saw Swee Hock School of Public Health, said allowing Sinovac through the private healthcare sector allows those who are medically ineligible for the Pfizer-BioNTech and Moderna jabs to access vaccines that use other technologies.

It also allows those who prefer to take other vaccines to have the option to do so without compromising the standards Singapore has set for the national programme, he said.

The Sinovac jab uses a more traditional vaccine technology where an inactivated form of the coronavirus - or a "killed virus" - teaches the body to protect itself from the Covid-19 virus. PHOTO: REUTERS

Asked why HSA has not authorised the Sinovac jab for wider use despite WHO's emergency-use approval, Prof Teo said it is important to realise the WHO has to take a global perspective when approving Covid-19 vaccines.

He said: "The WHO is always evaluating global needs, including that of low- and middle-income countries. They want to ensure that resource-poor countries will continue to have access to vaccines that are effective."

On the other hand, regulatory processes in Singapore and other countries depend on each country's specific needs, outbreak situation, and long-term ambition with respect to the pandemic, Prof Teo said.

"In Singapore, we want to ensure not just safety but maximum effectiveness when our people are vaccinated. That means we want to be very clear about the efficacy data for the vaccines that we roll out nationally," he said.

This is not the case with the Sinovac jab, Prof Teo added.

While the vaccine meets WHO's criteria of being safe and having an efficacy of at least 50 per cent, data published so far has shown that the jab has a divergent range of efficacy rates, from just over 50 per cent to about 90 per cent, Prof Teo said.

In contrast, both the Pfizer-BioNTech and Moderna vaccines have consistently shown an effectiveness greater than 90 per cent, he noted.

"I should highlight that 50 per cent efficacy for a vaccine is actually very good so it is not to say that it is a lower bar... (but) I think consistency helps with the entire evaluation process and there is a need to clarify more carefully what is the efficacy of Sinovac's vaccine," Prof Teo added.

University of Hong Kong molecular virologist Dongyan Jin told the Wall Street Journal prior to WHO's Sinovac approval that an approval would speak more to the need for additional vaccines rather than represent a vote of confidence.

Questions about the reliability of some of Sinovac's earlier clinical data remain, given a lack of details from the firm and researchers for the trial, he added.

Sinovac has not directly released its study results, in contrast to other vaccine makers, which have published details in peer-reviewed medical journals. Sinovac results have largely been made public by governments which have approved and rolled out its vaccines.

Some countries have reported higher efficacy rates in their clinical trials with Sinovac - Turkey with 83.5 per cent and Indonesia with 65 per cent - but health experts have given less weight to the figures given the limited sample size. The Indonesia trial had around 1,620 participants.

WHO had said in its statement that vaccine efficacy results showed that Sinovac prevented symptomatic disease in 51 per cent of those vaccinated and prevented severe Covid-19 infection and hospitalisation among all of those studied.

Few adults over 60 years old were enrolled in these trials and the studies do not cover those with co-morbidities - or those suffering from two or more diseases. Nonetheless, the organisation said it 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 for older and younger individuals.

In Singapore, those calling for the Sinovac vaccine's inclusion in the national Covid-19 vaccination programme included Progress Singapore Party secretary-general Francis Yuen.

In a Facebook post on Thursday, he said all viable vaccines should be used to combat the pandemic. Including the Sinovac vaccine in the vaccination programme could supplement any shortfall in supplies from Pfizer-BioNTech and Moderna, and lead to an acceleration in the pace of vaccinations here, he added.

In a forum letter published in ST on Friday, a reader also called for a less ambivalent stance on alternative Covid-19 vaccines, so that the 30,000 people who are not eligible for the mRNA vaccines can make more informed decision on taking alternative vaccinations.

Those who choose to receive unregistered Covid-19 vaccines, including Sinvoac's, will not be eligible for the Vaccine Injury Financial Assistance Programme should they develop any adverse reactions.

When asked if the assistance scheme should be extended to those who have no choice but to take alternative vaccines due to medical reasons, Prof Teo said the issue is a tricky one.

But he said there has to be a common evaluation criteria for deciding which vaccines get approved for national use here, and consequently whether there should be compensation if there are any adverse reactions.

Read the full MOH press release here.

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