Covid-19 vaccine not for children under 16, pregnant women, immuno-compromised persons: Expert committee

• More data is needed to understand how the Covid-19 vaccine will affect pregnant women, those under 16 and people who are immuno-compromised
• Groups who are at greater risk of Covid-19, including healthcare workers, frontline workers and the elderly, should be vaccinated first, said the committee
• A complete set of recommendations to the Government on the use and priority groups for vaccination will be provided in the coming weeks

SINGAPORE — Pregnant women, anyone under the age of 16 and immuno-compromised persons should not take the Pfizer-BioNTech Covid-19 vaccine when it becomes available here.

The Expert Committee on Covid-19 Vaccination, which was convened to recommend a vaccination strategy for the country, said on Monday (Dec 14) that they have made this recommendation as there is insufficient data on the safety and efficacy of the vaccine for these groups of people.

The Health Sciences Authority (HSA) in a separate statement added that those who have a history of anaphylaxis, or a rapid onset of severe allergic reactions, should also not take the vaccine.

Prime Minister Lee Hsien Loong said earlier on Monday that the HSA has approved the Pfizer-BioNTech vaccine after studying scientific evidence and clinical trial data surrounding it.

The first shipment should arrive by the end of this month and there will be enough doses for everyone in Singapore by the third quarter of next year.

He also said that vaccinations would be voluntary but the committee had recommended that everyone who is medically eligible should be vaccinated.

Elaborating on its recommendations in a press release on Monday, the committee said that the vaccine, which involves two doses administered 21 days apart, had an efficacy of 95 per cent. 

It added that its safety profile is consistent with the high standards set for other registered vaccines used in the immunisation against other diseases.

The committee also recommends that groups who are at greater risk of Covid-19, including healthcare workers, frontline workers and the elderly, should be vaccinated first.

Further details regarding its complete set of recommendations to the Government on the use and priority groups for vaccination will be provided in the coming weeks, it said.

During a press conference on Monday, the multi-ministry taskforce handling the pandemic was asked why the vaccination was not mandatory. 

In response, the Ministry of Health’s director of medical services Kenneth Mak said that it was “prudent” for the authorities to make recommendations but not necessarily force every Singaporean to take the vaccine, as the vaccine’s profile and its side effects are still being studied.

He added that Singaporeans may have a variety of medical conditions. This may require the authorities to specifically match those with medical conditions with a certain type of vaccine to ensure their safety.

Health Minister Gan Kim Yong added that the authorities want to “respect people’s choice”, pointing out that very few vaccines are mandatory here.

SAFE DISTANCING MEASURES MUST CONTINUE TO BE OBSERVED

Mr Gan also warned that the vaccine "cannot be seen as a single instrument in our fight against Covid-19".

“We have to be quite careful with the idea of vaccination. Currently, vaccination protects the person who is vaccinated and the evidence of whether it has protection against transmission from the person who is vaccinated to another person, the evidence is still being studied so we do not have clear evidence of that yet," he said.

"So we cannot assume that once you’re vaccinated therefore you’re not likely to transmit (the virus) to any other person and you can take off your mask and do whatever you want.

"... despite (having) vaccination, all the safe distancing measures must still continue to be observed and we will continue to monitor development in this area and we will adjust our safe management measures progressively as time goes on.”

POSSIBLE SIDE EFFECTS

In a separate news release, the HSA said some people may experience side effects such as pain, redness, swelling at the injection site, fatigue, headache, muscle ache, fever, chills, vomiting, diarrhoea and joint pain after vaccination.

“While not everyone will experience these side effects, they are common and expected as part of the body’s natural response so as to build immunity against Covid-19. These side effects usually resolve within a few days,” it said.

In rare instances, a person who receives the vaccine may experience severe allergic reactions, such as difficulty breathing, wheezing and swelling around the eyes and lips.

If these happen, immediate medical attention should be sought, it added.

CONTINUOUS REVIEW OF DATA

The Pfizer-BioNTech Covid-19 vaccine was approved here under an interim authorisation under the Pandemic Special Access Route, a regulatory pathway that allows HSA to start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies.

As the new vaccine was approved based on real-time data submitted on a “rolling” or staggered basis, instead of waiting for the full data set to be available, HSA said that one of the conditions was for Pfizer and BioNTech to follow up on the safety of the vaccine to determine its full safety profile.

The current safety data has been accrued for about 20,000 vaccine recipients with a median two-month follow-up period, during which no significant safety concerns were detected, it said. 

Another condition was for the companies to monitor the longer term efficacy of the vaccine to protect against Covid-19.

Available data shows that the vaccine continues to be effective for at least two months with no signs of protection levels waning, said HSA.

The companies will continue to study the safety of the vaccines in certain sub-populations such as pregnant women and children.

As new data comes in, HSA will actively review the data to ensure that the benefits of the vaccine continue to outweigh the known risks, it said.

And when sufficient data is available, the companies will need to apply for a full product registration, it added.