S'pore approves Pfizer bivalent jab for those aged 12 and above

SINGAPORE – The Health Sciences Authority (HSA) has granted interim authorisation for Pfizer-BioNTechs bivalent Covid-19 vaccine for people aged 12 and above.

The bivalent vaccine can be used as a booster jab for those who have received their primary series vaccination. It targets both the original strain of the coronavirus and the Omicron BA.4 and BA.5 variants.

The Expert Committee on Covid-19 Vaccination and Ministry of Health (MOH) will issue official recommendations on the use of the vaccine when ready, said HSA in its statement on Tuesday.

Although clinical studies for the latest bivalent Cominarty vaccine are still underway, HSA said a previous study for the bivalent Pfizer-BioNTech vaccine that protects against the original strain as well as the BA.1/2 variants showed promising results.

In that study, the bivalent vaccine was shown to elicit a stronger immune response against the Omicron BA.1 variant, while still being effective against the original Covid-19 strain.

HSA said it used this previous study as the primary basis for granting approval, as Omicron sub-variants are closely related to one another.

Under the Pandemic Special Access Route (PSAR), HSA is allowed to start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, instead of waiting for full data sets to be submitted.

As a condition for the interim authorisation under PSAR, Pfizer and BioNTech are required to submit data from its ongoing clinical study to ensure that the vaccines benefits continue to outweigh the risks, said HSA.

In their ongoing Phase 2/3 clinical study for the latest bivalent vaccine, a preliminary analysis of 80 participants aged 18 and above showed higher immune responses against the Omicron BA.4 and BA.5 sub-variants as well, said HSA.

The authority added that the safety of the bivalent jab was comparable with the original vaccine.

Those who have taken it would possibly experience pain and tenderness at the injection site, fatigue, headaches and muscle pain all of which were side effects associated with the original vaccine, and would typically clear up in a few days.

Health Minister Ong Ye Kung said in Parliament last Thursday that the vaccine will be made available by the end of this year.

Singapore has already approved the bivalent version of Modernas Spikevax vaccine, which was introduced at nine joint testing and vaccination centres (JTVC) on Oct 14.

The jab is available to those who have yet to receive minimum protection, or the equivalent of three mRNA doses, as well as those aged 50 and above and whose last Covid-19 vaccine jab was at least five months ago. More On This Topic askST: Should I take a third vaccine booster and will it affect my immunity system? Bivalent vaccine gives stronger and broader protection Related Stories What you need to know about S'pore's new Covid-19 vaccination strategy Asia stepping up fight against more infectious Covid-19 variants Hong Kong cements Covid-19 tests with centres just a 15-minute walk Covid-19 wave looms in Europe amid vaccine fatigue and false sense of security Long Covid remains a mystery, though theories are emerging askST: What is excess death and what is Covid-19's true toll on the world? Biden says pandemic is over; survivors and doctors disagree No plans to include Covid-19 vaccinations in childhood immunisation schedule: Ong Ye Kung Human development set back 5 years by Covid-19, other crises: UN report Covid-19's harmful effects on the brain reverberate years later: Study Your browser does not support iframes, but you can use the following link: Link