Medsafe approves Pfizer vaccine for over-12s – Expert Reaction

New Zealand’s medicines regulator has given the provisional tick for kids as young as 12 to get the Pfizer/BioNTech vaccine for COVID-19.

Prime Minister Jacinda Ardern said today that there are around 265,000 children in the 12-15 age group. The move follows similar approvals in places like Europe, the US, and Canada.

The SMC asked experts to comment on the news.

Professor Michael Baker, Professor of Public Health, University of Otago, Wellington, comments:

“This approval extends use of vaccine to youth aged 12 to 15 years, conditional on Pfizer providing further data from its clinical trials. Vaccinating children in this age group, and eventually down to infants, is important for any population hoping to reach sufficient vaccine coverage to largely interrupt circulation of the Covid-19 virus. While children only rarely get serious ill or die from this infection, they are important in the spread of the virus. Vaccinating them will protect the children themselves, and those around them, including grandparents and others who are vulnerable to serious outcomes.

“Overseas, the use of Pfizer vaccine has already been approved for children aged 12 to 15 years in several countries and regions, including the US and EU, and several million teenagers have already been vaccinated.

“This approval has little immediate effect in New Zealand as the vaccine roll-out underway here will not reach children of this age until late in 2021. By that time it is likely that vaccine use will be approved for even younger age groups as trials are currently underway vaccinating children down to 6 months of age. It is obviously important to test safety and efficacy in all groups prior to widespread administration.

“There is an ethical issue with vaccinating children in high income countries like New Zealand. The WHO has urged high income countries to instead donate supplies to low-income countries (through the global fair-access scheme Covax) ahead of vaccinating children and teenagers.”

No conflict of interest

Dr Hiran Thabrew, Child Psychiatrist and Paediatrician, The Werry Centre, University of Auckland, comments:

“This will be a relief for many parents and provide an increased sense of security for young people to be at school and travel overseas. However, given the slower-than anticipated vaccine rollout, it may also increase the public’s worries about whether the supply is adequate to meet the demands of a larger pool of individuals. The proposed age-related banding system will be even more important to ensure that the vaccination of more vulnerable older people in the community is not further delayed.”

No conflict of interest

Professor Michael Plank, Te Pūnaha Matatini and University of Canterbury, comments:

“It is very good news that Medsafe have now given approval for the Pfizer vaccine to be used in 12–15-year-olds. This approval is based on solid data showing the vaccine is safe and highly effective for this age group. The final decision to make the vaccine available to 12–15-year-olds will now be taken by Cabinet. If Cabinet approve this, then most 12–15-year-olds will become eligible for vaccination towards the end of the year, after older groups have had their turn.

“Although children are at lower risk of serious illness or death from Covid-19 than older people, it is still essential to vaccinate them for two reasons. Firstly, if children catch the virus, they can spread it to other people, including higher-risk groups or people who can’t be vaccinated for medical reasons.

“Secondly, although the risk of death is very small, children can still suffer significant long-term health complications as a result of Covid-19, often known as Long Covid.

“Vaccinating children will be an important part of maximising our collective immunity against Covid-19. The higher we can get this collective immunity, the more options we’ll have for safely allowing international travel to resume.”

Conflict of interest statement: “I am partly funded by MBIE for research on mathematical modelling of COVID-19.”

Dr Emma Best, Medical Advisor,  Immunisation Advisory Centre, University of Auckland, comments:

“The provisional licensing of the Pfizer mRNA vaccine is good news, showing the safety and efficacy of this vaccine in children 12- 15 years. It gives NZ some choices to make about when to consider this vaccine for children in the future. At present, ensuring those most at risk of COVID disease are protected means getting the vaccine out to all adults and older teenagers first as outlined in the roll out groups 1-4.

“For the health of Aotearoa/New Zealand tamariki, children need to continue to receive on-time vaccinations against all the routine diseases of childhood that protect them from diseases like whooping cough, measles and meningitis. School immunisation programmes also have important work to do ensuring the HPV vaccine against cervical cancer and booster tetanus and whooping cough vaccines are delivered for all

“As COVID-19 disease is much less severe in children, and appears to be less commonly acquired and transmitted by young children, it is likely there will need to be a considered approach to how to best to apply vaccination in children aged 12-15 years to help protect them and the community.”

Conflict of interest statement: “I work as a medical advisor to the Immunisation Advisory Centre in addition to my specialist clinical/hospital work and as a senior Lecturer, University of Auckland Department of Paediatrics; Child and Youth Health. I am a member of the PHARMAC anti-infectives subcommittee.”

Professor Kurt Krause, Infectious Diseases Physician; Professor of Biochemistry, University of Otago, comments:

“This is quite good news as the mRNA vaccines are clearly the best performing option against SARS-Cov2. The only slightly cautionary news is that small numbers of young people, mostly boys and men between age 16 and 30 may be developing, again in very small numbers, inflammation of the heart known as myocarditis and in some cases, pericarditis following mRNA vaccination.

“From the vaccine adverse reaction data base in the US there have been 573 cases of myocarditis following the second dose of an mRNA vaccine. Within this group 196 cases of myocarditis or pericarditis were found to occur following 10 million doses of mRNA vaccines which had been administered to 18-to-24-year-olds, which is reported to be about 2 to 20 times what would have been expected to occur naturally in a group of this size. It is important to note that no causal link has been established.

“And there, in fact, may be no link. It’s also good news is that numbers of cases are very small, and the symptoms have generally been mild.

“At this point the risk appears to be very small and the benefit from vaccination exceeds this risk. But given that there is not a lot known about the incidence of this issue in much younger children i.e., 12-15 year olds, as not many have been vaccinated, watching the data from this group would be a good idea.”

No conflict of interest