Jab tick for young likely to face delay
New Zealand may not be at the front of the queue for the data needed before the Pfizer vaccine can be approved for 12- to 15-year-olds, the Ministry of Health says.
The vaccine is Medsafe-approved for those aged 16 and over, but on Thursday Pfizer and BioNTech released the results of their phase three clinical trial that showed 100 per cent efficacy in those aged 12 to 15.
Medsafe expected to be provided the data on the trial in due course, a spokesperson for the Ministry of Health said, though New Zealand wasn’t expected to be high on the priority list. “It is likely they will prioritise countries with high Covid19 infection rates first,” a ministry spokesperson said.
Extending approval of the vaccine for 12- to 15-year-olds in New Zealand would first require an application from Pfizer.
“Medsafe will need to review the data to consider approving an extension,” the ministry spokesperson said, adding that rigorous safety and efficacy standards would have to be met.
The trial showed a robust antibody response and tolerable side effects consistent with those seen in adults aged 16 to 25.
It included 2260 adolescents in the United States, with and without evidence of prior SARS-CoV-2 (the virus that causes the disease) infection. There were 18 cases of Covid-19 in the placebo group and none in the vaccinated group.
A strong antibody response was observed in a subset of adolescents one month after the second dose.
Further clinical trials have commenced in children aged 5 to 11 and are expected to begin in younger children aged 2 to 5 in early April, followed by ages six months to 2 years old.
Vaccinating young people is considered vital to achieving herd immunity. In New Zealand, more than 1 million people — 20 per cent of the population — are under 16.
Immunisation Advisory Centre Clinical Director Dr Nikki Turner said the trial results were “very promising”.
“Hopefully, with data looking this promising, we will not be too far away from being able to broaden our New Zealand Covid-19 immunisation programme to children as well.
“In doing so we will ensure more New Zealanders are protected individually and also, with more New Zealanders vaccinated, the more we will be in a position to reduce the risk of community spread.”
Covid-19 Response Minister Chris Hipkins, who received his first vaccine dose this week, agreed the signs were encouraging, but it was “early days”.
Hipkins said the Government had ordered enough Pfizer stock to administer the vaccine to everyone in New Zealand — across all age groups.
“In the event that they don’t [get approved], we’ve got our bases covered because of the broad portfolio that we’ve got. For example, the AstraZeneca could prove to be the right vaccine for younger New Zealanders, or Novavax [or Janssen].”