Medsafe intends analysing paediatric vaccine data over Christmas break

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Medsafe has now clarified that it will continue the assessment of Pfizer vaccines for children over the Christmas break.

Children in school wearing masks. Photo: RNZ / Simon Rogers

By Jordan Bond of rnz.co.nz

Doctors say waiting longer may not be a bad thing as more data filters out of the United States.

However, one says that even a short delay will see hundreds more kids catch the virus.

Earlier today RNZ reported that when asked directly, Medsafe would not confirm or deny whether its assessors would be taking a two-and-a-half week break, along with the rest of the agency over summer.

"Medsafe's assessors are hard-working and are dedicated to their public responsibilities. This professional commitment continues with the assessment of the vaccine for 5-to-11-year-olds," a spokesperson said.

The statement did not answer a clear question: whether the data assessment would continue over Medsafe's shutdown period between 22 December and 10 January.

If they did down tools, it would delay approval of the vaccine to nearly 500,000 children.

This afternoon a spokesperson told RNZ Medsafe staff are rostered to work through weekends, public holidays and over Christmas to get Covid-19 vaccines assessed as quickly as possible and that won't change.

"In particular, Medsafe is prioritising the assessment of the Pfizer data for the 5-11 year old age group meaning the work to complete the data assessment will not be interrupted."

Dr Tony Walls, a paedaiatric infectious diseases expert at Otago University, said taking more time to approve it here - even a few months - is not an issue. He wants to wait until more children have received it overseas, and for Medsafe to analyse that data.

In Pfizer's trial the vaccine was given to just over 2000 children. Dr Walls said this was too small of a sample to be absolutely sure that it's safe for that age group.

"The risk of severe disease in children five-to-11 years of age is incredibly small," Dr Walls said.

"In elderly populations where there's a really big risk of severe Covid, you can't take those kind of risks. But when the risk of severe disease in children is so low, which it is in this age group, I think it's prudent to wait."

More data is likely to be released in coming weeks from US authorities, where around three million five-to-11 year olds have had one dose of the vaccine since it was approved earlier this month. The paediatric Pfizer vaccine is the same as the adult formulation but one-third the amount.

Pfizer said its trials showed its efficacy was comparable to that in adults. In the US, both the FDA and CDC have approved the Pfizer-BioNTech shot for this age group.

"This is one of the most amazing vaccines we've had in terms of its protection for individuals and keeping them safe from severe disease and going into hospital," Dr Walls said.

"The issue is that it may be that in normal, healthy children, because the risk [of Covid] is so low, the downside of vaccines may outweight the benefits. We really don't know... We really want to make sure it's been given to large numbers of children before we introduce it in New Zealand."

Dr Jin Russell, a developmental paediatrician, said the early data look good, but agreed we need to wait for more of it to come through.

"Currently there's no [negative] safety signal from those first three million doses, but we do need to wait for those three million children to be given their second dose so we have good, rigorous safety information," Russell said.

Russell had no issue waiting another month to get the full data, but warns children do need to be vaccinated.

"Previously there was a smaller proportion of children being infected with Covid-19. Now, because they are the last remaining susceptible group and they're not eligible to be vaccinated, there's a larger proportion of children who are being infected. And this is a particular concern for our vulnerable communities, in particular our Māori community."

In the last seven days there have been over 280 Covid cases in children nine years old and under.

Russell said the vast majority of children don't become unwell, but some with pre-existing conditions are at greater risk. She said those children should be vaccinated as soon as possible.

"A two-week delay translates to several hundred children who may be infected."

Director-General of Health Dr Ashley Bloomfield highlighted on Wednesday this week the number of children being admitted to hospital in this outbreak. Most of these were babies and toddlers.

"Forty-two children under age 12 have been assessed at hospital, and of these 19 have spent at least 24 hours or longer in hospital being cared for," Dr Bloomfield said.

"Of those, one was between aged five-and-12, six were aged one to four, and 12 were under the age of one.

"I just want to make the point: one of the best ways we can protect tamariki of all ages is for adults to be vaccinated. There's very clear evidence that's protective, particularly inside households."

In any case, getting the vaccine into children's arms may be a question of supply, rather than approval.

The government is hopeful the children's vaccine will arrive early next year, but they haven't publicised a delivery schedule.

Once it's gone through Medsafe, it needs approval from a Technical Advisory Group and then Cabinet before it can be used.

rnz.co.nz